BUSINESS AND PROFESSIONS CODE

Transcript

1 AWBOOK L 20 1 9 HARMACY FOR P The Pharmacy Law (Business and Professions Code 4000 et seq.) Excerpts from the Business and Professions Code Board of Pharmacy Regulations (California Code of Regulations Title 16 Section 1700 et seq.) Excerpts from the Califo rnia Uniform Controlled Substances Act (Health and Safety Code 11000 et seq.) Excerpts from the Confidentiality of Medical Information Act (Civil Code 56 et seq.) Excerpts from the Public Resources Code 1

2 Resources for Searching California Laws and Reg ulations: http://leginfo.legislature.ca.gov https://govt.westlaw.com/calregs 2

3 BUSINESS & PROFESSIONS CODE CHAPTER 9, DIVISION 2 Article 1. Administration Section Chapter Title 4000. 4001. Board of Pharmacy; Appointment; Terms Purpose of the Boa rd: Protection of the Public 4001.1. Pharmacist Shortage; Recommendations to Alleviate 4001.5. Officers 4002. Executive Officer; Records; Revenue 4003. Teaching by Board Members 4004. 4005. Adoption of Rules and Regulations Regulations Restricting Furnishing of Particular Drug 4006. Limitations of Rules 4007. 4008. Inspectors; Authority as Public Officers Board Rules; Exemption from Coverage under Industrial Welfare 4009 Commission Rules 4010. Immunity of Officers Administration and Enforcement of Uniform Co ntrolled Substances 4011. Act 4012 Board to Provide Copy of Laws or Regulations - Licensed Facilities to Join E Board 4013 Mail Notification List - Article 2. Definitions Section 4015. Definitions to Govern Construction 4016. Administer 4016.5. Advanced Practic e Pharmacist 4017. Authorized Officers of the Law 4017.3 Automated Drug Delivery Syst em; Automated Unit Dose System; Automated Patient Dispensing System 4018. Board 4019. Chart Order 4021. Controlled Substance 4021.5. Correctional Pharmacy Dangero 4022. - Dangerous Device Defined us Drug 4022.5. Designated Representative; Designated Representative - in - Charge 4022.6. Designated Representative - Reverse Distributor Designated Representative - 3PL; Responsible Manager 4022.7. Device 4023. 3

4 Section 4023.5. Direct Supervision and Control Dispense 4024. Drug 4025. 4025.2. Nonprescription Diabetes Test Device 4025.1. - Prescription Drug Non Furnish 4026. Good Standing 4026.5 Skilled Nursing Facility - - Other Health 4027. Intermediate Care Facility Care Facilities Licensed Hospital 4028. 4029. Hospital Pharmacy Intern Pharmacist 4030. Laboratory 4031. License 4032. Manufacturer 4033. Remote Dispensing Site Pharmacy 4033.3 4034. Outsourcing Facility 4034.5 Emergency Medical Services Automated Drug Delivery System Pe 4035. rson 4036. Pharmacist - Charge - 4036.5 . Pharmacist in 4037. Pharmacy 4038. Pharmacy Technician Physician; Other Practitioners Defined 4039. Prescription; Content Requirements 4040. 4040.5. Reverse Distributor 4041. Veterinary Food - Animal Drug Retailer 4042. V eterinary Food - Animal Drugs 4043. Wholesaler 4044. Repackager 4044.3 Remote Dispensing Site Pharmacy 4044.5. Party Logistics Provider Reverse Third - 4044.6 Supervising Pharmacy 4044.7 Telepharmacy 4045. Third - Party Logistics Provider 4045. Surplus Medicati on Collection and Distribution Intermediary Article 3. Scope of Practice and Exemptions Section 4050. Legislative Declaration 4051. Conduct Limited to Pharmacist; Conduct Authorized by Pharmacist 4052. Furnishing to Prescriber; Permitted Pharmacist Pro cedures Furnishing of Naloxone Hydrochloride; Permitted Procedures by 4052.01. Pharmacist 4

5 Permitted Pharmacist Procedures in Licensed Health Care Facility 4052.1. 4052.2. Permitted Pharmacist Procedures in Health Care Facility, Home c with Physician Oversight Health Agency or Clini Emergency Contraception Drug Therapy; Requirements and 4052.3. Limitations Skin Puncture by Pharmacist 4052.4. Pharmacist May Select Different Form of Medication with Same 4052.5. Active Chemical Ingredient; Exceptions 4052.6. Advanced Practice Pharmacist; Permitted Procedures Section 4052.7. Repackage Previously Dispensed Drug; Requirements 4052.8. Initiation and Administration of Vaccines; Requirements 4052.9. Pharmacist Furnishing Nicotine Replacement Products; Requirements 4052.10 Partial Fills of Schedule II Controlled Substance Designated Representative to Supervise Wholesaler or Veterinary 4053. - Animal Drug Retailer Food 4053.1. Designated Representative - 3PL to Supervise Third - Party Logistics Provider 4053.2. Designat ed Representative - Reverse Distributor – Licensing; Requirements 4054. Supply by Manufacturer, etc. of Certain Dialysis Drugs and Devices 4055. Sale of Devices to Licensed Clinics, etc. 4056. - Hospital Containing 100 Beds or Purchase of Drugs at Wholesale Less Exceptions to Application of this Chapter 4057. Display of Original License 4058. 4059. Furnishing Dangerous Drugs or Devices Prohibited Without Prescription: Exceptions 4059.5. Who May Order Dangerous Drugs or Devices: Exceptions; Compliance wi th Laws of All Involved Jurisdictions 4060. Controlled Substance - Prescription Required; Exceptions Distribution of Drug as Sample; Written Request Required 4061. 4062. Furnishing Dangerous Drugs during Emergency 4063. Refill of Prescription for Dange rous Drug or Device Requires Prescriber Authorization 4064. Emergency Refill of Prescription without Prescriber Authorization 4064.5. Dispensing a 90 - Day Supply of a Dangerous Drug or Device; Requirements and Exceptions Injection Card System; Requ irements for Administration 4065. Furnishing Dangerous Drugs to Master or First Officer of Vessel 4066. 4067. Internet; Dispensing Dangerous Drugs or Devices without Prescription Dispense Dangerous Drugs or Controlled Substances to Emergency 4068. Room Patien t; Requirements 5

6 Article 4. Requirements for Prescriptions Section Reduction of Oral or Electronic Prescription to Writing 4070. Prescriber May Authorize Agent to Transmit Prescription; Schedule II 4071. Excluded 4071.1. Electronic Prescription Entry into Pharmacy or Hospital Computer Oral or Electronic Transmission of Prescription - 4072. Health Care Facility - Requirements and Exceptions Substitution of Generic Drug 4073. Substitution of Alternative Biological Product; Requirements and 4073.5. ptions Exce 4074. Drug Risk: Informing Patient; Providing Consultation for Discharge Medications Section 4075. Proof of Identity Required Oral or Electronic Prescription - Prescription Container - 4076. Requirements for Labeling 4076.5 Standardized, Patient - Centered Prescription Labels; Requirements 4076.6. Patient - Centered Prescription Labels; Translated Directions for Use; Requirements Opioid an 4076.7 Caution Label Required for Drug Containing 4077. ainer Dispensing Dangerous Drug in Incorrectly Labeled Cont 4078. False or Misleading Label on Prescription Availability of 4079. Lower Retail Price for a Covered Drug a Article 5. Authority of Inspectors Section 4080. Stock of Dangerous Drugs and Devices Kept Open for Inspection 4081. Records of Dangero us Drugs and Devices Kept Open for Inspection; Maintenance of Records, Current Inventory Names of Owners, Managers and Employees Open for Inspection 4082. 4083. Orders of Correction Adulterated, Misbranded or Counterfeit Dangerous Drug or Device 4084. 4 084.1 Embargo of Nonprescription Diabetes Test Devices 4085. Unlawful to Remove, Sell, Dispose of Embargoed Dangerous Drug or Dangerous Device 4086. Adulterated or Counterfeit Dangerous Drug or Dangerous Device; Court Proceedings Article 6. General Re quirements Section Notification to Board - 4100. Change of Address or Name 6

7 - 4101. Pharmacist - in - Charge, Designated Representative in - Charge: Termination of Employment; Notification to Board - 4103. Taking by Pharmacist Blood Pressure loyee, Theft or Impairment: Pharmacy Procedures 4104. Licensed Emp Retaining Records of Dangerous Drugs and Devices on Licensed 4105. Premises; Temporary Removal; Waivers; Access to Electronically Maintained Records 4105.5 Automated Drug Delivery Systems; Requirements 4106. License Verification Using Board Web Site 4106.5 Requirement for Safe Storage Products 4107. One Site License per Premises; Exception Counterfeit Dangerous Drugs or Device; Fraudulent Transaction; 4107.5. Required Notice to the Board Article 7. Pharm acies Section 4110. License Required; Temporary Permit upon Transfer of Ownership; Temporary Use of Mobile Pharmacy 4111. Restrictions on Prescriber Ownership 4112. Nonresident Pharmacy: Registration; Provision of Information to Board; Maintaining Reco rds; Patient Consultation 4113. Pharmacist in Charge: Notification to Board; Responsibilities Community Pharmacies: Required Staffing 4113.5 4114. Intern Pharmacist: Activities Permitted 4115. Pharmacy Technician: Activities Permitted; Required Supervi sion; Activities Limited to Pharmacist; Registration; Requirements for Registration; Ratios Pharmacy Technician Trainee; Placement; Supervision; Requirements 4115.5 4116. Security of Dangerous Drugs and Devices in Pharmacy: Pharmacist Responsibility for Individuals on Premises; Regulations Who May Enter 4117. Admission to Area Where Narcotics are Stored, etc. - 4118. Waiving of Minimum Requirements by Board Risk 4118.5 Hospital Pharmacies: Medication Profiles or Lists for High - Patients 4119. Furnis h Prescription Drug to Licensed Health Care Facility – Secured Emergency Supplies 4119.01 Emergency Medical Services Automated Drug Delivery Systems – Licensing; Fee; Restocking and Removing Drugs; Invent ory and eeping; Licensed Des Reconciliation; Record K ignated Paramedic 4119.1 Pharmacy May Provide Services to Health Facility 4119.2. Furnish Epinephrine Auto - Injectors to School; Requirements 4119.3. Furnish Epinephrine Auto - Injectors to First Responder or Lay Rescuer; Requirements Repackaging Dangerous Drugs by Pharmacy 4119.5. Transfer or Section 7

8 Section 4119.6. Health Care Facility; Stocking of Emergency Pharmaceutical Su pplies edical System Supplies Container and Emergency M Health Care Facility; Inspection of Drugs; Furnishing Per Standing 4119.7. Orders, etc. Naloxone Hydrochloride Furnished to School District, County Office 4119.8 of Education or Charter School; Records Requirements 4119.9 Naloxone Hydrochloride Furnished to a Law Enforcement Agency 4119.11 Automated Patient Dispensing Systems 4120. Nonresident Pharmacy: Registration Required 4121. Advertisement for Prescription Drug: Requirements; Restrictions 4122. Required Notice of Availability of Prescription Price Information, General Product Availability, Pharmacy Services; Providing D rug Price Information; Limitations on Price Information Requests 4123. Compounding Drug for Other Pharmacy for Parenteral Therapy; Notice to Board 4124. Dispensing Replacement Contact Lenses: Requirements; Patient Warnings; Registration with Medical Boar d; Application of Section to Nonresident Pharmacies 4125. Pharmacy Quality Assurance Program Required; Records Considered Peer Review Documents 4126. Covered Entity May Contract with Pharmacy to Provide Pharmacy Services; Segregation of Drug Stock; Retur n of Drugs not Dispensed; Wholesale License Not Permitted or Required Furnishing Dangerous Drug by Pharmacy 4126.5 Recall of Nonsterile Compounded Drugs: Requirements 4126.9 Article 7.5. Compounded Sterile Drug Products Section 4127. Board Shall Adop t Regulations Establishing Standards 4127.1 License to Compound Injectable Sterile Drug Products Required Nonresident Pharmacy – License to Compound and Ship Injectable 4127.2 Drug Products into California Required 4127.3 Cease and Desist Order; Hearin g 4127.4 Fine for Violation 4127.6 Article Operative upon Allocation of Positions Temporary License to Compound Injectable Sterile Drug Products 4127.7 When a Change of Ownership 4127.8 Pharmacies that Compound Sterile Drug Products; Recalls; Requirem ents 4127.15. Hospital Satellite Compounding Pharmacy 8

9 Article 7.6. Centralized Hospital Packaging Pharmacy Section Centralized Hospital Packaging 4128. 4128.2. Specialty License Required; Application; Fees Preparing and Storing Limited Qua ntity of Unit Dose Drugs in 4128.3. - Specific Prescription Advance of a Patient 4128.4. Barcode Required; Information Retrievable Upon Reading Barcode Labeling for Unit Dose Medications 4128.5. 4128.6. Compounding 4128.7. Integrity, Potency, Quality and Labeled Strength of Unit Dose Drug Products Article 7.7. Outsourcing Facilities Section 4129 Outsourcing Facility; License Required 4129.1 Licensing Requirements 4129.2 Nonresident Outsourcing Facility; License Required 4129.3 Board Report to the Legislature 4129.4 Cease and Desist Order 4129.5 Violation Fine 4129.8 Temporary License Recall: Notice Required 4129.9 Article 8. Telepharmacy Systems and Remote Dispensing Site Pharmacies Section . Use of Telepharmacy Syste R emote Dispensing Site Pharmacy – 4130 m; Medically Underserved Areas; Staffing; Transition to Full - Service Pharmacy 4131. Remote Dispensing Si te Pharmacy – Distance from Supervising Pharmacy; Common Ownership; Staffing by Pharmacy Technician; Pharmacist - in - Charge 4132. Pharmacy Technician; Permitted – Remote Dispensing Site P harmacy Duties; Prohibited Duties; Pharmacist - Pharmacy Technician Ratio to - Visual System; Use in Patient – Audio - 4133. Telepharmacy System Counseling; System Capabilities; Recordkeeping 4134. Remote Dispensing Site Pharmacy – Pharmacist Inspection; Perpetual Inventory; Securing Controlled Substances; Inventory and Reconciliation; Requirement to Report Losses 4135. Remote Dispensing Site Pharmacy – Alarm Required; Closed When llance Recording Supervising Pharmacy Is Closed; Maintaining Survei 9

10 Article 9. Hypodermic Needles and Syringes Section Furnishing without License 4141. Prescription Required 4142. 4143. Exemption: Sale to Other Entity, Physician, etc. 4144.5. Industrial Use; Exception Conditions for Furnishi 4145.5. ng Hypodermic Needles and Syringes for Human Use or Specified Animal Use without a Prescription Needle/Syringe Return in Sharps Container 4146 Disposal of Needle or Syringe 4147. Confiscation if Found Outside Licensed Premises 4148.5. 4149. Sale by Nonr esident Distributor; License Required Article 10. Pharmacy Corporations Section Definitions 4150. Licensure Requirements 4151. 4152. Corporate Name Requirements 4153. Shareholder Income While Disqualified 4154. Regulations Authorized te Form Not Required Corpora 4155. 4156. Unprofessional Conduct by Corporation Article 11. Wholesalers and Manufacturers Section 4160. Wholesaler: License Required 4160.5 Nonprescription Diabetes Test Devices – Authorized Distributors Posted on Board Website 4161. Nonresident Wholesaler Requirements 4161.5. Nonresident Wholesaler or Nonresident Third - Party Logistics Provider Party Logistics Provider; Surety Bond - 4162. Wholesaler or Third Requirements 4162.5 Nonresident Wholesaler or Nonresident Third - Party Logist ics Provider; Surety Bond Requirements 4163. Unauthorized Furnishing by Manufacturer or Wholesaler 4164. Reports Required 4165. Sale or Transfer of Dangerous Drug or Device into State: Furnishing Records to Authorized Officer on Demand; Citation for Non - compliance Shipping of Dangerous Drugs or Devices - Wholesaler or Distributor 4166. Liable for Security and Integrity until Delivery 10

11 Section 4167. Wholesaler: Bar on Obtaining Dangerous Drugs or Devices It Cannot Maintain on Licensed Premises Boa rd License Required for Local Business License 4168. Prohibited Acts 4169. 4169.1. Wholesaler Obligation to Report Suspicious Orders to Board Article 11.5. Surplus Medication Collection and Distribution Intermediaries Section 4169.5 Surplus Medication Colle ction and Distribution Intermediary; License Required Article 12. Prescriber Dispensing Section Dispensing by Prescriber: Requirements and Restrictions; 4170. Enforcement 4170.5 Veterinarian in Teaching Hospital May Dispense and Administer Dangerous D rugs and Devices; Requirements 4171. Exceptions to Section 4170: Samples; Clinics; Veterinarians; Narcotic Treatment Programs; Certain Cancer Medications 4172. Storage Requirements Dispensing by Registered Nurses 4173. 4174. on Order of Nurse Practitioner Dispensing by Pharmacist up 4175. Processing of Complaints Article 13. Nonprofit or Free Clinics Section 4180. Purchase of Drugs at Wholesale Only with License: Eligible Clinics Independent Clinics Sharing Office Space – Licensing; Separate 4180.5. Boards, Drug Stocks, Records; Reporting Losses; Application Fee; Department of Health Care Ownership Change; Review by Services and Department of Public Health 4181. License Requirements; Policies and Procedures; Who May Dispense 4182. Duties of Prof essional Director; Consulting Pharmacist Required 4183. No Professional Dispensing Fee 4184. Dispensing Schedule II Substance by Clinic is Prohibited 4185. Inspection Permitted 4186. Automated Drug Delivery Systems Correctional Clinics 4187. 11

12 Section 4 187.1 Correctional Clinics: Licensing; Dispensing and Administering of Drugs Correctional Clinics: Policies and Procedures 4187.2 4187.3 Correctional Clinics: Administering Controlled Substances Correctional Clinics: Board Inspections 4187.4 4187.5 C orrectional Clinics: Automated Drug Delivery Systems Article 14. Clinics Section 4190. Clinic Defined; License Required; Purchase of Drugs at Wholesale: Drug Distribution Service of a Clinic; Information Reported to the Board 4191. Compliance with Dep artment of Health Services Requirements; Who May Dispense Drugs Section 4192. Duties of Professional Director; Providing Information to Board 4193. Clinic Not Eligible for Professional Dispensing Fee; Ban on Offering Drugs for Sale Dispensing of S 4194. chedule II Substance by Clinic Prohibited; Physician May Dispense; Administration Authorized in Clinic Inspection Authorized 4195. - Animal Drug Retailers Article 15. Veterinary Food Section 4196. License Required: Temporary License on Transfer of Owner ship; Board Approval of Designated Representative - in - Charge Minimum Standards: Security; Sanitation; Board Regulations; 4197. Waivers 4198. Written Policies and Procedures Required: Contents; Training of Personnel; Quality Assurance; Consulting Pharmacis t 4199. Labeling Requirements; Maintaining Prescription Records Article 16. Applications Section 4200. Pharmacist License Requirements: Age; Education; Experience; Examination; Proof of Qualifications; Fees 4200.1. Multiple Failures of License Examin ation: Additional Education Requirement California Practice Standards and Jurisprudence Examination for 4200.2. Pharmacist; Required Inclusions 12

13 Section 4200.3. Examination Process to be Reviewed Regularly; Required Standards xamination after Failure; Waiting Period 4200.4. Retaking National E 4200.5. Retired Licensee: Eligibility; Bar on Practice; Requirement for Status Restoration to Active Application Form: Required Information; Authority Granted by 4201. License; Reporting Changes in Beneficial Owne rship 4202. Pharmacy Technician: License Requirements for Education, Experience; Board Regulations; Criminal Background Check; Discipline 4202.5 Designated Paramedic License; Fee Profit Clinic License Application: Form; Investigation - 4203. Non Cl inic Application 4203.5. 4203.6 Correctional Clinics: License Application 4204. Surgical Clinic Application: Form; Investigation 4205. Sale or Dispensing of Hypodermic Syringes and Needles: When Separate License Required; Form and Content of Application; Renewa bility; Discipline Investigation by Board 4207. 4208. Intern Pharmacist License 4209. Intern Pharmacist; Minimum Hours of Practice to Apply for Pharmacist Exam 4210. Advanced Practice Pharmacist License Article 17. Continuing Education Section 423 1. Requirements for Renewal of Pharmacist License: Clock Hours; Exemption for New Licensee 4232. Content of Courses 4233. Advanced Practice Pharmacist; Continuing Education Requirements 4234. Exceptions: Emergencies; Hardship Article 18. Poisons S ection 4240. California Hazardous Substances Act; Application of Act Article 19. Disciplinary Proceedings Section Revocation and Suspension: Authority; Conditions; Issuance of 4300. Probationary License; Application of Administrative Procedure Act; dicial Review Ju 13

14 Section 4300.1 . Board Authority to Render a Decision on a License 4301. Obtaining License by Fraud or Misrepresentation; Unprofessional Conduct 4301.1. Investigative Priority: Greatest Threat of Patient Harm of 4301.5 Pharmacist License; O ut - . - State Suspension or Revocation to Apply to California License 4302. Discipline of Corporate Licensee for Conduct of Officer, Director, Shareholder 4303. Nonresident Pharmacy: Grounds for Discipline Outsourcing Facility: License Canceled, R evoked or Suspended by 4303.1. Operation of Law 4304. Nonresident Wholesaler: Authority to Discipline 4305. Disciplinary Grounds: Failure of Pharmacy, Pharmacist to Notify Board of Termination of Pharmacist - in - Charge; Continuing to Operate Without Pharmacist 430 5.5. Disciplinary Grounds: Failure of Wholesaler, Veterinary Food - Animal Drug Retailer or Third - Party Logistics Provider to Notify Board of Charge or Responsible - Termination of Designated Representative - in Manager; Continuing to Operate Without a Designat ed Representative - Charge or Responsible Manager in - Violation of Professional Corporation Act as Unprofessional Conduct 4306. Acts or Omissions by Pharmacist: Unprofessional Conduct 4306.5. Mitigating Factors for Pharmacist - 4306.6 in - Charge Reporting Vio lations of Others 4307. Individuals with Denied, Revoked, Suspended, etc., Licenses Prohibited from Pharmacy Ownership or Association with Board Licensed Entities 4308. Prohibited Association: Notification of Affected Licensees Known to Board tion for Reinstatement, etc. of Disciplined License: Time for Peti 4309. Filing; Contents; Investigation; Hearing; Factors to Be Considered; Effect of Ongoing Criminal Sentence or Accusation or Petition to Revoke Probation 4310. Notice of Denial of Application: Peti tion for Licensure; Application of Administrative Procedure Act 4311. Suspension of License for Felony Conviction: Automatic Suspension; Summary Suspension; Other Suspensions; Applicable Proceedings 4312. Voiding License of Entity Remaining Closed: Notic e; Disposition of Stock; Distribution of Proceeds Where Board Sells Stock 4313. Evidence of Rehabilitation; Priority of Public Protection 4314. Orders of Abatement 4315. Letters of Admonishment Cease and Desist Orders 4316. 14

15 nd Offenses Article 20. Prohibitions a Section Penalties for Violation of Pharmacy Law: Actions Authorized; Who 4320. May File Actions 4321. Penalties: Misdemeanors; Infractions 4322. Misdemeanor or Infraction: False Representations to Secure License for Self or Others; False Re presentation of Licensure; Penalties Misdemeanor: False Representation of Self as Physician, Agent of 4323. Physician, etc. to Obtain Drug 4324. Felony or Misdemeanor: Forgery of Prescription; Possession of Drugs Obtained Through Forged Prescription . Misdemeanor: Manufacture, Possession, etc. of False Prescription 4325 Blank Misdemeanor: Obtaining Needle or Syringe by Fraud, etc.; Unlawful 4326. Use of Needle or Syringe Obtained from Another Section 4327. Misdemeanor: Sale, Dispensing, or Compounding W hile under the Influence of Drugs or Alcoholic Beverages 4328. Misdemeanor: Permitting Compounding, Dispensing, or Furnishing by Non Pharmacist - 4329. - Pharmacist Acting as Manager; Compounding, Misdemeanor: Non Dispensing or Furnishing Drugs eanor: Non - in - 4330. Misdem Pharmacist Owner Failing to Place Pharmacist - Charge; Dispensing or Compounding Except by Pharmacist; Interfering with Pharmacist in - Charge - - 4331. Misdemeanor: Medical Device Retailer, Wholesaler, Veterinary Food Animal Drug Retailer Failing t o Place Pharmacist or Designated - in - Charge; Permitting Dispensing or Compounding Representative Except by Pharmacist or Designated Representative Misdemeanor: Failure or Refusal to Maintain or Produce Required 4332. Drug or Device Records; Willful Product ion of False Records 4333. Maintaining Prescriptions, Other Drug Records on Premises, Open to Inspection; Waiver; Willful Failure to Keep or Permit Inspection of Records of Prescriptions, Other Records is Misdemeanor 4335. Knowingly Failing to Arrange fo r Disposition of Stock of Closed or Discontinued Business: Misdemeanor 4336. Felony: Knowing or Willful Use of Minor to Violate Specified Sections of Pharmacy Law: Exception for Pharmacist Furnishing Pursuant to a Prescription Distribution of Fine s Collected 4337. 4338. Additional Fines May be Assessed 4339. Board Action to Enjoin Violation of Pharmacy Law; Exception for Certain Drugs and Devices 4340. Unlawful Advertising by Nonresident Pharmacy Not Registered with Board ription Drugs or Devices Advertisement of Presc 4341. 15

16 Section 4342. Actions by Board to Prevent Sales of Preparations or Drugs Lacking Quality or Strength; Penalties for Knowing or Willful Violation of Regulations Governing Those Sales 4343. Buildings: Prohibition Against Use of Cer tain Signs Unless Licensed Pharmacy Within Article 21. Pharmacists Recovery Program Section 4360. Impaired Pharmacists: Legislative Intent 4361. Definitions 4362. Function of Program: Board Referrals; Voluntary, Confidential Participation ria for Participation to Be Established by Board 4364. Crite 4365. Contracting with Employee Assistance Program: Selection 4366. Function of the Employee Assistance Program 4369. Board Referrals to Program: Written Information Provided to Licensee; Termination for - Compliance; Report to Board of Non Termination When Public Safety Threatened; Authority to Discipline 4371. Review of Activities of Program 4372. Confidential Records; Exception for Disciplinary Proceeding Immunity from Civil Liability 4373. 2. Unfair Trade Practices Article 2 Section Resale of Preferentially Priced Drugs: Prohibition; Exceptions 4380. Violation of Article as Unfair Competition; Private Actions 4381. Authorized; Triple Damages and Attorneys’ Fees; Proof Required 4382. Board May Audit Sales to Walk - in Customers Article 23. Revenue and Renewal Section 4400. Fees 4401. Pharmacist: Biennial Renewal 4402. Cancellation: of Pharmacist after Non - Renewal for Three Years; All Other Licenses after 60 Days 4403. Reissuance without Payment o f Fees Prohibited 4404. Reissuance of Lost or Destroyed License; Proof of Loss, etc. 4405. Disposition of Fines 4406. Report of Fees Collected 4407. Compensation of Members Pharmacist Scholarship Program, Donations 4409. 16

17 Article 24. Prescription Rat es for Medicare Beneficiaries Section 4425. Pharmacy Participation in Medi - Cal Program; Conditions; Department of Health Care Services Utilization Review and Monitoring Department of Health Services to Study Reimbursement Rates 4426. ated Drug Delivery System Article 24. Autom Section Definitions of Drugs and Devices 4427. 4427.1 Requirements for Installation or Operation 4427.2 Licensing Requirements 4427.3 Location Requirements Ownership and Operation by Pharmacy 4427.4 4427.5 Personnel Training Req uired 4427.6 Requirements for Using APDS 4427.7 Self - Assessment and Recordkeeping Requirements 4427.8 Report to Legislature during Sunset Process Other Important Sections of the Business & Professions Code Section inquencies List Licensee or Applicant Name on Tax Del 31 40 Expert Consultant Agreement 114.5. Applicants; Military Service Inquiry Expedited Licensure For Honorably Discharged Member of the Armed 115.4. Forces 115.5. Expedited Licensure Process 125.3. Recovery of Investigation and Enforcement Costs: Procedures; Proof; Enforcement 125.9. Citation and Fine 144.5. Authority to Receive Certified Records 148. Unlicensed Activity 208. CURES Fee Assessment 209. CURES Prescription Drug Monitoring Program; Application and ess Approval Proc Violation of Probation; Order for Licensee to Cease Practice 315.2 315.4 Order Clinical Diagnostic Evaluation for Licensee 460 Licensed Department of Consumer Affairs Businesses 476 Licensure/Registration Related to Section 31 480 Denial of License s 494.5 . License Shall Not be Issued, Reactivated, Reinstated, or Renewed and be Suspended if Named on Certified Tax Delinquencies List Rebates or Discounts for Referral Prohibited 650. 17

18 Section 650.1. Lease Prohibition - Hospitals or Prescribers 651. Pro fessional Advertising Requirements 652. Violation as Unprofessional Conduct Violation as Misdemeanor 652.5. 733. Dispensing Prescription Drugs and Devices 901 . Authorization for Out - of - State Health Practitioners to Participate in Sponsored Events in Cal ifornia False or Misleading Statements, Generally 17500. 18

19 BUSINESS & PROFESSIONS CODE CHAPTER 9, DIVISION 2 Article 1. Administration 4000. Chapter Title This chapter constitutes, and may be cited as, the Pharmacy Law. 4001. Board of Pharmacy; Appo intment; Terms ( a) There is in the Department of Consumer Affairs a California State Board of Pharmacy in which the administration and enforcement of this chapter is vested. The board consists of 13 members. (b) The Governor shall appoint seven competen t pharmacists who reside in different parts of the state to serve as members of the board. The Governor shall appoint four public members, and the Senate Committee on Rules and the Speaker of the Assembly shall each appoint a public member who shall not be a licensee of the board, any other board under this division, or any board referred to in Section 1000 or 3600. (c) At least five of the seven pharmacist appointees to the board shall be pharmacists who are actively engaged in the practice of pharmacy. Additionally, the membership of the board shall include at least one pharmacist representative from each of the following practice settings: an acute care hospital, an independent community pharmacy, a chain community pharmacy, - term health care or skilled nursing facility. The pharmacist and a long appointees shall also include a pharmacist who is a member of a labor union that represents pharmacists. For the purposes of this subdivision, a "chain community pharmacy" means a chain of 75 or more stores in Ca lifornia under the same ownership, and an "independent community pharmacy" means a pharmacy owned by a person or entity who owns no more than four pharmacies in California. (d) Members of the board shall be appointed for a term of four years. No person s hall serve as a member of the board for more than two consecutive terms. Each member shall hold office until the appointment and qualification of his or her successor or until one year shall have elapsed since the expiration of the term for which the membe r was appointed, whichever first occurs. Vacancies occurring shall be filled by appointment for the unexpired term. (e) Each member of the board shall receive a per diem and expenses as 103. provided in Section (f) This section shall remain in e ffect only until January 1, 2021 , and as of that date is repealed. N otwithstanding any other law, the repeal of this section renders the board subject to review by the appropriate policy committees of the Legislature. 19

20 4001.1. Protection of the Public is Boar d’s Highest Priority Protection of the public shall be the highest priority for the California State Board of Pharmacy in exercising its licensing, regulatory, and disciplinary functions. Whenever the protection of the public is inconsistent with other interests sought to be promoted, the protection of the public shall be paramount. 4002. Officers (a) The board shall elect a president, a vice president, and a treasurer. The officers of the board shall be elected by a majority of the membership of th e board. (b) The principal office of the board shall be located in Sacramento. The board shall hold a meeting at least once in every four months. Seven members of the board constitute a quorum. 4003 . Executive Officer; Records; Revenue with the approval of the director, may appoint a person exempt (a) The board, from civil service who shall be designated as an executive officer and who shall exercise the powers and perform the duties delegated by the board and vested in him or her by this chapter. The executive officer may or may not be a member of the board as the board may determine. (b) The executive officer shall receive the compensation as established by the board with the approval of the Director of Finance. The executive officer shall entitled to travel and other expenses necessary in the performance of his also be or her duties. (c) The executive officer shall maintain and update in a timely fashion records containing the names, titles, qualifications, and places of business of all persons subject to this chapter. (d) The executive officer shall give receipts for all money received by him or her and pay it to the department, taking its receipt therefor. Besides the duties required by this chapter, the executive officer shall perform other duties pertaining to the office as may be required of him or her by the board. (e) This section shall remain in effect only until January 1, 2021, and as of that date is repealed. Teaching by Board Members 4004. No member of the board shall teach p harmacy in any of its branches, unless he or she teaches as either one of the following: (a) A teacher in a public capacity and in a college of pharmacy. (b) A teacher of an approved continuing education class as, or under the control of, an accredited provider of continuing education. Adoption of Rules and Regulations 4005. (a) The board may adopt rules and regulations, not inconsistent with the laws of this state, as may be necessary for the protection of the public. Included right to adopt rules and regulations as follows: for the therein shall be the proper and more effective enforcement and administration of this chapter; pertaining to the practice of pharmacy; relating to the sanitation of persons and 20

21 pertaining to establishments establishments licensed under this chapter; wherein any drug or device is compounded, prepared, furnished, or dispensed; providing for standards of minimum equipment for establishments licensed under this chapter; pertaining to the sale of drugs by or through any mechan ical device; and relating to pharmacy practice experience necessary for licensure as a pharmacist. (b) Notwithstanding any provision of this chapter to the contrary, the board may adopt regulations permitting the dispensing of drugs or devices in emergen cy situations, and permitting dispensing of drugs or devices pursuant to a prescription of a person licensed to prescribe in a state other than California where the person, if licensed in California in the same licensure classification would, under Califor nia law, be permitted to prescribe drugs or devices and where the pharmacist has first interviewed the patient to determine the authenticity of the prescription. (c) The adoption, amendment, or repeal by the board of these or any other board rules or reg ulations shall be in accordance with Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code. 4006 . Regulations Restricting Furnishing of Particular Drug The board may adopt regulations consistent with this chapter and Section 111485 of the Health and Safety Code or regulations adopted thereunder, limiting or restricting the furnishing of a particular drug upon a finding that the otherwise unrestricted retail sale of the drug pursuant to Section 4057 is dang erous to the public health or safety. 4007. Limitations of Rules (a) Nothing in Section 4005 shall be construed as authorizing the board to adopt rules of professional conduct relating to price fixing or advertising of commodities. (b) Nothing in Sec tion 4005 shall be construed as authorizing the board to adopt any rule or regulation that would require that a pharmacist personally perform any function for which the education, experience, training, and specialized knowledge of a pharmacist are not reas onably required. However, rules and regulations may require that the function be performed only under the effective supervision of a pharmacist who shall have the overall responsibility for supervising all activities that take place in the pharmacy. 4008 . Inspectors; Authority as Public Officers (a) Except as provided by Section 159.5, the board may employ legal counsel and inspectors of pharmacy. The inspectors, whether the inspectors are employed by the board or the department’s Division of Investigat ion, may inspect during business hours all pharmacies, wholesalers, dispensaries, stores, or places where drugs or devices are compounded, prepared, furnished, dispensed, or stored. (b) Notwithstanding subdivision (a), a pharmacy inspector may inspect or examine a physician’s office or clinic that does not have a permit under Section 21

22 4180 or 4190 only to the extent necessary to determine compliance with and to enforce either Section 4080 or 4081. (c) (1) (A) A pharmacy inspector employed by the board or i n the department’s Division of Investigation shall have the authority, as a public officer, to arrest, without warrant, any person whenever the officer has reasonable cause to believe that the person to be arrested has, in his or her presence, violated a p rovision of this chapter or of Division 10 (commencing with Section 11000) of the Health and Safety Code. (B) If the violation is a felony, or if the arresting officer has reasonable cause on that is to believe that the person to be arrested has violated any provisi declared to be a felony, although no felony has in fact been committed, he or she may make an arrest although the violation or suspected violation did not occur in his or her presence. (2) In any case in which an arrest authorized by this subdi vision is made for an offense declared to be a misdemeanor, and the person arrested does not demand to be taken before a magistrate, the arresting inspector may, instead of taking the person before a magistrate, follow the procedure prescribed by Chapter 5 C (commencing with Section 853.5) of Title 3 of Part 2 of the Penal Code. That chapter shall thereafter apply with reference to any proceeding based upon the issuance of a citation pursuant to this authority. (d) There shall be no civil liability on the p art of, and no cause of action shall arise against, a person, acting pursuant to subdivision (a) within the scope of his or her authority, for false arrest or false imprisonment arising out of an arrest that is lawful, or that the arresting officer, at the time of the arrest, had reasonable cause to believe was lawful. An inspector shall not be deemed an - defense by the use of reasonable force aggressor or lose his or her right to self to effect the arrest, to prevent escape, or to overcome resistance. (e) Any inspector may serve all processes and notices throughout the state. (f) A pharmacy inspector employed by the board may enter a facility licensed pursuant to subdivision (c) or (d) of Section 1250 of the Health and Safety Code to inspect an automated d rug delivery system operated pursuant to Section 4119 or 4119.1. (g) This section shall become inoperative on July 1, 2019, and, as of January 1, 2020, is repealed. 4009. Board Rules; Exemption From Coverage Under Industrial Welfare Commission Rules T he board may not adopt or amend any rule or regulation that thereby would conflict with Section 1186 of the Labor Code. 4010. Immunity of Officers All authorized officers of the law, while investigating violations of this r official duties, and any person working under chapter in performance of thei their immediate direction, supervision, or instruction are immune from prosecution under this chapter. 22

23 4011. Administration and Enforcement of Uniform Controlled Substances Act The board shall administe r and enforce this chapter and the Uniform Controlled Substances Act (Division 10 (commencing with Section 11000) of the Health and Safety Code). 4012. Board to Provide Copy of Laws or Regulations The board shall upon request furnish any person with a copy of the laws or regulations relating to dangerous drugs, the furnishing or possession of which is restricted by this article or by further rules of the board. 4013. Board licensed Facilities Required to Join Board’s E Mail - Notification List acility licensed by the (a) Any f board shall join the board’s e mail notification list within 60 days of obtaining a license or at the time of license renewal. (b) Any facility licensed by the board shall update its email address with the list within 30 days board’s e mail notification of a change in the facility’s e mail address. (c) An owner of two or more facilities licensed by the board may comply with subdivisions (a) and (b) by subscribing a single email address to the board’s owner maintains an electronic notice system email notification list, where the within all of its licensed facilities that, upon receipt of an email notification from the board, immediately transmits electronic notice of the same notification hooses to comply with this section to all of its licensed facilities. If an owner c by using such an electronic notice system, the owner shall register the electronic notice system with the board by July 1, 2011, or within 60 days of e email initial licensure, whichever is later, informing the board of the singl address to be utilized by the owner, describing the electronic notice system, and listing all facilities to which immediate notice will be provided. The owner shall update its email address with the board’s email notification list within 30 any change in the owner’s email address. days of (d) (1) Each pharmacist, intern pharmacist, pharmacy technician, designated representative, and designated representative - 3PL licensed in this state shall join the board’s email notification list within 60 days of obtaining a license or at the time of license renewal. Each pharmacist, intern pharmacist, pharmacy technician, designated (2) - 3PL licensed in this state shall representative, and designated representative update his or her email address with the board’s email notification list within 30 days of a change in the licensee’s email address. The email address provided by a licensee shall not be posted on the (3) board’s online license verification system. (4) The board shall, with each renewal application, r emind licensees of their obligation to report and keep current their email address with the board’s email notification list. This subdivision shall become operative on July 1, 2017. (5) 23

24 Article 2. Definitions 4015. Definitions to Govern Construction For purposes of this chapter, the definitions of the terms in this article shall govern the construction of this chapter, unless otherwise indicated. 4016. Administer "Administer" means the direct application of a drug or device to the body of a patie nt or research subject by injection, inhalation, ingestion, or other means. 4016.5. Advanced Practice Pharmacist “Advanced practice pharmacist” means a licensed pharmacist who has been recognized as an advanced practice pharmacist by the board, pursuant to - recognized advanced practice pharmacist is entitled to Section 4210. A board practice advanced practice pharmacy, as described in Section 4052.6, within or outside of a licensed pharmacy as authorized by this chapter. 4017. Authorized Officers of the Law "Authorized officers of the law" means inspectors of the California State Board of Pharmacy, inspectors of the Food and Drug Branch of the State Health, and investigators of the department's Division of Public Department of Investigation or peace off icers engaged in official investigations. 4017.3 Automated Drug Delivery System; Automated Unit Dose System; Automated Patient Dispensing System (a) An “automated drug delivery system” (ADDS) means a mechanical system that performs operations or activitie s, other than compounding or administration, relative to the storage, dispensing, or distribution of drugs. An ADDS shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for se curity, accuracy, and accountability. (b) An “automated unit dose system” (AUDS) is an ADDS for storage and retrieval of unit doses of drugs for administration to patients by persons authorized to perform these functions. ng system” (APDS) is an ADDS for storage (c) An “automated patient dispensi and dispensing of prescribed drugs directly to patients pursuant to prior authorization by a pharmacist. (d) This section shall become operative on July 1, 2019. 4018. Board "Board" means the California State Bo ard of Pharmacy. 4019. Chart Order An "order," entered on the chart or medical record of a patient registered in a hospital or a patient under emergency treatment in the hospital, by or on the s, shall be order of a practitioner authorized by law to prescribe drug 24

25 authorization for the administration of the drug from hospital floor or ward stocks furnished by the hospital pharmacy or under licensure granted under Section 4056, and shall be considered to be a prescription if the medication is to be furnis hed directly to the patient by the hospital pharmacy or another pharmacy furnishing prescribed drugs for hospital patients; provided that the chart or medical record of the patient contains all of the information required by Sections 4040 and 4070 and the order is signed by the practitioner authorized by law to prescribe drugs, if he or she is present when the drugs are given. If he or she is not present when the drugs are given, the order shall be signed either by the attending physician responsible for t he patient's care at the time the drugs are given to the patient or by the practitioner who ordered the drugs for the patient on the practitioner's next visit to the hospital. 4021. Controlled Substance "Controlled substance" means any substance listed in Chapter 2 (commencing with Section 11053) of Division 10 of the Health and Safety Code. 4021.5. Correctional Pharmacy (a) “Correctional pharmacy” means a pharmacy, licensed by the board, located ding drugs to a within a correctional facility for the purpose of provi correctional clinic, as defined in Section 4187, and providing pharmaceutical care to inmates of the correctional facility. (b) As part of its pharmaceutical care, a correctional pharmacy may dispense or chart order, as defined in Section 4019, or administer medication pursuant to a other valid prescription consistent with this chapter. 4022. Dangerous Drug – Dangerous Device Defined "Dangerous drug" or "dangerous device" means any drug or device unsafe for use in humans or animals, - and includes the following: self (a) Any drug that bears the legend: "Caution: federal law prohibits dispensing without prescription," "Rx only," or words of similar import. (b) Any device that bears the statement: "Caution: federal law restricts this device to sale by or on the order of a ____," "Rx only," or words of similar import, the blank to be filled in with the designation of the practitioner licensed to use or order use of the device. (c) Any other drug or device that by federal or state law can be lawfully dispensed only on prescription or furnished pursuant to Section 4006. Charge 4022.5. Designated Representative; Designated Representative - in - (a) "Designated representative" means an individual to whom a license has to Section 4053. A pharmacist fulfilling the duties of been granted pursuant Section 4053 shall not be required to obtain a license as a designated representative. - (b) "Designated representative in - charge" means a designated representative proposed by a or a pharmacist or designated representative - revers e distributor, animal drug retailer and approved by the board as wholesaler or veterinary food - the supervisor or manager responsible for ensuring the wholesaler’s or 25

26 - animal drug retailer’s compliance with all s tate and federal veterinary food laws and regulations pertaining to practice in the ap plicable license category. 4022.6. Designated Representative Reverse Distributor - “Designated representative reverse distributor” means an individual to whom a - license has been granted pursuant to Section 4053.2, who is responsible for supervision over a licensed wholesaler that only acts as a reverse distributor. A pharmacist fulfilling the duties of Section 4053.2 shall not be required to obtain a license as a designated representative - reverse distributor. - 3PL; Responsible Manager 4022.7. Designated Representative (a) “Designated representative - 3PL” means an individual to whom a license has been granted pursuant to Section 4053.1. (b) “Responsible manager” means a designated repre sentative - 3PL selected by a third - party logistics provider and approved by the board as responsible for ensuring compliance of the licensed place of business with state and federal red laws with respect to dangerous drugs and dangerous devices received by, sto party logistics - in, or shipped from the licensed place of business of the third provider. 4023. Device "Device" means any instrument, apparatus, machine, implant, in vitro reagent, or contrivance, including its components, parts, products, or the b yproducts of a device, and accessories that are used or intended for either of the following: (a) Use in the diagnosis, cure, mitigation, treatment, or prevention of disease in a human or any other animal. (b) To affect the structure or any function of the body of a human or any other animal. For purposes of this chapter, "device" does not include contact lenses, or any prosthetic or orthopedic device that does not require a prescription. 4023.5. Direct Supervision and Control is chapter, "direct supervision and control" means that a For the purposes of th pharmacist is on the premises at all times and is fully aware of all activities performed by either a pharmacy technician or intern pharmacist. 4024. Dispense (a) Except as provided in subdivisi on (b), "dispense" means the furnishing of drugs or devices upon a prescription from a physician, dentist, optometrist, podiatrist, veterinarian, or naturopathic doctor pursuant to Section 3640.7, or n from a certified nurse - upon an order to furnish drugs or transmit a prescriptio midwife, nurse practitioner, physician assistant, naturopathic doctor pursuant to Section 3640.5, or pharmacist acting within the scope of his or her practice. (b) "Dispense" also means and refers to the furnishing of drugs or de vices directly to a patient by a physician, dentist, optometrist, podiatrist, or midwife, nurse practitioner, naturopathic - veterinarian, or by a certified nurse doctor, or physician assistant acting within the scope of his or her practice. 26

27 4025. Drug " Drug" means any of the following: (a) Articles recognized in the official United States Pharmacopoeia, official National Formulary or official Homeopathic Pharmacopoeia of the United States, or any supplement of any of them. (b) Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals. (c) Articles (other than food) intended to affect the structure or any function of the body of humans or other animals. (d) Articles intended for use as a component of any article specified in subdivision (a), (b), or (c). 4025.1. Non - Prescription Drug "Nonprescription drug" means a drug which may be sold without a prescription and which is labeled for use by the consumer in accordance with the r equirements of the laws and rules of this state and the federal government. 4025.2. Nonprescription Diabetes Test Device “Nonprescription diabetes test device” means a glucose meter or test strip for iduals that may be sold use in the treatment of prediabetic or diabetic indiv without a prescription and that is labeled for use by the consumer in accordance with the requirements of the laws and rules of this state and the federal government. 4026. Furnish "Furnish" means to supply by any means, by sale or otherwise. 4026.5. Good Standing "Good standing" means a license issued by the board that is unrestricted by disciplinary action taken pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code. Intermediate Care Facility Other Health 4027. Skilled Nursing Facility – – Care Facilities (a) As used in this chapter, the terms "skilled nursing facility," "intermediate care facility," and other references to health facilities shall be construed wit h respect to the definitions contained in Article 1 (commencing with Section 1250) of Chapter 2 of Division 2 of the Health and Safety Code. (b) As used in Section 4052 .1 , "licensed health care facility" means a facility licensed pursuant to Article 1 (c ommencing with Section 1250) of Chapter 2 of Division 2 of the Health and Safety Code or a facility, as defined in Section 1250 of the Health and Safety Code, operated by a health care service plan licensed pursuant to Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code. (c) As used in Section 4052 .2 , "health care facility" means a facility, other than a facility licensed under Division 2 (commencing with Section 1200) of 27

28 the Health and Safety Code, that is owned or oper ated by a health care service plan licensed pursuant to Chapter 2.2 (commencing with Section 1340) of the Health and Safety Code, or by an organization under common ownership or control of the health care service plan; "licensed home health agency" means a private or public organization licensed by the State Department of Public Health pursuant to Chapter 8 (commencing with Section 1725) of Division 2 of the Health and Safety Code, as further defined in Section 1727 of the Health and Safety Code; and "licen sed clinic" means a clinic licensed pursuant to Article 1 (commencing with Section 1200) of Chapter 1 of Division 2 of the Health and Safety Code. (d) "Licensed health care facility" or "facility," as used in Section 4065, means d pursuant to Article 1 (commencing with Section 1250) a health facility license of Chapter 2 of Division 2 of the Health and Safety Code or a facility that is owned or operated by a health care service plan licensed pursuant to Chapter 2.2 (commencing with Section 1340) of Divisio n 2 of the Health and Safety Code or by an organization under common ownership or control with the health care service plan. 4028. Licensed Hospital "Licensed hospital" means an institution, place, building, or agency that maintains and operates organi zed facilities for one or more persons for the diagnosis, care, and treatment of human illnesses to which persons may be admitted for overnight stay, and includes any institution classified under Health regulations issued by the State Department of as a general or Public specialized hospital, as a maternity hospital, or as a tuberculosis hospital, but does not include a sanitarium, rest home, a nursing or convalescent home, a maternity home, or an institution for treating alcoholics. 4029. Hospital Pharma cy (a) "Hospital pharmacy" means and includes a pharmacy, licensed by the board, located within any licensed hospital, institution, or establishment that maintains and operates organized facilities for the diagnosis, care, and treatment of human illnesse s to which persons may be admitted for overnight stay and that meets all of the requirements of this chapter and the rules and regulations of the board. a pharmacy that (b) A hospital pharmacy may include is located in any ed under the license of a general acute care hospital physical plant that is regulat of the Health and Safety Code. As as defined in subdivision (a) of Section 12 50 a condition of licensure by the board, the pharmacy in another physical plant shall provide pharmaceutical services only t o registered hospital patients who are on the premises of the same physical plant in which the pharmacy is located, except as provided in Article 7.6 (commencing with Section 4128). r The pharmacy services provided shall be directly related to the services o treatment plan administered in the physical plant. Nothing in this subdivision shall be construed to restrict or expand the services that a hospital pharmacy may provide. 28

29 (c) “Hospital satellite compounding pharmacy” means an area licensed by the board to perform sterile compounding that is separately licensed by the board pursuant to Section 4127.15 to perform that compounding and is located outside of the hospital in another physical plant that is regulated as a general acute care hospital as defined i n subdivision (a) of Section 1250 of the Health and Safety Code. 4030. Intern Pharmacist "Intern pharmacist" means a person issued a license pursuant to Section 4208. 4031. Laboratory "Laboratory" means a research, teaching, or testing laboratory n ot engaged in the dispensing or furnishing of drugs or devices but using dangerous drugs or dangerous devices for scientific or teaching purposes. Every laboratory shall maintain an established place of business and keep purchase records. Every laboratory shall be subject to the jurisdiction of the board. 4032. License "License" means and includes any license, permit, registration, certificate, or exemption issued by the board and includes the process of applying for and renewing the same. facturer 4033. Manu (a) (1) "Manufacturer" means and includes every person who prepares, derives, produces, compounds, or repackages any drug or device except a pharmacy that manufactures on the immediate premises where the drug or device is sold to the ultimate con sumer. (2) Notwithstanding paragraph (1), "manufacturer" shall not mean a pharmacy compounding a drug for parenteral therapy, pursuant to a prescription, for delivery to another pharmacy for the purpose of delivering or administering the nt or patients named in the prescription, provided that neither drug to the patie the components for the drug nor the drug are compounded, fabricated, packaged, or otherwise prepared prior to receipt of the prescription. (3) Notwithstanding paragraph (1), "manufacturer" sh all not mean a pharmacy that, at a patient's request, repackages a drug previously dispensed to the patient, or to the patient's agent, pursuant to a prescription. (b) Notwithstanding subdivision (a), as used in Sections 4034, 4163, 4163.1, 4163.2, 4163. 3, 4163.4, and 4163.5, "manufacturer" means a person who prepares, derives, manufactures, produces, or repackages a dangerous drug, as defined in Section 4022, device, or cosmetic. Manufacturer also means the holder or holders of a New Drug Application (N DA), an Abbreviated New Drug Application (ANDA), or a Biologics License Application (BLA), provided that such application has been approved; a manufacturer's third party logistics provider; a private label distributor (including colicensed partners) for wh om the private label distributor's prescription drugs are originally manufactured and labeled for the distributor and have not been repackaged; or the distributor agent for the manufacturer, contract manufacturer, or private 29

30 establishment is a member of the manufacturer's label distributor, whether the affiliated group (regardless of whether the member takes title to the drug) or is a contract distributor site. 4034. Outsourcing Facility ing: “Outsourcing facility” means a facility that meets all of the follow (a) Is located within the United States of America at one address that is engaged in the compounding of sterile drugs and nonsterile drugs. (b) Has registered as an outsourcing facility with the federal Food and Drug Administration under Section 503B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 353b). (c) Is doing business within or into California. (d) Is licensed with the board as an outsourcing facility pursuant to Article 7.7 (commencing with Section 4129). 4034.5. Emergency Medical Service Automated Drug Delivery System An “emergency medical services automated drug delivery system” or “EMSADDS” means an automated drug delivery system that stores and distributes drugs for the sole purpose of restocking a secured emergency pharmaceut ical supplies container that is used by an emergency medical services agency to provide emergency medical services. Person 4035. “Person” includes, but is not limited to, firm, association, partnership, corporation, limited liability company, state go vernmental agency, trust, or political subdivision. 4036. Pharmacist "Pharmacist" means a natural person to whom a license has been issued by the board, under Section 4200, except as specifically provided otherwise in this chapter. The holder of an une xpired and active pharmacist license issued by the board is entitled to practice pharmacy as defined by this chapter, within or outside of a licensed pharmacy as authorized by this chapter. in - 4036.5. Pharmacist - Charge “Pharmacist - in - charge” means a pha rmacist proposed by a pharmacy and approved by the board as the supervisor or manager responsible for ensuring the pharmacy’s compliance with all state and federal laws and regulations pertaining to the practice of pharmacy. 4037. Pharmacy y" means an area, place, or premises licensed by the board in (a) "Pharmac which the profession of pharmacy is practiced and where prescriptions are compounded. "Pharmacy" includes, but is not limited to, any area, place, or he board wherein controlled premises described in a license issued by t substances, dangerous drugs, or dangerous devices are stored, possessed, prepared, manufactured, derived, compounded, or repackaged, and from which 30

31 the controlled substances, dangerous drugs, or dangerous devices are furnished, sold, or dispensed at retail. (b) "Pharmacy" shall not include any area in a facility licensed by the State Department of Public Health where floor supplies, ward supplies, operating room supplies, or emergency room supplies of dangerous drugs or danger ous devices are stored or possessed solely for treatment of patients registered for treatment in the facility or for treatment of patients receiving emergency care in the facility. 4038. Pharmacy Technician who assists a pharmacist in a (a) "Pharmacy technician" means an individual pharmacy in the performance of his or her pharmacy related duties, as specified in Section 4115. (b) A "pharmacy technician trainee" is a person who is enrolled in a pharmacy technician training program operated by a Califo rnia public postsecondary education institution or by a private postsecondary vocational institution approved by the Bureau for Private Postsecondary and Vocational Education. 4039. Physician; Other Practitioners Defined "Physicians," "dentists," "optome trists," "pharmacists," "podiatrists," "veterinarians," "veterinary surgeons," "registered nurses," "naturopathic doctors," and "physician's assistants" are persons authorized by a currently valid and unrevoked license to practice their respective professi ons in this state. "Physician" means and includes any person holding a valid and unrevoked physician' s and surgeon's certificate or certificate to practice medicine and surgery, issued by the Medical Board of California or the Osteopathic Medical Board o f California, and includes an unlicensed person lawfully practicing medicine pursuant to Section 2065, when acting within the scope of that section. 4040. Prescription; Content Requirements mission order that (a) “Prescription” means an oral, written, or electronic trans is both of the following: Given individually for the person or persons for whom ordered that (1) includes all of the following: (A) The name or names and address of the patient or patients. (B) device prescribed and the directions The name and quantity of the drug or for use. The date of issue. (C) (D) Either rubber stamped, typed, or printed by hand or typeset, the name, address, and telephone number of the prescriber, his or her license classification, and his or her federal r egistry number, if a controlled substance is prescribed. (E) A legible, clear notice of the condition or purpose for which the drug is being prescribed, if requested by the patient or patients. If in writing, signed by the prescriber issuing the or (F) der, or the certified midwife, nurse practitioner, physician assistant, or naturopathic doctor - nurse 31

32 who issues a drug order pursuant to Section 2746.51, 2836.1, 3502.1, or 3640.5, respectively, or the pharmacist who issues a drug order pursuant to Section 4052.1, 4052.2, or 4052.6. (2) Issued by a physician, dentist, optometrist, podiatrist, veterinarian, or naturopathic doctor pursuant to Section 3640.7 or, if a drug order is issued nurse pursuant to Section 2746.51, 2836.1, 3502.1, or 3460.5, by a certified - midwife, nurse practitioner, physician assistant, or naturopathic doctor licensed in this state, or pursuant to Section 4052.1, 4052.2, or 4052.6 by a pharmacist licensed in this state. (b) Notwithstanding subdivision (a), a written order of the pr escriber for a dangerous drug, except for any Schedule II controlled substance, that contains at least the name and signature of the prescriber, the name and address of the patient in a manner consistent with paragraph (2) of subdivision (a) of Section 64 of the Health and Safety Code, the name and quantity of the drug 111 prescribed, directions for use, and the date of issue may be treated as a prescription by the dispensing pharmacist as long as any additional information dily retrievable in the pharmacy. In the event required by subdivision (a) is rea of a conflict between this subdivision and Section 11164 of the Health and Safety Code, Section 11164 of the Health and Safety Code shall prevail. (c) “Electronic transmission prescription” includes both ima ge and data prescriptions. “Electronic image transmission prescription” means any prescription order for which a facsimile of the order is received by a pharmacy from a licensed prescriber. “Electronic data transmission prescription” means any prescription order, other than an electronic image transmission prescription, that is electronically transmitted from a licensed prescriber to a pharmacy. The use of commonly used abbreviations shall not invalidate an otherwise (d) valid prescription. (e) Nothing in the amendments made to this section (formerly Section 4036) at the 1969 Regular Session of the Legislature shall be construed as expanding or limiting the right that a chiropractor, while acting within the scope of his or her license, may have to prescr ibe a device. 4040.5. Reverse Distributor “Reverse distributor” means every person who acts as an agent for pharmacies, drug wholesalers, third - party logistics providers, manufacturers, naging the and other entities by receiving, inventorying, warehousing, and ma or nonsaleable dangerous drugs or dangerous devices. disposition of outdated 4041. Veterinary Food - Animal Drug Retailer - animal drug retailer" is an area, place, or premises, other "Veterinary food than a pharmacy, that holds a valid license from the Board of Pharmacy of the State of California as a wholesaler and, in and from which veterinary drugs for food - producing animals are dispensed pursuant to a prescription from a is not animal retailer" includes, but licensed veterinarian. "Veterinary food - limited to, any area, place, or premises described in a permit issued by the animal drugs, as defined in Section 4042, are - board wherein veterinary food stored, possessed, or repackaged, and from which veterinary drugs are 32

33 sed at retail pursuant to a prescription from a licensed furnished, sold, or dispen veterinarian. 4042. - Animal Drugs Veterinary Food - animal drugs" as used in this chapter shall include the "Veterinary food following: (a) Any drug to be used in food producing animals bearing t he legend, - "Caution, federal law restricts this drug to use by or on the order of a licensed veterinarian" or words of similar import. (b) Any other drug as defined in Section 14206 of the Food and Agricultural Code that is used in a manner that would re quire a veterinary prescription. 4043. Wholesaler “Wholesaler” means and includes a person who acts as a wholesale merchant, broker, jobber, customs broker, reverse distributor, agent, or a nonresident r distribution, or takes wholesaler, who sells for resale, or negotiates fo possession of, any drug or device included in Section 4022. Unless otherwise authorized by law, a wholesaler may not store, warehouse, or authorize the storage or warehousing of drugs with any person or at any location not licensed by the board. 4044. Repackager "Repackager" means a person or entity that is registered with the federal Food and Drug Administration as a repackager and operates an establishment that into packages finished drugs from bulk or that repackages dangerous drugs different containers, excluding shipping containers. 4044.3. Remote Dispensing Site Pharmacy (a) “Remote dispensing site pharmacy” means a licensed pharmacy located in this state that is exclusively overseen and operated by a supervising pharmacy d staffed by one or more qualified registered pharmacy technicians, as an defined in Section 4132, where pharmaceutical care services, including, but not limited to, the storage and dispensing of prescription drugs and controlled substances, drug regimen revi ew, and patient counseling, are remotely monitored or provided, or both, by a licensed pharmacist through the use of telepharmacy technology. (b) Unless otherwise specified in this chapter, a remote dispensing site pharmacy shall comply with all state and federal laws regulating the practice of pharmacy. - Party Logistics Provider 4044.5. Reverse Third “Reverse third - party logistics provider” means an entity that processes or drug or manages the disposition of an outdated or nonsaleable dangerous manufacturer, dangerous device on behalf of a wholesaler, or dispenser of the does dangerous drug or dangerous device, but the not take ownership of dangerous drug or dangerous device nor have the responsibility to direct its sale provision of or disposition. Unless otherwise sp ecified in this chapter, every 33

34 shall this chapter that applies to a third - party logistics provider also apply to a reverse third - party logistics provider. 4044.6. Pharmacy Supervising loca pharmacy” means a licensed pharmacy ted in this state (a) “Supervising is owned that and operated by a person or persons where the majority of the interest in, as well as the management and control, resides with at beneficial board - licensed pharmacist, as defined in Section 4036, least that one the operations of a versees remote dispensing site pharmacy. exclusively o (b) A supervising pharmacy shall be exclusively responsible for the operation remote dispensing of site pharmacy and its employees pursuant to Section the 4131. Telepharmacy 4044.7. used “Telepharm means a system is acy” by a supervising pharmacy for that remote a the purpose of monitoring the dispensing of prescription drugs by dispensing pharmacy and provides for related drug regimen review and site counseling by an electronic method, including, but not limited to, the patient of and audio, visual, still image capture, use store and forward technology. Third - Party Logistics Provider 4045. “Third - party logistics provider” means an entity that provides or coordinates warehousing or other logis tics services for a dangerous drug or dangerous in device manufacturer, intrastate or interstate commerce on behalf of a wholesaler, dispenser of the dangerous drug or or dangerous device, but does not take ownership of the dangerous drug or dangerous devi ce, nor have responsibility to direct its sale or disposition. 4046. Surplus Medication Collection and Distribution Intermediary “Surplus medication collection and distribution intermediary” means a firm, iability company, state association, partnership, corporation, limited l governmental agency, or political subdivision that performs the functions specified in Section 4169.5 for the purpose of a program established pursuant to 116 (commencing with section Division 150200) of the Health and Safety Code. Article 3. Scope of Practice and Exemptions 4050. Legislative Declaration (a) In recognition of and consistent with the decisions of the appellate courts of this state, the Legislature hereby declares the practice of pharmacy to be a profession. (b) Pharmacy practice is a dynamic, patient - oriented health service that applies a scientific body of knowledge to improve and promote patient health related therapy, and communication for - by means of appropriate drug use, drug ses. Pharmacy practice is continually evolving to clinical and consultative purpo include more sophisticated and comprehensive patient care activities. 34

35 (c) The Legislature further declares that pharmacists are health care providers who have the authority to provide health care services . 4051. Conduct Limited to Pharmacist; Conduct Authorized by Pharmacist Except as otherwise provided in this chapter, it is unlawful for any person (a) dangerous drug or a to manufacture, compound, furnish, sell, or dispense prescription pursuant to a dangerous device, or to dis pense or compound Section 4040 of a prescriber unless he or she is a pharmacist under this chapter. (b) Notwithstanding any other law, a pharmacist may authorize the initiation 4052.6, and 2.2, 4052.3, of a prescription, pursuant to Section 4052.1, 405 or advice, services, information, or patient consultation, otherwise provide clinical as set forth in this chapter, if all of the following conditions are met: The clinical (1) or patient consultati on is advice, services, information, provided to a health care professional or to a patient. (2) The pharmacist has access to prescription, patient profile, or other relevant medical information for purposes of patient and clinical consultation and advice. Access to the informat ion described in paragraph (2) is secure from (3) unauthorized access and use. 4052. Furnishing to Prescriber; Permitted Procedures by Pharmacist any other law, a pharmacist may: (a) Notwithstanding a reasonable quantity of (1) compounded drug pr oduct to Furnish a prescriber use by office the prescriber. for (2) Transmit a valid prescription to another pharmacist. Administer drugs and biological products that have been ordered by a (3) prescriber. Perform procedures or functions in a (4) licensed he alth care facility as by Section 4052.1. authorized (5) Perform procedures or functions as part of the care provided by a health licensed care a licensed home health agency, a facility, clinic in which there is a health physician oversight, a provider care who contr acts with a licensed that service with regard to the care or services provided to the enrollees of plan health care service plan, or a as authorized by Section 4052.2. physician, (6) Perform procedures or functions as authorized by Section 40 52.6. Manufacture, measure, fit to the patient, or sell and repair dangerous (7) devices, or furnish instructions to the patient or the patient’s representative concerning the use of those devices. (8) Provide consultation, training, and education to p atients about drug management, therapy, and disease prevention. disease including (9) professional information, clinical or pharmacological Provide information, advice, or consultation to other health care professionals, and of participate multidisciplin ary review in patient progress, including appropriate access to medical records. Furnish the medications described (10) in subparagraph (A) in accordance (B): subparagraph with 35

36 administered (1) Emergency contraception drug therapy and self - (A) hormonal contraceptives, as authorized by Section 4052.3. (2) replacement products, as authorized by Section 4052.9. Nicotine Prescription medications not requiring a diagnosis that are recommended (3) individuals Centers for the Disease Control and Prevention for federal by outside of the States. traveling United The pharmacist shall notify the patient’s primary care provider of any (B) or devices furnished to the patient, or enter the appropriate information in drugs patient care record system shared with the primary provider, as permitted by a not primary care provider. If the patient does have a primary care provider, that pharmacist shall provide the patient with a written record the the drugs or of devices furnished and advise the patient to consult a ph ysician of the patient’s choice. Administer immunizations pursuant to a protocol with a prescriber. (11) purpose (12) and interpret tests for the Order of monitoring and managing the and toxicity of drug therapies. A pharmacist who orders and interprets efficacy paragraph to this tests shall ensure that the ordering of those tests is pursuant coordination with the patient’s primary care provider done or diagnosing in appropriate, including promptly prescriber, transmitting written notification as entering to diagnosing prescriber or the the appropriate information in patient’s as a patient record system and shared with the prescriber, when available permitted that prescriber. by a pharmacist who is authorized to issue an order to initiate or adjust (b) A register therapy pursuant to this section shall personally controlled substance federal Drug the Enforcement Administration. with (c) This section does not affect the applicable requirements of law relating to the following: either of (1) g the confidentiality of medical records. Maintainin health licensing of a (2) care facility. The Furnishing of Naloxone Hydrochloride; Permitted Procedures by 4052.01. Pharmacist (a) Notwithstanding any other provision of law, a pharmacist furnish may naloxone hydrochloride in accordance standardized procedures or with protocols developed and approved by both the board and the Medical Board of California, in consultation with the California Society of Addiction Medicine, the Pharmacists Association, a nd other appropriate entities. In California the standardized procedures or protocols, board and the developing those Board of California shall include Medical following: the Procedures to ensure education of the (1) person to whom the drug is furnished, including, but not limited to, opioid overdose prevention, recognition, response, safe administration of naloxone hydrochloride, and effects potential or adverse events, and side the imperative to seek emergency medical care for the patient. Procedures to ensu re the education of (2) the person to whom the drug is treatment programs. furnished regarding the availability of drug 36

37 the Procedures for the notification of patient’s primary care provider with (3) of any drugs or devices furnished patient to the p atient, or entry of consent information in a patient record system shared with the primary care appropriate as by that primary care provider, permitted and with patient consent. provider, A pharmacist furnishing naloxone hydrochloride pursuant this sectio n (b) to permit the person to whom the not drug is furnished to waive the shall required by the board and the Medical Board of California. consultation (c) Prior to performing a procedure authorized under this section, a pharmacist use a training pro gram on the of opioid antagonists that consists shall complete at least one hour of approved continuing education on the use of naloxone of hydrochloride. to (d) The board and the Medical Board of California are each authorized ensure compliance with this section. Each board is specifically charged with does section enforcing this section with respect to its respective licensees. This to not the authority of a pharmacist prescribe any prescription expand medication. (e) The board may adopt emergency regulations to establish the standardized or protocols. The adoption of regulations pursuant to this procedures subdivision shall be deemed to be an emergency and necessary for the immediate preservation of the public peace, health, safety, or general welfare. The emerg ency regulations authorized by this subdivision are exempt from of review by the Office regulations Administrative Law. The emergency authorized by this subdivision shall be submitted to the Office of Law Administrative for filing with the Secretary of Sta te and shall remain in following effect until the earlier of 180 days effective their effective date or the subdivision date of regulations adopted pursuant to (a). 4052.1. Permitted Pharmacist Procedures in Licensed Health Care Facility (a) Notwithsta nding any other provision of law, a pharmacist may perform the following procedures or functions in a licensed health care facility in accordance with policies, procedures, or protocols developed by health professionals, including physicians, pharmacists, and registered nurses, with the concurrence of the facility administrator: (1) Ordering or performing routine drug therapy - related patient assessment procedures including temperature, pulse, and respiration. (2) Ordering drug therapy - related labora tory tests. (3) Administering drugs and biologicals by injection pursuant to a prescriber's order. (4) Initiating or adjusting the drug regimen of a patient pursuant to an order or authorization made by the patient's prescriber and in accordance wi th the policies, procedures, or protocols of the licensed health care facility. (b) Prior to performing any procedure authorized by this section, a pharmacist shall have received appropriate training as prescribed in the policies and censed health care facility. procedures of the li 37

38 Permitted Pharmacist Procedures in Health Care Facility; Home 4052.2. Health Agency or Clinic with Physician Oversight (a) Notwithstanding any other provision of law, a pharmacist may perform the ctions as part of the care provided by a health care following procedures or fun licensed correctional center, a licensed facility, a licensed home health agency, clinic in which there is a physician oversight, a provider who contracts with a licensed health care service plan with re gard to the care or services provided to the enrollees of that health care service plan, or a physician, in accordance with the policies, procedures, or protocols of that facility, home health agency, licensed clinic, health c licensed correctional clinic , are service plan, or physician, and in accordance with subdivision (c): (1) Ordering or performing routine drug therapy - related patient assessment procedures including temperature, pulse, and respiration. (2) Ordering drug therapy - related laborator y tests. (3) Administering drugs and biologicals by injection pursuant to a prescriber's order. (4) Initiating or adjusting the drug regimen of a patient pursuant to a specific g written order or authorization made by the individual patient's treatin prescriber, and in accordance with the policies, procedures, or protocols of the licensed licensed correctional clinic, health care facility, home health agency, clinic, health care service plan, or physician. Adjusting the drug regimen does not include substituting or selecting a different drug, except as authorized by the protocol. The pharmacist shall provide written notification to the patient's treating prescriber, or enter the appropriate information in an electronic patient record system shared by the prescriber, of any drug regimen initiated pursuant to this paragraph within 24 hours. (b) A patient's treating prescriber may prohibit, by written instruction, any adjustment or change in the patient's drug regimen by the pharmacist. (c) The polici es, procedures, or protocols referred to in this subdivision shall be developed by health care professionals, including physicians, pharmacists, and registered nurses, and shall, at a minimum, do all of the following: (1) Require that the pharmacist fu nction as part of a multidisciplinary group that includes physicians and direct care registered nurses. The multidisciplinary group shall determine the appropriate participation of the pharmacist and the direct care registered nurse. (2) Require that t he medical records of the patient be available to both the patient's treating prescriber and the pharmacist. (3) Require that the procedures to be performed by the pharmacist relate to a condition for which the patient has first been seen by a physicia n. (4) Except for procedures or functions provided by a health care facility, a licensed correctional clinic, as defined in Section 4187, a licensed clinic in which there is physician oversight, or a provider who contracts with a licensed health care pl an with regard to the care or services provided to the enrollees of that health care service plan, require the procedures to be performed in - accordance with a written, patient specific protocol approved by the treating or supervising physician. Any change, adjustment, or modification of an approved 38

39 preexisting treatment or drug therapy shall be provided in writing to the treating or supervising physician within 24 hours. (d) Prior to performing any procedure authorized by this section, a pharmacist shall have done either of the following: (1) Successfully completed clinical residency training. (2) Demonstrated clinical experience in direct patient care delivery. 4052.3. Emergency Contraception Drug Therapy; Requirements and Limitations (1) Notwithstanding any other a pharmacist may furnish self - (a) law, hormonal administered in accordance with standardized contraceptives protocols developed and approved by or both the board and the procedures Board of California in consultation with the American Medical of Congress Obstetricians and Gynecologists, the California Pharmacists Association, and or entities. The standardized procedure protocol shall require other appropriate the patient use a self - screening tool that that will identify patient risk fa ctors for use of self - administered hormonal contraceptives, based on the current United States Medical Eligibility Criteria (USMEC) for Contraceptive Use developed by federal Centers for Disease Control and Prevention, and that the the primary the patient to the patient’s pharmacist care provider or, if the refer not have a primary care does provider, to nearby clinics, upon patient furnishing a self - administered hormonal contraceptive pursuant to this a subdivision, if it is determined that use of or self - administered hormonal contraceptive is not recommended. (2) The board and the Medical Board of California are both authorized to ensure compliance with this subdivision, and each board is specifically charged respective licensees. with the enforcement of this subdivision with respect to its This does not expand the authority of a pharmacist to prescribe any subdivision prescription medication. (b) (1) Notwithstanding any other law, a pharmacist may furnish emergency contraception drug therapy in accorda nce either of the following: with (A) Standardized procedures or protocols developed by the pharmacist and an authorized who is acting within his prescriber or her scope of practice. (B) Standardized procedures or protocols developed and approved by bo th the the board and the Medical Board of California in consultation with American Gynecologists, Congress of Obstetricians and the California Pharmacists The Association, and other appropriate entities. board and the Medical Board of California both a uthorized to ensure compliance with this clause, and each are with specifically charged with the enforcement of this provision board is its respective licensees. respect subdivision does not expand the to This authority of a pharmacist to any prescri ption medication. prescribe (2) Prior to performing a procedure authorized under this subdivision, a pharmacist complete a training program shall on emergency contraception that consists of at least one hour of approved continuing education on emergency contracept drug therapy. ion (3) A pharmacist, employer, or pharmacist’s agent shall not pharmacist’s for emergency directly charge a patient a separate consultation fee 39

40 contraception therapy services initiated pursuant drug to this subdivision, but may a dministrative fee not to charge exceed ten dollars ($10) above the an cost of the drug. Upon an oral, telephonic, electronic, or written request retail or a or customer, a pharmacist patient pharmacist’s employee shall from the total retail price that a con sumer would pay for emergency disclose drug therapy. As used in this paragraph, total retail price includes contraception the consumer with specific information regarding the price of the providing contraception drugs and the price of the administrative f ee charged. emergency with is not intended to interfere This other contractually agreed - upon limitation between a pharmacist, a pharmacist’s employer, or a pharmacist’s agent, terms Patients a health care service plan or insurer. who are insured or covered and r eceive a pharmacy benefit that covers the cost of emergency and contraception shall not be required to pay an administrative fee. These patients shall be their pay copayments pursuant required to the terms and conditions of to coverage. This paragraph shall be come inoperative for dedicated emergency counter contraception products drugs if these drugs are reclassified as over - the - by federal Food and Drug Administration. the (4) individually A pharmacist shall not require a patient to provide identifiable Section al medic that is not specified in 1707.1 of Title 16 of the information California Code of Regulations before initiating emergency contraception drug therapy to this subdivision. pursuant (c) For each contraception drug therapy or self - admini stered emergency hormonal contraception initiated pursuant to this section, the pharmacist shall provide the recipient of the drug with a standardized factsheet that includes, but limited is not to, the indications and contraindications for use of the drug, the appr opriate method for using the drug, the need for medical followup, and other The board shall appropriate develop this form in consultation with information. the the Department of Public Health, State American Congress of Obstetricians and Gynecologists, the California Pharmacists Association, and other health preclude care This section does not organizations. the use of existing publications developed by nationally recognized medical organizations. 4052.4. Skin Puncture by Pharmacist; Conditions Permitting Notwithstanding Section 2038 or any other provision of law, a pharmacist may perform skin puncture in the course of performing routine patient assessment procedures or in the course of performing any procedure authorized under Section 1206.5 or 1206.6. For purposes of this section, "routine patient assessment procedures" means: (a) procedures that a patient could, with or without a prescription, perform for himself or herself, or (b) clinical laboratory tests that are classified as waived pursuant to th e federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a) and the regulations adopted thereunder by the federal Health Care Financing Administration, as authorized by paragraph (11) of subdivision (a) of Section 1206.5 or Section 1 206.6. A pharmacist performing these functions shall report the results obtained from a test to the patient and any physician designated by the patient. Any pharmacist who performs the service authorized by this section shall not 2052. be in violation of Section 40

41 4052.5. Pharmacist May Select Different Form of Medication with Same Active Chemical Ingredients (a) In addition to the authority allowed under Section 4073, a pharmacist filling a prescription order for a drug product may select a different fo rm of medication with the same active chemical ingredients of equivalent strength and duration of therapy as the prescribed drug product when the change will improve the ability of the patient to comply with the prescribed drug therapy. (b) In no case sh all a selection be made pursuant to this section if the prescriber personally indicates, either orally or in his or her own handwriting, "Do not substitute" or words of similar meaning. g a box on Nothing in this subdivision shall prohibit a prescriber from checkin a prescription marked "Do not substitute" if the prescriber personally initials the box or checkmark. (c) Selection pursuant to this section is within the discretion of the pharmacist, except as provided in subdivision (b). The pharmacist who selects the drug product to be dispensed pursuant to this section shall assume the same responsibility for selecting the dispensed drug product as would be incurred in filling a prescription for a drug product using the prescribed form of medication. The re shall be no liability on the prescriber for an act or omission by a pharmacist in selecting, preparing, or dispensing a drug product pursuant to this section. (d) This section shall apply to all prescriptions, including those presented by or on behalf of persons receiving assistance from the federal government or pursuant to the California Medical Assistance Program set forth in Chapter 7 (commencing with Section 14000) of Part 3 of Division 9 of the Welfare and Institutions Code. tion is made pursuant to this section, the use of the (e) When a substitu different form of medication shall be communicated to the patient, and the name of the dispensed drug product shall be indicated on the prescription label, unless the prescriber orders otherwise. (f) This section shall not permit substitution between long acting and short - - acting forms of a medication with the same chemical ingredients or between one drug product and two or more drug products with the same chemical ingredients. e Pharmacist; Permitted Procedures 4052.6. Advanced Practic (a) A pharmacist recognized by the board as an advanced practice pharmacist may do all of the following: (1) Perform patient assessments. Order and interpret drug therapy - related tests. (2) (3) Refer patients to o ther health care providers. (4) Participate in the evaluation and management of diseases and health conditions in collaboration with other health care providers. (5) Initiate, adjust, or discontinue drug therapy in the manner specified in of subdivision (a) of Section 4052.2. paragraph (4) 41

42 (b) A pharmacist who adjusts or discontinues drug therapy shall promptly transmit written notification to the patient’s diagnosing prescriber or enter the appropriate information in a patient record system shared wi th the prescriber, as permitted by that prescriber. A pharmacist who initiates drug therapy shall promptly transmit written notification to, or enter the appropriate information into, a patient record system shared with the patient’s primary care provider or diagnosing provider, as permitted by that provider. (c) This section shall not interfere with a physician’s order to dispense a ritten, or other order of similar meaning. prescription drug as w Prior to initiating or adjusting a controlled substa nce therapy pursuant to (d) this section, a pharmacist shall personally register with the federal Drug Enforcement Administration. (e) A pharmacist who orders and interprets tests pursuant to paragraph (2) of subdivision (a) shall ensure that the ordering of those tests is done in coordination with the patient’s primary care provider or diagnosing prescriber, as appropriate, including promptly transmitting written notification to the patient’s diagnosing prescriber or entering the appropriate information in a patient record system shared with the prescriber, when available and as permitted by that prescriber. 4052.7. Repackage Previously Dispensed Drug; Requirements (a) A pharmacy may, at a patient's request, repackage a drug previously dispensed to the pa tient or to the patient's agent pursuant to a prescription. (b) Any pharmacy providing repackaging services shall have in place policies and procedures for repackaging these drugs and shall label the repackaged prescription container with the following: (1) All the information required by Section 4076. (2) The name and address of the pharmacy repackaging the drug and the name and address of the pharmacy that initially dispensed the drug to the patient. (c) The repackaging pharmacy and the pharma cy that initially dispensed the drug shall only be liable for its own actions in providing the drug to the patient or the patient's agent. 4052.8. Initiation and Administration of Vaccines; Requirements In addition to the authority provided in par agraph (11) of subdivision (a) of (a) Section 4052, a pharmacist may independently initiate and administer vaccines listed on the routine immunization schedules recommended by the federal Advisory Committee on Immunization Practices (ACIP), in compliance with individual ACIP vaccine recommendations, and published by the federal Centers for Disease Control and Prevention (CDC) for persons three years of age and older. (b) In order to initiate and administer an immunization described in subdivision (a), a pharm acist shall do all of the following: Complete an immunization training program endorsed by the CDC or the (1) Accreditation Council for Pharmacy Education that, at a minimum, includes on injection technique, clinical evaluation of indications and - hands 42

43 ontraindications of vaccines, and the recognition and treatment of emergency c reactions to vaccines, and shall maintain that training. (2) Be certified in basic life support. (3) Comply with all state and federal recordkeeping and reporting requirements , including providing documentation to the patient’s primary care provider and entering information in the appropriate immunization registry designated by the immunization branch of the State Department of Public Health. (c) A pharmacist administering im munizations pursuant to this section, or paragraph (11) of subdivision (a) of Section 4052, may also initiate and administer epinephrine or diphenhydramine by injection for the treatment of a severe allergic reaction. 4052.9. Pharmacist Furnishing Nicot ine Replacement Products; Requirements (a) A pharmacist may furnish nicotine replacement products approved by the federal Food and Drug Administration for use by prescription only in accordance with standardized procedures and protocols developed and app roved by both the board and the Medical Board of California in consultation with other appropriate entities and provide smoking cessation services if all of the following conditions are met: and devices The pharmacist maintains records of all prescription drugs (1) furnished for a period of at least three years for purposes of notifying other health care providers and monitoring the patient. (2) The pharmacist notifies the patient’s primary care provider of any drugs or devices furnished to the patient, or enters the appropriate information in a patient record system shared with the primary care provider, as permitted by that primary care provider. If the patient does not have a primary care provider, the pharmacist provides the patient with a written re cord of the drugs or devices furnished and advises the patient to consult a physician of the patient’s choice. (3) The pharmacist is certified in smoking cessation therapy by an organization recognized by the board. (4) r of continuing education focused on The pharmacist completes one hou smoking cessation therapy biennially. (b) The board and the Medical Board of California are both authorized to ensure compliance with this section, and each board is specifically charged with the enforcement of this s ection with respect to their respective licensees. Nothing in this section shall be construed to expand the authority of a pharmacist to prescribe any other prescription medication. 4052.10 Partial Fills of Schedule II Controlled Substance st may dispense a Schedule II controlled substance, as listed in (a) A pharmaci Section 11055 of the Health and Safety Code, as a partial fill if requested by the patient or the prescriber. (b) If a pharmacist dispenses a partial fill on a prescription pursuant to this ection, the pharmacy shall retain the original prescription, with a notation of s how much of the prescription has been filled, until the prescription has been 43

44 fully dispensed. The total quantity dispensed shall not exceed the total quantity prescribed. (c) Subsequent fills, until the original prescription is completely dispensed, shall occur at the pharmacy where the original prescription was partially filled. The full prescription shall be dispensed not more than 30 days after the date on which the prescrip one days after the date on which the tion was written. Thirty - prescription was written, the prescription shall expire and no more of the drug shall be dispensed without a subsequent prescription. (d) The pharmacist shall record in the state prescription dr ug monitoring program only the actual amounts of the drug dispensed. (e) The pharmacist shall record the date and amount of each partial fill in a readily retrievable form and on the original prescription, and shall include the ho dispensed each partial fill. initials of the pharmacist w (f) A pharmacist may charge a professional dispensing fee to cover the actual supply and labor costs associated with dispensing each partial fill associated with the original prescription. (g) This section shall not be const rued to limit the authority of the Department of Managed Health Care, pursuant to Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code. (h) This section is not intended to conflict with or supersede any other requirement e stablished for the prescription of a Schedule II controlled substance. (i) For purposes of this section, the following definitions apply: (1) “Original prescription” means the prescription presented by the patient to the pharmacy or submitted electronicall y to the pharmacy. (2) “Partial fill” means a part of a prescription filled that is of a quantity less than the entire prescription. (j) This section shall become operative on July 1, 2018. 4053. Designated Representative to Supervise Wholesaler or Veter inary Food - Animal Drug Retailer (a) Notwithstanding Section 4051, the board may issue a license as a designated representative to provide sufficient and qualified supervision in a wholesaler or veterinary food - animal drug retailer. The designated represe ntative shall protect the public health and safety in the handling, storage, and shipment of dangerous drugs and dangerous devices in the wholesaler or - animal drug retailer. veterinary food An individual who is at least 18 years of age may apply for a designated (b) representative license. In order to obtain and maintain that license, the individual shall meet all of the following requirements: (1) He or she shall be a high school graduate or possess a general education development certificate equivalen t. He or she shall have a minimum of one year of paid work experience in a (2) licensed pharmacy, or with a drug wholesaler, drug distributor, or drug manufacturer, in the past three years, related to the distribution or dispensing of dangerous devices or meet all of the prerequisites to take dangerous drugs or the examination required for licensure as a pharmacist by the board. 44

45 (3) He or she shall complete a training program approved by the board that, at a minimum, addresses each of the following subj ects: (A) Knowledge and understanding of California law and federal law relating to the distribution of dangerous drugs and dangerous devices. Knowledge and understanding of California law and federal law relating (B) to the distribution of controlled substances. Knowledge and understanding of quality control systems. (C) (D) Knowledge and understanding of the United States Pharmacopoeia standards relating to the safe storage and handling of drugs. (E) Knowledge and understanding of prescription t erminology, abbreviations, dosages, and format. (4) The board may, by regulation, require training programs to include additional material. (5) The board may not issue a license as a designated representative until the etion of the required training to the board. applicant provides proof of compl The veterinary food animal drug retailer or wholesaler shall not operate (c) - without a pharmacist or a designated representative on its premises. (d) Only a pharmacist or a designated representative shall pr epare and affix the label to veterinary food animal drugs. - (e) Section 4051 shall not apply to any laboratory licensed under Section 351 of Title III of the Public Health Service Act (Public Law 78 - 410). vise Third PL to Super 4053.1. Party - Designated Representative 3 - Logistics Provider (a) Notwithstanding Section 4051, the board may issue a license to a qualified individual as a designated representative - 3PL to provide sufficient and qualified supervision of a third f business. The - party logistics provider’s place o - 3PL shall protect the public health and safety in the designated representative handling, storage, warehousing, distribution, and shipment of dangerous drugs - party logistics provider’s place of business. and dangerous devices in the third An individual who is at least 18 years of age may apply for a designated (b) - 3PL license. In order to obtain and maintain that license, the representative individual shall meet all of the following requirements: (1) uate or possess a general education He or she shall be a high school grad development certificate equivalent. (2) He or she shall meet one of the following requirements: (A) Have a minimum of one year of paid work experience in the past three years with a third - party logistics provider. (B) Have a minimum of one year of paid work experience in the past three years in a licensed pharmacy, or with a drug wholesaler, drug distributor, or drug manufacturer, performing duties related to the distribution or dispensing of dangerous drugs or dang erous devices. (C) Meet all of the prerequisites to take the examination required for licensure as a pharmacist by the board. (3) (A) He or she shall complete a training program approved by the board that, at a minimum, addresses each of the following subjects: 45

46 (i) Knowledge and understanding of California law and federal law relating to the distribution of dangerous drugs and dangerous devices. (ii) Knowledge and understanding of California law and federal law relating to the distribution of contro lled substances. (iii) Knowledge and understanding of quality control systems. (iv) Knowledge and understanding of the United States Pharmacopoeia or federal Food and Drug Administration standards relating to the safe storage, handling, and transport o f dangerous drugs and dangerous devices. (B) The board may, by regulation, require the training program required under this paragraph to include additional material. (C) The board shall not issue a license as a designated representative - 3PL until the a pplicant provides proof of completion of the training required by this paragraph to the board. (c) A third - party logistics provider shall not operate without at least one designated representative - 3PL present at each of its licensed places of business as required under Section 4160. Licensing; – Reverse Distributor 4053.2. Designated Representative - Requi rements (a) Notwithstanding Sections 4051 and 4053, the board may issue a designated representative - l who shall reverse distributor license to a qualified individua provide sufficient and qualified supervision over a licensed wholesaler that only acts as a reverse distributor. The designated representative - reverse distributor shall protect the public health and safety in the handling, storage, warehousing, and destruction of outdated or nonsaleable dangerous drugs and dangerous devices. (b) An individual who is at least 18 years of age may apply for a designated representative - reverse distributor license. In order to obtain and maintain that license, the in dividual shall meet all of the following requirements: (1) He or she shall be a high school graduate or possess a general education development certificate equivalent. (2) He or she shall meet one of the following requirements: (A) Have a minimum of one ye ar of paid work experience in the past three years with a licensed wholesaler, third - party logistics provider, or pharmacy performing duties related to the distribution, dispensing, or destruction of dangerous drugs or dangerous devices. (B) Have a minimum of one year of paid work experience in the destruction of outdated or nonsaleable dangerous drugs or dangerous devices pharmaceutical waste. (C) Meet all of the prerequisites to take the examination required for licensure as a pharmacist by the board. (3) (A) He or she shall complete a training program approved by the board that, at a minimum, addresses each of the following subjects: (i) Knowledge and understanding of California law and federal law relating to rous devices. the distribution of dangerous drugs and dange (ii) Knowledge and understanding of California law and federal law relating to the distribution of controlled substances. 46

47 (iii) Knowledge and understanding of California law and federal law relating to the removal and destruction of dangerous drugs, dangerous devices, and pharmaceutical waste. (iv) Knowledge and understanding of the United States Pharmacopoeia or federal Food and Drug Administration standards relating to the safe storage, handling, and transport of dangerous drugs and dangerou s devices. (B) The board may, by regulation, require the training program required under this paragraph to include additional material. (C) The board shall not issue a license as a designated representative - reverse distributor until the applicant provides proof of completion of the training required by this paragraph to the board. (c) A reverse distributor shall not operate without at least one designated representative or designated representative - reverse distributor present at each of of business as required under Section 4160. its licensed places 4054. Supply by Manufacturer, etc. of Certain Dialysis Drugs and Devices Section 4051 shall not apply to a manufacturer or wholesaler that provides dialysis drugs and devices directly to patients. ale of Devices to Licensed Clinics, etc. 4055. S Nothing in this chapter, nor any other law, shall prohibit the sale of devices to clinics that have been issued a clinic license pursuant to Article 13 nursing facilities (commencing with Section 4180) of this chapter, or to skilled or intermediate care facilities licensed pursuant to Chapter 2 (commencing with Section 1250) of, or to home health agencies licensed pursuant to Chapter 8 (commencing with Section 1725) of, or to hospices licensed pursuant to Chapter 8 .5 (commencing with Section 1745) of, Division 2 of, the Health and Safety Code, as long as the devices are furnished only upon the prescription or order of a physician, dentist, or podiatrist. 4056. Purchase of Drugs at Wholesale – Hospital Containing 10 0 Beds or Less (a) Notwithstanding any provision of this chapter, a licensed hospital that time pharmacist, - contains 100 beds or fewer, and that does not employ a full may purchase drugs at wholesale for administration, under the direction of a physician , or for dispensation by a physician, to persons registered as inpatients of the hospital, to emergency cases under treatment in the hospital, or, under the conditions described in subdivision (f), to persons registered as outpatients in a rural hospital a s defined in Section 124840 of the Health and Safety Code. The hospital shall keep records of the kind and amounts of drugs so purchased and administered or dispensed, and the records shall be available for inspection by all properly authorized personnel of the board. (b) No hospital shall be entitled to the benefits of subdivision (a) until it has obtained a license from the board. Each license shall be issued to a specific hospital and for a specific location. (c) Each application for a license unde r this section shall be made on a form furnished by the board. Upon the filing of the application and payment of the 47

48 fee prescribed in subdivision (a) of Section 4400, the executive officer of the board shall issue a license authorizing the hospital to wh ich it is issued to purchase drugs at wholesale pursuant to subdivision (a). The license shall be renewed annually on or before November 1 of each year upon payment of the renewal fee prescribed in subdivision (b) of Section 4400 and shall not be transfera ble. (d) The form of application for a license under this section shall contain the name and address of the applicant, the number of beds, whether the applicant is a licensed hospital, whether it does or does not employ a full - time pharmacist, f its chief medical officer, and the name of its administrator. the name o (e) The board may deny, revoke, or suspend a license issued under this section in the manner and for the grounds specified in Article 19 (commencing with Section 4300). (f) A physician him self or herself may dispense drugs to outpatients directly pursuant to subdivision (a) only if the physician determines that it is in the best interest of the patient that a particular drug regimen be immediately commenced or continued, and the physician r easonably believes that a pharmacy located outside the hospital is not available and accessible at the time of dispensation to the patient within 30 minutes of the hospital pharmaceutical mile radius from the hospital pharmaceutical services by - services or within a 30 means of the method of transportation the patient states that he or she intends to use. The quantity of drugs dispensed to any outpatient pursuant to this subdivision shall be limited to that amount necessary to maintain uninterrupted therapy during the period when pharmaceutical services outside the hospital are not readily available or accessible, but shall not exceed a 72 - hour supply. The physician shall ensure that the label on the drug contains all the information required by Section 407 6. (g) A rural hospital, as defined in Section 124840 of the Health and Safety Code, shall obtain information regarding the hours of operation of each pharmacy located within the 30 minute or 30 - mile radius of the hospital. The hospital shall update thi s information annually, and shall make this information available to its medical staff. (h) A licensed hospital that contains 100 beds or fewer, does not employ a full - time pharmacist, and purchases drugs at wholesale for administration or dispensation p ursuant to subdivision (a), shall retain the services of a pharmacist consultant to monitor and review the pharmaceutical services provided by the hospital to inpatients of the hospital, and the dispensing of drugs by physicians to outpatients pursuant to subdivision (f). (i) This section shall not be construed to eliminate the requirements of Section 11164 or 11167 of the Health and Safety Code. 4057. Exceptions to Application of this Chapter (a) Except as provided in Section 4006, subdivision (d) of S ection 4081, Section 4240, subdivisions (t) and (u) of Section 4301, and Section 4342, this chapter does not apply to the retail sale of nonprescription drugs that are not subject to Section 4022 and that are packaged or bottled in the manufacturer’s 48

49 or di stributor’s container and labeled in accordance with applicable federal and state drug labeling requirements. (b) This chapter does not apply to specific dangerous drugs and dangerous devices listed in board regulations, where the sale or furnishing is mad e to any of the following: (1) A physician, dentist, podiatrist, pharmacist, medical technician, medical technologist, optometrist, or chiropractor holding a currently valid and unrevoked license and acting within the scope of his or her profession. (2) A clinic, hospital, institution, or establishment holding a currently valid and unrevoked license or permit under Division 2 (commencing with Section 1200) of the Health and Safety Code, or Chapter 2 (commencing with Section 3300) of Division 3 of, or Part 2 (commencing with Section 6250) of Division 6 of, the Welfare and Institutions Code. (3) A correctional clinic, as defined in Section 4187, holding a currently valid and unrevoked license or permit under Article 13.5 (commencing with Section 4187). (c) Thi s chapter shall not apply to a home health agency licensed under Chapter 8 (commencing with Section 1725) of, or a hospice licensed under Chapter 8.5 (commencing with Section 1745) of, Division 2 of, the Health and Safety Code, urnishes, or transports specific dangerous drugs and when it purchases, stores, f dangerous devices listed in board regulations in compliance with applicable law and regulations including: (1) Dangerous devices described in subdivision (b) of Section 4022, as long as these dangerous d evices are furnished only upon the prescription or order of a physician, dentist, or podiatrist. (2) Hypodermic needles and syringes. (3) Irrigation solutions of 50 cubic centimeters or greater. (d) This chapter does not apply to the storage of devices in secure central or ward supply areas of a clinic, hospital, institution, or establishment holding a currently valid and unrevoked license or permit pursuant to Division 2 (commencing with Section 1200) of the Health and Safety Code, or pursuant to Chapter 2 (commencing with Section 3300) of Division 3 of, or Part 2 (commencing with Section 6250) of Division 6 of, the Welfare and Institutions Code. (e) This chapter does not apply to the retail sale of vitamins, mineral products, or combinations thereof or to foods, supplements, or nutrients used to fortify the diet of humans or other animals or poultry and labeled as such that are not subject to Section 4022 and that are packaged or bottled in the manufacturer’s ance with applicable federal and or distributor’s container and labeled in accord state labeling requirements. (f) This chapter does not apply to the furnishing of dangerous drugs and dangerous devices to recognized schools of nursing. These dangerous drugs and dangerous devices shall not include contro lled substances. The dangerous drugs and dangerous devices shall be used for training purposes only, and not for the , or treatment of disease in humans. Recognized schools of cure, mitigation nursing for purposes of this subdivision are those schools reco gnized as training facilities by the California Board of Registered Nursing. 49

50 4058. Display of Original License Every person holding a license issued under this chapter to operate a premises e upon the licensed shall display the original license and current renewal licens premises in a place where it may be clearly read by the public. 4059. Furnishing Dangerous Drugs or Devices Prohibited Without Prescription: Exceptions (a) A person may not furnish any dangerous drug, except upon the prescription of a physician, dentist, podiatrist, optometrist, veterinarian, or naturopathic doctor pursuant to Section 3640.7. A person may not furnish any dangerous device, except upon the prescription of a physician, dentist, podiatrist, optometrist, veterinarian, or naturopathic doctor pursuant to Section 3640.7. (b) This section does not apply to the furnishing of any dangerous drug or dangerous device by a manufacturer, wholesaler, or pharmacy to each other or to a physician, dentist, podiatrist, optometrist, v eterinarian, or naturopathic doctor pursuant to Section 3640.7, or to a laboratory under sales and purchase records that correctly give the date, the names and addresses of the supplier and not apply to the buyer, the drug or device, and its quantity. This section does the furnishing of any dangerous device by a manufacturer, wholesaler, or pharmacy to a physical therapist acting within the scope of his or her license under sales and purchase records that correctly provide the date the device is provided, t he names and addresses of the supplier and the buyer, a description of the device, and the quantity supplied. (c) A pharmacist, or a person exempted pursuant to Section 4054, may distribute dangerous drugs and dangerous devices directly to dialysis patie nts pursuant to regulations adopted by the board. The board shall adopt any regulations as are necessary to ensure the safe distribution of these drugs and devices to dialysis patients without interruption thereof. A person who violates a regulation adopte d pursuant to this subdivision shall be liable upon order of the board to surrender his or her personal license. These penalties shall be in addition to penalties that may be imposed pursuant to Section 4301. If the board finds any dialysis drugs or device s distributed pursuant to this subdivision to be ineffective or unsafe for the intended use, the board may institute immediate recall of any or all of the drugs or devices distributed to individual patients. (d) Home dialysis patients who receive any dru gs or devices pursuant to subdivision (c) shall have completed a full course of home training given by a Public dialysis center licensed by the State Department of Health. The physician prescribing the dialysis products shall submit proof satisfactory to t he manufacturer or wholesaler that the patient has completed the program. (e) A pharmacist may furnish a dangerous drug authorized for use pursuant to Section 2620.3 to a physical therapist. A record containing the date, name and d name and quantity of the drug shall be maintained. address of the buyer, an This subdivision shall not be construed to authorize the furnishing of a controlled substance. 50

51 (f) A pharmacist may furnish electroneuromyographic needle electrodes or hypodermic needles used for the p urpose of placing wire electrodes for kinesiological electromyographic testing to physical therapists who are certified by the Physical Therapy Board of California to perform tissue penetration in accordance with Section 2620.5. (g) Nothing in this secti on shall be construed as permitting a licensed physical therapist to dispense or furnish a dangerous device without a prescription of a physician, dentist, podiatrist, optometrist, or veterinarian. animal drug retailer shall dispens - e, furnish, transfer, or (h) A veterinary food sell veterinary food animal drugs only to another veterinary food - animal drug - retailer, a pharmacy, a veterinarian, or to a veterinarian's client pursuant to a prescription from the veterinarian for food - producing animals. 4059.5. Who May Order Dangerous Drugs or Devices: Exceptions; Compliance With Laws of All Involved Jurisdictions (a) Except as otherwise provided in this chapter, dangerous drugs or dangerous devices may only be ordered by an entity licensed by the board and s hall be delivered to the licensed premises and signed for and received by a pharmacist. Where a licensee is permitted to operate through a designated or in the case of a reverse distributor a designated representative, representative - revers e distributor, t hat individual shall sign for and receive the delivery. (b) A dangerous drug or dangerous device transferred, sold, or delivered to a person within this state shall be transferred, sold, or delivered only to an entity licensed by the board, to a manufact urer, or to an ultimate user or the ultimate user's agent. (c) Notwithstanding subdivisions (a) and (b), deliveries to a hospital pharmacy may be made to a central receiving location within the hospital. However, the dangerous drugs or dangerous devices shall be delivered to the licensed pharmacy premises within one working day following receipt by the hospital, and the pharmacist on duty at that time shall immediately inventory the dangerous drugs or dangerous devices. (d) Notwithstanding any other law , a dangerous drug or dangerous device may be ordered by and provided to a manufacturer, physician, dentist, podiatrist, optometrist, veterinarian, naturopathic doctor pursuant to Section 3640.7, or laboratory, or a physical therapist acting within the sco pe of his or her license. A person or entity receiving delivery of a dangerous drug or dangerous device, or a duly authorized representative of the person or entity, shall sign for the receipt of the dangerous drug or dangerous device. (e) A dangerous dr ug or dangerous device shall not be transferred, sold, or delivered to a person outside this state, whether foreign or domestic, unless the transferor, seller, or deliverer does so in compliance with the laws of this state and of the United States and of t he state or country to which the dangerous drugs or dangerous devices are to be transferred, sold, or delivered. Compliance with the laws of this state and the United States and of the state or country to to be delivered shall which the dangerous drugs or dangerous devices are include, but not be limited to, determining that the recipient of the dangerous 51

52 drugs or dangerous devices is authorized by law to receive the dangerous drugs or dangerous devices. (f) Notwithstanding subdivision (a), a pharmacy may take delivery of dangerous drugs and dangerous devices when the pharmacy is closed and no pharmacist is on duty if all of the following requirements are met: (1) The drugs are placed in a secure storage facility in the same building as the pharmacy. (2) Only the pharmacist - in - charge or a pharmacist designated by the in - charge has access to the secure storage facility after dangerous pharmacist - drugs or dangerous devices have been delivered. ing whether it has been (3) The secure storage facility has a means of indicat entered after dangerous drugs or dangerous devices have been delivered. (4) The pharmacy maintains written policies and procedures for the delivery of dangerous drugs and dangerous devices to a secure storage facility. (5) T he agent delivering dangerous drugs and dangerous devices pursuant to this subdivision leaves documents indicating the name and amount of each dangerous drug or dangerous device delivered in the secure storage facility. for the dangerous drugs and dangerous The pharmacy shall be responsible devices delivered to the secure storage facility. The pharmacy shall also be responsible for obtaining and maintaining records relating to the delivery of ity. dangerous drugs and dangerous devices to a secure storage facil (g) Notwithstanding subdivision (a), dangerous drugs and devices and controlled substances may be ordered by a remote dispensing site pharmacy licensed by the board and may be signed for and received by a registered pharmacy technician, who meets the qualifications of Section 4132, at the remote site. A controlled substance signed for by a pharmacy technician under this section shall be stored separately from existing inventory until the time the pharmacist. Any controlled substance is reviewed and countersigned by a receipt and storage of a controlled substance by a pharmacy technician pursuant to this section shall be captured on video, and that video shall be made accessible to the supervising pharmacy and maintained by the remote dispensing site ph armacy for 120 days. 4060. Controlled Substance : Prescription Required; Exceptions A person shall not possess any controlled substance, except that furnished to a person upon the prescription of a physician, dentist, podiatrist, optometrist, veterina or naturopathic doctor pursuant rian, to Section 3640.7, or furnished to Section pursuant to a drug order issued by a certified nurse - midwife pursuant Section 2746.51, nurse practitioner pursuant to a 2836.1, a physician assistant doctor to Section 3502. 1, a naturopathic pursuant pursuant to Section 3640.5, or a pharmacist pursuant to Section 4052.1, 4052.2, or 4052.6. This section does controlled not apply to the possession of any manufacturer, substance by a physician, - party logistics provider, third pha rmacy, pharmacist, wholesaler, podiatrist, dentist, optometrist, veterinarian, naturopathic doctor, certified nurse - midwife, nurse practitioner, or physician assistant, if in stock in or containers correctly labeled with the name and address of the supplier producer. 52

53 This section does not authorize a certified nurse - midwife, a nurse practitioner, of a physician assistant, or a naturopathic doctor, to order his or her own stock dangerous drugs devices. and equest Required 4061. Distribution of a Drug as Sample; Written R (a) No manufacturer's sales representative shall distribute any dangerous drug or dangerous device as a complimentary sample without the written request of a r physician, dentist, podiatrist, optometrist, veterinarian, or naturopathic docto pursuant to Section 3640.7. However, a certified nurse - midwife who functions pursuant to a standardized procedure or protocol described in Section 2746.51, a nurse practitioner who functions pursuant to a standardized procedure 1, or protocol, a physician assistant who functions described in Section 2836. pursuant to a protocol described in Section 3502.1, or a naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, may sign for the request and receip t of complimentary samples of a dangerous drug or dangerous device that has been identified in the standardized procedure, protocol, or practice agreement. Standardized procedures, protocols, and practice agreements shall include specific approval by a phy sician. A review process, consistent with the requirements of Section 2725, 3502.1, or 3640.5, of the complimentary samples requested and received by a nurse practitioner, certified nurse - midwife, physician assistant, or naturopathic doctor, shall be defin ed within the standardized procedure, protocol, or practice agreement. (b) Each written request shall contain the names and addresses of the supplier and the requester, the name and quantity of the specific dangerous drug desired, midwife, nurse practitioner, physician assistant, the name of the certifi ed nurse - or naturopathic doctor, if applicable, receiving the samples pursuant to this section, the date of receipt, and the name and quantity of the dangerous drugs or dangerous devices provided. These rec ords shall be preserved by the supplier with the records required by Section 4059. (c) Nothing in this section is intended to expand the scope of practice of a certified nurse - midwife, nurse practitioner, physician assistant, or naturopathic doctor. uring Emergency 406 2. Furnishing Dangerous Drugs d ; Mobile Pharmacy or a clinic (a) Notwithstanding Section 4059 or any other law, a pharmacist licensed and acting under Section 4180 may, in good faith, furnish a dangerous drug or dangerous device in reason able quantities without a prescription during a federal, state, or local emergency, to further the health and safety of the public. A record containing the date, name, and address of the person to whom the drug or device is furnished, and the name, streng th, and quantity of the drug shall or device furnished shall be maintained. The pharmacist or clinic communicate this information to the patient's attending physician as soon as possible. Notwithstanding Section 4060 or any other law, a person may posses s a dangerous drug or dangerous device furnished without prescription pursuant to this section. 53

54 (b) During a declared federal, state, or local emergency, the board may waive application of any provisions of this chapter or the regulations adopted pursuan t to it if, in the board's opinion, the waiver will aid in the protection of public health or the provision of patient care. (c) During a declared federal, state, or local emergency, the board shall allow for the employment of a mobile pharmacy c in impacted areas in order or clini to ensure the continuity of patient care, if all of the following conditions are met: or clinic shares common ownership with at least one (1) The mobile pharmacy or clinic in good standing. currently licensed pharmacy (2) T he mobile pharmacy or clinic retains records of dispensing, as required by subdivision (a). (3) A licensed pharmacist or, in the case of a clinic, a professional director, is , on the premises and the mobile pharmacy is under the control and management a pharmacist , of while the or, in the case of a clinic, a professional director, drugs are being dispensed. (4) Reasonable security measures are taken to safeguard the drug supply maintained in the mobile pharmacy or clinic . is located within the declared emergency inic or cl (5) The mobile pharmacy area or affected areas. (6) The mobile pharmacy or clinic ceases the provision of services within 48 hours following the termination of the declared emergency. (d) Notwithstanding any other law, the board ma y elect to continue to waive application of any provision of this chapter for up to 90 days following the termination of the declared emergency if, in the board’s opinion, the continued waiver will aid in the protection of the public health or in the provi sion of patient care. 4063. Refill of Prescription for Dangerous Drug or Device Requires Prescriber Authorization No prescription for any dangerous drug or dangerous device may be refilled except upon authorization of the prescriber. The authorization may be given orally or at the time of giving the original prescription. No prescription for any dangerous drug that is a controlled substance may be designated refillable as needed. 4064. Emergency Refill of Prescription without Prescriber Authorizati on (a) A prescription for a dangerous drug or dangerous device may be refilled without the prescriber's authorization if the prescriber is unavailable to authorize the refill and if, in the pharmacist's professional judgment, failure to refill the prescr iption might interrupt the patient's ongoing care and have a significant adverse effect on the patient's well - being. (b) The pharmacist shall inform the patient that the prescription was refilled pursuant to this section. m the prescriber within a reasonable period of (c) The pharmacist shall infor time of any refills dispensed pursuant to this section. 54

55 (d) Prior to refilling a prescription pursuant to this section, the pharmacist shall make every reasonable effort to contact the prescriber. The pharm acist shall make an appropriate record, including the basis for proceeding under this section. (e) The prescriber shall not incur any liability as the result of a refilling of a prescription pursuant to this section. (f) Notwithstanding Section 4060 or any other law, a person may possess a dangerous drug or dangerous device furnished without prescription pursuant to this section. (g) During a proclaimed state of emergency, nothing in either this section or a pharmacist, a clinic licensed any other provision of this chapter prohibits under Section 4180, or a mobile pharmacy or clinic described in subdivision (c) of Section 4062 from refilling a prescription if the prescriber is unavailable, or if after a reasonable effort has been made, the pharmacist, c linic, or mobile pharmacy is unable to contact the prescriber. 4064.5. Dispensing a 90 - Day Supply of a Dangerous Drug or Device; Requirements and Exceptions (a) A pharmacist may dispense not more than a 90 - day supply of a dangerous drug other than a cont rolled substance pursuant to a valid prescription that - day supply followed by periodic specifies an initial quantity of less than a 90 refills of that amount if all of the following requirements are satisfied: - day supply of the dangerous drug. (1) The patient has completed an initial 30 (2) The total quantity of dosage units dispensed does not exceed the total quantity of dosage units authorized by the prescriber on the prescription, including refills. (3) The prescriber has not specified on the pr escription that dispensing the prescription in an initial amount followed by periodic refills is medically necessary. (4) The pharmacist is exercising his or her professional judgment. he same (b) For purposes of this section, if the prescription continues t day - - medication as previously dispensed in a 90 day supply, the initial 30 supply under paragraph (1) of subdivision (a) is not required. (c) A pharmacist dispensing an increased supply of a dangerous drug pursuant to this section shall notify th e prescriber of the increase in the quantity of dosage units dispensed. (d) In no case shall a pharmacist dispense a greater supply of a dangerous drug pursuant to this section if the prescriber personally indicates, either orally or in his or her own h andwriting, "No change to quantity," or words of similar meaning. Nothing in this subdivision shall prohibit a prescriber from checking a box on a prescription marked "No change to quantity," provided that the kmark. To indicate that an prescriber personally initials the box or chec increased supply shall not be dispensed pursuant to this section for an electronic data transmission prescription as defined in subdivision (c) of Section 4040, a prescriber may indicate "No change to quantity," or words of ar meaning, in the prescription as transmitted by electronic data, or may simil check a box marked on the prescription "No change to quantity." In either 55

56 instance, it shall not be required that the prohibition on an increased supply be manually initialed by the prescriber. (e) This section shall not apply to psychotropic medication or psychotropic drugs as described in subdivision (d) of Section 369.5 of the Welfare and Institutions Code. (f) Except for the provisions of subdivision (d), this section does n ot apply to FDA - approved, self - administered hormonal contraceptives. month - (1) A pharmacist shall dispense, at a patient’s request, up to a 12 - approved, self - administered hormonal contraceptive supply of an FDA pursuant to a valid prescription that spec ifies an initial quantity followed by periodic refills. (2) A pharmacist furnishing an FDA - approved, self - administered hormonal contraceptive pursuant to Section 4052.3 under protocols developed by the Board of Pharmacy may furnish, at the patient’s req uest, up to a 12 - month supply at one time. Nothing in this subdivision shall be construed to require a pharmacist to (3) dispense or furnish a drug if it would result in a violation of Section 733. (g) Nothing in this section shall be construed to re quire a health care service plan, health insurer, workers’ compensation insurance plan, pharmacy benefits manager, or any other person or entity, including, but not limited to, a state a program or state employer, to provide coverage for a dangerous drug in manner inconsistent with a beneficiary’s plan benefit. 4065. Injection Card System; Requirements for Administration (a) "Injection card system," as used in this section, means a system that enables a facility to authorize an outpatient to receive inj ections of controlled substances at the facility pursuant to a prior written order by a physician, through the use of a card that is maintained at the location in the facility where the injections are administered. (1) The injection card shall include, at a minimum, the following information: the date of authorization, the number and frequency of injections authorized, the name of the drug including the strength and amount authorized, the names of the prescribing physician and the patient, the date and time of each injection, and the signature of the person administering the injection. (2) In addition, the patient's medical record maintained by the facility shall contain all of the information required under Sections 4040 and 4070 and Chapter 1 (com mencing with Section 70001) of Division 5 of Title 22 of the California Code of Regulations. (b) Notwithstanding any other provision of law, a licensed health care facility may provide for the administration of controlled substances through the use of injection card system for controlled substances. an (c) A facility that employs an injection card system shall have a written protocol for the use of this system. The protocol shall be developed by a team of health care professionals, including at least o ne physician, one registered nurse, and one pharmacist. The protocol shall provide for, but not be limited to, the following: (1) Identification of drugs to be included in the injection card system. 56

57 (2) Distinction among classes of drugs. (3) Periodic review of the efficacy of the injection card system, including, but not limited to, its effectiveness and safety for different classes of drugs. (4) Determination as to whether each drug included in the injection card system requires the prese nce of a physician or only the ready availability of a physician. (5) Implementation of recordkeeping systems that, at a minimum, record each injection and each visit, provide for the immediate entry of the injection in the patient's medical record, pr ovide a system for discontinuance of the order by the prescribing physician, and allow for ready identification of patterns of possible or actual patient abuse of controlled substances and other potential adverse drug interactions. (6) Retention of the injection card by the facility at all times when a controlled substance is being administered. (7) Adequate initial evaluation of patients, including, but not limited to, a determination as to whether each patient is a proper subject for the injection card system. (8) Ongoing medical evaluation of the patient's response to the injection card system. (9) That all injection cards shall become a permanent part of the patient's medical record within 15 days from the date the last authorized dose is administered. (d) Nothing in this section shall be construed to prohibit the use, or impose new requirements on the use, of an injection card system for noncontrolled substances. 4066. Furnishing Dangerous Drugs to Master or First Officer of Vessel (a) Notwithstanding Section 4059, a wholesaler or pharmacy may furnish dangerous drugs to the master or first officer of an ocean vessel, pursuant to a written prescription. The requisition shall be on the vessel's official stationery, signed by the vesse l's first officer. The drugs shall be maintained on board the vessel and dispensed from medicine chests, first aid packets, or dispensaries, pursuant to standardized procedures established by a registered medical officer. (b) Dangerous drugs shall be fu rnished in a sealed container to the vessel's first officer, on proper identification, or delivered aboard the vessel. (c) Wholesalers or pharmacies engaging in the activities authorized by this section shall give notice to the board within 30 days of un dertaking the activity. (d) Distribution of controlled substances shall be in accordance with federal requirements contained in Section 1301.28 of Title 21 of the Code of Federal Regulations. 4067. Internet; Dispensing Dangerous Drugs or Devices withou t Prescription (a) No person or entity shall dispense or furnish, or cause to be dispensed or furnished, dangerous drugs or dangerous devices, as defined in Section 4022, on the Internet for delivery to any person in this state without a prescription ued pursuant to a good faith prior examination of a human or animal for iss 57

58 whom the prescription is meant if the person or entity either knew or reasonably should have known that the prescription was not issued pursuant to a good faith prior examination of a human or animal, or if the person or entity did not act in accordance with Section 1761 of Title 16 of the California Code of Regulations. (b) Notwithstanding any other provision of law, a violation of this section may subject the person or entity that h as committed the violation to either a fine of up to twenty - five thousand dollars ($25,000) per occurrence pursuant to a citation issued by the board or a civil penalty of twenty - five thousand dollars ($25,000) per occurrence. (c) The Attorney General ma y bring an action to enforce this section and to collect the fines or civil penalties authorized by subdivision (b). (d) For notifications made on and after January 1, 2002, the Franchise Tax of a final Board, upon notification by the Attorney General or the board judgment in an action brought under this section, shall subtract the amount of the fine or awarded civil penalties from any tax refunds or lottery winnings due to the person who is a defendant in the action using the offset authority under Secti on 12419.5 of the Government Code, as delegated by the Controller, and the processes as established by the Franchise Tax Board for this purpose. That amount shall be forwarded to the board for deposit in the Pharmacy Board Contingent Fund. n this section shall be construed to permit the unlicensed practice (e) Nothing i of pharmacy, or to limit the authority of the board to enforce any other provision of this chapter. (f) For the purposes of this section, "good faith prior examination" includes irements for a physician and surgeon in Section 2242 and the the requ requirements for a veterinarian in Section 2032.1 of Title 16 of the California Code of Regulations. 4068. Dispense Dangerous Drug or Controlled Substance to Emergency s Room Patient; Requirement (a) Notwithstanding any provision of this chapter, a prescriber may dispense a dangerous drug, including a controlled substance, to an emergency room patient if all of the following apply: (1) The hospital pharmacy is closed and there is no pharmac ist available in the hospital. (2) The dangerous drug is acquired by the hospital pharmacy. (3) The dispensing information is recorded and provided to the pharmacy when the pharmacy reopens. (4) The hospital pharmacy retains the dispensing info rmation and, if the drug is a schedule II, schedule III, or schedule IV controlled substance, reports the dispensing information to the Department of Justice pursuant to Section 11165 of the Health and Safety Code. (5) The prescriber determines that it is in the best interest of the patient that a particular drug regimen be immediately commenced or continued, and the prescriber reasonably believes that a pharmacy located outside the hospital is not available and accessible at the time of dispensing to t he patient. 58

59 (6) The quantity of drugs dispensed to any patient pursuant to this section are limited to that amount necessary to maintain uninterrupted therapy during the period when pharmacy services outside the hospital are not readily available or ac cessible, but shall not exceed a 72 - hour supply. (7) The prescriber shall ensure that the label on the drug contains all the information required by Section 4076. (b) The prescriber shall be responsible for any error or omission related to the dispensed. drugs Article 4. Requirements for Prescriptions 4070. Reduction of Oral or Electronic Prescription to Writing (a) Except as provided in Section 4019 and subdivision (b), an oral or an electronic data transmission prescription as defined in subdi vision (c) of Section 4040 shall as soon as practicable be reduced to writing by the pharmacist and shall be filled by, or under the direction of, the pharmacist. The pharmacist need not reduce to writing the address, telephone number, license classificat ion, federal registry number of the prescriber or the address of the patient or patients if the information is readily retrievable in the pharmacy. (b) A pharmacy receiving an electronic transmission prescription shall not be cription to writing or to hard copy form if, for three required to reduce that pres years from the last date of furnishing pursuant to that prescription or order, the pharmacy is able, upon request by the board, to immediately produce a hard dispensing of a dangerous drug or copy report that includes for each date of dangerous device pursuant to that prescription or order: (1) all of the information described in subparagraphs (A) to (E), inclusive, of paragraph (1) of subdivision (a) of Section 4040, and (2) the name or identifier of t he pharmacist who dispensed the dangerous drug or dangerous device. This subdivision shall not apply to prescriptions for controlled substances classified in Schedule II, III, IV, or V, except as permitted pursuant to Section 11164.5 of ety Code. the Health and Saf (c) If only recorded and stored electronically, on magnetic media, or in any other computerized form, the pharmacy's computer system shall not permit the received information or the dangerous drug or dangerous device dispensing information requ ired by this section to be changed, obliterated, destroyed, or disposed of, for the record maintenance period required by law once the information has been received by the pharmacy and once the dangerous drug or dangerous device has been dispensed. Once a dangerous drug or dangerous device has been dispensed, if the previously created record is determined to be incorrect, a correcting addition may be made only by or with the approval of a pharmacist. After a pharmacist enters the change or enters his or h er approval of the change into the computer, the resulting record shall include the correcting addition and the date it was made to the record, the identity of the person or pharmacist making the correction, and the identity of the pharmacist correction. approving the (d) Nothing in this section shall impair the requirement to have an electronically transmitted prescription transmitted only to the pharmacy of the 59

60 patient's choice or to have a written prescription. This requirement shall not apply to order s for medications to be administered in an acute care hospital. 4071. Prescriber May Authorize Agent to Transmit Prescription; Schedule II Excluded Notwithstanding any other provision of law, a prescriber may authorize his or her agent on his or her b ehalf to orally or electronically transmit a prescription to the furnisher. The furnisher shall make a reasonable effort to determine that the person who transmits the prescription is authorized to do so and shall record f the prescriber who transmits the order. This the name of the authorized agent o section shall not apply to orders for Schedule II controlled substances. 4071.1. Electronic Prescription Entry i nto Pharmacy or Hospital Computer (a) A prescriber, a prescriber's authorized agent, or a ph armacist may electronically enter a prescription or an order, as defined in Section 4019, into a pharmacy's or hospital's computer from any location outside of the pharmacy or hospital with the permissio n of the pharmacy or hospital. For purposes of this s ection, a "prescriber's authorized agent" is a person licensed or registered under Division 2 This subdivision shall not (commencing with Section 500). apply to prescriptions for controlled substances classified in Schedule II, III, IV, or V, except as per mitted pursuant to Section 11164.5 of the Health and Safety Code. (b) Nothing in this section shall reduce the existing authority of other hospital personnel to enter medication orders or prescription orders into a hospital's computer. (c) No dangerous drug or dangerous device shall be dispensed pursuant to a prescription that has been electronically entered into a pharmacy's computer without the prior approval of a pharmacist. 4072. Oral or Elec tronic Transmission of Prescription ―Health Care Facility (a) Notwithstanding any other provision of law, a pharmacist, registered nurse, licensed vocational nurse, licensed psychiatric technician, or other healing arts licentiate, if so authorized by ad ministrative regulation, who is employed by or serves as a consultant for a licensed skilled nursing, intermediate care, or other health care facility, may orally or electronically transmit to the furnisher a prescription lawfully ordered by a person autho rized to prescribe drugs or devices pursuant to Sections 4040 and 4070. The furnisher shall take appropriate steps to determine that the person who transmits the prescription is authorized to do so and shall record the name of the person who transmits the order. This section shall not apply to orders for Schedule II controlled substances. (b) In enacting this section, the Legislature recognizes and affirms the role of Public Health in regulating drug order processing the Department of censed health care facilities as set forth in Title 22 of the requirements for li California Code of Regulations as they may be amended from time to time. 60

61 4073. Substitution of Generic Drug ―Requirements and Exceptions (a) A pharmacist filling a prescription order for a drug product prescribed by its trade or brand name may select another drug product with the same active chemical ingredients of the same strength, quantity, and dosage form, and of the same generic drug name as determined by the United States Adopted Names (USAN) and accepted by the federal Food and Drug Administration (FDA), of those drug products having the same active chemical ingredient s. (b) In no case shall a selection be made pursuant to this section if the prescriber personally indicates, either orally or in his or her own handwriting, "Do not substitute," or words of similar meaning. Nothing in this subdivision shall prohibit a pr escriber from checking a box on a prescription marked "Do not substitute"; provided that the prescriber personally initials the box or checkmark. To indicate that a selection shall not be made pursuant to this section for an electronic data transmission pr escription as defined in subdivision (c) of Section 4040, a prescriber may indicate "Do not substitute," or words of similar meaning, in the prescription as transmitted by electronic data, or may check a box marked on the prescription "Do not substitute." In either instance, it shall not be required that the prohibition on substitution be manually initialed by the prescriber. (c) Selection pursuant to this section is within the discretion of the pharmacist, n who selects the drug product except as provided in subdivision (b). The perso to be dispensed pursuant to this section shall assume the same responsibility for selecting the dispensed drug product as would be incurred in filling a prescription for a drug product prescribed by generic name. There shall be no liability on the prescriber for an act or omission by a pharmacist in selecting, preparing, or dispensing a drug product pursuant to this section. In no case shall the pharmacist select a drug product pursuant to this section unless the drug selected costs the patient less than the prescribed drug product. Cost, as product used in this subdivision, is defined to include any professional fee that may be charged by the pharmacist. (d) This section shall apply to all prescriptions, including those pres ented by or on behalf of persons receiving assistance from the federal government or pursuant to the California Medical Assistance Program set forth in Chapter 7 (commencing with Section 14000) of Part 3 of Division 9 of the Welfare and Institutions Code. (e) When a substitution is made pursuant to this section, the use of the cost - saving drug product dispensed shall be communicated to the patient and the name of the dispensed drug product shall be indicated on the prescription label, except where the pre scriber orders otherwise. Substitution of Alternative Biological Product; Requirements and 4073.5. Exceptions (a) A pharmacist filling a prescription order for a prescribed biological product may select an alternative biological product only if all of the following: The alternative biological product is interchangeable. (1) 61

62 (2) The prescriber does not personally indicate “Do not substitute,” or words of similar meaning, in the manner provided in subdivision (d). (b) Within five days following the dispensing of a biological product, a dispensing pharmacist or the pharmacists’ designee shall make an entry of the specific biological product provided to the patient, including the name of the biological product and the manufacturer. The communication s hall be conveyed by making an entry that can be electronically accessed by the prescriber through one or more of the following electronic records systems: (1) An interoperable electronic medical records system. An electronic prescribing technology. (2) A pharmacy benefit management system. (3) (4) A pharmacy record. (c) Entry into an electronic records system as described in subdivision (b) is presumed to provide notice to the prescriber. (d) If the pharmacy does not have access to one or more o f the entry systems in subdivision (b), the pharmacist or the pharmacist’s designee shall communicate the name of the biological product dispensed to the prescriber using facsimile, telephone, electronic transmission, or other prevailing means, communication shall not be required in this instance to the except that prescriber when either of the following apply: There is no interchangeable biological product approved by the federal (1) Food and Drug Administration for the product prescribed. prescription is not changed from the product dispensed on the prior A refill (2) filling of the prescription. (e) In no case shall a selection be made pursuant to this section if the prescriber personally indicates, either orally or in his or her own handwriting, “D o not substitute,” or words of similar meaning. This subdivision shall not prohibit a prescriber from checking a box on a (1) not substitute,” provided that the prescriber personally prescription marked “Do initials the box or checkmark. (2) To indicat e that a selection shall not be made pursuant to this section for an electronic data transmission prescription, as defined in subdivision (c) of Section 4040, a prescriber may indicate “Do not substitute,” or words of similar meaning, in the prescription a s transmitted by electronic data, or may check a box marked on the prescription “Do not substitute.” In either instance, it shall not be required that the prohibition on substitution be manually initialed by the prescriber. (f) Selection pursuant to this section is within the discretion of the pharmacist, except as provided in subdivision (e). A pharmacist who selects an alternative biological product to be dispensed pursuant to this section shall assume the same responsibility for substituting the biolog ical product as would be incurred in filling a prescription for a biological product prescribed by name. There shall be no liability on the prescriber for an act or omission by a pharmacist in selecting, preparing, or dispensing a biological product pursua nt to this section. In no case shall the pharmacist select a biological product that meets the requirements of subdivision (a) unless the cost to the patient of the biological product selected is the same or less than the cost of the prescribed biological 62

63 product. Cost, as used in this subdivision, includes any professional fee that may be charged by the pharmacist. (g) This section shall apply to all prescriptions, including those presented by or on behalf of persons receiving assistance from the federal government or pursuant to the Medi - Cal Act set forth in Chapter 7 (commencing with Section 14000) of Part 3 of Division 9 of the Welfare and Institutions Code. (h) When a selection is made pursuant to this section, the substitution of a ct shall be communicated to the patient. biological produ (i) The board shall maintain on its public Internet Web site a link to the current list, if available, of biological products determined by the federal Food and Drug Administration to be interchangeable. (j) For purposes of this section, the following terms shall have the following meanings: (1) “Biological product” has the same meaning that applies to that term under Section 351 of the federal Public Health Service Act (42 U.S.C. Sec. 262(i)). “Interchan geable” means a biological product that the federal Food and (2) Drug Administration has determined meets the standards set forth in Section 262(k)(4) of Title 42 of the United States Code, or has been deemed therapeutically equivalent by the federal Food and Drug Administration as set forth in the latest addition or supplement of the Approved Drug Products with Therapeutic Equivalence Evaluations. “Prescription,” with respect to a biological product, means a prescription (3) for a product that is subject to Section 503(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 353(b)). (k) This section shall not prohibit the administration of immunizations, as permitted in Sections 4052 and 4052.8. (l) This section shall not prohibit a disability insu rer or health care service plan from requiring prior authorization or imposing other appropriate utilization controls in approving coverage for any biological product. (Added by Stats. 2015, Ch. 545, Sec. 1. Effective January 1, 2016.) 4074. Drug Risk: In forming Patient; Providing Consultation for Discharge Medications (a) A pharmacist shall inform a patient orally or in writing of the harmful effects of a drug dispensed by prescription if both of the following apply: (1) The drug poses substantial ris k to the person consuming the drug when taken in combination with alcohol or the drug may impair a person’s ability to drive a motor vehicle, whichever is applicable. (2) The drug is determined by the board pursuant to subdivision (c) to be a drug or dru g type for which this warning shall be given. (b) In addition to the requirement described in subdivision (a), on and after July 1, 2014, if a pharmacist exercising his or her professional judgment determines that a drug may impair a person’s ability to operate a vehicle or vessel, the pharmacist shall include a written label on the drug container indicating that the drug may impair a person’s ability to operate a vehicle or vessel. The label required by this subdivision may be printed on an auxiliary el that is affixed to the prescription container. lab 63

64 (c) The board may by regulation require additional information or labeling. (d) This section shall not apply to a drug furnished to a patient in conjunction in a health facility or, except as with treatment or emergency services provided provided in subdivision (e), to a drug furnished to a patient pursuant to subdivision (a) of Section 4056. A health facility shall establish and implement a written policy to ensure (e) information regarding each drug given at the time that each patient shall receive of discharge and each drug given pursuant to subdivision (a) of Section 4056. This information shall include the use and storage of each drug, the precautions mpliance with directions. This and relevant warnings, and the importance of co information shall be given by a pharmacist or registered nurse, unless already provided by a patient’s prescriber, and the written policy shall be developed in rse. The collaboration with a physician, a pharmacist, and a registered nu written policy shall be approved by the medical staff. Nothing in this subdivision or any other law shall be construed to require that only a pharmacist provide this consultation. – Oral or Electronic Prescriptio n 4075. Proof of Identity Required No prescription for a controlled substance transmitted by means of an oral or electronically transmitted order shall be furnished to any person unknown and unable to properly establish his or her identity. The board may by regulation establish procedu res to prevent unauthorized persons from receiving prescription drugs furnished to a patient or a representative of the patient. 4076. Prescription Container Requirements for Labeling – A pharmacist shall not dispense any prescription except in a c ontainer that (a) meets the requirements of state and federal law and is correctly labeled with all of the following: (1) Except when the prescriber or the certified nurse - midwife who functions pursuant to a standardized procedure or protocol described in Se ction 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standard ized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6 orders otherwise, either the manufacturer’s trade name of the drug or the gen eric name and the name of the manufacturer. Commonly used abbreviations may be used. Preparations containing two or more active ingredients may be identified by the manufacturer’s trade name or the commonly used name or the principal active ingredients. The directions for the use of the drug. (2) (3) The name of the patient or patients. (4) The name of the prescriber or, if applicable, the name of the certified nurse - midwife who functions pursuant to a standardized procedure or protocol described in S ection 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician 64

65 assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standar dized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6. (5) The date of issue. (6) The name and address of the pharmacy, and pre scription number or other means of identifying the prescription. (7) The strength of the drug or drugs dispensed. (8) The quantity of the drug or drugs dispensed. (9) The expiration date of the effectiveness of the drug dispensed. (10) The conditio n or purpose for which the drug was prescribed if the condition or purpose is indicated on the prescription. (A) Commencing January 1, 2006, the physical description of the (11) dispensed medication, including its color, shape, and any identification cod e that appears on the tablets or capsules, except as follows: Prescriptions dispensed by a veterinarian. (i) (ii) An exemption from the requirements of this paragraph shall be granted to a new drug for the first 120 days that the drug is on the market and for the 90 days during which the national reference file has no description on file. Dispensed medications for which no physical description exists in any (iii) commercially available database. (B) This paragraph applies to outpatient pharmacies on ly. The information required by this paragraph may be printed on an auxiliary (C) label that is affixed to the prescription container. (D) This paragraph shall not become operative if the board, prior to January 1, 2006, adopts regulations that mandate the same labeling requirements set forth in this paragraph. (b) If a pharmacist dispenses a prescribed drug by means of a unit dose medication system, as defined by administrative regulation, for a patient in a skilled nursing, intermediate care, or oth er health care facility, the requirements of this section will be satisfied if the unit dose medication system contains the aforementioned information or the information is otherwise readily available at the time of drug administration. (c) If a pharmaci st dispenses a dangerous drug or device in a facility licensed pursuant to Section 1250 of the Health and Safety Code, it is not necessary to include on individual unit dose containers for a specific patient, the name of the certified nurse - midwife who fun ctions pursuant to a standardized procedure or protocol described in Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Secti on 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6. (d) If a pharmacist dispenses a prescription drug for use in a facility licensed 1250 of the Health and Safety Code, it is not necessary to pursuant to Section include the information required in paragraph (11) of subdivision (a) when the 65

66 administered to a patient by a person licensed under the prescription drug is Medical Practice Act (Chapter 5 (commencing with Section 2000)), the 6 (commencing with Section 2700)), or the Nursing Practice Act (Chapter Vocational Nursing Practice Act (Chapter 6.5 (commencing with Section 2840)), who is acting within his or her scope of practice. (e) A pharmacist shall use professional judgment to provide a patient with directions for use that enhance the patient’s understanding of those directions, consistent with the prescr iber’s instructions. (Amended by Stats. 2015, Ch. 784, Sec. 1. Effective January 1, 2016.) 4076.5. Standardized, Patient - Centered Prescription Labels; Requirements (a) The board shall promulgate regulations that require, on or before January 1, 2011, a standardized, patient - centered, prescription drug label on all prescription medicine dispensed to patients in California. (b) To ensure maximum public comment, the board shall hold public meetings statewide that are separate from its normally scheduled hearings in order to seek information from groups representing consumers, seniors, pharmacists or the practice of pharmacy, other health care professionals, and other interested parties. (c) When developing the requirements for prescription drug labels, the board shall consider all of the following factors: (1) Medical literacy research that points to increased understandability of labels. (2) Improved directions for use. (3) Improved font types and sizes. (4) Placement of information that is patient - centered. (5) The needs of patients with limited English proficiency. (6) The needs of senior citizens. (7) Technology requirements necessary to implement the standards. (d) The board may exempt from the requirements of regulations promulgated pursuant to subdivision (a) prescriptions dispensed to a patient in a health facility, as defined in Section 1250 of the Health and Safety Code, if the prescriptions are administered by a licensed health care professional. Prescriptions dispensed to a patient in a health facility that will not be administered by a licensed health care professional or that are provided to the patient upon discharge from the facility shall be subject to the requirements of this section and the regulations promulgated pursuant to subd ivision (a). Nothing in this subdivision shall alter or diminish existing statutory and regulatory informed consent, patients’ rights, or pharmaceutical labeling and storage requirements, including, but not limited to, the requirements of Section 1418.9 of the Health and Safety Code or Section 72357, 72527, or 72528 of Title 22 of the California Code of Regulations. (e) (1) The board may exempt from the requirements of regulations promulgated pursuant to subdivision (a) a prescription dispensed to a patie nt if all of the following apply: 66

67 (A) The drugs are dispensed by a JCAHO - accredited home infusion or specialty pharmacy. (B) The patient receives health professional - directed education prior to the - beginning of therapy by a nurse or pharmacist. (C) T he patient receives weekly or more frequent followup contacts by a nurse or pharmacist. (D) Care is provided under a formal plan of care based upon a physician and surgeon’s orders. (2) For purposes of paragraph (1), home infusion and specialty therapi es include parenteral therapy or other forms of administration that require regular laboratory and patient monitoring. 4076.6. Patient - Translated Directions for Centered Prescription Labels; Use; Requirements (a) Upon the request of a patient or patie nt’s representative, a dispenser shall provide translated directions for use, which shall be printed on the prescription container, label, or on a supplemental document. If translated directions for use appear on a prescription container or label, the Engl ish - language version of the directions for use shall also appear on the container or label, whenever possible, and may appear on other areas of the label outside the patient - centered area. - to appear on language directions for use When it is not possible for the English the container or label, it shall be provided on a supplemental document. (b) A dispenser may use translations made available by the board pursuant to subdivision (b) of Section 1707.5 of Title 16 of the California Code of Regulations to com ply with this section. (c) A dispenser shall not be required to provide translated directions for use beyond the languages that the board has made available or beyond the directions that the board has made available in translated form. (d) A dispenser may provide his or her own translated directions for use to comply with the requirements of this section, and nothing in this section shall be construed to prohibit a dispenser from providing translated directions for use in languages beyond those that the board has made available or beyond the directions that the board has made available in translated form. language - (e) A dispenser shall be responsible for the accuracy of the English ct a directions for use provided to the patient. This section shall not affe dispenser’s existing responsibility to correctly label a prescription pursuant to Section 4076. (f) For purposes of this section, a dispenser does not include a veterinarian. (Added by Stats. 2015, Ch. 784, Sec. 2. Effective January 1, 2016.) 4076. 7 . Caution Label Required for Drug Containing an Opioid In addition to the requirements of Sections 4076 and 4076.5, whenever a prescription drug containing an opioid is dispensed to a patient for outpatient drug shall prominently display use, the pharmacy or practitioner dispensing the on the label or container, by means of a flag or other notification mechanism attached to the container, a notice that states “Caution: Opioid. Risk of overdose and addiction.” 67

68 4077. Dispensing Dangerous Drug in Incorrectl y Labeled Container (a) Except as provided in subdivisions (b) and (c), no person shall dispense any dangerous drug upon prescription except in a container correctly labeled with the information required by Section 4076. (b) Physicians, dentists, podia trists, and veterinarians may personally furnish any dangerous drug prescribed by them to the patient for whom prescribed, provided that the drug is properly labeled to show all information required in Section 4076 except the prescription number. ices that bear the legend "Caution: federal law restricts this device to (c) Dev sale by or on the order of a _____," or words of similar meaning, are exempt from the requirements of Section 4076, and Section 111480 of the Health and Safety Code, when provided to patients in skilled nursing facilities or intermediate care facilities licensed pursuant to Chapter 2 (commencing with Section 1250) of Division 2 of the Health and Safety Code. (d) The following notification shall be affixed to all quantities of dimeth yl sulfoxide (DMSO) prescribed by a physician, or dispensed by a pharmacy pursuant to the order of a physician in California: "Warning: DMSO may be hazardous to your health. Follow the directions of the physician who prescribed the DMSO for you." e label of any retail package of DMSO shall include appropriate (e) Th precautionary measures for proper handling and first aid treatment and a warning statement to keep the product out of reach of children. 4078. False or Misleading Label on Prescription (a) (1) No person shall place a false or misleading label on a prescription. (2) No prescriber shall direct that a prescription be labeled with any information that is false or misleading. (b) Notwithstanding subdivision (a), a person may label a prescript ion, or a prescriber may direct that a prescription be labeled, with information about the drug that is false under either of the following circumstances: (1) If the labeling is a necessary part of a clinical or investigational drug e federal Food and Drug Administration or a legitimate program approved by th investigational drug project involving a drug previously approved by the federal Food and Drug Administration. (2) If, in the medical judgment of the prescriber, the labeling is appropriate for the pr oper treatment of the patient. (c) The furnisher of a prescription labeled pursuant to subdivision (b) shall make, and retain for three years from the date of making, a record stating the rom the manner in which the information on the prescription label varies f actual drug in the container and documenting the order of the prescriber to so label the container. The prescriber shall make, and retain for at least three years, a record of his or her order to so label the container. a 4079. 5. Availability of Lower Retail Price for a Covered Drug (a) A pharmacy shall inform a customer at the point of sale for a covered prescription drug whether the retail price is lower than the applicable cost - 68

69 atically sharing amount for the prescription drug, unless the pharmacy autom charges the customer the lower price. (b) If the customer pays the retail price, the pharmacy shall submit the claim to the health care service plan or health insurer in the same manner as if the ing the cost - sharing customer had purchased the prescription drug by pay amount when submitted by the network pharmacy. (c) The payment rendered shall constitute the applicable cost sharing and shall - of - pocket limit in apply to the deductible, if any, and also to the maximum out the same manner as if the en rollee had purchased the prescription drug by paying the cost - sharing amount. (d) A contract provision that is inconsistent with this section is void and unenforceable. (e) The provisions of this section are severable. If any provision of this section or i ts application is held invalid, that invalidity shall not affect other provisions or applications that can be given effect without the invalid provision or application. (f) A violation of this provision shall not be grounds for disciplinary action or a cri minal action. Article 5. Authority of Inspectors 4080. Stock of Dangerous Drugs and Devices Kept Open for Inspection All stock of any dangerous drug or dangerous device or of shipments through business hours, open to a customs broker or carrier shall be, at all times during inspection by authorized officers of the law. 4081. Records of Dangerous Drugs and Devices Kept Open for Inspection; Maintenance of Records, Current Inventory ; Nonprescription Diabetes Test Devices (a) All records of manufacture and of sale, acquisition, receipt, shipment, or disposition of dangerous drugs or dangerous devices shall be at all times during business hours open to inspection by authorized officers of the law, and shall be preserved for at least three years from the d ate of making. A current inventory shall be kept by every manufacturer, wholesaler, third - party logistics provider, pharmacy, veterinary food - animal drug retailer, outsourcing facility, physician, rectional clinic, as dentist, podiatrist, veterinarian, laboratory, licensed cor defined in Section 4187, clinic, hospital, institution, or establishment holding a currently valid and unrevoked certificate, license, permit, registration, or exemption under Division 2 (commencing with Section 1200) of the Health and Safety Code or under Part 4 (commencing with Section 16000) of Division 9 of the Welfare and Institutions Code who maintains a stock of dangerous drugs or dangerous devices. - (b) The owner, officer, and partner of a pharmacy, wholesaler, third party logist ics provider, or veterinary food - animal drug retailer shall be jointly responsible, with the pharmacist - in - charge, responsible manager, or designated - charge, for maintaining the records and inventory described in representative - in this section. 69

70 charge, responsible manager, or designated (c) The pha rmacist - in - representative - in - charge shall not be criminally responsible for acts of the owner, officer, partner, or employee that violate this section and of which the - in - pharmacist - in - charge, responsible manager, or designated representative charge had no knowledge, or in which he or she did not knowingly participate. (d) Pharmacies that dispense nonprescription diabetes test devices pursuant to prescriptions shall retain records of acquisition and sale of those n onprescription diabetes test devices for at least three years from the date of making. The records shall be at all times during business hours open to inspection by authorized officers of the law. 4082. Names of Owners, Managers and Employees Open for Inspection When called upon by an inspector, the owner or manager of any entity licensed by the board, or other store, shop, building, or premises retailing, wholesaling, or storing drugs or devices shall furnish the inspector with the r or owners, manager or managers, and employees together names of the owne with a brief statement of the capacity in which these persons are employed on the premises. 4083. Orders of Correction (a) An inspector may issue an order of correction to a licensee directing the licensee to comply with this chapter or regulations adopted pursuant to this chapter. (b) The order of correction shall be in writing and shall describe in detail the nature and facts of the violation, including a reference to the statute or regulations violated. (c) The order of correction shall inform the licensee that within 30 days of service of the order of correction, the licensee may do either of the following: (1) Submit a written request for an office conference with the board's cer to contest the order of correction. executive offi (A) Upon a timely request, the executive officer, or his or her designee, shall hold an office conference with the licensee or the licensee's legal counsel or authorized representative. Unless so authorized by the executive officer, or his or her designee, no individual other than the licensee's legal counsel or authorized representative may accompany the licensee to the office conference. (B) Prior to or at the office conference, the licensee may submit to the cutive officer declarations and documents pertinent to the subject matter of exe the order of correction. (C) The office conference is intended to be an informal proceeding and shall not be subject to the provisions of the Administrative Procedure Act (Chapte r 3.5 (commencing with Section 11340), Chapter 4 (commencing with Section 11370), Chapter 4.5 (commencing with Section 11400), and Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code). (D) The executive offi cer, or his or her designee, may affirm, modify, or withdraw the order of correction. Within 14 calendar days from the date of the office conference, the executive officer, or his or her designee, shall personally 70

71 serve or send by certified mail to the li censee's address of record with the board a written decision. This decision shall be deemed the final administrative decision concerning the order of correction. (E) Judicial review of the decision may be had by filing a petition for a writ of mandate in accordance with the provisions of Section 1094.5 of the Code of Civil Procedure within 30 days of the date the decision was personally served or sent by certified mail. The judicial review shall extend to the question of whether or not there was a prejudi cial abuse of discretion in the issuance of the order of correction. (2) Comply with the order of correction and submit a written corrective action plan to the inspector documenting compliance. If an office conference is not requested pursuant to this se ction, compliance with the order of correction shall not constitute an admission of the violation noted in the order of correction. (d) The order of correction shall be served upon the licensee personally or by certified mail at the licensee's address of record with the board. If the licensee is served by certified mail, service shall be effective upon deposit in the United States mail. (e) The licensee shall maintain and have readily available on the pharmacy premises a copy of the order of correction a nd corrective action plan for at least three years from the date of issuance of the order of correction. (f) Nothing in this section shall in any way limit the board's authority or ability to do any of the following: ion 125.9, 148, or 4067 or pursuant to (1) Issue a citation pursuant to Sect Section 1775, 1775.15, 1777, or 1778 of Title 16 of the California Code of Regulations. (2) Issue a letter of admonishment pursuant to Section 4315. (3) Institute disciplinary proceedings pursuant to Article 19 (co mmencing with Section 4300). (g) Unless a writ of mandate is filed, a citation issued, a letter of admonishment issued, or a disciplinary proceeding instituted, an order of correction shall not be considered a public record and shall not be disclosed pur suant to a request under the California Public Records Act (Chapter 3.5 (commencing with Section 6250) of Division 7 of Title 1 of the Government Code). 4084. Adulterated, Misbranded or Counterfeit Dangerous Drug or Device (a) When a board inspector fi nds, or has probable cause to believe, that any dangerous drug or dangerous device is adulterated, misbranded, or counterfeit, the board inspector shall affix a tag or other marking to that dangerous drug or dangerous device. The board inspector shall give notice to the person that the dangerous drug or dangerous device bearing the tag or marking has been embargoed. (b) When a board inspector has found that an embargoed dangerous drug or dangerous device is not adulterated, misbranded, or counterfeit, a b oard inspector shall remove the tag or other marking. 71

72 (c) A board inspector may secure a sample or specimen of a dangerous drug or dangerous device. If the board inspector obtains a sample prior to leaving the premises, the board inspector shall leave a receipt describing the sample. (d) For the purposes of this article, "counterfeit" shall have the meaning defined in Section 109905 of the Health and Safety Code. (e) For the purposes of this article, "adulterated" shall have the meaning icle 2 (commencing with Section 111250) of Chapter 6 of Part 5 defined in Art of Division 104 of the Health and Safety Code. (f) For the purposes of this article, "misbranded" shall have the meaning defined in Article 3 (commencing with Section 111330) of Chapter 6 of Part 5 of Division 104 of the Health and Safety Code. 40 84.1 Embargo of Nonprescription Diabetes Test Devices The board may embargo any nonprescription diabetes test device that a board inspector finds or has probable cause to believe was not purchased e ither directly from the manufacturer or from the nonprescription diabetes test device manufacturer’s authorized distributors as identified in Section 4160.5. For the purposes of this section, the board shall embargo these products following the ures and protections used for adulterated, misbranded, or same proced counterfeit drugs or dangerous devices in Sections 4084, 4085, and 4086. 4085. Unlawful to Remove, Sell, or Dispose of Embargoed Dangerous Drugs or Dangerous Devices (a) It is unlawful for any pe rson to remove, sell, or dispose of an embargoed dangerous drug or dangerous device without permission of the board. (b) When a board inspector has reasonable cause to believe, that the embargo will be violated, a board inspector may remove the embargoed dangerous drug or dangerous device from the premises. 4086. Adulterated or Counterfeit Dangerous Drug or Dangerous Device; Court Proceedings (a) If a dangerous drug or dangerous device is alleged to be adulterated or counterfeit, the board shall commen ce proceedings in the superior court in whose jurisdiction the dangerous drug or dangerous device is located, for condemnation of the dangerous drug or dangerous device. (b) If the court finds that an embargoed dangerous drug or dangerous device is adult erated or counterfeit, the dangerous drug or dangerous device shall, after entry of the judgment, be destroyed at the expense of the claimant or owner, under the supervision of the board. All court costs and fees and all reasonable costs incurred by the b oard in investigating and prosecuting the action, including, but not limited to, the costs of storage and testing, shall be paid by the claimant or owner of the dangerous drug or dangerous device. ous drug or (c) A superior court of this state may condemn any danger dangerous device pursuant to this article. In the absence of an order, the dangerous drug or dangerous device may be destroyed under the supervision of the board who has the written consent of the owner, his or her attorney, or esentative. If the board cannot ascertain ownership of the authorized repr 72

73 dangerous drug or dangerous device within 30 days of establishing an embargo, the board may destroy the dangerous drug or dangerous device. Article 6. General Requirements ess or Name Notification to Board – 4100. Change of Addr Within 30 days after changing his or her address of record with the board or after changing his or her name according to law, a pharmacist, intern designated representative, designated representa tive - pharmacist, technician, - reverse distributor shall notify the executive 3PL, or designated representative officer of the board of the change of address or change of name. - Pharmacist in - Charge, Designated Representative 4101. in - Charge: - n to Board Termination of Employment; Notificatio (a) A pharmacist may charge of and act as the pharmacist - in - charge of a take pharmacy upon application by the pharmacy approval by the board. A and pharmacist - in - charge who ceases to act as the pharmacist - in - charge of the pharmacy notify the board in writing within 30 days shall of the date of that change in status. (b) A designated representative or a pharmacist may take charge of, and act as, the designated representative - in - charge of a wholesaler or veterinary food - - food veterinary animal drug retailer upo n application by the wholesaler or board. animal retailer and approval by the A designated representative - in - drug - ceases to act as the designated representative - in charge charge at that who entity shall notify the board in writing within 30 days of the date of that change in status. (c) A designated representative - 3PL may take charge of, and act as, the of responsible manager the a third - party logistics provider upon application by third logistics provider and approval by party the board. A responsible manager - who ceases to act as the responsible manager at that entity shall notify the change board in writing within 30 days of the date of that in status. 4103. Blood Pressure―Taking by Pharmacist Notwithstanding Section 2038, or any other provision of law, a pharmacist may take a person's blood pressure and may inform the person of the results, render an opinion as to whether the reading is within a high , low, or normal range, and may advise the person to consult a physician of the person's choice. Pharmacists rendering this service shall utilize commonly accepted community standards in rendering opinions and referring patients to physicians. Enforcemen t of this section is vested in the Board of Pharmacy of the State of California. Any pharmacist who performs this service shall not be in violation of Section 2052. 4104. Licensed Employee, Theft or Impairment: Pharmacy Procedures (a) Every pharmacy sh all have in place procedures for taking action to protect the public when a licensed individual employed by or with the pharmacy is discovered or known to be chemically, mentally, or physically impaired to the 73

74 ce the profession or occupation extent it affects his or her ability to practi authorized by his or her license, or is discovered or known to have engaged in - the theft, diversion, or self use of dangerous drugs. (b) Every pharmacy shall have written policies and procedures for addressing ntal, or physical impairment, as well as theft, diversion, or self - use chemical, me of dangerous drugs, among licensed individuals employed by or with the pharmacy. (c) Every pharmacy shall report and provide to the board, within 14 days of the receipt or development there of the following information with regard to any licensed individual employed by or with the pharmacy: (1) Any admission by a licensed individual of chemical, mental, or physical impairment affecting his or her ability to practice. (2) Any admission by a licensed individual of theft, diversion, or self - use of dangerous drugs. (3) Any video or documentary evidence demonstrating chemical, mental, or physical impairment of a licensed individual to the extent it affects his or her ability to practice. (4) Any video or documentary evidence demonstrating theft, diversion, or use of dangerous drugs by a licensed individual. - self (5) Any termination based on chemical, mental, or physical impairment of a er ability to practice. licensed individual to the extent it affects his or h (6) Any termination of a licensed individual based on theft, diversion, or self - use of dangerous drugs. (d) The report required in subdivision (c) shall include sufficient detail to inform the board of the facts upon which the rep ort is based, including an estimate of the type and quantity of all dangerous drugs involved, the timeframe over which the losses are suspected, and the date of the last controlled substances inventory. Upon request of the board, the pharmacy shall and submit an audit involving the dangerous drugs suspected to be prepare missing. ( e ) Anyone making a report authorized or required by this section shall have immunity from any liability, civil or criminal, that might otherwise arise from the making of the repo rt. Any participant shall have the same immunity with respect to participation in any administrative or judicial proceeding resulting from the report. 4105. Retaining Records of Dangerous Drugs and Devices on Licensed Premises; Temporary Removal; Waivers ; Access to Electronically Maintained Records (a) All records or other documentation of the acquisition and disposition of dangerous drugs and dangerous devices by any entity licensed by the board shall be retained on the licensed premises in a readily re trievable form. (b) The licensee may remove the original records or documentation from the related purposes. However, licensed premises on a temporary basis for license - a duplicate set of those records or other documentation shall be retained on the licen sed premises. 74

75 (c) The records required by this section shall be retained on the licensed premises for a period of three years from the date of making. (d) Any records that are maintained electronically shall be maintained so (1) in in ch arge, or the pharmacist on duty if the pharmacist - - - that the pharmacist - charge is not on duty, shall, at all times during which the licensed premises are open for business, be able to produce a hardcopy and electronic copy of all records of acquisition or disposition or othe r drug or dispensing - related records maintained electronically. (2) In the case of a veterinary food animal drug retailer, wholesaler, or third - - party logistics provider, any records that are maintained electronically shall be ated representative in - charge or the responsible maintained so that the design - manager, or the designated representative on duty or the designated - 3PL on duty if the designated representative - in representative charge or - responsible manager is not on duty, shall, at all times during whi ch the licensed place of business is open for business, be able to produce a hardcopy and electronic copy of all records of acquisition or disposition or other drug or dispensing - related records maintained electronically. ons (a), (b), and (c), the board may, upon Notwithstanding subdivisi (e) (1) written request, grant to a licensee a waiver of the requirements that the records described in subdivisions (a), (b), and (c) be kept on the licensed premises. (2) A waiver granted pursuant to this subdivision s hall not affect the board’s authority under this section or any other provision of this chapter. (f) When requested by an authorized officer of the law or by an authorized representative of the board, the owner, corporate officer, or manager of an licensed by the board shall provide the board with the requested records entity within three business days of the time the request was made. The entity may request in writing an extension of this timeframe for a period not to exceed 14 calendar days from the date the records were requested. A request for an extension of time is subject to the approval of the board. An extension shall be deemed approved if the board fails to deny the extension request within two business days of the time the extension request was m ade directly to the board. 4105.5 Automated Drug Delivery System ; Requirements . (a) For purposes of this section, an “automated drug delivery system” has the same meaning as that term is defined in paragraph (1) of subdivision (a) of Section 1261.6 of t he Health and Safety Code. (b) Except as provided by subdivision (e), a pharmacy that owns or provides dangerous drugs dispensed through an automated drug delivery system shall register the automated drug delivery system by providing the board in writing with the location of each device within 30 days of installation of the device, and on an annual basis as part of the license renewal pursuant to subdivision (a) of Section 4110. The pharmacy shall also advise the board in writing within 30 days if the phar macy discontinues operating an automated drug delivery system. A pharmacy may only use an automated drug delivery system if all of the (c) following conditions are satisfied: 75

76 (1) Use of the automated drug delivery system is consistent with legal requirem ents. (2) The pharmacy’s policies and procedures related to the automated drug delivery system to include appropriate security measures and monitoring of the inventory to prevent theft and diversion. (3) The pharmacy reports drug losses from the automate d drug delivery system to the board as required by law. (4) The pharmacy license is unexpired and not subject to disciplinary conditions. The board may prohibit a pharmacy from using an automated drug (d) delivery system if the board determines that the conditions provided in subdivision (c) are not satisfied. If such a determination is made, the board shall provide the pharmacy with written notice including the basis for the determination. The pharmacy may request an office conference to appeal the board ’s decision within 30 days of receipt of the written notice. The executive officer or designee may affirm or overturn the prohibition as a result of the office conference. An automated drug delivery system operated by a licensed hospital (e) pharmacy as d efined in Section 4029 for doses administered in a facility operated under a consolidated license under Section 1250.8 of the Health and Safety Code shall be exempt from the requirements of subdivision (b). (f) This section shall become inoperative on Jul y 1, 2019, and, as of January 1, 2020, is repealed. 4106. License Verification Using Board Web Site For purposes of license verification, a person may rely upon the licensing information as it is displayed on the board's Internet Web site that includes the issuance and expiration dates of any license issued by the board. 4106.5 Requirement for Safe Storage Products (a) For purposes of this section, the following terms shall have the following meanings: ets both of the following (1) “Pharmacy” does not include a pharmacy that me requirements: (A) It is owned and operated by a person or persons in which the majority of the beneficial interest, as well as management and control, resides with at least licensed pharmacist, as that term is defined i one board - n Section 4036, that exclusively oversees the operations of the pharmacy. (B) The owner and operator with the beneficial interest, management, and control described in subparagraph (A) owns, operates, and has management and control of no more than four pha rmacies. (2) “Safe storage products” means a device or product made with the purpose of storing prescription medications that includes a locking mechanism that is accessible only by the designated patient with a passcode, alphanumeric code, her secure mechanism. A safe storage product includes, but is key, or by anot not limited to, medicine lock boxes, locking medicine cabinets, locking medication bags, and prescription locking vials. 76

77 efined (3) “Schedule II, III, or IV controlled substances” means any substance d as a Schedule II, III, or IV controlled substance in Sections 11055, 11056, and 11057 of the Health and Safety Code. (b) A pharmacy that dispenses Schedule II, III, or IV controlled substances shall display safe storage products in a place on the bu ilding premises that is located close to the pharmacy. (c) (1) The board shall assess a fine in an amount to be determined by the board for a violation of this section. (2) Notwithstanding paragraph (1), the board may choose not to take administrative acti on against a pharmacy if it determines that compliance with this section would create a financial hardship on the pharmacy or that the pharmacy is temporarily out of stock of safe storage products. (d) Section 4321 shall not apply to a violation of this se ction. (e) This section shall remain in effect only until January 1, 2023, and as of that date is repealed. 4107. One Site License per Premises; Exception The board shall not issue more than one site license to a single premises (a) except as follows: (1) To issue a veterinary food - animal drug retailer license to a wholesaler pursuant to Section 4196. (2) To issue a license to compound sterile drugs to a pharmacy pursuant to 4127.1 or 4127.2 . Section To issue a centralized hospital packaging l (3) icense pursuant to Section 4128. (4) To issue licenses to two independently owned clinics that share a clinic office space pursuant to Section 4180.5. (b) For the purposes of this subdivision, “premises” means a location with its own address and an inde pendent means of ingress and egress. 4107.5. Counterfeit Dangerous Drugs or Device; Fraudulent Transaction; Required Notice to Board If a manufacturer, wholesaler, third - party logistics provider, or pharmacy has reasonable cause to believe that a dange rous drug or dangerous device in, or having been in, its possession is counterfeit or the subject of a fraudulent transaction, the manufacturer, wholesaler, third party logistics provider, or - pharmacy shall notify the board within 72 hours of obtaining tha t knowledge. This section shall apply to any dangerous drug or dangerous device that has been sold or distributed in or through this state. 77

78 Article 7. Pharmacies License Required; Temporary Permit Upon Transfer of 4110. y Requirements Ownership ; Mobile Pharmac (a) No person shall conduct a pharmacy in the State of California unless he or she has obtained a license from the board. A license shall be required for each A separate license shall be pharmacy owned or operated by a specific person. quired for each of the premises of any person operating a pharm acy in more re The lice than one location. The board may, by nse shall be renewed annually. regulation, determine the circumstances under which a license may be transferred. (b) The board may, at its discretion, issue a temporary permit upon the to be in the conditions and for any periods of time as the board determines public interest. A temporary permit fee shall be required in an amount When established by the board as specified in subdivision (a) o f Section 4400. needed to protect public safety, a temporary permit may be issued for a period ons the not to exceed 180 days, and may be issued subject to terms and conditi board deems necessary. If the board determines a temporary permit was issued b y mistake or denies the application for a permanent license or registration, the temporary license or registration shall terminate upon either personal service of the notice of termination upon the permitholder or service by certified mail, requested, at the permitholder's address of record with the board, return receipt hever comes first. Neither for purposes of retaining a temporary permit nor whic for purposes of any disciplinary or license denial proceeding before the board er be deemed to have a vested property right or shall the temporary permithold interest in the permit. (c) The board may allow the temporary use of a mobile pharmacy when a pharmacy is destroyed or damaged, the mobile pharmacy is necessary to protect the health and safety of the public , and the following conditions are met: (1) The mobile pharmacy shall provide services only on or immediately contiguous to the site of the damaged or destroyed pharmacy. (2) The mobile pharmacy is under the control and management of the pharmacist - in - ch arge of the pharmacy that was destroyed or damaged. (3) A licensed pharmacist is on the premises while drugs are being dispensed. (4) Reasonable security measures are taken to safeguard the drug supply maintained in the mobile pharmacy. (5) The pharmacy operating the mobile pharmacy provides the board with records of the destruction of, or damage to, the pharmacy and an expected restoration date. (6) Within three calendar days of restoration of the pharmacy services, the board is provided with notice of the restoration of the permanent pharmacy. (7) The mobile pharmacy is not operated for more than 48 hours following the restoration of the permanent pharmacy. 4111. Restrictions on Prescriber Ownership (a) b), Except as otherwise provided in subdivision ( (d), or (e), the board shall the following: not issue or renew a license to conduct a pharmacy to any of 78

79 prescription, A person or persons authorized to prescribe or write a (1) as specified in Section 4040, in the State of California. (2) person o r persons with whom a person or persons specified in paragraph A shares interest a community or other financial in the permit sought. (1) in (3) that is controlled by, or Any which 10 percent or more of corporation stock is owned by a person or persons prohibited from pharmacy ownership the (1) or (2). by paragraph (b) Subdivision (a) shall not preclude the issuance of a permit for an inpatient to the owner of the hospital in which it is located. hospital pharmacy (c) The board may require any information the board deems is reasonably necessary for the enforcement of this section. issuance (d) Subdivision (a) shall not preclude the of a new or renewal license or for on a pharmacy to be owned or owned and operated by a person licensed Health before 1, 1981, under the Knox - Keene Care Service Plan Act of August (Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health 1975 on Safety Code) and qualified and or before August 1, 1981, under subsection (d) of Section 1310 of Title XIII of the federal Public Health Service Act, as amended, whose ownership includes persons defined pursuant to paragraphs (1) and (a). (2) of subdivision issuance Subdivision (a) shall not preclude the of a new or renewal license (e) for a pharmacy to be owned or owned and operated by a pharmacist authorized issue to a drug order pursuant to Section 4052.1, 4052.2, or 4052.6. 4112. Nonresident Pharmacy: Registration; Provision of Information to Board; Maintaining Records; Patient Consultation (a) Any pharmacy located out side this state that ships, mails, or delivers, in any manner, controlled substances, dangerous drugs, or dangerous devices into this state shall be considered a nonresident pharmacy. (b) A person may not act as a nonresident pharmacy unless he or she ha s obtained a license from the board. The board may register a nonresident pharmacy that is organized as a limited liability company in the state in which it is licensed. (c) A nonresident pharmacy shall disclose to the board the location, names, and titl es of (1) its agent for service of process in this state, (2) all principal corporate officers, if any, (3) all general partners, if any, and (4) all pharmacists who are dispensing controlled substances, dangerous drugs, or dangerous devices to residents o f this state. A report containing this information shall be made on an annual basis and within 30 days after any change of office, corporate officer, partner, or pharmacist. (d) All nonresident pharmacies shall comply with all lawful directions and requ ests for information from the regulatory or licensing agency of the state in which it is licensed as well as with all requests for information made by the board pursuant to this section. The nonresident pharmacy shall maintain, at all times, a valid unexp ired license, permit, or registration to conduct the pharmacy in compliance with the laws of the state in which it is a resident. As a prerequisite to registering with the board, the nonresident pharmacy shall submit a copy of the most recent inspection r eport resulting from an inspection 79

80 conducted by the regulatory or licensing agency of the state in which it is located. (e) All nonresident pharmacies shall maintain records of controlled ients in this substances, dangerous drugs, or dangerous devices dispensed to pat state so that the records are readily retrievable from the records of other drugs dispensed. (f) Any pharmacy subject to this section shall, during its regular hours of hours operation, but not less than six days per week, and for a minimum of 40 per week, provide a toll - free telephone service to facilitate communication between patients in this state and a pharmacist at the pharmacy who has access to the patient's records. This toll - free telephone number shall be disclosed on a d to each container of drugs dispensed to patients in this state. label affixe (g) A nonresident pharmacy shall not permit a pharmacist whose license has been revoked by the board to manufacture, compound, furnish, sell, dispense, or initiate the prescription of a da ngerous drug or dangerous device, or to provide any pharmacy - related service, to a person residing in California. ( h ) The board shall adopt regulations that apply the same requirements or standards for oral consultation to a nonresident pharmacy that ope rates pursuant to this section and ships, mails, or delivers any controlled substances, dangerous drugs, or dangerous devices to residents of this state, as are applied to an in - state pharmacy that operates pursuant to Section 4037 when the pharmacy ships, mails, or delivers any controlled substances, dangerous drugs, or dangerous devices to residents of this state. The board shall not adopt any regulations that require face - to - face consultation for a prescription that is shipped, mailed, or delivered to t he patient. The regulations adopted pursuant to this subdivision shall not result in any unnecessary delay in patients receiving their medication. ) The registration fee shall be the fee specified in subdivision (a) of Section i ( 4400. ( j ) The registrat ion requirements of this section shall apply only to a nonresident pharmacy that ships, mails, or delivers controlled substances, dangerous drugs, and dangerous devices into this state pursuant to a prescription. ( k ) Nothing in this section shall be cons trued to authorize the dispensing of contact lenses by nonresident pharmacists except as provided by Section 4124. 4113. Pharmacist - in - Charge: Notification to Board; Responsibilities - in (a) Every pharmacy shall designate a pharmacist 30 - charge and, within days thereof, shall notify the board in writing of the identity and license number of that pharmacist and the date he or she was designated. charge shall be subject to approval by the (b) The proposed pharmacist - in - renew a pharmacy license without board. The board shall not issue or identification of an approved pharmacist - in - charge for the pharmacy. charge shall be responsible for a pharmacy's compliance - (c) The pharmacist - in ce of with all state and federal laws and regulations pertaining to the practi pharmacy. 80

81 (d) Every pharmacy shall notify the board in writing, on a form designed by the board, within 30 days of the date when a pharmacist - in - charge ceases to act - - charge, and shall on the same form propose another as the pharmacist in to take over as the pharmacist - in - pharmacist charge. The proposed replacement pharmacist - in - charge shall be subject to approval by the board. If disapproved, the pharmacy shall propose another replacement within 15 days of the date of disapproval and shall continue to name proposed replacements until a pharmacist - in - charge is approved by the board. (e) If a pharmacy is unable, in the exercise of reasonable diligence, to identify - - charge to propose to the within 30 days a permanent replacement pharmacist in board on the notification form, the pharmacy may instead provide on that form the name of any pharmacist who is an employee, officer, or administrator of the pharmacy or the entity that owns the pharmacy and who is actively involved in the management of the pharmac y on a daily basis, to act as the interim pharmacist - in - charge for a period not to exceed 120 days. The pharmacy, or the entity that owns the pharmacy, shall be prepared during normal business hours to provide a representative of the board with the name of the interim pharmacist - in - charge with documentation of the active involvement of the charge in the daily management of the pharmacy, and - in - interim pharmacist with documentation of the pharmacy’s good faith efforts prior to naming the interim pharmacist i n - - - in - charge. By charge to obtain a permanent pharmacist no later than 120 days following the identification of the interim pharmacist - in - charge, the pharmacy shall propose to the board the name of a pharmacist to . The proposed permanent - in - charge serve as the permanent pharmacist pharmacist - in - charge shall be subject to approval by the board. If disapproved, the pharmacy shall propose another replacement within 15 days of the date of disapproval, and shall continue to name proposed replacements until a macist - phar charge is approved by the board. in - 4113.5 Community Pharmacies: Required Staffing (a) A community pharmacy shall not require a pharmacist employee to engage in the practice of pharmacy at any time the pharmacy is open to the public, another employee of the pharmacy or, if the pharmacy is located unless either within another establishment, an employee of the establishment within which the pharmacy is located, is made available to assist the pharmacist at all times. (b) This section shall not apply t o any of the following: (1) A hospital pharmacy, as defined in Section 4029 or 4056. (2) A pharmacy located in a hospital facility, including, but not limited to, a building where outpatient services are provided in accordance with the hospital’s license. (3) A pharmacy owned or operated by a federal, state, local, or tribal government entity, including, but not limited to, a correctional pharmacy, a University of California pharmacy, or a pharmacy operated by the State Department of State Hospitals. pharmacy owned by a person or persons who, collectively, control the (4) A majority of the beneficial interest in no more than four pharmacies in California. 81

82 (5) A pharmacy entirely owned and operated by a health care service plan that exclusively contracts with no more than two medical groups in the state to provide, or arrange for the provision of, professional medical services to the enrollees of the plan. (6) A pharmacy that permits patients to receive medications at a drive - through window when both of the fo llowing conditions are met: (A) A pharmacist is working during the times when patients may receive medication only at the drive - through window. (B) The pharmacist’s employer does not require the pharmacist to retrieve items for sale to patients if the item s are located outside the pharmacy. These items include, but are not limited to, items for which a prescription is not required. (7) Any other pharmacy from which controlled substances, dangerous drugs, or dangerous devices are not furnished, sold, or disp ensed at retail. (c) A violation of subdivision (a) is not subject to subdivision (a) of Section 4321. (d) The board shall not take action against a pharmacy for a violation of this section if both of the following apply: (1) Another employee is unavailabl e to assist the pharmacist due to reasonably unanticipated circumstances, including, but not limited to, illness, injury, family emergency, or the employee’s termination or resignation. (2) The pharmacy takes all reasonable action to make another employee available to assist the pharmacist. (e) This section shall not be construed to permit an employee who is not licensed under this chapter to engage in any act for which a license is required under this chapter. d 4114. Intern Pharmacist: Activities Permitte (a) An intern pharmacist may perform all functions of a pharmacist at the discretion of and under the direct supervision and control of a pharmacist whose license is in good standing with the board. (b) A pharmacist may not supervise more than two in tern pharmacists at any one time. 4115. Pharmacy Technician: Activities Permitted; Required Supervision; Activities Limited to Pharmacist; Registration; Requirements for Registration; Ratio (a) repetitive, A pharmacy technician may perform packaging, manipulative, or other nondiscretionary tasks, only while assisting, and while under the direct supervision and control of a pharmacist. The pharmacist shall be responsible for the duties performed under his or her supervision by a technician. ction does not authorize the performance of any tasks specified in (b) This se subdivision (a) by a pharmacy technician without a pharmacist on duty. (c) This section does not authorize a pharmacy technician to perform any act requiring the exercise of professional judgment by a pharmacist. (d) The board shall adopt regulations to specify tasks pursuant to subdivision (a) that a pharmacy technician may perform under the supervision of a 82

83 pharmacist. Any pharmacy that employs a pharmacy technician shall do so in conf ormity with the regulations adopted by the board. (e) No person shall act as a pharmacy technician without first being licensed by the board as a pharmacy technician. (1) A pharmacy with only one pharmacist shall have no more than one (f) pharmacy techn ician performing the tasks specified in subdivision (a). The ratio of pharmacy technicians performing the tasks specified in subdivision (a) to any additional pharmacist shall not exceed 2:1, except that this ratio shall not apply to personnel performing c lerical functions pursuant to Section 4116 or 4117. This ratio is applicable to all practice settings, except for an inpatient of a licensed health facility, a patient of a licensed home health agency, as specified in paragraph (2), an inmate of a correcti onal facility of the Department of Corrections and Rehabilitation, and for a person receiving treatment in a facility operated by the State Department of State Hospitals, the State Department of Developmental Services, or the Department of Veterans Affairs . The board may adopt regulations establishing the ratio of pharmacy (2) technicians performing the tasks specified in subdivision (a) to pharmacists applicable to the filling of prescriptions of an inpatient of a licensed health facility and for a patie nt of a licensed home health agency. Any ratio established by the board pursuant to this subdivision shall allow, at a minimum, at least one pharmacy technician for a single pharmacist in a pharmacy and two st, except that this ratio shall pharmacy technicians for each additional pharmaci not apply to personnel performing clerical functions pursuant to Section 4116 or 4117. (3) A pharmacist scheduled to supervise a second pharmacy technician may refuse to supervise a second pharmacy technician if the pharm acist determines, in the exercise of his or her professional judgment, that permitting the second pharmacy technician to be on duty would interfere with the effective performance of the pharmacist’s responsibilities under this chapter. A pharmacist assigne d to supervise a second pharmacy technician shall notify the pharmacist in charge in writing of his or her determination, specifying the circumstances of concern with respect to the pharmacy or the pharmacy technician that have led to the determination, wi thin a reasonable period, but not to exceed 24 hours, after the posting of the relevant schedule. No entity employing a pharmacist may discharge, discipline, or otherwise discriminate against any pharmacist in the terms and conditions of employment for exe rcising or attempting to exercise in good faith the right established pursuant to this paragraph. (g) Notwithstanding subdivisions (a) and (b), the board shall by regulation establish conditions to permit the temporary absence of a pharmacist for breaks and lunch periods pursuant to Section 512 of the Labor Code and the orders of the Industrial Welfare Commission without closing the pharmacy. During these temporary absences, a pharmacy technician may, at the discretion of the rmacy but may only perform nondiscretionary pharmacist, remain in the pha tasks. The pharmacist shall be responsible for a pharmacy technician and shall review any task performed by a pharmacy technician during the pharmacist’s temporary absence. Nothing in this subdivision shall be co nstrued to authorize 83

84 a pharmacist to supervise pharmacy technicians in greater ratios than those described in subdivision (f). (h) The pharmacist on duty shall be directly responsible for the conduct of a pharmacy technician supervised by that pharmacist . (i) In a health care facility licensed under subdivision (a) of Section 1250 of the Health and Safety Code, a pharmacy technician’s duties may include any of the following: (1) Packaging emergency supplies for use in the health care facility and the hospital’s emergency medical system or as authorized under Section 4119. (2) Sealing emergency containers for use in the health care facility. (3) Performing monthly checks of the drug supplies stored throughout the health care facility. Irregularities shall be reported within 24 hours to the pharmacist in charge and the director or chief executive officer of the health care facility in accordance with the health care facility’s policies and procedures. 4115.5. Pharmacy Technician Trainee; Placement; Supervision; Requirements (a) Notwithstanding any other provision of law, a pharmacy technician trainee may be placed in a pharmacy to complete an externship for the purpose of obtaining practical training required to become licensed as a pharmacy cian. techni (b) (1) A pharmacy technician trainee participating in an externship as described in subdivision (a) may perform the duties described in subdivision (a) of Section 4115 only under the direct supervision and control of a pharmacist. (2) A pharmacist supervising a pharmacy technician trainee participating in an externship as described in subdivision (a) shall be directly responsible for the conduct of the trainee. (3) A pharmacist supervising a pharmacy technician trainee participating in an externsh ip as described in subdivision (a) shall verify any prescription prepared by the trainee under supervision of the pharmacist by initialing the prescription label before the medication is disbursed to a patient or by engaging in other verification procedure s that are specifically approved by board regulations. (4) A pharmacist may only supervise one pharmacy technician trainee at any given time. (5) A pharmacist supervising a pharmacy technician trainee participating in an externship as described in subdiv ision (a) shall certify attendance for the pharmacy technician trainee and certify that the pharmacy technician trainee has met the educational objectives established by a California public postsecondary education institution or the private postsecondary v ocational institution in which the trainee is enrolled, as established by the institution. (c) (1) Except as described in paragraph (2), an externship in which a pharmacy technician trainee is participating as described in subdivision (a) shall be for a p eriod of no more than 120 hours. (2) When an externship in which a pharmacy technician trainee is participating as described in subdivision (a) involves rotation between a community and hospital pharmacy for the purpose of training the student in distinct practice 84

85 settings, the externship may be for a period of up to 320 hours. No more than 120 of the 320 hours may be completed in a community pharmacy setting or in a single department in a hospital pharmacy. n trainee may participate as (d) An externship in which a pharmacy technicia described in subdivision (a) shall be for a period of no more than six consecutive months in a community pharmacy and for a total of no more than 12 months if the externship involves rotation between a community and hospital ph armacy. The externship shall be completed while the trainee is enrolled in a course of instruction at the institution. (e) A pharmacy technician trainee participating in an externship as described s his or her trainee in subdivision (a) shall wear identification that indicate status. 4116. Security of Dangerous Drugs and Devices in Pharmacy: Pharmacist Responsibility for Individuals on Premises; Regulations (a) No person other than a pharmacist, an intern pharmacist, an authorized officer of the law, or a person authorized to prescribe shall be permitted in that area, place, or premises described in the license issued by the board wherein controlled substances or dangerous drugs or dangerous devices are stored, compounded, dispensed, or possessed, prepared, manufactured, derived, repackaged. However, a pharmacist shall be responsible for any individual who enters the pharmacy for the purposes of receiving consultation from the pharmacist or performing clerical, inventory control, housekeeping, delivery, m aintenance, or similar functions relating to the pharmacy if the pharmacist remains present in the pharmacy during all times as the authorized individual is present. (b) (1) The board may, by regulation, establish reasonable security measures consistent with this section in order to prevent unauthorized persons from gaining access to the area, place, or premises or to the controlled substances or dangerous drugs or dangerous devices therein. (2) The board shall, by regulation, establish conditions for the temporary absence of a pharmacist for breaks and lunch periods pursuant to Section 512 of the Labor Code and the orders of the Industrial Welfare Commission without closing the pharmacy and removing authorized personnel from the pharmacy. These condi tions shall ensure the security of the pharmacy and its operations during the temporary absence of the pharmacist and shall allow, at the discretion of the pharmacist, nonpharmacist personnel to remain and perform any lawful activities during the pharmacis t's temporary absence. 4117. Admission to Area Where Narcotics are Stored, etc. – Who May Enter No person other than a pharmacist, an intern pharmacist, a pharmacy technician, an authorized officer of the law, a person authorized to prescribe, a regist ered nurse, a licensed vocational nurse, a person who enters the pharmacy for purposes of receiving consultation from a pharmacist, or a person authorized by the pharmacist in charge to perform clerical, inventory control, housekeeping, delivery, maintenan ce, or similar functions relating to the 85

86 pharmacy shall be permitted in that area, place, or premises described in the license issued by the board to a licensed hospital wherein controlled substances, ssed, prepared, dangerous drugs, or dangerous devices are stored, posse manufactured, derived, compounded, dispensed, or repackaged. 4118. Waiving of Minimum Requirements by Board (a) When, in the opinion of the board, a high standard of patient safety, the licensure of a consistent with good patient care, can be provided by pharmacy that does not meet all of the requirements for licensure as a pharmacy, the board may waive any licensing requirements. (b) When, in the opinion of the board, a high standard of patient safety, consistent with good patient car e, can be provided by the licensure of a hospital pharmacy, as defined by subdivision (a) of Section 4029, that does not meet all of the requirements for licensure as a hospital pharmacy, the board may waive any licensing requirements. However, when a wai ver of any requirements is granted by the board, the pharmaceutical services to be rendered by this pharmacy shall be limited to patients registered for treatment in the hospital, whether or not they are actually staying in the hospital, or to emergency ca ses under treatment in the hospital. 4118.5 Hospital Pharmacies: Medication Profiles or Lists for High - Risk Patients (a) A pharmacist at a hospital pharmacy shall obtain an accurate medication risk patient - f the high risk patient upon admission o profile or list for each high - under the following conditions: (1) The hospital has more than 100 beds. (2) The accurate medication profile or list may be acquired by the pharmacist during the hospital pharmacy’s hours of operation. (b) Notwithstanding any othe r law, a pharmacy technician or an intern pharmacist may perform the task of obtaining an accurate medication profile or list for a high - risk patient if both of the following conditions are satisfied: (1) The hospital pharmacy has a quality assurance progr am to monitor competency. (2) The hospital has established policies and procedures for training and proctoring pharmacy technicians or intern pharmacists by the hospital pharmacy department and the pharmacy technician or intern pharmacist has completed tha t training and proctoring. (c) The hospital shall establish criteria regarding who is a high - risk patient for purposes of this section, and shall determine the timeframe for completion of the medication profile or list, based on the patient populations ser ved by the hospital. (d) The board may adopt rules and regulations to carry out the purposes and objectives of this section. (e) This section shall not apply to the State Department of State Hospitals. ibit a healing arts licensee (f) Nothing in this section shall be construed to proh licensed pursuant to this division from obtaining an accurate medication profile or list. 86

87 4119. Furnish Prescription Drug to Licensed Health Care Facility – Secured Emergency Supplies (a) Notwithstanding any other law, a phar macy may furnish a dangerous drug or dangerous device to a licensed health care facility for storage in a secured emergency pharmaceutical supplies container maintained within the facility in accordance with facility regulations of the State Department of Public Health set forth in Title 22 of the California Code of Regulations and the requirements set forth in Section 1261.5 of the Health and Safety Code. These emergency supplies shall be approved by the facility’s patient care policy committee or pharmace utical service committee and shall be readily available to each nursing station. Section 1261.5 of the Health and Safety Code limits the number of oral dosage form or suppository form drugs in these emergency supplies to 48. law, a pharmacy may furnish a dangerous drug (b) Notwithstanding any other or a dangerous device to an approved service provider within an emergency medical services system for storage in a secured emergency pharmaceutical supplies container, in accordance with the policies and procedu res of the local emergency medical services agency, if all of the following are met: (1) The dangerous drug or dangerous device is furnished exclusively for use in conjunction with services provided in an ambulance, or other approved emergency medical ser vices service provider, that provides prehospital emergency medical services. (2) The requested dangerous drug or dangerous device is within the licensed or certified emergency medical technician’s scope of practice as established by the Emergency Medical Services Authority and set forth in Title 22 of the California Code of Regulations. (3) The approved service provider within an emergency medical services system provides a written request that specifies the name and quantity of dangerous drugs or danger ous devices. (4) The approved emergency medical services provider administers dangerous drugs and dangerous devices in accordance with the policies and procedures of the local emergency medical services agency. (5) The approved emergency medical services provider documents, stores, and restocks dangerous drugs and dangerous devices in accordance with the policies and procedures of the local emergency medical services agency. Records of each request by, and dangerous drugs or dangerous devices furnished to , an approved service provider within an emergency medical services system, shall be maintained by both the approved service provider and the dispensing pharmacy for a period of at least three years. mergency medical The furnishing of controlled substances to an approved e services provider shall be in accordance with the California Uniform Controlled Substances Act (Division 10 (commencing with Section 11000) of the Health and Safety Code). 87

88 – 4119.01 Emergency Medical Services Automated Drug Delivery System s Licensing; Fee; Restocking and Removing Drugs; Inventory and Reconciliation; Record keeping; Licensed Designated Paramedic (a) Notwithstanding any other law, a pharmacy, or a licensed wholesaler that cy, may restock dangerous is also an emergency medical services provider agen drugs or dangerous devices into an emergency medical services automated drug delivery system (EMSADDS) that is licensed by the board under this section. Dangerous drugs and dangerous devices stored or maintained in an EMSADDS shal l be used for the sole purpose of restocking a secured emergency pharmaceutical supplies container as authorized in subdivision (b) of Section 4119. The EMSADDS may be used only if all of the following conditions are met: (1) The emergency medical service s provider agency obtains a license from the board to operate the EMSADDS. As a requirement for licensure, the EMSADDS shall be located on the premises of a fire department headquarters, a fire station, or at an emergency medical services provider agency’s location. A separate license shall be required for each location. (A) As part of its license application, the emergency medical services provider agency shall provide: the address where the EMSADDS will be located; the sible for overseeing the emergency medical name of the medical director respon services provider agency; the name of any designated pharmacist or licensed designated paramedic who is responsible for performing the duties as required he provisions under under this section; the policies and procedures detailing t which the EMSADDS will operate; and the name and license number of the pharmacy or emergency medical services provider agency wholesaler that will furnish the dangerous drugs and dangerous devices through the EMSADDS. on and initial license fee to operate EMSADDS shall be one (B) The applicati hundred dollars ($100) per machine. The license shall be renewed annually. The license fee may not be transferred to a different location if the EMSADDS is moved. The penalty fee for failure to ren ew an EMSADDS license shall be thirty - five dollars ($35). (C) The application and renewal fee for a licensed wholesaler that is also an emergency medical services provider agency shall be seven hundred eighty dollars ($780). (2) Each EMSADDS shall collec t, control, and maintain all transaction information necessary to accurately track the movement of drugs into and out of the system for purposes of security, accuracy, and accountability. (3) The medical director and designated pharmacist, or the medical director and the licensed designated paramedic, shall develop, adopt, and maintain policies and procedures detailing the provisions under which the EMSADDS will operate. At a minimum, the policies and procedures shall address (A) inventory controls, (B) tr aining, (C) storage and security of the dangerous drugs and dangerous devices, and (D) safeguards to limit access to the EMSADDS to authorized staff only. (4) The licensed EMSADDS operator shall limit access to the EMSADDS r who are licensed by the state and as only to employees of the operato authorized in this section. 88

89 (A) An EMSADDS may only be restocked by the medical director, a pharmacist, or a licensed designated paramedic, each of whom may possess and transport dangerous drugs or dangerous devices for that purpose. The transport of dangerous drugs or dangerous devices for restocking into an EMSADDS shall be done in a secured manner to prevent theft or unauthorized access, and shall be done under conditions appropriate to meet storage and handling re quirements of the dangerous drugs or dangerous devices. While the dangerous drugs or dangerous devices may be transported, representatives shall not store a dangerous drug or dangerous device at an unlicensed location. (B) Only a medical director, a pharm acist, or a paramedic may remove dangerous drugs or dangerous devices from an EMSADDS to fill a secured emergency pharmaceutical supplies container. This access shall be observed by a second person who is also a paramedic, a pharmacist, or a medical direct or. Both the individual who removes dangerous drugs or dangerous devices from the EMSADDS and the observer shall record their participation in the removal of the dangerous drugs or dangerous devices via their signatures or use of biometric identifiers. The restocking of the secured emergency pharmaceutical supplies container from the EMSADDS shall occur at the licensed location of the EMSADDS. (C) A medical director, a pharmacist, or a licensed designated paramedic may ngerous devices from an EMSADDS. remove outdated dangerous drugs or da Any outdated dangerous drugs or dangerous devices shall be provided to a licensed reverse distributor for destruction. (5) Every EMSADDS operator shall perform monthly inventory and inventory reconciliation functions. The medical director, designated pharmacist, or licensed designated paramedic shall perform a reconciliation and prepare a written report based on written policies and procedures developed to maintain the security and quality of the dangerous drugs and dangero us devices. The written inventory reconciliation report shall include all of the following: (A) A physical count of all quantities of dangerous drugs and dangerous devices stored in the EMSADDS. (B) A review of all dangerous drugs and dangerous devices a dded into and removed from each EMSADDS since the last monthly inventory. (C) A comparison of subparagraphs (A) and (B), and identification of any variances. (D) A review of all individuals who accessed the EMSADDS since the last inventory and identifica tion of unauthorized individuals accessing the EMSADDS or suspicious activity. (E) Identification of possible causes of shortages and overages. (6) The medical director and designated pharmacist, or medical director and licensed designated paramedic, sha ll be jointly responsible for monthly review of the inventory reconciliation report, the training, storage, and security of dangerous drugs and dangerous devices, and the restocking of the EMSADDS. the board within Any inventory losses from an EMSADDS shall be reported to seven days from identification of the loss. (7) In order for an individual to perform the functions of a licensed designated paramedic described in this section, that individual shall be licensed by the 89

90 board pursuant to Section 4202.5. A paramedic who only restocks a secured emergency pharmaceutical supplies container from an EMSADDS need not be licensed with the board. (8) A record of each access to the EMSADDS, as well as all records used to compile an inventory reconciliation report, shall be maintained at the operator’s location for at least three years in a readily retrievable form. The records shall include the identity of every individual who accessed the system or witnessed such access; the date of each access; and the drug, dosag e, form, strength, and quantity of dangerous drugs or dangerous devices added or removed. (b) A violation of any of the provisions of this section shall constitute unprofessional conduct and provides the board the authority to take action DDS operator’s license. against the EMSA 4119.1. Pharmacy May Provide Services to Health Facility (a) A pharmacy may provide pharmacy services to a health facility licensed pursuant to subdivision (c), (d), or both, of Section 1250 of the Health and Safety Code, throug h the use of an automated drug delivery system that need not be located at the same location as the pharmacy. (b) Drugs stored in an automated drug delivery system shall be part of the inventory of the pharmacy providing pharmacy services to that facility , and drugs dispensed from the pharmacy system shall be considered to have been dispensed by that pharmacy. (c) (1) The pharmacy shall maintain records of the acquisition and disposition g of dangerous drugs and dangerous devices stored in the automated dru delivery system separate from other pharmacy records. (2) The pharmacy shall own and operate the automated drug delivery system. (3) The pharmacy shall provide training regarding the operation and use of the automated drug delivery system to both pharm acy and health facility personnel using the system. (4) The pharmacy shall operate the automated drug delivery system in compliance with Section 1261.6 of the Health and Safety Code. (d) The operation of the automated drug delivery system shall be under the supervision of a licensed pharmacist. To qualify as a supervisor for an automated drug delivery system, the pharmacist need not be physically present at the site of the automated drug delivery system and may supervise the system electronically. (e) T be construed to revise or limit the use of automated not his section shall drug delivery systems as permitted by the board in any licensed health facility other than a facility defined in subdivision (c) or (d), or both, of Section 1250 of the Health and S afety Code. (f) This section shall become inoperative on July 1, 2019, and, as of January 1, 2020, is repealed. 4119.2. Furnish Epinephrine Auto - Injectors to School; Requirements Notwithstanding any other law, a pharmacy may furnish epinephrine au - (a) to injectors to a school district, county office of education, or charter school pursuant to Section 49414 of the Education Code if all of the following are met: 90

91 (1) The epinephrine auto - injectors are furnished exclusively for use at a school district si te, county office of education, or charter school. (2) A physician and surgeon provides a written order that specifies the - injectors to be furnished. quantity of epinephrine auto (b) Records regarding the acquisition and disposition of epinephrine auto - injectors furnished pursuant to subdivision (a) shall be maintained by the school district, county office of education, or charter school for a period of three years from the date the records were created. The school district, county office of education, or charter school shall be responsible for monitoring the supply of epinephrine auto - injectors and ensuring the destruction of expired epinephrine auto - injectors. 4119.3. Furnish Epinephrine Auto - Injectors to First Responder or Lay ; Requirements Rescuer (a) Notwithstanding any other law, a pharmacy may dispense epinephrine auto - injectors to a prehospital emergency medical care person or lay rescuer for the purpose of rendering emergency care in accordance with Section 1797.197a of the Health and Safety C ode, if both of the following requirements are met: (1) A physician and surgeon provides a written order that specifies the quantity of epinephrine auto - injectors to be dispensed to a person described in subdivision (b) of Section 1797.197a of the Health and Safety Code. The physician and surgeon may issue the prescription only upon presentation of a current certificate demonstrating that the person is trained and qualified under Section 1797.197a of the Health and Safety Code to administer an epinephrine auto injector to another person in an emergency situation. The prescription - shall specify that the dispensed epinephrine auto injector is for “First Aid - Purposes Only” and that the named recipient is a “Section 1797.197a Responder.” A new prescription sha ll be written for any additional epinephrine auto - injectors required. (2) (A) The pharmacy shall label each epinephrine auto - injector dispensed with all of the following: (i) The name of the person to whom the prescription was issued. (ii) The design ations “Section 1797.197a Responder” and “First Aid Purposes Only.” The dosage, use, and expiration date. (iii) (B) Each dispensed prescription shall include the manufacturer’s product injector. information sheet for the epinephrine auto - on described in subdivision (b) of Section 1797.197a of the Health (b) The pers - injectors pursuant to this section and Safety Code receiving epinephrine auto shall make and maintain a record for five years reflecting dates of receipt, use, - injector dispensed, the name of any person to and destruction of each auto - whom epinephrine was administered using an auto injector, and the circumstances and manner of destruction of any auto - injectors. injectors dispensed pursuant to this section may be (c) The epinephrine auto - us ed only for the purpose, and under the circumstances, described in Section 1797.197a of the Health and Safety Code. 91

92 4119.4. - injector ; Labeling; Records Requirements Epinephrine Auto (a) Notwithstanding any other law, a pharmacy may furnish epinephrine au to - injectors to an authorized entity, for the purpose of rendering emergency care in accordance with Section 1797.197a of the Health and Safety Code, if both of the following requirements are met: (1) injectors are furnished exclusive The epinephrine auto - ly for use by, or in connection with, an authorized entity. (2) An authorized health care provider provides a prescription that specifies the quantity of epinephrine auto - injectors to be furnished to an authorized entity described in subdivision (a) of Se ction 1797.197a of the Health and Safety - Code. A new prescription shall be written for any additional epinephrine auto injectors required for use. (b) - injector dispensed with all The pharmacy shall label each epinephrine auto of the following: (1) The na me of the person or entity to whom the prescription was issued. The designations “Section 1797.197a Responder” and “First Aid Purposes (2) Only.” (3) The dosage, use, and expiration date. (c) product Each dispensed prescription shall include the manufacturer’s information sheet for the epinephrine auto injector. - (d) Records regarding the acquisition and disposition of epinephrine auto - injectors furnished pursuant to subdivision (a) shall be maintained by the authorized entity for a period of three years from the date the records were created. The authorized entity shall be responsible for monitoring the supply of epinephrine auto - injectors and ensuring the destruction of expired epinephrine auto injectors. - (e) The epinephrine auto - injector dispensed pur suant to this section may be used only for the purpose, and under the circumstances, described in Section 1797.197a of the Health and Safety Code. (f) injector” means a - For purposes of this section, “epinephrine auto disposable delivery device designed fo r the automatic injection of a premeasured dose of epinephrine into the human body to prevent or treat a life - threatening allergic reaction. 4119.5. Transfer or Repackaging Dangerous Drugs by Pharmacy (a) A pharmacy can transfer a reasonable supply of dangerous drugs to another pharmacy. (b) A pharmacy may repackage and furnish to a prescriber a reasonable quantity of dangerous drugs and dangerous devices for prescriber office use. 4119.6. Health Care Facility; Stocking of Emergency Pharmaceutical Supplies Container and Emergency Medical System Supplies An intern pharmacist under the direct supervision and control, as defined in Section 4023.5, of a pharmacist may stock, replenish, and inspect the he emergency medical emergency pharmaceutical supplies container and t system supplies of a health care facility licensed under subdivision (a) of Section 1250 of the Health and Safety Code. 92

93 4119.7. Health Care Facility; Inspection of Drugs; Furnishing Per Standing Orders, etc. (a) Notwithstanding an y other law, a hospital pharmacy serving a health care facility licensed under subdivision (a) of Section 1250 of the Health and Safety Code may furnish a dangerous drug or dangerous device pursuant to preprinted or electronic standing orders, order sets, and protocols established under the policies and procedures of the health care facility, as approved according to the policies of the health care facility’s governing body, if the order is dated, timed, and authenticated in the medical record of the patien t to whom the dangerous drug or dangerous device will be provided. A health care facility shall store and maintain drugs in accordance with (b) national standards regarding the storage area and refrigerator or freezer temperature, and otherwise pursuant t o the manufacturer’s guidelines. The health care facility’s policies and procedures shall specify these storage parameters. (c) An intern pharmacist under the direct supervision and control, as defined in Section 4023.5, of a pharmacist, may inspect the d rugs maintained in the health care facility at least once per month. The health care facility shall establish specific written policies and procedures for inspections pursuant to this subdivision. For purposes of this section, “health care facility” m (d) eans a health facility licensed under subdivision (a) of Section 1250 of the Health and Safety Code. 4119.8. Naloxone Hydrochloride Furnished to School District, County Office of Education or Charter School; Records Requirements (a) Notwithstanding any other law, a pharmacy may furnish naloxone hydrochloride or another opioid antagonist to a school district, county office of education, or charter school pursuant to Section 49414.3 of the Education Code if all of the following are met: The naloxone hydrochloride or another opioid antagonist is furnished (1) exclusively for use at a school district schoolsite, county office of education schoolsite, or charter school. (2) A physician and surgeon provides a written order that specifies the quantity of nalo xone hydrochloride or another opioid antagonist to be furnished. (b) Records regarding the acquisition and disposition of naloxone hydrochloride or another opioid antagonist furnished pursuant to subdivision (a) shall be maintained by the school district, county office of education, or charter school for a period of three years from the date the records were created. The school district, county office of education, or charter school shall another be responsible for monitoring the supply of naloxone hydrochloride or opioid antagonist and ensuring the destruction of expired naloxone hydrochloride or another opioid antagonist. 93

94 4119.9 Naloxone Hydrochloride Furnished to a Law Enforcement Agency Notwithstanding any other law, a pharmacy, wholesaler, or manufac turer may furnish naloxone hydrochloride or other opioid antagonists to a law enforcement agency if both of the following are met: (a) The naloxone hydrochloride or other opioid antagonist is furnished exclusively for use by employees of the law enforcemen t agency who have completed training, provided by the law enforcement agency, in administering naloxone hydrochloride or other opioid antagonists. (b) Records regarding the acquisition and disposition of naloxone urnished pursuant to this section hydrochloride or other opioid antagonists f shall be maintained by the law enforcement agency for a period of three years from the date the records were created. The law enforcement agency shall be responsible for monitoring the supply of naloxone hydrochloride or o ther opioid antagonists and ensuring the destruction of expired naloxone hydrochloride or other opioid antagonists. 4119.11 Automated Patient Dispensing Systems (a) A pharmacy located in the state may provide pharmacy services to the patients of a “cover ed entity,” as defined in Section 256b of Title 42 of the United States Code, through the use of an automated patient dispensing system located on the premises of the covered entity or on the premises of vide medical services to medical professional practices under contract to pro covered entity patients, which need not be the same location as the pharmacy, if all of the following conditions are met: (1) The pharmacy obtains a license from the board to operate the automated patient dispensing system at the c overed entity or affiliated site. As part of the application, the pharmacy shall provide the address at which the automated patient dispensing system shall be placed and identify the covered entity. A separate license shall be required for each location an d shall be renewed annually concurrent with the pharmacy license. The application and renewal fee shall be three hundred dollars ($300) and may be increased to five hundred dollars ($500). The board is authorized to lower the renewal fee to not less than t wo hundred dollars ($200) if a lower fee level will provide sufficient resources to support the regulatory activities. (2) The pharmacy providing the pharmacy services to the patients of the er law, covered entity, including, unless otherwise prohibited by any oth patients enrolled in the Medi - Cal program, shall be under contract with that covered entity as described in Section 4126 to provide those pharmacy services through the use of the automated patient dispensing system. (3) Drugs stored in an automated patient dispensing system shall be part of the inventory of the pharmacy providing pharmacy services to the patients of the covered entity and drugs dispensed from the automated patient dispensing pharmacy. system shall be considered to have been dispensed by that (4) The pharmacy shall maintain records of the acquisition and disposition of dangerous drugs stored in the automated patient dispensing system separate from other pharmacy records. 94

95 (5) The pharmacy shall be solely responsible for the security, o peration, and maintenance of the automated patient dispensing system. (6) The pharmacy shall provide training regarding the operation and use of the automated patient dispensing system to both pharmacy and covered entity personnel using the system. (7) The operation of the automated patient dispensing system shall be under the supervision of a licensed pharmacist acting on behalf of the pharmacy providing services to the patients of the covered entity. The pharmacist need not be physically present at the si te of the automated patient dispensing system and may supervise the system electronically. (8) Notwithstanding Section 4107, the board may issue a license for the operation of an automated patient dispensing system at an address for which it ther site license. has issued ano (9) The board, within 30 days after receipt of an application for an automated patient dispensing system license, shall conduct a prelicensure inspection at the proposed location of the automated patient dispensing system. Relocation of the automated patient dispensing system shall require a new application for licensure. Replacement of an automated patient dispensing system shall require notice to the board within 30 days. celed by (10) The automated patient dispensing system license shall be can operation of law if the underlying pharmacy license is not current, valid, and active. Upon reissuance or reinstatement of the underlying pharmacy license, a new application for an automated patient dispensing system license may be submitted to th e board. (11) A pharmacy that holds an automated patient dispensing system license shall advise the board in writing within 30 days if use of the automated patient dispensing system is discontinued. (b) For purposes of this section, the following definitio ns shall apply: (1) An “automated drug delivery system” (ADDS) means a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, dispensing, or distribution of drugs. An ADDS shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability. (2) An “automated patient dispensing system” (APDS) is an ADDS for storage and dispensing of prescribed drugs directly to patients pursuant to prior authorization by a pharmacist. (3) An “automated unit dose system” (AUDS) is an ADDS for storage and retrieval of unit doses of drugs for administration to patients by persons authorized to perform t hese functions. (c) (1) An automated patient dispensing system shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability. information shall be made readily available in a downloadable (2) Transaction format for review and inspection by individuals authorized by law. These records shall be maintained by the pharmacy for a minimum of three years. 95

96 (d) Drugs from the automated patient dispensin g system may be dispensed directly to the patient if all of the following requirements are met: (1) The pharmacy shall develop, implement, and annually review written policies and procedures with respect to all of the following: (A) Maintaining the securit y of the automated patient dispensing system and the dangerous drugs and devices within that automated patient dispensing system. (B) Determining and applying inclusion criteria regarding which drugs and devices are appropriate for placement in the automat ed patient dispensing system and for which patients. (C) Ensuring that patients are aware that consultation with a pharmacist is available for any prescription medication, including those delivered via the automated patient dispensing system. g assignment of responsibilities to, and training of, pharmacy (D) Describin personnel, and other personnel using the automated patient dispensing system at the location where the automated patient dispensing system is placed, regarding maintenance and filing procedures for the automated patient dispensing system. (E) Orienting participating patients on the use of the automated patient dispensing system, notifying patients when expected prescription medications , and ensuring that are not available in the automated patient dispensing system patient use of the automated patient dispensing system does not interfere with delivery of drugs and devices. (F) Ensuring delivery of drugs and devices to patients expecting to receive them from the automated patient dispensing system in the event the automated patient dispensing system is disabled or malfunctions. (2) The automated patient dispensing system shall only be used for patients who have signed a written consent demonstrating their informed consent to receive prescribed drugs and devices from an automated patient dispensing system and whose use of the automated patient dispensing system meet the criteria pursuant to paragraph (1). (3) The automated patient dispensing system shall have a means to identify release the identified patient’s drugs and devices to the each patient and only patient or the patient’s agent. (4) A pharmacist shall perform all clinical services conducted as part of the dispensing process, including, but not limited to, drug utilization review and consultat ion. (5) Drugs shall be dispensed from the automated patient dispensing system only upon authorization from a pharmacist after the pharmacist has reviewed the prescription and the patient’s profile for potential contraindications and adverse drug reactions . (6) All prescribed drugs and devices dispensed from the automated patient dispensing system for the first time shall be accompanied by a consultation conducted by a pharmacist licensed by the board via a telecommunications video. link that has two - way audio and (7) The automated patient dispensing system shall include a notice, prominently posted on the automated patient dispensing system, that provides 96

97 the name, address, and telephone number of the pharmacy that holds the automated patient dispensing sys tem license for that automated patient dispensing system. (8) The labels on all drugs dispensed by the automated patient dispensing system shall comply with Section 4076 of this code and with Section 1707.5 of Title 16 of the California Code of Regulations . (9) Any complaint, error, or omission involving the automated patient dispensing system shall be reviewed as part of the pharmacy’s quality assurance program pursuant to Section 4125. tomated (10) The board shall not issue a pharmacy more than 15 licenses for au patient dispensing system units under this section. Consistent with Section 4001.1, the board may adopt regulations to reduce the number of automated patient dispensing system licenses that may be issued to a pharmacy. (11) The pharmacy holding the license for the automated patient dispensing system shall maintain the policies and procedures developed pursuant to paragraph (1) for three years after the last date of use of that automated patient dispensing system. dispensing system shall be controlled and (e) Access to the automated patient tracked using an identification or password system or biosensor. A system that is accessed via a password system shall include a camera that records a picture s shall be maintained of the individual accessing the machine. Picture record for a minimum of 180 days. (f) The automated patient dispensing system shall make a complete and accurate record of all transactions that will include all users accessing the system and all drugs added to, or removed from, the system. (g) The stocking of an automated patient dispensing system shall be performed by a pharmacist. If the automated patient dispensing system utilizes removable pockets, cards, drawers, similar technology, or unit of use or single dose containers as defined b y the United States Pharmacopeia, the stocking system may be done outside of the facility and be delivered to the facility if all of the following conditions are met: (1) The task of placing drugs into the removable pockets, cards, drawers, similar technol ogy, or unit of use or single dose containers is performed by a pharmacist, or by an intern pharmacist or a pharmacy technician working under the direct supervision of a pharmacist. use (2) The removable pockets, cards, drawers, similar technology, or unit of or single dose containers are transported between the pharmacy and the facility in a secure tamper - evident container. (3) The pharmacy, in conjunction with the covered entity, has developed policies and procedures to ensure that the removable pockets, cards, drawers, similar technology, or unit of use or single dose containers are properly placed into the automated patient dispensing system. (h) Review of the drugs contained within, and the operation and maintenance system shall be done in accordance with of, the automated patient dispensing law and shall be the responsibility of the pharmacy. The review shall be conducted on a monthly basis by a pharmacist and shall include a physical inspection of the drugs in the automated patient dispensing system, a n 97

98 inspection of the automated patient dispensing system machine for cleanliness, and a review of all transaction records in order to verify the security and accountability of the system. (i) A pharmacy holding an automated patient dispensing system license shall complete an annual self - assessment, performed pursuant to Section 1715 of Title 16 of the California Code of Regulations, evaluating the pharmacy’s compliance with pharmacy law relating to the use of the automated patient dispensing system. All info rmation regarding operation, maintenance, compliance, error, omissions, or complaints pertaining to the automated patient dispensing system shall be included in the self - assessment. (j) The pharmacy shall comply with all recordkeeping and quality assurance requirements pursuant to this chapter, and shall maintain those records within the pharmacy holding the automated patient dispensing system license and separately from other pharmacy records. (Added by Stats. 2018, Ch. 647, Sec. 1. (AB 2037) Effective Sep tember 21, 2018.) 4120. Nonresident Pharmacy: Registration Required (a) A nonresident pharmacy shall not sell or distribute dangerous drugs or dangerous devices in this state through any person or media other than a wholesaler or third - party logistics provider who has obtained a license pursuant to this chapter or through a selling or distribution outlet that is licensed as a - party logistics provider pursuant to this chapter without wholesaler or third registering as a nonresident pharmacy. Applic ations for a nonresident pharmacy registration shall be made on a (b) form furnished by the board. The board may require any information as the board deems reasonably necessary to carry out the purposes of this section. (c) The Legislature, by enacting this section, does not intend a license issued to any nonresident pharmacy pursuant to this section to change or affect the tax liability imposed by Chapter 3 (commencing with Section 23501) of Part 11 of Division 2 of the Revenue and Taxation Code on any nonre sident pharmacy. The Legislature, by enacting this section, does not intend a license issued (d) to any nonresident pharmacy pursuant to this section to serve as any evidence that the nonresident pharmacy is doing business within this state. 4121. Adve rtisement for Prescription Drug: Requirements; Restrictions (a) Notwithstanding Section 651, an advertisement of the retail price for a drug that requires a prescription shall be limited to quantities of the drug that a re consistent with good medical pra ctice and shall include the strength, dosage form, and the exact dates during which the advertised price will be in effect. (b) This section shall not apply to a pharmacy that is located in a licensed hospital and that is accessible only to hospital medi cal staff and personnel. Required Notice of Availability of Prescription Price Information, 4122. General Product Availability, Pharmacy Services; Providing Price Information; Limitations on Price Information Requests 98

99 (a) In every pharmacy there shall be prominently posted in a place conspicuous to, and readable by, prescription drug consumers a notice provided by the board concerning the availability of prescription price information, the possibility of generic drug product selection, the type of service s provided by pharmacies, and a statement describing patients' rights relative to the requirements imposed on pharmacists pursuant to Section 733. The format and wording of the notice shall be adopted by the board by regulation. A written receipt that cont ains the required information on the notice may be provided to consumers as an alternative to posting the notice in the pharmacy. (b) A pharmacist, or a pharmacist's employee, shall give the current retail price for any drug sold at the pharmacy upon requ est from a consumer, however that request is communicated to the pharmacist or employee. (c) If a requester requests price information on more than five prescription drugs and does not have valid prescriptions for all of the drugs for which price informat ion is requested, a pharmacist may require the requester to meet any or all of the following requirements: (1) The request shall be in writing. (2) The pharmacist shall respond to the written request within a reasonable period of time. A reasonable perio d of time is deemed to be 10 days, or the time period stated in the written request, whichever is later. (3) A pharmacy may charge a reasonable fee for each price quotation, as long as the requester is informed that there will be a fee charged. (4) No ph armacy shall be required to respond to more than three requests as month - described in this subdivision from any one person or entity in a six period. (d) This section shall not apply to a pharmacy that is located in a licensed ble only to hospital medical staff and personnel. hospital and that is accessi (e) Notwithstanding any other provision of this section, no pharmacy shall be required to do any of the following: (1) Provide the price of any controlled substance in response to a telephone request. (2 ) Respond to a request from a competitor. (3) Respond to a request from an out - of - state requester. 4123. Compounding Drug for Other Pharmacy for Parenteral Therapy; Notice to Board Any pharmacy that contracts to compound a drug for parenteral therapy, pursuant to a prescription, for delivery to another pharmacy shall report that contractual arrangement to the board. That information shall be reported by the pharmacy performing the compounding services within 30 days of commencing that compounding. 412 4. Dispensing Replacement Contact Lenses: Requirements; Patient Warnings; Registration with Medical Board; Application of Section to Nonresident Pharmacies (a) Notwithstanding Section 2543, a pharmacist may dispense replacement contact lenses pursuant to a valid prescription of a physician or optometrist. 99

100 Nothing in this section authorizes a pharmacist to conduct an examination of the eyes or to fit or adjust contact lenses. For purposes of this section, "replacement contact lenses" means soft contact l enses that require no fitting or adjustment, and that are dispensed as packaged and sealed by the manufacturer. (b) No replacement contact lenses may be sold or dispensed except pursuant to a prescription that meets all of the following requirements: (1) Conforms to state and federal statutes and regulations governing those prescriptions and includes the name, address, and state license number of the prescribing practitioner. (2) Explicitly states an expiration date of not more than one year from the dat e of the last prescribing examination. (3) Explicitly states that the prescription is for contact lenses and includes the lens brand name, type, and tint, including all specifications necessary for the ordering of lenses. (c) The contact lenses that ar e dispensed shall be the exact contact lenses that have been prescribed, and no substitutions shall be made. (d) Any pharmacist and pharmacy that dispenses replacement contact lenses in the event shall direct the patient to confer with his or her eyecare practitioner of any eye problem or reaction to the lenses. (e) Any pharmacist and pharmacy that sells replacement contact lenses shall provide the following or substantially equivalent written notification to the ed: patient whenever contact lenses are suppli WARNING: IF YOU ARE HAVING ANY UNEXPLAINED EYE DISCOMFORT, WATERING, VISION CHANGE, OR REDNESS, REMOVE YOUR LENSES IMMEDIATELY AND CONSULT YOUR EYE CARE PRACTITIONER BEFORE WEARING YOUR LENSES AGAIN. lacement contact lenses shall (f) Any pharmacy and pharmacist dispensing rep be subject to all statutes, regulations, and ordinances governing the advertisement of contact lenses. In addition, any advertisement by a pharmacy or pharmacist that mentions replacement contact lenses shall include within t he advertisement all fees, charges, and costs associated with the purchase of the lenses from that pharmacy and pharmacist. (g) Any pharmacy dispensing replacement contact lenses shall register with the Medical Board of California at the time of initial a pplication for a license or at the time of annual renewal of that license. (h) All nonresident pharmacies shall maintain records of replacement contact lenses shipped, mailed, or delivered to persons in California for a period of at least three years. Th e records shall be available for inspection upon request by the board or the Division of Licensing of the Medical Board of California. (i) The requirements of this section are applicable to nonresident pharmacies 112. A nonresident pharmacy may as defined in subdivision (a) of Section 4 dispense contact lenses only as provided in this section. 100

101 4125. Pharmacy Quality Assurance Program Required; Records Considered Peer Review Documents (a) Every pharmacy shall establish a quality assurance program tha t shall, at a minimum, document medication errors attributable, in whole or in part, to the pharmacy or its personnel. The purpose of the quality assurance program shall be to assess errors that occur in the pharmacy in dispensing or furnishing n medications so that the pharmacy may take appropriate action to prescriptio prevent a recurrence. (b) Records generated for and maintained as a component of a pharmacy's ongoing quality assurance program shall be considered peer review documents and not subject to discovery in any arbitration, civil, or other proceeding, except as provided hereafter. That privilege shall not prevent review of a pharmacy's quality assurance program and records maintained as part of that system by the board as necessary to protect t he public health and safety or if fraud is alleged by a government agency with jurisdiction over the pharmacy. Nothing in this section shall be construed to prohibit a patient from accessing his or her own prescription records. Nothing in this section sha ll affect the discoverability of any records not solely generated for and maintained as a component of a pharmacy's ongoing quality assurance program. (c) This section shall become operative on January 1, 2002. 4126. Covered Entity May Contract With Ph armacy to Provide Pharmacy Services; Segregation of Drug Stock; Return of Drugs Not Dispensed; Wholesale License Not Permitted or Required (a) Notwithstanding any other provision of law, a covered entity may contract with a pharmacy to provide pharmacy s ervices to patients of the covered entity, as defined in Section 256b of Title 42 of the United States Code, including dispensing preferentially priced drugs obtained pursuant to Section 256b of Title 42 of the United States Code. Contracts between those covered entities and pharmacies shall comply with guidelines published by the Health Resources and Services Administration and shall be available for inspection by board staff during normal business hours. Title 42 of the United States (b) Drugs purchased pursuant to Section 256b of Code and received by a pharmacy shall be segregated from the pharmacy's other drug stock by either physical or electronic means. All records of acquisition and disposition of these drugs shall be readily retrievable in a form separate from the pharmacy's other records. (c) Drugs obtained by a pharmacy to be dispensed to patients of a covered entity pursuant to Section 256b of Title 42 of the United States Code that cannot be distributed because of a change in circumstances f or the covered entity or the pharmacy shall be returned to the distributor from which they were obtained. For the purposes of this section, a change in circumstances includes, e but is not limited to, the termination or expiration of the contract between th pharmacy and the covered entity, the closure of a pharmacy, disciplinary action against the pharmacy, or closure of the covered entity. 101

102 (d) A licensee that participates in a contract to dispense preferentially priced drugs pursuant to this section shal l not have both a pharmacy and a wholesaler license. (e) Neither a covered entity nor a pharmacy shall be required to obtain a license as a wholesaler based on acts reasonably necessary to fully participate in the drug purchase program established by Sec tion 256b of Title 42 of the United States Code. 4126.5. Furnishing Dangerous Drugs by Pharmacy (a) A pharmacy may furnish dangerous drugs only to the following: (1) A wholesaler owned or under common control by the wholesaler from whom the dangerous drug was acquired. (2) The pharmaceutical manufacturer from whom the dangerous drug was acquired. (3) A licensed wholesaler acting as a reverse distributor. (4) Another pharmacy or wholesaler to alleviate a temporary shortage of a dangerous drug that co uld result in the denial of health care. A pharmacy furnishing dangerous drugs pursuant to this paragraph may only furnish a quantity sufficient to alleviate the temporary shortage. herwise (5) A patient or to another pharmacy pursuant to a prescription or as ot authorized by law. (6) A health care provider that is not a pharmacy but that is authorized to purchase dangerous drugs. (7) To another pharmacy under common control. During a proclaimed state of emergency, “another pharmacy” as used in this para graph shall include a mobile pharmacy, as described in subdivision (c) of Section 4062. (b) Notwithstanding subdivision (a), or any other law, a clinic licensed under Section 4180 may furnish dangerous drugs to any of the following during a proclaimed stat e of emergency: (1) Another clinic or wholesaler to alleviate a temporary shortage of a dangerous drug that could result in the denial of health care. A clinic furnishing dangerous drugs pursuant to this paragraph may only furnish a quantity sufficient to alleviate the temporary shortage. (2) A patient pursuant to a prescription or as otherwise authorized by law. (3) A health care provider that is not a clinic but that is authorized to purchase dangerous drugs. (4) To another clinic under common control, in cluding a mobile clinic, as described in subdivision (c) of Section 4062. (c ) Notwithstanding any other law, a violation of this section may subject the person or persons who committed the violation to a fine not to exceed the amount specified in Section 125.9 for each occurrence pursuant to a citation issued by the board. ) Amounts due from any person under this section on or after January 1, (d 2005, shall be offset as provided under Section 12419.5 of the Government Code. Amounts received by the boar d under this section shall be deposited into the Pharmacy Board Contingent Fund. 102

103 (e ) For purposes of this section, "common control" means the power to direct or cause the direction of the management and policies of another person voting rights, by contract, or by other means. whether by ownership, by 4126.9. Recall of Nonsterile Compounded Drug Products – Requirements (a) A pharmacy that issues a recall notice regarding a nonsterile compounded drug product shall, in addition to any other duties, contac t the recipient pharmacy, prescriber, or patient of the recalled drug and the board within 12 hours of the recall notice if both of the following apply: (1) Use of or exposure to the recalled drug may cause serious adverse health consequences or death. ( 2) The recalled drug was dispensed, or is intended for use, in this state. (b) A recall notice issued pursuant to subdivision (a) shall be made as follows: (1) If the recalled drug was dispensed directly to the patient, the notice shall be made to the pa tient. (2) If the recalled drug was dispensed directly to the prescriber, the notice shall be made to the prescriber, who shall ensure the patient is notified. (3) If the recalled drug was dispensed directly to a pharmacy, the notice shall be made to the pharmacy, which shall notify the prescriber or patient, as appropriate. If the pharmacy notifies the prescriber, the prescriber shall ensure the patient is notified. (c) A pharmacy that has been advised that a patient has been harmed by using a nonsteril e compounded product potentially attributable to the pharmacy shall report the event to MedWatch within 72 hours of the pharmacy being advised. Article 7.5 Compounded Sterile Drug Products 4127. License to Compound Sterile Drug Products Required (a) A pharmacy that compounds sterile drug products shall possess a sterile compounding pharmacy license as provided in this article. (b) The board shall adopt regulations in accordance with the Administrative Procedure Act (Chapter 3.5 (commencing with Sec tion 11340) of Part 1 of Division 3 of Title 2 of the Government Code) to establish policies, guidelines, and procedures to implement this article. The board shall review any formal revision to General Chapter 797 of the (c) d The National Formulary (USP – NF), relating United States Pharmacopeia an to the compounding of sterile preparations, not later than 90 days after the revision becomes official, to determine whether amendments are necessary for the regulations adopted by the board pursuant to subdivisi on (b). 4127.1. License to Compound Injectable Sterile Drug Products Required (a) A pharmacy shall not compound sterile drug products unless the pharmacy has obtained a sterile compounding pharmacy license from the board pursuant to this section. The l icense shall be renewed annually and is not transferable. (b) A license to compound sterile drug products shall be issued only to a location that is licensed as a pharmacy and shall be issued only to the owner of the pharmacy licensed at that location. 103

104 ( c) A license to compound sterile drug products shall not be issued or renewed until the location is inspected by the board and found in compliance with this article and regulations adopted by the board. (d) A license to compound sterile drug products sha ll not be issued or renewed until the board does all of the following: (1) Reviews a current copy of the pharmacy’s policies and procedures for sterile compounding. (2) Reviews the pharmacy’s completed self - assessment form required by Section 1735.2 of Title 16 of the California Code of Regulations. (3) Is provided with copies of all inspection reports conducted of the pharmacy’s premises, and any reports from a private accrediting agency, erations. conducted in the prior 12 months documenting the pharmacy’s op (4) Receives a list of all sterile medications compounded by the pharmacy since the last license renewal. (e) A pharmacy licensed pursuant to this section shall do all of the following: (1) Provide to the board a copy of any disciplinary or other action taken by another state within 10 days of the action. (2) Notify the board within 10 days of the suspension of any accreditation held by the pharmacy. Provide to the board, within 12 hours, any recall notice issued by the (3) pharmacy for sterile drug products it has compounded. (f) Adverse effects reported or potentially attributable to a pharmacy’s sterile drug product shall be reported to the board within 12 hours and immediately reported to the MedWatch program of the federal Food and Drug Administration. The reconstitution of a sterile powder shall not require a license pursuant (g) to this section if both of the following requirements are met: (1) The sterile powder was obtained from a manufacturer. The drug is reconstitute d for administration to patients by a health care (2) professional licensed to administer drugs by injection pursuant to this division. (h) This section shall become operative on July 1, 2014. 4127.2. and Ship License to Compound Nonresident Pharmacy – In Drug Products into California Required jectable Sterile (a) A nonresident pharmacy shall not compound sterile drug products for shipment into this state without a sterile compounding pharmacy license issued by the board pursuant to this section. The lic ense shall be renewed annually and shall not be transferable. A license to compound sterile drug products shall be issued only to a (b) location that is licensed as a nonresident pharmacy and shall be issued only to the owner of the nonresident pharmacy licensed at that location. (c) A license to compound sterile drug products shall not be issued or renewed until the location is inspected by the board and found in compliance with this article and any regulations adopted by the board. The nonresident pha rmacy shall reimburse the board for all actual and necessary costs incurred by the board in conducting an inspection of the pharmacy at least once annually pursuant to subdivision (v) of Section 4400. 104

105 (d) A license to compound sterile drug products shall not be issued or renewed until the board does all of the following: (1) Reviews a current copy of the nonresident pharmacy’s policies and procedures for sterile compounding. (2) - assessment form required by Reviews the pharmacy’s completed self Section 1735.2 of Title 16 of the California Code of Regulations. (3) Is provided with copies of all inspection reports conducted of the nonresident pharmacy’s premises, and any reports from a private accrediting agency, conducted in the prior 12 months documen ting the nonresident pharmacy’s operations. Receives a list of all sterile drug products compounded by the pharmacy (4) within the prior 12 months. (e) A pharmacy licensed pursuant to this section shall do all of the following: Provide to the boa rd a copy of any disciplinary or other action taken by its (1) state of residence or another state within 10 days of the action. (2) Notify the board within 10 days of the suspension of any accreditation held by the pharmacy. Provide to the board, with (3) in 12 hours, any recall notice issued by the pharmacy for sterile drug products it has compounded that have been shipped into, or dispensed in, California. (4) Advise the board of any complaint it receives from a provider, pharmacy, nia. or patient in Califor (f) Adverse effects reported or potentially attributable to a nonresident pharmacy’s sterile compounded drug product shall be reported to the board within 12 hours and immediately reported to the MedWatch program of the tration. federal Food and Drug Adminis (g) On or before January 1, 2018, the board shall provide a report to the Legislature regarding the regulation of nonresident pharmacies. The report shall be submitted to the Legislature in the manner required pursuant to Section 9795 of the Gov ernment Code. At a minimum, the report shall address all of the following: (1) A detailed description of board activities related to the inspection and licensure of nonresident pharmacies. (2) Whether fee revenue collected pursuant to subdivision (v) o f Section 4400 and travel cost reimbursements collected pursuant to subdivision (c) of this section provide revenue in an amount sufficient to support the board’s activities related to the inspection and licensure of nonresident pharmacies. (3) The statu s of proposed changes to federal law that are under serious consideration and that would govern compounding pharmacies, including legislation pending before the United States Congress, administrative rules, regulations, or orders under consideration by the federal Food and Drug Administration or other appropriate federal agency, and cases pending before the courts. If applicable, recommended modifications to the board’s statutory duties (4) al law or any related to nonresident pharmacies as a result of changes to feder additional modifications necessary to protect the health and safety of the public. 105

106 (h) The requirement for submitting a report imposed under subdivision (g) is inoperative on January 1, 2022, pursuant to Section 10231.5 of the Government Co de. (i) This section shall become operative on July 1, 2014. 4127.3. Cease and Desist Order; Hearing Whenever the board has a reasonable belief, based on information obtained (a) during an inspection or investigation by the board, that a pharmacy comp ounding sterile drug products poses an immediate threat to the public health or safety, the executive officer of the board may issue an order to the pharmacy to immediately cease and desist from compounding sterile drug products. The cease and desist order shall remain in effect for no more than 30 days or the date of a hearing seeking an interim suspension order, whichever is earlier. (b) Whenever the board issues a cease and desist order pursuant to subdivision (a), the board shall immediately issue the owner a notice setting forth the acts or omissions with which the owner is charged, specifying the pertinent code section or sections. The order shall provide that the owner, within 15 days of receipt of the (c) esident of the board to contest the notice, may request a hearing before the pr cease and desist order. Consideration of the owner’s contest of the cease and desist order shall comply with the requirements of Section 11425.10 of the Government Code. The hearing shall be held no later than five days from the date the request of the owner is received by the board. The president shall render a written decision within five days of the hearing. In the absence of the president of the board, the vice president of the board may conduct the hearing permitted by this subdivision. Review of the decision of the president of the board may be sought by the owner or person in possession or control of the pharmacy pursuant to Section 1094.5 of the Code of Civil Procedure. (d) Failure to comply with a cease and desis t order issued pursuant to this section shall be unprofessional conduct. 4127.4. Fine for Violation Notwithstanding any other provision of law, a violation of this article, or regulations adopted pursuant thereto, may subject the person or entity that c ommitted the violation to a fine of up to two thousand five hundred dollars ($2,500) per occurrence pursuant to a citation issued by the board. 4127.6. Article Operative Upon Allocation of Positions This article shall become operative upon the allocati on of positions to the board for the implementation of the provisions of this article in the annual Budget Act. 4127.7 . Temporary License to Compound Injectables The board may, at its discretion, issue a temporary license to compound sterile drug produ cts upon the conditions and for any periods of time as the board determines to be in the public interest. A temporary license fee shall be 106

107 required in an amount established by the board as specified in subdivision (u) of Section 4400. W hen needed to protec t public safety, a temporary license may be issued for a period not to exceed 180 days, and may be issued subject to terms and conditions the board deems necessary. If the board determines a for a temporary license was issued by mistake or denies the application permanent license, the temporary license shall terminate upon either personal service of the notice of termination upon the licenseholder or service by certified mail, return receipt requested at the licenseholder's address of record with the board, whichever comes first. Neither for purposes of retaining a temporary license nor for purposes of any disciplinary or license denial proceeding before the board shall the temporary licenseholder be deemed to have a vested property right or interest in the license. 4127 .8 . Pharmacies That Compound Sterile Drug Products; Recalls; Requirements (a) A pharmacy licensed pursuant to Section 4127.1 or 4127.2 that issues a recall notice regarding a sterile compounded drug shall, in addition to any other duties, contact the recipient pharmacy, prescriber, or patient of the recalled drug and the board as soon as possible within 12 hours of the recall notice if both of the following apply: th Use of or exposure to the recalled drug may cause serious adverse heal (1) consequences or death. (2) The recalled drug was dispensed, or is intended for use, in this state. (b) A recall notice issued pursuant to subdivision (a) shall be made as follows: (1) If the recalled drug was dispensed directly to the patient, the notice shall be made to the patient. (2) If the recalled drug was dispensed directly to the prescriber, the notice shall be made to the prescriber, who shall ensure the patient is notified. If the recalled drug was dispensed directly to a pharmacy (3) , the notice shall be made to the pharmacy, who shall notify the prescriber or patient, as If the pharmacy notifies the prescriber, the prescriber shall ensure appropriate. the patient is notified. 4127.15. Hospital Satellite Compounding Pharmacy Subject to the requirements of this section, the board may issue a license to a hospital satellite compounding pharmacy. The license fee and annual renewal fee shall be in an amount established by the board in subdivision (u) of Section t be transferable. 4400. The license shall no (a) A hospital satellite compounding pharmacy license shall not be issued or renewed until the location is inspected by the board and found to be in compliance with this article and regulations adopted by the board. (1) A hospital satell ite compounding pharmacy shall compound sterile drug products for administration only to registered hospital patients who are on the premises of the same physical plant in which the hospital satellite compounding pharmacy is located. ded shall be directly related to the services or treatment (2) The services provi plan administered in the physical plant. 107

108 (b) A hospital satellite compounding pharmacy license shall not be issued or renewed until the board does all of the following: (1) Reviews a current copy o f the hospital satellite compounding pharmacy’s policies and procedures for sterile compounding. (2) Reviews the hospital satellite compounding pharmacy’s completed self - assessment form as described in Section 1735.2 of Title 16 of the California Code of R egulations. (3) Receives a list of all products compounded by the hospital satellite compounding pharmacy since the last license renewal. (c) A hospital satellite compounding pharmacy shall do all of the following: n all components through the license (1) Purchase, procure, or otherwise obtai of the hospital pharmacy as defined in subdivision (a) of Section 4029. (2) Satisfy the ratio of not less than one pharmacist on duty for a total of two pharmacy technicians on duty. (3) Ensure immediate supervision, as defined in Section 70065 of Title 22 of the California Code of Regulations, by a pharmacist of licensed ancillary staff involved in sterile compounding. (4) Provide to the board, within 12 hours, any recall notice issued by the hospital satellite compound ing pharmacy for sterile drug products it has compounded. (5) Report to the board, within 12 hours, adverse effects reported or potentially attributable to the sterile drug products compounded by the hospital satellite rse effects shall also be, within 12 compounding pharmacy. Unexpected adve hours, reported to the MedWatch program of the federal Food and Drug Administration. ies Article 7.6. Centralized Hospital Packaging Pharmac Centralized Hospital Packaging 4128. (a) Notwithstanding Section 4029, a centralized hospital packaging pharmacy may prepare medications, by performing the following specialized functions, for administration only to inpatients within its own general acute care hospital and one or more general acute care hospitals if the hospit als are under common ownership and located within a 75 - mile radius of each other: Preparing unit dose packages for single administration to inpatients from (1) bulk containers, if each unit dose package is barcoded pursuant to Section 4128.4. (2) Prepa ring sterile compounded unit dose drugs for administration to inpatients, if each compounded unit dose drug is barcoded pursuant to Section 4128.4. (3) Preparing compounded unit dose drugs for administration to inpatients, if each unit dose package is ba rcoded pursuant to Section 4128.4. (b) For purposes of this article, “common ownership” means that the ownership information on file with the board pursuant to Section 4201 for the th the licensed pharmacy is consistent with the ownership information on file wi board for the other licensed pharmacy or pharmacies for purposes of preparing medications pursuant to this section. 108

109 4128.2. Specialty License Required ; Application; Fees (a) In addition to the pharmacy license requirement described in Section 411 0, a centralized hospital packaging pharmacy shall obtain a specialty license from the board prior to engaging in the functions described in Section 4128. (b) An applicant seeking a specialty license pursuant to this article shall apply to the board on forms established by the board. (c) Before issuing the specialty license, the board shall inspect the pharmacy and ensure that the pharmacy is in compliance with this article and regulations established by the board. tions described in Section 4128 may only be (d) A license to perform the func issued to a pharmacy that is licensed by the board as a hospital pharmacy. (e) A license issued pursuant to this article shall be renewed annually and is not transferrable. (f) An applicant seeking renewal of a specialty license shall apply to the board on forms established by the board. (g) A license to perform the functions described in Section 4128 shall not be renewed until the pharmacy has been inspected by the board and found to be in compliance wit h this article and regulations established by the board. (h) Until July 1, 2017, the fee for issuance or annual renewal of a centralized hospital packaging pharmacy license shall be six hundred dollars ($600) and may be increased by the board to eight h undred dollars ($800). (Amended by Stats. 2016, Ch. 799, Sec. 24. Effective January 1, 2017.) Preparing and Storing Limited Quantity of Unit Dose Drugs in 4128.3. Specific Prescription - Advance of a Patient A centralized hospital packaging pharmacy m ay prepare and store a limited 4128 in advance of receipt quantity of the unit dose drugs authorized by Section of a patient - specific prescription in a quantity as is necessary to ensure continuity of care for an identified population of inpatients of the general acute care hospital based on a documented history of prescriptions for that patient population. Barcode Required; Information Retrievable Upon Reading 4128.4. September Barcode (Effective 2, 2015) (a) Any unit dose medication produced by a ce ntralized hospital packaging pharmacy shall be barcoded to be machine readable at the inpatient’s bedside using barcode medication administration software. The barcode medication administration software shall permit health care (b) practitioners to ensur e that, before a medication is administered to an inpatient, it is the right medication, for the right inpatient, in the right dose, and via the right route of administration. The software shall verify that the medication satisfies these criteria by readin g the barcode on the medication and comparing the information retrieved to the electronic medical record of the inpatient. For purposes of this section, “barcode medication administration (c) ication errors software” means a computerized system designed to prevent med in health care settings. 109

110 4128.5. Labeling for Unit Dose Medications (a) Any label for each unit dose medication produced by a centralized hospital packaging pharmacy shall display a human - readable label that contains all of : the following (1) The date that the medication was prepared. (2) The beyond - use date. (3) The established name of the drug. (4) The quantity of each active ingredient. (5) Special storage or handling requirements. (6) The lot number or control number assig ned by the centralized hospital packaging pharmacy. The name of the centralized hospital packaging pharmacy. (7) (b) For quality control and investigative purposes, a pharmacist shall be able to retrieve all of the following information using the lot n umber or control number described in subdivision (a): The components used in the drug product. (1) (2) The expiration date of each of the drug’s components. (3) The National Drug Code Directory number. (Amended by Stats. 2015, Ch. 241, Sec. 3. Effect ive September 2, 2015.) 4128.6. Compounding All compounding and packaging functions specified in Section 4128 shall be performed only in the licensed centralized hospital packaging pharmacy and that pharmacy shall comply with all applicable federal and state statutes and regulations, including, but not limited to, regulations regarding compounding and, when appropriate, sterile compounding. 4128.7. Integrity, Potency, Quality and Labeled Strength of Unit Dose Drug Products packaging pharmacy and the pharmacists working in A centralized hospital the pharmacy shall be responsible for the integrity, potency, quality, and labeled strength of any unit dose drug product prepared by the centralized hospital packaging pharmacy. Article 7.7. Outsourcing F acilities License Required 4129. Outsourcing Facility – (a) A facility licensed as an outsourcing facility with the federal Food and Drug Administration (FDA) shall be concurrently licensed with the board as an le medication or nonsterile medication outsourcing facility if it compounds steri for nonpatient - specific distribution within or into California. (b) A facility premises licensed with the board as a sterile compounding pharmacy shall not be concurrently licensed with the board as an outsourcing f acility at the same location. (c) The board may adopt regulations in accordance with the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of 110

111 Division 3 of Title 2 of the Government Code) to establish policies, guideline s, and procedures to implement this article. (d) The board shall review any formal requirements or guidance documents developed by the FDA regarding outsourcing facilities within 90 days after their release in order to determine whether revisions are nec essary for any regulations promulgated by the board. (e) An outsourcing facility licensed by the board shall not perform the duties of a pharmacy, such as filling individual prescriptions for individual patients. 4129.1. Licensing Requirements (a) An outsourcing facility that is licensed with the federal Food and Drug Administration (FDA) and with an address in this state shall also be licensed by the board as an outsourcing facility before doing business within this state. The license shall be renewed annually and is not transferable. b) An outsourcing facility shall compound all sterile products and nonsterile ( products in compliance with regulations issued by the board and with federal current good manufacturing practices applicable to outsourcing facilities. (c) An outsourcing facility license shall not be issued or renewed until the location is inspected by the board and found in compliance with this article and regulations adopted by the board. issued or renewed until the (d) An outsourcing facility license shall not be board does all of the following: (1) Prior to inspection, reviews a current copy of the outsourcing facility’s policies and procedures for sterile compounding and nonsterile compounding. (2) Is provided with copies of all f ederal and state regulatory agency inspection reports, as well as accreditation reports, and certification reports of facilities or equipment of the outsourcing facility’s premises conducted in the prior 12 months. (3) Prior to inspection, receives a lis t of all sterile drugs and nonsterile drugs compounded by the outsourcing facility as reported to the FDA in the last 12 months. (e) An outsourcing facility licensed pursuant to this section shall provide the board with all of the following: of any disciplinary or other action taken by another state or the (1) A copy FDA within 10 days of the action. (2) Notice within 24 hours of any recall notice issued by the outsourcing facility. (3) A copy of any clinically related complaint it receives involvin g an outsourcing facility’s compounded products from or involving any provider, pharmacy, or patient in California within 72 hours of receipt. (4) Notice within 24 hours after learning of adverse effects reported or potentially attributable to the outsou rcing facility’s products. 4129.2. Nonresident Outsourcing Facility – License Required (a) An outsourcing facility that is licensed with the federal Food and Drug Administration (FDA) as an outsourcing facility and has an address outside of but in the United States of America is a nonresident outsourcing this state 111

112 facility. A nonresident outsourcing facility shall not compound sterile drug products or nonsterile drug products for distribution or use into this state without an outsourcing license issued by the board pursuant to this section. The license shall be renewed annually and shall not be transferable. (b) A nonresident outsourcing facility shall compound all sterile products and nonsterile products to be distributed or used in this state in com pliance with regulations of the board and with federal current good manufacturing practices applicable to outsourcing facilities. (c) A license for a nonresident outsourcing facility shall not be issued or oard and found in compliance renewed until the location is inspected by the b with this article and any regulations adopted by the board. The nonresident outsourcing facility shall reimburse the board for all actual and necessary costs incurred by the board in conducting an inspection of the nonresident outsourcing facility at least once annually pursuant to subdivision (x) of Section 4400. (d) A license for a nonresident outsourcing facility shall not be issued or renewed until the board: (1) Prior to inspection, reviews a current copy of the nonresi dent outsourcing facility’s policies and procedures for sterile compounding and nonsterile compounding. (2) (A) Is provided with copies of all federal and state regulatory agency inspection reports, as well as accreditation reports, and certification rep orts of facilities or equipment of the nonresident outsourcing facility’s premises conducted in the prior 12 months. (B) For purposes of this paragraph, “state” refers to the state in which the nonresident outsourcing facility resides. (3) Prior to ins pection, receives a list of all sterile drug products and nonsterile drug products compounded by the pharmacy as reported to the FDA within the prior 12 months. (e) A nonresident outsourcing facility licensed pursuant to this section shall provide the bo ard with all of the following: (1) A copy of any disciplinary or other action taken by another state or the FDA within 10 days of the action. (2) Notice within 24 hours of any recall notice issued by the nonresident outsourcing facility. (3) A copy o f any complaint it receives involving an outsourcing facility’s compounded products from or involving any provider, pharmacy, or patient in California within 72 hours of receipt. (4) Notice within 24 hours after learning of adverse effects reported or po tentially attributable to a nonresident outsourcing facility’s products. 4129.3. Board Report to Legislature (a) On or before January 1, 2018, the board shall provide a report to the ities. The Legislature regarding the regulation of nonresident outsourcing facil report shall be submitted to the Legislature in the manner required pursuant to Section 9795 of the Government Code. At a minimum, the report shall address all of the following: 112

113 (1) A detailed description of board activities related to the ins pection and licensure of non resident outsourcing facilities. (2) Whether fee revenue collected pursuant to subdivision (x) of Section 4400 and travel cost reimbursements collected pursuant to subdivision (c) of Section 4129.2 provide revenue in an amount sufficient to support the board’s activities related to the inspection and licensure of nonresident outsourcing facilities. (3) The status of proposed changes to federal law that are under serious ies and compounding consideration and that would govern outsourcing facilit pharmacies, including, but not limited to, legislation pending before Congress, administrative rules, regulations or orders under consideration by the FDA or other appropriate federal agency, and cases pending before the courts. (4) I f applicable, recommended modifications to the board’s statutory duties related to nonresident outsourcing facilities as a result of changes to federal law or any additional modifications necessary to protect the health and safety of the public. (b) The requirement for submitting a report imposed under subdivision (a) is inoperative on January 1, 2022, pursuant to Section 10231.5 of the Government Code. 4129.4. Cease and Desist Order btained (a) Whenever the board has a reasonable belief, based on information o during an inspection or investigation by the board, that an outsourcing facility compounding sterile drug products or nonsterile drug products poses an immediate threat to the public health or safety, the executive officer of the board may issue an order to the outsourcing facility to immediately cease and desist compounding sterile drug products or nonsterile drug products. The cease and desist order shall remain in effect for no more than 30 days or the date of a hearing seeking an interim suspens ion order, whichever is earlier. (b) Whenever the board issues a cease and desist order pursuant to subdivision (a), the board shall immediately issue a notice to the owner setting forth the acts pertinent code or omissions with which the owner is charged, specifying the section or sections and any regulations. (c) The cease and desist order shall state that the owner, within 15 days of receipt of the notice, may request a hearing before the president of the board to contest the cease and desist order. Cons ideration of the owner’s contest of the cease and desist order shall comply with the requirements of Section 11425.10 of the Government Code. The hearing shall be held no later than five days after the date the request of the owner is received by the board . The president shall render a written decision within five days after the hearing. In the absence of the president of the board, the vice president of the board may conduct the hearing permitted by this subdivision. Review of the decision may be sought by the owner or person in possession or control of the outsourcing facility pursuant to Section 1094.5 of the Code of Civil Procedure. (d) Failure to comply with a cease and desist order issued pursuant to this section shall be unprofessional conduct. 113

114 4129 .5. Violation Fine Notwithstanding any other law, a violation of this article, or regulation adopted pursuant thereto, may subject the person or entity that committed the violation to a fine of up to five thousand dollars ($5,000) per occurrence pursuant to a citation issued by the board. 4129.8. Temporary License The board, at its discretion, may issue a temporary license to an outsourcing facility upon the conditions and for any periods of time as the board determines to be in the public interest. A temporary license fee shall be required as specified in subdivision (w) of Section 4400. When needed to protect public safety, a temporary license may be issued for a period not to exceed 180 days, and may be issued subject to terms and conditions the boar d deems necessary. If the board determines a temporary license was issued by mistake or denies the application for a permanent license, the temporary license shall terminate upon the earlier of personal service of the notice of termination upon the license holder or service by certified mail with return receipt requested at the licenseholder’s address of record with the board. The temporary licenseholder shall not be deemed to have a vested property right or interest in the license for a temporary license or for purposes of any disciplinary or purposes of retaining license denial proceeding before the board. – Notice Required 4129.9. Recall (a) An outsourcing facility licensed pursuant to Section 4129.1 or 4129.2 that issues a recall notice for a sterile dr ug or nonsterile drug compounded by the outsourcing facility, in addition to any other duties, shall contact the recipient pharmacy, prescriber, or patient of the recalled drug and the board as soon as possible within 24 hours of the recall notice if both of the following apply: (1) Use of or exposure to the recalled drug may cause serious adverse health consequences or death. (2) The recalled drug was dispensed, or is intended for use, in this state. ) shall be made as follows: (b) A recall notice issued pursuant to subdivision (a (1) If the recalled drug was dispensed directly to the prescriber, the notice shall be made to the prescriber and the prescriber shall ensure the patient is notified. (2) If the recalled drug was dispensed directly to a pharma cy, the notice shall be made to the pharmacy and that pharmacy shall notify the prescriber or patient, as appropriate. If the pharmacy notifies the prescriber, the prescriber shall ensure the patient is notified. 114

115 Article 8. Telepharmacy Systems and Remote Dispensing Site Pharmacies R emote Dispensing Site Pharmacy – 4130. Use of Telepharmacy System; Medically Underserved Areas; Staffing; Transition to Full - Service Pharmacy (a) A telepharmacy system shall be used for the dispensing of prescription drugs an d providing related drug regimen review and patient counseling services at a remote dispensing site pharmacy. (b) If all of the requirements of this article and other relevant provisions of this chapter are met, the board shall issue a remote dispensing s ite pharmacy license for the purpose of increasing access to dispensing or pharmaceutical care services in the geographic area in which the remote dispensing site pharmacy is to be located. (c) (1) A remote dispensing site pharmacy shall only be located i n a medically underserved area unless otherwise approved by the board. For purposes of this section, a “medically underserved area” means a location that does not have a pharmacy that serves the general public within 10 road miles of the remote site. dispensing (2) Notwithstanding paragraph (1), if a pharmacy serving the general public is later established within 10 road miles of a remote dispensing site pharmacy, the remote dispensing site pharmacy may continue to operate. (d) A remote dispensing site ph armacy shall only be staffed by pharmacists or pharmacy technicians, or both, and shall not employ any unlicensed personnel. (e) A remote dispensing site pharmacy license shall be issued only to the supervising pharmacy. A supervising pharmacy shall not o btain more than one remote dispensing site pharmacy license. (f) A remote dispensing site pharmacy shall not be operated by the state and shall not be located in any state facility, including, but not limited to, or developmental centers. This section correctional facilities, state hospitals, shall not be construed to preclude a pharmacist who is otherwise eligible to operate a remote dispensing site pharmacy pursuant to this section from leasing the purpose of space in property owned by the state, provided it is not for serving individuals otherwise served by pharmacists and pharmacy technicians employed by the state. (g) A remote dispensing site pharmacy shall not be located or operated for the purpose of displacing state employees. (h) If a remote disp ensing site pharmacy dispenses more than 225 prescriptions per day, calculated each calendar year, it shall cease to be a - remote dispensing site pharmacy and may become a full service pharmacy licensed under Section 4110 with a pharmacist onsite if it meet s all the requirements for licensure for a pharmacy. 115

116 Distance from 4131. – Remote Dispensing Site Pharmacy Supervising Pharmacy; Common Ownership; Staffing by Pharmacy Technician; - - Pharmacist Charge in (a) A supervising pharmacy shall provide telepharmac y services for only one remote dispensing site pharmacy. (b) A supervising pharmacy shall not be located greater than 150 road miles from a remote dispensing site pharmacy, unless otherwise approved by the board. (c) A supervising pharmacy and remote dis pensing site pharmacy shall be under common ownership. (d) Unless staffed by a pharmacist, a remote dispensing site pharmacy shall be staffed by at least one registered pharmacy technician meeting the qualifications of Section 4132. A technician shall rem ain under the direct supervision and control of a pharmacist at the supervising pharmacy at all times that the remote dispensing site pharmacy is operational. For the purposes of this article, direct supervision and control does not require the pharmacist to be physically present at the remote dispensing site pharmacy, but the pharmacist shall use a telepharmacy system to supervise operations through audio and visual technology from the supervising pharmacy. may serve as the pharmacist - (e) Notwithstanding any other law, a pharmacist in charge of a charge for a pharmacy in addition to serving as pharmacist - in - - - charge of the supervising - in supervising pharmacy. The designated pharmacist pharmacy shall also serve as the designated pharmacist in - charge at the re mote - dispensing site pharmacy. (f) Notwithstanding any other law, the pharmacist - in - charge of the remote dispensing site pharmacy and the pharmacist on - duty at the supervising - pharmacy shall be responsible for ensuring that both the supervising pharmacy a nd remote dispensing site pharmacy are sufficiently staffed to allow for appropriate supervision, which is supervision that would not be reasonably expected to result in an unreasonable risk of harm to public health, safety, or welfare. Remote Dispe nsing Site Pharmacy 4132. Technician: Pharmacy – - Permitted Prohibited Duties; Pharmacist - to Duties; Pharmacy Technician Ratio (a) In addition to the requirements of Section 4202, a pharmacy technician working at a remote dispensing site pharmacy shall meet the qualifications promulgated by the board. The regulations developed by the board shall only apply to pharmacy technicians working at remote dispensing sites. (b) Notwithstanding Section 4115, a registered pharmacy technician may perform order entry, packag ing, manipulative, repetitive, and other nondiscretionary tasks at a remote dispensing site pharmacy under the supervision of a pharmacist at a supervising pharmacy using a telepharmacy system. (c) A pharmacy technician at a remote dispensing site pharmac y shall not do any of the following: 116

117 (1) Receive a new prescription order orally from a prescriber or other person authorized to prescribe by law. (2) Consult with a patient or his or her agent regarding a prescription, either g, or regarding any medical information contained in a prior to or after dispensin patient medication record system or patient chart. (3) Identify, evaluate, or interpret a prescription. (4) Interpret the clinical data in a patient medication record system or patient chart. (5) Co nsult with any prescriber, nurse, or other health care professional or authorized agent thereof. (6) Supervise the packaging of drugs and check the packaging procedure and product upon completion. (7) Perform any function that requires the professional j udgment of a licensed pharmacist. (8) Compound drug preparations. (d) Notwithstanding Section 4115, a pharmacist at a supervising pharmacy may supervise up to two pharmacy technicians at each remote dispensing site pharmacy. This subdivision shall not be construed to alter a pharmacist’s ability to also supervise pharmacy technicians at the supervising pharmacy. Visual System; Patient Use in 4133. Telepharmacy System – Audio - Counseli keeping ng; System Capabilities; Record (a) A telepharmacy system shall maintain a video and audio communication system that provides for effective communication between the supervising pharmacy and the remote dispensing site pharmacy’s personnel and patients. (b) A telepharmacy system shall facilitate adequate pharmacist sup ervision and allow the appropriate exchange of visual, verbal, and written communications for patient counseling and other matters involved in the lawful dispensing of drugs. (c) Patient counseling shall be provided using audio - visual communication prior to all prescriptions being dispensed from a remote dispensing site pharmacy. (d) A telepharmacy system shall be able to do all of the following: (1) Identify and record the pharmacy technician preparing each prescription and the supervising pharmacist wh o reviewed and authorized the dispensing of the prescription. (2) Require a pharmacist to review and compare the electronic image of any new prescription presented at the remote dispensing site pharmacy with the data entry record of the prescription. Require the pharmacy technician to use barcode technology to verify the (3) accuracy of the drug to be dispensed. (4) Require remote visual confirmation by a pharmacist at the supervising pharmacy of the drug stock bottle and the drug to be dispensed prior t o dispensing. (5) Ensure that a prescription is not sold or delivered to a patient prior to a pharmacist performing final verification of the accuracy of the prescription and releasing the prescription for sale and delivery. 117

118 (e) The video and audio commu nication system used to counsel and interact with each patient or patient’s caregiver shall be secure and compliant with the - federal Health Insurance Portability and Accountability Act (Public Law 104 191). (f) All records of prescriptions dispensed inclu ding the records of the actions performed through the telepharmacy system shall be maintained at the remote dispensing site pharmacy and shall be maintained for three years after the filling of the prescription. Inspection; 4134. Remote Dispensing Site Pharmacy – Pha rmacist Perpetual Inventory; Securing Controlled Substances; Inventory and ; Requirement to Report Reconciliation; Controlled Substances Inventory Losses (a) A pharmacist from the supervising pharmacy shall complete a monthly in - person, self - in spection of each remote dispensing site pharmacy using a form designated by the board and shall retain all inspection reports. (b) A perpetual inventory shall be kept for all controlled substances stored at a remote dispensing site pharmacy. (c) All cont rolled substances at a remote dispensing site pharmacy shall be stored in a secure cabinet or safe that is locked. (d) A pharmacist from the supervising pharmacy shall perform inventory and inventory reconciliation functions at a remote dispensing site ph armacy to detect and prevent the loss of any controlled substance. (e) The pharmacist - in - charge of a remote dispensing site pharmacy shall review all inventory and inventory reconciliation reports taken and shall establish and maintain secure methods to p revent losses of any controlled substance. The board shall develop written policies and procedures for performing the inventory reconciliation reports required by this section. (f) A pharmacist from the supervising pharmacy shall compile an inventory reco nciliation report of all Schedule II controlled substances at a remote dispensing site pharmacy at least once every three months. This compilation shall require all of the following: (1) A physical count, not an estimate, of all quantities of Schedule II controlled substances at the remote dispensing site pharmacy. The biennial inventory of controlled substances as required under federal law may serve as one of the mandated inventories under this section in the year that the federal erformed, provided that the biennial inventory was taken biennial inventory is p no more than three months from the last inventory required by this section. (2) A review of all acquisitions and dispositions of Schedule II controlled substances since the last inventory reconcilia tion report. (3) A comparison of paragraphs (1) and (2) in order to determine if there are any variances. (4) All records used to compile each inventory reconciliation report shall be maintained in the remote dispensing site pharmacy for at least three y ears in a readily retrievable form. 118

119 (g) A remote dispensing site pharmacy shall report to the board, in writing, any identified losses of controlled substances and possible causes of the loss within 30 days of discovering the loss unless the cause of loss is theft, diversion, or self - use in which case the report shall be made within 14 days of discovering the loss. If the remote dispensing site pharmacy is unable to identify the cause of the loss, the remote dispensing site pharmacy shall undertake further investigation to identify the cause of the loss and security improvements necessary to prevent any additional losses of controlled substances. The pharmacist - in - charge shall be responsible for submitting the report to the board. (h) Possible causes of ov erages shall be identified in writing and incorporated into the inventory reconciliation report. (i) The inventory reconciliation report shall be dated and signed by the individual or individuals performing the inventory and countersigned by the pharmacis - in - charge of the remote dispensing site pharmacy. A t countersignature shall not be required if the pharmacist - in - charge personally completed the inventory reconciliation report. The inventory reconciliation report shall be maintained in the remote dispens ing site pharmacy for at least three years in a readily retrievable form. osed When Required; Cl Alarm 4135. Remote Dispensing Site Pharmacy – Supervising Pharmacy I s Closed; Maintaining Surveillance Recording (a) While closed, a remote dispensing site ph armacy shall utilize an alarm or other comparable monitoring system to protect its equipment, records, and supply of drugs, devices, and other restricted sale items from unauthorized access, acquisition, or use. (b) Unless a pharmacist is present at the r emote dispensing site pharmacy, a remote dispensing site pharmacy shall not be open or its employees allowed access to it during times the supervising pharmacy is closed. The security system shall allow for tracking of entries into the remote dispensing si te pharmacy and the pharmacist - in - charge shall periodically review the record of entries. Pharmacy services shall not be provided at a remote dispensing site pharmacy if the telepharmacy system is unavailable. retain a recording of facility (c) The remote dispensing site pharmacy shall surveillance, excluding patient communications, for a minimum of 120 days. Article 9. Hypodermic Needles and Syringes 4141. Furnishing without License therwise, No person shall furnish hypodermic needles or syringes, by sale or o without a license issued by the board, except as otherwise provided by this article. 4142. Prescription Required Except as otherwise provided by this article, no hypodermic needle or syringe of a physician, dentist, shall be sold at retail except upon the prescription veterinarian, podiatrist, or naturopathic doctor pursuant to Section 3640.7. 119

120 4143. Exemption: Sale to Other Entity, Physician, etc. This article shall not apply to the sale of hypodermic syringes and needles at wholesale by ph armacies, drug wholesalers, drug manufacturers or manufacturers and dealers in surgical instruments to pharmacies, physicians, dentists, podiatrists, veterinarians, or persons to whom a license has been issued under this article. 4144.5 . Industrial Use; E xception A person may sell or obtain hypodermic needles and hypodermic syringes without a prescription or permit, for uses that the board determines are industrial, and that person shall not be required to comply with Section 4145.5 or 4146. .5 4145 . C onditions for Furnishing Hypodermic and Syringes for Human Use and Specified Animal Use without a Prescription Notwithstanding any other provision of law, a pharmacist or physician (a) may, without a prescription or a permit, furnish hypodermic needles a nd syringes for human use, and a person may, without a prescription or license, obtain hypodermic needles and syringes from a pharmacist or physician for human use, if the person is known to the furnisher and the furnisher has previously been provided a pr escription or other proof of a legitimate medical need requiring a hypodermic needle or syringe to administer a medicine or treatment. (b) Notwithstanding any other provision of law and until January 1, 2021, as a public health measure intended to preven t the transmission of HIV, viral hepatitis, and other bloodborne diseases among persons who use syringes and hypodermic needles, and to prevent subsequent infection of sexual partners, newborn children, or other persons, a physician or pharmacist may, with out a prescription or a permit, furnish hypodermic needles and syringes for human use to a person 18 years of age or older, and a person 18 years of age or older may, without a prescription or license, obtain hypodermic needles and syringes onal use from a physician or pharmacist. solely for pers Notwithstanding any other provision of law, a pharmacist, veterinarian, or (c) person licensed pursuant to Section 4141 may, without a prescription or license, furnish hypodermic needles and syringes for use on an imals, and a person may, without a prescription or license, obtain hypodermic needles and syringes from a pharmacist, veterinarian, or person licensed pursuant to Section 4141 for use on animals, providing that no needle or syringe shall be furnished to a person who is unknown to the furnisher and unable to properly establish his or her identity. (d) A pharmacy that furnishes nonprescription hypodermic needles and syringes shall store hypodermic needles and syringes in a manner that ensures that they are available only to authorized personnel, and are not accessible to other persons. In order to provide for the safe disposal of hypodermic needles and (e) syringes, a pharmacy or hypodermic needle and syringe exchange program that 120

121 hypodermic needles and syringes shall counsel furnishes nonprescription consumers on safe disposal and provide consumers with one or more of the following disposal options: (1) It shall establish an onsite, safe, hypodermic needle and syringe collection t meets applicable state and federal standards for and disposal program tha collection and disposal of medical sharps waste. (2) It shall furnish, or make available, mail - back sharps containers authorized by the United States Postal Service that meet applicable state and federal requirements for the transport of medical sharps waste, and shall provide tracking forms to verify destruction at a certified disposal facility. (3) It shall furnish, or make available, a sharps container that meets applicable state and federal standard s for collection and disposal of medical sharps waste. (f) Until January 1, 2021, a pharmacy that furnishes nonprescription syringes shall provide written information or verbal counseling to consumers at the time of furnishing or sale of nonprescription hypodermic needles or syringes on how to do the following: (1) Access drug treatment. Access testing and treatment for HIV and hepatitis C. (2) (3) Safely dispose of sharps waste. 4146. Needle/Syringe Return in Sharps Container A pharmacy may acce pt the return of needles and syringes from the public if contained in a sharps container, as defined in Section 117750 of the Health and Safety Code. 4147. Disposal of Needle or Syringe (a) For the purposes of this section, "playground" means any park or outdoor recreational area specifically designed to be used by children that has play equipment installed or any similar facility located on public or private school grounds or county parks. f, shall be (b) Any hypodermic needle or syringe that is to be disposed o contained, treated, and disposed of, pursuant to Part 14 (commencing with Section 117600) of Division 104 of the Health and Safety Code. (c) It is unlawful to discard or dispose of a hypodermic needle or syringe upon the grounds of a playgrou nd, beach, park, or any public or private elementary, vocational, junior high, or high school. (d) A person who knowingly violates subdivision (c) is guilty of a misdemeanor, and upon conviction shall be punished by a fine of not less than two hundred do llars ($200) and not more than two thousand dollars ($2,000), or by imprisonment in a county jail for up to six months, or by both that fine and imprisonment. (e) Subdivision (c) does not apply to the containment, treatment, and disposal of medical sharp s waste from medical care or first aid services rendered on school grounds, nor to the containment, treatment, and disposal of hypodermic needles or syringes used for instructional or educational purposes on school grounds. 121

122 .5 . Confiscation if Found O utside Licensed Premises 4148 All stocks of hypodermic needles or syringes shall be confiscated if found outside the licensed premises of any person holding a permit under Section 4141 and found not in the possession or under the control of a person entitled to an exemption under Section 4143, 4144.5, or 4145.5, or under Section 11364, 121349, or 121349.1 of the Health and Safety Code. License Required for Nonresident Distributor of Needles or Syringes 4149. distribute hypodermic needles or A nonresident distributor shall not sell or (a) syringes in this state without obtaining a license from the board pursuant to Section 4141. Notwithstanding subdivision (a), a license is not required if the (b) nonresident distributor sells or distributes solely through a person who is licensed as a wholesaler or third - party logistics provider pursuant to Section 4160. The Legislature, by enacting this section, does not intend a license issued (c) ence that to any nonresident distributor pursuant to this article to serve as evid the entity is doing business within this state. Article 10. Pharmacy Corporations 4150. Definitions (a) A pharmacy corporation means a corporation that is authorized to render ations Code, so professional services, as defined in Section 13401 of the Corpor long as that corporation and its shareholders, officers, directors, and employees rendering professional services who are pharmacists are in compliance with the Moscone - Knox Professional Corporation Act, this article, and all other statutes and regulations now or hereafter enacted or adopted pertaining to the corporation and the conduct of its affairs. (b) With respect to a pharmacy corporation, the governmental agency referred - Knox Professional Corporation Act is the Boa rd of to in the Moscone Pharmacy of the State of California. 4151. Licensure Requirements Each shareholder, director, and officer of a pharmacy corporation, except an assistant secretary and an assistant treasurer, shall be a licensed person as the Corporations Code. defined in Section 13401 of 4152. Corporate Name Requirements The name of a pharmacy corporation and any name or names under which it may render professional services shall contain the word "pharmacist," "pharmacy," or "pharmaceutical" and wording or abbre viations denoting corporate existence. 4153. Shareholder Income While Disqualified The income of a pharmacy corporation attributable to professional services rendered while a shareholder is a disqualified person, as defined in Section 122

123 orations Code, shall not in any manner accrue to the benefit 13401 of the Corp of the shareholder or his or her shares in the pharmacy corporation. 4154. Regulations Authorized The board may adopt and enforce regulations to carry out the purposes and objectives of this article, including regulations requiring (a) that the bylaws of a pharmacy corporation shall include a provision whereby the capital stock of the corporation owned by a disqualified person, as defined in Section 13401 of the Corporations Code, or a decease d person, shall be sold to the corporation or to the remaining shareholders of the corporation within the time as the regulations may provide, and (b) that a pharmacy corporation shall provide adequate security by insurance or otherwise for claims against it by its patients or clients arising out of the rendering of professional services. 4155. Corporate Form Not Required Nothing in this article shall be construed as requiring the applicant or holder pharmacy corporation. of a pharmacy permit pursuant to Section 4110 to be a 4156. Unprofessional Conduct by Corporation A pharmacy corporation shall not do, or fail to do, any act where doing or failing to do the act would constitute unprofessional conduct under any statute or regulation. In the conduct of its practice, a pharmacy corporation shall observe and be bound by the laws and regulations that apply to a person licensed under this chapter. Article 11. Wholesalers , Third - Party Logistics Providers and Manufacturers ty Logistics Provider Par 4160. Wholesaler : License Required or Third - A person shall not act as a wholesaler or third - party logistics provider of (a) any dangerous drug or dangerous device unless he or she has obtained a license from the board. (b) Upon approval by the board and th e payment of the required fee, the board shall issue a license to the applicant. A separate license shall be required for each place of business owned (c) (1) - party logistics provider. Each place of or operated by a wholesaler or third be issued a single license by the board, except as provided in business may only paragraph (2). Each license shall be renewed annually and shall not be transferable. At all times during which a place of business is open for business, in the case of a wholesaler, or designated at least one designated representative, representative - 3PL in the case of a third - party logistics provider, shall be present. A wholesaler that only acts as a reverse distributor may use either a designated representative or a designated representative - reverse distributor to fulfill this requirement. party logistics provider under common - (2) A wholesaler and a third ownership may be licensed at the same place of business provided that all of the following requirements are satisfied: 123

124 (A) The wholesale r and the third - party logistics provider each separately maintain the records required under Section 4081. (B) Dangerous drugs and dangerous devices owned by the wholesaler are not commingled with the dangerous drugs and dangerous devices handled by the - party logistics provider. third (C) Any individual acting as a designated representative for the wholesaler is - 3PL on behalf of the not concurrently acting as a designated representative - third be construed party logistics provider. Nothing in this subparagraph shall to prohibit an individual from concurrently holding a license to act as a designated representative and to act as a designated representative - 3PL. - (D) charge The wholesaler has its own designated representative - in - party logistics ons of the wholesaler and the third responsible for the operati provider has its own responsible manager responsible for the operations of the party logistics provider. The same individual shall not concurrently serve third - as the responsible manager and the designate d representative - in - charge for a party logistics provider licensed at the same place of wholesaler and a third - business. (E) The third - party logistics provider does not handle the prescription drugs or prescription devices owned by a prescriber. - party logistics (F) Th e third - party logistics provider is not a reverse third provider. The wholesaler is not acting as a reverse distributor. (G) (d) Every wholesaler shall be supervised or managed by a designated - in - charge. The designated re presentative - in representative charge shall be - responsible for the wholesaler’s compliance with state and federal laws governing wholesalers. As part of its initial application for a license, and for rovide each renewal, each wholesaler shall, on a form designed by the board, p identifying information and the California license number for a designated representative or pharmacist proposed to serve as the designated representative - in - charge. The proposed designated representative - in - charge shall be subject to approval by th e board. The board shall not issue or renew a wholesaler license - without identification of an approved designated representative - in charge for charge shall maintain an - the wholesaler. The designated representative in - active license as a designated represen tative with the board at all times during which he or she is designated as the designated representative - in - charge. A wholesaler that only acts as a reverse distributor may identify and allow a designated representative - reverse distributor to perform in th is capacity. That individual shall maintain an active license as a designated representative - reverse distributor. (e) Each place of business of a third - party logistics provider shall be supervised and managed by a responsible manager. The responsible man ager shall be responsible for the compliance of the place of business with state and party federal laws governing third - party logistics providers and with the third - logistics provider’s customer specifications, except where the customer’s nflict with state or federal laws. As part of its initial specifications co party logistics - application for a license, and for each renewal, each third provider shall, on a form designated by the board, provide identifying 124

125 designated representative - information and the California license number for a 3PL proposed to serve as the responsible manager. The proposed responsible manager shall be subject to approval by the board. The board shall not issue or renew a third n - party logistics provider license without identification of a party logistics provider. The - approved responsible manager for the third responsible manager shall maintain an active license as a designated 3PL with the board at all times during which he or she is representative - designated as the responsible manager. (f) A wholesaler shall notify the board in writing, on a form designed by the - in - charge board, within 30 days of the date when a designated representative - - ceases to act as the designated representative charge, and shall on the same in r to take over as the designated form propose anothe authorized licensee - in - charge. The proposed replacement designated representative - representative - charge shall be subject to approval by the board. If disapproved, the in 5 days of the date of wholesaler shall propose another replacement within 1 disapproval, and shall continue to name proposed replacements until a designated representative in - charge is approved by the board. - party logistics provider shall notify the board in writing, on a form - A third (g) designed by the bo ard, within 30 days of the date when a responsible manager ceases to act as the responsible manager, and shall on the same form propose another designated representative - 3PL to take over as the responsible manager. ger shall be subject to approval by The proposed replacement responsible mana - party logistics provider shall propose the board. If disapproved, the third another replacement within 15 days of the date of disapproval, and shall continue to name proposed replacements until a responsible manager is a pproved by the board. (h) A drug manufacturer premises licensed by the Food and Drug Administration or licensed pursuant to Section 111615 of the Health and Safety Code that only distributes dangerous drugs and dangerous devices of its own exempt from this section and Section 4161. manufacture is The board may issue a temporary license, upon conditions and for periods (i) of time as the board determines to be in the public interest. A temporary license fee shall be required in an amount established by t he board as specified in subdivision (f) of Section 4400. When needed to protect public safety, a temporary license may be issued for a period not to exceed 180 days, subject to terms and conditions that the board deems necessary. If the board determines t hat a temporary license was issued by mistake or denies the application for a permanent license, the temporary license shall terminate upon either personal service of the notice of termination upon the licenseholder or service by certified mail, return rec eipt requested, at the licenseholder’s address of record with the board, whichever occurs first. For purposes of retaining a temporary license, or for purposes of any disciplinary or license denial proceeding before s hall not be deemed to have a vested the board, the temporary licenseholder property right or interest in the license. 125

126 4160.5 Nonprescription Diabetes Test Devices – Authorized Distributors Posted on Board Website Within 30 days of the effective date of the act adding this section, a manufact urer of a nonprescription diabetes test device shall make the names of its authorized distributors available on its Internet Web site and shall provide the board with the names of its authorized distributors. Within 30 days of receiving that information fr om a manufacturer of a nonprescription diabetes test device, the board shall post the names of authorized distributors of nonprescription diabetes test devices on the board’s Internet Web site. A manufacturer of a nonprescription diabetes test device shall , within 30 days of making changes to its authorized distributors, update its Internet Web site and inform the board of changes to its authorized distributors. Within 30 days of receiving notice of any change from a manufacturer of a nonprescription diabet es test device, the board shall post the updated list of the manufacturer’s authorized distributors on its Internet Web site. 4161. Nonresident Wholesaler or Nonresident Third - Party Logistics ; Requirements Provider A person located outside this sta te that (1) ships, sells, mails, warehouses, (a) distributes, or delivers dangerous drugs or dangerous devices into this state or (2) sells, brokers, warehouses, or distributes dangerous drugs or devices within this state shall be considered a nonresident whol esaler or a nonresident third - party logistics provider. A nonresident wholesaler or nonresident third party logistics provider shall - (b) be licensed by the board prior to shipping, selling, mailing, warehousing, distributing, or delivering dangerous drug s or dangerous devices to a site located in this state or selling, brokering, warehousing, or distributing dangerous drugs or devices within this state. (1) A separate license shall be required for each place of business owned (c) or operated by a nonres ident wholesaler or nonresident third - party logistics provider from or through which dangerous drugs or dangerous devices are shipped, sold, mailed, warehoused, distributed, or delivered to a site located in this state or sold, brokered, warehoused, or dis tributed within this state. Each place of business may only be issued a single license by the board, except as provided in paragraph (2). A license shall be renewed annually and shall not be transferable. - (2) A nonresident wholesaler and a nonresident thi rd party logistics provider under common ownership may be licensed at the same place of business provided that all of the following requirements are satisfied: (A) The wholesaler and the third party logistics provider each separately - maintain the records required under Section 4081. (B) Dangerous drugs and dangerous devices owned by the wholesaler are not commingled with the dangerous drugs and dangerous devices handled by the third - party logistics provider. (C) Any individual acting as a designated repr esentative for the wholesaler is 3PL on behalf of the not concurrently acting as a designated representative - - third party logistics provider. Nothing in this subparagraph shall be construed 126

127 t as a to prohibit an individual from concurrently holding a license to ac designated representative and to act as a designated representative - 3PL. (D) - in - charge The wholesaler has its own designated representative party logistics - responsible for the operations of the wholesaler and the third ble manager responsible for the operations of the provider has its own responsi third - party logistics provider. The same individual shall not concurrently serve in - charge for a as the responsible manager and the designated representative - party logistics provider - wholesaler and a third licensed at the same place of business. (E) The third - party logistics provider does not handle the prescription drugs or prescription devices owned by a prescriber. (F) The third - party logistics provider is not a reverse third - party logistics provider. The wholesaler is not acting as a reverse distributor. (G) The following information shall be reported, in writing, to the board at the (d) time of initial application for licensure by a nonresident wholesaler or a - party logistics provid er, on renewal of a nonresident nonresident third wholesaler or nonresident third - party logistics provider license, or within 30 days of a change in that information: (1) Its agent for service of process in this state. (2) Its principal corporate officers, as specified by the board, if any. Its general partners, as specified by the board, if any. (3) (4) Its owners if the applicant is not a corporation or partnership. (e) A report containing the information in subdivision (d) shall be made within 30 days of any cha nge of ownership, office, corporate officer, or partner. (f) A nonresident wholesaler or nonresident third - party logistics provider shall comply with all directions and requests for information from the regulatory or h it is licensed, as well as with all requests licensing agency of the state in whic for information made by the board. (g) A nonresident wholesaler or nonresident third - party logistics provider shall maintain records of dangerous drugs and dangerous devices sold, traded, transferred, wareho used, or distributed to persons in this state or within this state, so that the records are in a readily retrievable form. - party logistics provider shall A nonresident wholesaler or nonresident third (h) at all times maintain a valid, unexpired license, permit, or registration to conduct the business of the wholesaler or nonresident third - party logistics provider in compliance with the laws of the state in which it is a resident. An application for a nonresident wholesaler or nonresident third - party logis tics provider license in this state shall include a license verification from the licensing authority in the applicant’s state of residence. (i) (1) The board shall not issue or renew a nonresident wholesaler license until the nonresident wholesaler iden tifies a designated representative - in - charge and notifies the board in writing of the identity and license number of the - in - charge. designated representative (2) The board shall not issue or renew a nonresident third - party logistics l the nonresident third party logistics provider identifies a - provider license unti responsible manager and notifies the board in writing of the identity and license 127

128 number of the designated representative - 3PL who will be the responsible manager. (j) The designated representat ive - in - charge shall be responsible for the compliance of the nonresident wholesaler with state and federal laws governing wholesalers. The responsible manager shall be responsible for the compliance of the nonresident third - party logistics provider’s place of business with state and federal laws governing third - party logistics providers. A nonresident party logistics provider shall identify and notify - wholesaler or nonresident third the board of a new designated representative in - charge or responsible manag er - within 30 days of the date that the prior designated representative - in - charge or - responsible manager ceases to be the designated representative in - charge or responsible manager. (k) The board may issue a temporary license, upon conditions and for peri ods of time as the board determines to be in the public interest. A temporary license fee shall be five hundred fifty dollars ($550) or another amount established by the board not to exceed the annual fee for renewal of a license to compound roducts. When needed to protect public safety, a temporary license sterile drug p may be issued for a period not to exceed 180 days, subject to terms and conditions that the board deems necessary. If the board determines that a temporary license was issued by mistake or denies the application for a permanent license, the temporary license shall terminate upon either personal service of the notice of termination upon the licenseholder or service by record certified mail, return receipt requested, at the licenseholder’s address of with the board, whichever occurs first. Neither for purposes of retaining a temporary license, nor for purposes of any disciplinary or license denial proceeding before the board, shall the temporary licenseholder be deemed to have a vested property right or interest in the license. (l) The registration fee shall be the fee specified in subdivision (f) of Section 4400. 4161.5. Nonresident Wholesaler or Nonresident Third - Party Logistics Provider ed to implement Section 584 At such time as federal regulations are promulgat of the federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 360eee 3), the - board shall immediately identify any standard, requirement, or regulation in deral California law governing interstate commerce that is in conflict with the fe regulations and act to remove the conflict in the manner permitted by law. - Wholesaler or Third Party Logistics Provider; 4162. Surety Bond Requirements (a) (1) An applicant for the issuance or renewal of a wholesaler license, which ment owned and operated, shall submit a surety bond of one is not govern hundred thousand dollars ($100,000) or other equivalent means of security acceptable to the board payable to the Pharmacy Board Contingent Fund. The of any administrative fine purpose of the surety bond is to secure payment imposed by the board and any cost recovery ordered pursuant to Section 125.3. 128

129 (2) An applicant for the issuance or renewal of a third - party logistics provider license, which is not government owned and operated, shall submit a surety bond of ninety thousand dollars ($90,000) or other equivalent means of security acceptable to the board payable to the Pharmacy Board Contingent Fund. The purpose of the surety bond is to secure payment of any administrative fine d and any cost recovery ordered pursuant to Section 125.3. imposed by the boar For purposes of paragraphs (1) and (2), the board may accept a surety bond (3) less than the amount required under paragraph (1) or (2) if the annual gross receipts of the previous tax year for t he wholesaler or third - party logistics provider is ten million dollars ($10,000,000) or less, in which case the surety bond shall be twenty - five thousand dollars ($25,000). (4) A person to whom an approved new drug application has been issued by the Unit ed States Food and Drug Administration who engages in the wholesale distribution of only the dangerous drug specified in the new drug application, and is licensed or applies for licensure as a wholesaler or third - party logistics provider, shall not be requ ired to post a surety bond as provided in paragraph (1) or (2). (5) For licensees subject to paragraph (3) or (4), the board may require a bond up to one hundred thousand dollars ($100,000) for any licensee who has been disciplined by any state or federa l agency or has been issued an administrative fine pursuant to this chapter. (b) The board may make a claim against the bond if the licensee fails to pay a fine within 30 days after the order imposing the fine, or costs become final. (c) A single suret y bond or other equivalent means of security acceptable to the board shall satisfy the requirement of subdivision (a) for all licensed sites under common control as defined in Section 4126.5. 4162.5. Nonresident Wholesaler or Nonresident Third - Party Log istics Provider; Surety Bond Requirements (a) (1) An applicant for the issuance or renewal of a nonresident wholesaler license shall submit a surety bond of one hundred thousand dollars ($100,000), or other equivalent means of security acceptable to the board, such as an irrevocable letter of credit, or a deposit in a trust account or financial institution, payable to the Pharmacy Board Contingent Fund. The purpose of the surety bond is to secure payment of any administrative fine imposed by the board and any cost recovery ordered pursuant to Section 125.3. (2) An applicant for the issuance or renewal of a nonresident third - party logistics provider license shall submit a surety bond of ninety thousand dollars ($90,000), or other equivalent means of secur ity acceptable to the board, such as an irrevocable letter of credit, or a deposit in a trust account or financial institution, payable to the Pharmacy Board Contingent Fund. The purpose of the surety bond is to secure payment of any administrative fine im posed by the board and any cost recovery ordered pursuant to Section 125.3. (3) For purposes of paragraphs (1) and (2), the board may accept a surety bond less than the amount required under paragraph (1) or (2) if the annual gross us tax year for the nonresident wholesaler or the receipts of the previo nonresident third party logistics provider is ten million dollars ($10,000,000) or - 129

130 less, in which case the surety bond shall be twenty - five thousand dollars ($25,000). (4) For applicants who satisfy parag raph (3), the board may require a bond up to one hundred thousand dollars ($100,000) for any nonresident wholesaler or nonresident third - party logistics provider who has been disciplined by any state or federal agency or has been issued an administrative f ine pursuant to this chapter. A person to whom an approved new drug application or a biologics license (5) application has been issued by the United States Food and Drug Administration specified who engages in the wholesale distribution of only the dangerous drug in the new drug application or biologics license application, and is licensed or - party applies for licensure as a nonresident wholesaler or a nonresident third logistics provider, shall not be required to post a surety bond as provided in this se ction. (b) The board may make a claim against the bond if the licensee fails to pay a fine within 30 days of the issuance of the fine or when the costs become final. (c) A single surety bond or other equivalent means of security acceptable to the board shall satisfy the requirement of subdivision (a) for all licensed sites under common control as defined in Section 4126.5. 4163. Unauthorized Furnishing by Manufacturer or Wholesaler A manufacturer, wholesaler, repackager, or pharmacy may not furn ish a (a) dangerous drug or dangerous device to an unauthorized person. (b) Dangerous drugs or dangerous devices shall be acquired from a person authorized by law to possess or furnish dangerous drugs or dangerous devices. If the person acquiring the dangero us drugs or dangerous devices is a wholesaler, the obligation of the wholesaler shall be limited to obtaining confirmation of licensure of those sources from whom it has not previously acquired dangerous drugs or dangerous devices. 4164. Reports Required A wholesaler or third - party logistics provider licensed by the board that (a) distributes controlled substances, dangerous drugs, or dangerous devices within or into this state shall report to the board all distributions of dangerous drugs and controlle d substances that are subject to abuse, as determined by the board. (b) Each wholesaler shall develop and maintain a system for tracking individual sales of dangerous drugs at preferential or contract prices to pharmacies that primarily or solely dispens e prescription drugs to patients of long - term care facilities. The system shall be capable of identifying purchases of any dangerous drug at preferential or contract prices by customers that vary significantly from prior ordering patterns for the same cust omer, including by identifying purchases in the preceding 12 calendar months by that customer or similar customers and identifying current purchases that exceed prior purchases by either that customer or similar customers by a factor of 20 percent. pon written, oral, or electronic request by the board, a wholesaler shall U (c) furnish data tracked pursuant to subdivision (b) to the board in written, hardcopy, or electronic form. The board shall specify the dangerous drugs, the 130

131 ous drugs and customers for which data are to be customers, or both the danger furnished, and the wholesaler shall have 30 calendar days to comply with the request. (d) As used in this section, “preferential or contract prices” means and refers to purchases by contract of dangerous d rugs at prices below the market wholesale price for those drugs. 4165. Sale or Transfer of Dangerous Drug or Device Into State: horized Officer on Demand Furnishing Records to Aut - party logistics provider licensed by the board who sells A wholesaler or third or transfers any dangerous drug or dangerous device into this state or who receives, by sale or otherwise, any dangerous drug or dangerous device from any person in this state shall, on request, furnish an authorized officer of the law with all recor ds or other documentation of that sale or transfer. 4166. – Wholesaler or Shipping of Dangerous Drugs or Devices Distributor Liable for Security and Integrity Until Delivery (a) A wholesaler that uses the services of a third - party logistics provider or carrier, including, but not limited to, the United States Postal Service or a common carrier, shall be liable for the security and integrity of any dangerous drugs or dangerous devices through that provider or carrier until the drugs or devices are delive red to the transferee at its board - licensed premises. party logistics provider that uses the services of a carrier, - A third (b) including, but not limited to, the United States Postal Service or a common carrier, shall have in place and comply with writt en policies and procedures that provide for both of the following: Verification that the third - party logistics provider, or the owner of the (1) dangerous drugs or dangerous devices stored at the third - party logistics provider, has imposed obligations on the carrier that provide for the security and integrity of any dangerous drugs or dangerous devices transported by the carrier until the drugs or devices are delivered to the transferee at its premises. (2) Confirmation, prior to shipping a dangerous dr ug or dangerous device, that the intended recipient is legally authorized to receive the dangerous drug or dangerous device. Nothing in this section is intended to affect the liability of a wholesaler, (c) third - party logistics provider, or other distrib utor for dangerous drugs or dangerous devices after their delivery to the transferee. or Third 4167. Wholesaler : Bar on Obtaining Party Logistics Provider - Dangerous Drugs or Devices it Cannot Securely Maintain on Licensed Premises party logistics provider shall not obtain, by purchase or A wholesaler or third - otherwise, any dangerous drugs or dangerous devices that it cannot maintain, in a secure manner, at the place of business licensed by the board. 131

132 icense 4168. Board License Required for Local Business L A county or municipality shall not issue a business license for any - establishment that requires a wholesaler or third party logistics provider license unless the establishment possesses a current wholesaler or third - party logistics issued by the board. For purposes of this section, an provider license “establishment” is the licensee’s physical location in California. 4169. Prohibited Acts (a) A person or entity shall not do any of the following: (1) Purchase, trade, sell, warehouse, distribute , or transfer dangerous drugs or dangerous devices at wholesale with a person or entity that is not licensed with the board as a wholesaler, third party logistics provider, or pharmacy. - Purchase, trade, sell, or transfer dangerous drugs that the pers on knew or (2) reasonably should have known were adulterated, as set forth in Article 2 (commencing with Section 111250) of Chapter 6 of Part 5 of Division 104 of the Health and Safety Code. (3) Purchase, trade, sell, or transfer dangerous drugs that the per son knew or reasonably should have known were misbranded, as defined in Section 111335 of the Health and Safety Code. Purchase, trade, sell, or transfer dangerous drugs or dangerous devices (4) after the beyond use date on the label. (5) Fail to mainta in records of the acquisition or disposition of dangerous drugs or dangerous devices for at least three years. (b) Notwithstanding any other law, a violation of this section may subject the person or entity that has committed the violation to a fine not to exceed the amount specified in Section 125.9 for each occurrence, pursuant to a citation issued by the board. Amounts due from any person under this section shall be offset as (c) provided under Section 12419.5 of the Government Code. Amounts received by the board under this section shall be deposited into the Pharmacy Board Contingent Fund. (d) This section shall not apply to a pharmaceutical manufacturer licensed by the Food and Drug Administration or by the State Department of Public Health. 4169 .1. Wholesaler Obligation to Report Suspicious Orders to Board A wholesaler, upon discovery, shall notify the board in writing of any suspicious orders of controlled substances placed by a California - licensed pharmacy or wholesaler by providing the board a copy of the information that the wholesaler provides to the United States Drug Enforcement Administration. Suspicious orders include, but are not limited to, orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusu al frequency. 132

133 Article 11.5. Surplus Medication Collection and Distribution Intermediaries 4169.5. Surplus medication Collection and Distribution Intermediary; License (a) A surplus medication collection and distribution intermediary established for the purpose of facilitating the donation of medications to or transfer of medications between participating entities under a program established pursuant to Division 116 (commencing with Section 150200) of the Health and Safety Code shall be licensed by t he board. The board shall enforce the requirements set forth in Section 150208 of the Health and Safety Code. The license shall be renewed annually. (b) An application for licensure as a surplus medication collection and distribution intermediary shall be made on a form furnished by the board, and shall state the name, address, usual occupation, and professional qualifications, if any, of the applicant. If the applicant is an entity other than a natural person, the application shall state the information as to each person beneficially interested in that entity. (c) As used in this section, and subject to subdivision (e), the term “person beneficially interested” means and includes: (1) ion, each If the applicant is a partnership or other unincorporated associat partner or member. (2) If the applicant is a corporation, each of its officers, directors, and stockholders, provided that no natural person shall be deemed to be beneficially interested in a nonprofit corporation. (3) If the applicant is a l imited liability company, each officer, manager, or member. (d) If the applicant is a charitable organization described in Section 501(c)(3) of the Internal Revenue Code, the applicant shall furnish the board with the tion. The applicant shall also furnish the organization’s articles of incorpora board with the names of the controlling members. (e) If the applicant is a partnership or other unincorporated association, a limited liability company, or a corporation, and if the number of partners, members, or stockholders, as the case may be, exceeds five, the application shall so state, and shall further state the information required by subdivision (b) as to each of the five partners, members, or stockholders who own the five largest interests in the appli cant’s entity. Upon request by the executive officer of the board, the applicant shall furnish the board with the information required by subdivision (b) as to partners, members, or stockholders not named in the application, or shall refer the board to an appropriate source of that information. (f) The application shall contain a statement to the effect that the applicant or persons beneficially interested have not been convicted of a felony and have the applicant cannot make not violated any of the provisions of this chapter. If this statement, the application shall contain a statement of the violation, if any, or reasons which will prevent the applicant from being able to comply with the requirements with respect to the statement. 133

134 (g) Upon the approval of the application by the board and payment of a fee in the amount of three hundred dollars ($300), the executive officer of the board shall issue or renew a license to operate as a surplus medication collection and distribution intermediary, if all of th e provisions of this chapter have been complied with. Fees received by the board pursuant to this section shall be deposited into the Pharmacy Board Contingent Fund. An applicant for licensure as a surplus medication collection and distribution intermediar y that is government owned or is a nonprofit organization pursuant to subdivision (d) is exempt from the fee requirement. A surplus medication collection and distribution intermediary licensed (h) pursuant to this section is exempt from licensure as a wh olesaler. (i) A surplus medication collection and distribution intermediary licensed pursuant to this section shall keep and maintain for three years complete records for which the intermediary facilitated the donation of medications to or transfer of me dications between participating entities. Article 12. Prescriber Dispensing 4170. Dispensing by Prescriber: Requirements and Restrictions; Enforcement (a) No prescriber shall dispense drugs or dangerous devices to patients in his or her office or pl ace of practice unless all of the following conditions are met: (1) The dangerous drugs or dangerous devices are dispensed to the prescriber's own patient, and the drugs or dangerous devices are not furnished by a nurse or physician attendant. (2) The da ngerous drugs or dangerous devices are necessary in the treatment of the condition for which the prescriber is attending the patient. (3) The prescriber does not keep a pharmacy, open shop, or drugstore, advertised or otherwise, for the retailing of dange rous drugs, dangerous devices, or poisons. (4) The prescriber fulfills all of the labeling requirements imposed upon pharmacists by Section 4076, all of the recordkeeping requirements of this utical practice, chapter, and all of the packaging requirements of good pharmace including the use of childproof containers. (5) The prescriber does not use a dispensing device unless he or she personally owns the device and the contents of the device, and personally dispenses the dangerous drugs or dangerous devices to the patient packaged, labeled, and recorded in accordance with paragraph (4). (6) The prescriber, prior to dispensing, offers to give a written prescription to the patient that the patient may elect to have filled by the prescriber or by any pharmacy. (7) The prescriber provides the patient with written disclosure that the patient has a choice between obtaining the prescription from the dispensing prescriber or obtaining the prescription at a pharmacy of the patient's choice. mid - wife who functions pursuant to a standardized (8) A certified nurse procedure or protocol described in Section 2746.51, a nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1, or 134

135 to Section 3502.1, or a protocol, a physician assistant who functions pursuant naturopathic doctor who functions pursuant to Section 3640.5, may hand to a patient of the supervising physician and surgeon a properly labeled prescription drug prepackaged by a physician and surgeon, a manufacturer as defined in this chapter, or a pharmacist. (b) The Medical Board of California, the State Board of Optometry, the the Bureau of Naturopathic Medicine, the Dental Board of California, the Osteopathic Medical Board of California Board of Podiatric Medicine, California , the Board of Registered Nursing, the Veterinary Medical Board, and the Physician Assistant Committee shall have authority with the California State Board of Pharmacy to ensure compliance with this section, and those he enforcement of this chapter with boards are specifically charged with t respect to their respective licensees. (c) "Prescriber," as used in this section, means a person, who holds a physician's and surgeon's certificate, a license to practice optometry, a license to practice naturopathic m edicine, a license to practice dentistry, a license to practice veterinary medicine, or a certificate to practice podiatry, and who is the Osteopathic Medical duly registered by the Medical Board of California, Board of California, the State Board of Optom etry, the Bureau of Naturopathic Medicine, the Dental Board of California, the Veterinary Medical Board, or the California Board of Podiatric Medicine . Veterinarian in Teaching Hospital May Dispense and Administer 4170.5. Dangerous Drugs and Devices; Re quirements (a) Veterinarians in a veterinary teaching hospital operated by an accredited veterinary medical school may dispense and administer dangerous drugs and devices and controlled substances from a common stock. (b) The veterinary teaching hospit al shall designate a pharmacist to be responsible for ordering the drugs for the common stock and the designated pharmacist - in - charge shall be professionally responsible to insure that inventories, security procedures, training, protocol development, recor dkeeping, packaging, labeling, and dispensing occur in a manner that is consistent with the promotion and protection of the health and safety of the public. - in (c) The veterinary teaching hospital's pharmacist charge shall develop - nd guidelines that recognize the unique relationship policies, procedures, a between the institution's pharmacists and veterinarians in the control, management, dispensation, and administration of drugs. (d) The board may inspect a veterinary teaching hospital dispensing or inistering drugs pursuant to this section. adm 4171. Exceptions to Section 4170: Samples; Clinics; Veterinarians; Narcotic Treatment Programs; Certain Cancer Medications (a) Section 4170 shall not prohibit the furnishing of a limited quantity of a prescriber, if the prescriber dispenses the samples to the patient in samples by the package provided by the manufacturer, no charge is made to the patient therefor, and an appropriate record is entered in the patient's chart. 135

136 (b) Section 4170 shall not apply to clinics, as defined in subdivision (a) of Section 1204 or subdivision (b) or (c) of Section 1206 of the Health and Safety Code, to programs licensed pursuant to Sections 11876, 11877, and 11877.5 of g parenteral the Health and Safety Code, or to a prescriber dispensin chemotherapeutic agents, biologicals, or delivery systems used in the treatment of cancer. 4172. Storage Requirements A prescriber who dispenses drugs pursuant to Section 4170 shall store all . The Medical Board of drugs to be dispensed in an area that is secure California shall, by regulation, define the term "secure" for purposes of this section. 4173. Dispensing by Registered Nurses This chapter does not prevent the dispensing of drugs or devices by registered nurses functioning purs uant to Section 2725.1. 4174. Dispensing by Pharmacist Upon Order of Nurse Practitioner Notwithstanding any other law, a pharmacist may dispense drugs or devices upon the drug order of a nurse practitioner functioning pursuant to Section midwife functioning pursuant to Section 2746.51, a - 2836.1 or a ce rtified nurse drug order of a physician assistant functioning pursuant to Section 3502.1 or a naturopathic doctor functioning pursuant to Section 3640.5, or the order of a pharmacist acting under Section 4 052.1, 4052.2, 4052.3, or 4052.6. 4175. Processing of Complaints (a) The California State Board of Pharmacy shall promptly forward to the appropriate licensing entity, including the Medical Board of California, the Veterinary Medical Board, the Dental Board of California, the State Board of Optometry, the California Board of Podiatric Medicine, the Osteopathic Medical Board of California, the Board of Registered Nursing, the Bureau of Naturopathic Medicine, or the Physician Assistant Committee, all comp laints received related to dangerous drugs or dangerous devices dispensed by a - prescriber, certified nurse midwife, nurse practitioner, naturopathic doctor, or physician assistant pursuant to Section 4170. (b) All complaints involving serious bodily inju ry due to dangerous drugs or dangerous devices dispensed by prescribers, certified nurse - midwives, nurse practitioners, naturopathic doctors, or physician assistants pursuant to Section 4170 shall be handled by the Medical Board of California, the Dental B oard of California, the State Board of Optometry, the California Board of Podiatric Medicine , the Osteopathic Medical Board of California, the Bureau of Naturopathic Medicine, the Board of Registered Nursing, the Veterinary Assistant Committee as a case of greatest Medical Board, or the Physician potential harm to a patient. 136

137 Article 13. Nonprofit or Free Clinics 4180. Purchase of Drugs at Wholesale Only with License: Eligible Clinics (a) (1) Notwithstanding any provision of this chapter, any of the f ollowing clinics may purchase drugs at wholesale for administration or dispensing, under the direction of a physician and surgeon, to patients registered for care at the clinic: (A) A licensed nonprofit community clinic or free clinic as defined in paragr aph (1) of subdivision (a) of Section 1204 of the Health and Safety Code. (B) A primary care clinic owned or operated by a county as referred to in subdivision (b) of Section 1206 of the Health and Safety Code. (C) A clinic operated by a federally recogn ized Indian tribe or tribal organization as referred to in subdivision (c) of Section 1206 of the Health and Safety Code. (D) A clinic operated by a primary care community or free clinic, operated on separate premises from a licensed clinic, and that is o pen no more than 20 hours per week as referred to in subdivision (h) of Section 1206 of the Health and Safety Code. (E) A student health center clinic operated by a public institution of higher education as referred to in subdivision (j) of Section 1206 o f the Health and Safety Code. (F) A nonprofit multispecialty clinic as referred to in subdivision (l) of Section 1206 of the Health and Safety Code. (2) The clinic shall keep records of the kind and amounts of drugs purchased, , and the records shall be available and maintained administered, and dispensed for a minimum of three years for inspection by all properly authorized personnel. (b) No clinic shall be entitled to the benefits of this section until it has obtained a license from the board. A separat e license shall be required for each clinic location. A clinic shall notify the board of any change in the clinic's address on a form furnished by the board. (c) The board shall synchronize license renewal dates and aggregate fees for multiple clinics und er common nonprofit ownership at the request of the parent organization. Independent Clinics Sharing Office Space; Licensing; Separate 4180.5. Boards, Reporting Losses; Application Fee; Records; Drug Stocks , h Care Services and Ownership Change; Review by Department of Healt Department of Public Health (a) The board may issue licenses authorized under Section 4180 to two independently owned clinics that share a clinic office space, provided that the clinics comply with the following: (1) Each clinic maint ains a separate clinic license with the board with its own professional directors, administrators, owners, and officers. (2) Each clinic maintains physically separate and locked drug stocks. (3) Each clinic separately maintains all records required by th is article, including acquisition and disposition records. 137

138 (4) Dangerous drugs and dangerous devices shall not be loaned between the two licensed clinics. (b) Dangerous drugs and dangerous device losses at the shared clinic office shall be reported to th e board as required by law. Each clinic may be jointly and severally responsible for the drug losses. (c) The applicants shall also provide the board with a copy of the co - location - 750) time application fee of seven hundred fifty dollars ($ agreement and a one for the licenses. (d) Any change in ownership in either clinic shall require a new application under this section and fees as required by subdivision (q) of Section 4400 and subdivision (c) of this section. (e) The board shall not issue licenses aut horized under Section 4180 to two independently owned clinics that share a clinic office space pursuant to this section until the board is provided with documentation from the Director of the Department of Health Care Services that any Medi - Cal financing i ssues, including the ability to claim associated federal financial participation or 340(b) program participation, have been sufficiently addressed to the director’s satisfaction. The Department of Health Care Services may seek any federal approvals it deem s necessary to implement this section. (f) The board shall not issue licenses authorized under Section 4180 to two independently owned clinics that share a clinic office space pursuant to the section until the board is provided with documentation from the Director of the Department of Public Health that any licensing and regulatory issues have been sufficiently addressed to the director’s satisfaction. (g) This section shall become inoperative on January 1, 2021, and as of that date is repealed. 4181. L icense Requirements; Policies and Procedures; Who May Dispense (a) Prior to the issuance of a clinic license authorized under Section 4180, the clinic shall comply with all applicable laws and regulations of the State Health relating to the drug distribution service to ensure Department of Public that inventories, security procedures, training, protocol development, recordkeeping, packaging, labeling, dispensing, and patient consultation occur in a manner that is consistent with the promotion and protecti on of the health and safety of the public. The policies and procedures to implement the laws and regulations shall be developed and approved by the consulting pharmacist, the professional director, and the clinic administrator. (b) The dispensing of dru gs in a clinic shall be performed only by a physician, a pharmacist, or other person lawfully authorized to dispense drugs, and only in compliance with all applicable laws and regulations. 4182. Duties of Professional Director; Consulting Pharmacist Requ ired (a) Each clinic that makes an application for a license under Section 4180 shall show evidence that the professional director is responsible for the safe, orderly, and lawful provision of pharmacy services. In carrying out the s responsibilities, a consulting pharmacist shall be retained professional director' to approve the policies and procedures in conjunction with the professional 138

139 director and the administrator. In addition, the consulting pharmacist shall be required to visit the clinic regularly and at least quarterly. However, nothing in this section shall prohibit the consulting pharmacist from visiting more than quarterly to review the application of policies and procedures based on the rocedures. agreement of all the parties approving the policies and p (b) The consulting pharmacist shall certify in writing quarterly that the clinic is, or is not, operating in compliance with the requirements of this article. Each completed written certification shall be kept on file in the clinic for three y ears and shall include recommended corrective actions, if appropriate. (c) For the purposes of this article, "professional director" means a physician and surgeon acting in his or her capacity as medical director or a dentist or or her capacity as a director in a clinic where only dental podiatrist acting in his or podiatric services are provided. (d) Licensed clinics shall notify the board within 30 days of any change in professional director on a form furnished by the board. 4183. No Professional Di spensing Fee No clinic dispensing drugs pursuant to this article shall be eligible for any professional dispensing fee that may be authorized under the Medi - Cal program (Chapter 7 (commencing with Section 14000) of Part 3 of Division 9 of the Institutions Code). Welfare and 4184. Dispensing Schedule II Substance by Clinic Prohibited No Schedule II controlled substance shall be dispensed by the clinic. This limitation shall not be construed to prohibit a physician dispensing a Schedule extent permitted by law. II drug to the 4185. Inspection Permitted The board shall have the authority to inspect a clinic at any time in order to determine whether a clinic is, or is not, operating in compliance with this article. 4186. Automated Drug Delivery Syst ems (a) Automated drug delivery systems, as defined in subdivision (h), may be located in any clinic licensed by the board pursuant to Section 4180. If an automated drug delivery system is located in a clinic, the clinic shall develop and implement writ ten policies and procedures to ensure safety, accuracy, accountability, security, patient confidentiality, and maintenance of the quality, potency, and purity of drugs. All policies and procedures shall be maintained at the location where the automated dr ug system is being used. (b) Drugs shall be removed from the automated drug delivery system only upon authorization by a pharmacist after the pharmacist has reviewed the prescription and the patient's profile for potential contraindications and adverse rug reactions. Drugs removed from the automated drug delivery system shall d be provided to the patient by a health professional licensed pursuant to this division. 139

140 (c) The stocking of an automated drug delivery system shall be performed by a pharmacist. (d) Review of the drugs contained within, and the operation and maintenance of, the automated drug delivery system shall be the responsibility of the clinic. The review shall be conducted on a monthly basis by a pharmacist and shall include a physical i nspection of the drugs in the automated drug delivery system, an inspection of the automated drug delivery system machine for cleanliness, and a review of all transaction records in order to verify the security and accountability of the system. utomated drug delivery system used at the clinic shall provide for (e) The a patient consultation pursuant to Section 1707.2 of Title 16 of the California Code of Regulations with a pharmacist via a telecommunications link that has two - way audio and video. (f) The pharmacist operating the automated drug delivery system shall be located in California. (g) Drugs dispensed from the automated drug delivery system shall comply with the labeling requirements in Section 4076. mated drug delivery system" means a (h) For purposes of this section, an "auto mechanical system controlled remotely by a pharmacist that performs operations or activities, other than compounding or administration, relative to or the storage, dispensing, or distribution of prepackaged dangerous drugs dangerous devices. An automated drug delivery system shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability. l become inoperative on July 1, 2019, and, as of January 1, (i) This section shal 2020, is repealed. 4187. Correctional Clinics For purposes of this article the following terms shall have the following meanings: (a) “Correctional clinic” means a primary care clinic, as referre d to in subdivision (b) of Section 1206 of the Health and Safety Code, conducted, maintained, or operated by the state to provide health care to eligible patients of the Department of Corrections and Rehabilitation. (b) “Chief executive officer” means the highest ranking health care administrator at a correctional institution. (c) “Chief medical executive” means a physician and surgeon acting in the capacity of medical director within the correctional institution. (d) “Chief nurse executive” means the highe st ranking nurse within the correctional institution. (e) “Licensed correctional clinic” means a correctional clinic that is licensed pursuant to this article. (f) “Supervising dentist” means the highest ranking dentist within the correctional institution. 140

141 4187.1 Correctional Clinics: Licensing; Dispensing and Administering of Drugs (a) Notwithstanding any other provision of this chapter, a correctional clinic licensed by the board under this article may obtain drugs from a licensed correctional pharmacy, the Department of Correction and Rehabilitation’s Central Fill Pharmacy, or from another correctional clinic licensed by the board under this article within the same institution for the administration or for care at the correctional dispensing of drugs or devices to patients eligible facility if under either: (1) The direction of a physician and surgeon, dentist, or other person lawfully authorized to prescribe. (2) An approved protocol as identified within the statewide Inmate Medical Services Policies an d Procedures. (b) The dispensing or administering of drugs in a correctional clinic may be performed pursuant to a chart order, as defined in Section 4019, a valid prescription consistent with this chapter, or pursuant to an approved protocol as identified within the statewide Inmate Medical Services Policies and Procedures. The dispensing of drugs in a correctional clinic shall only be performed by a physician and surgeon, a dentist, a pharmacist, or other person lawfully authorized to dispense drugs. Medi cations dispensed to patients that are to be kept on the patient’s person for use shall meet the labeling requirements of Section 4076 and all recordkeeping requirements of this chapter. (c) A correctional clinic shall keep records of the kind and amounts of drugs acquired, administered, transferred, and dispensed. The records shall be available and maintained for a minimum of three years for inspection by all properly authorized personnel. (d) (1) A correctional clinic shall not be entitled to the benefits of this section until it has obtained a license from the board. (2) A separate license shall be required for each correctional clinic location and shall not be transferrable. (3) A correctional clinic’s location and address shall be identified by correcti onal institution and building within that correctional institution. (4) A clinic shall notify the board in advance of any change in the clinic’s address on a form furnished by the board. 4187.2 Correctional Clinics: Policies and Procedures s and procedures to implement the laws and regulations of this (a) The policie article within a correctional clinic shall be developed and approved by the statewide Correctional Pharmacy and Therapeutics Committee referenced in Section 5024.2 of the Penal Code. Prior to t he issuance of a correctional clinic license by the board, an acknowledgment shall be signed by the correctional charge facility pharmacist - in - charge servicing that institution, the pharmacist - in - on’s Central Fill for the California Department of Correction and Rehabilitati Pharmacy, and the correctional clinic’s chief medical executive, supervising dentist, chief nurse executive, and chief executive officer. 141

142 (b) (1) The chief executive officer shall be responsible for the safe, orderly, and - lawful provision of pharmacy services. The pharmacist - in charge of the correctional facility shall implement the policies and procedures developed and approved by the statewide Correctional Pharmacy and Therapeutics Committee referenced in Section 5024.2 of the Penal Code and the statewide Inmate Medical Services Policies and Procedures in conjunction with the chief executive officer, the chief medical executive, the supervising dentist, and the chief nurse executive. rd within 30 days of any (2) A licensed correctional clinic shall notify the boa change in the chief executive officer on a form furnished by the board. (c) A correctional facility pharmacist shall be required to inspect the clinic at least quarterly. 4187.3 Correctional Clinics: Administering Controlled Subst ances A Schedule II, III, IV, or V controlled substance may be administered by health care staff of the licensed correctional clinic lawfully authorized to administer in Section 4019, a valid prescription pursuant to a chart order, as defined th this chapter, or pursuant to an approved protocol as identified consistent wi within the statewide Inmate Medical Services Policies and Procedures. 4187.4 Correctional Clinics: Board Inspections any time in The board shall have the authority to inspect a correctional clinic at order to determine whether a correctional clinic is, or is not, operating in compliance with this article. 4187.5 Correctional Clinics: Automated Drug Delivery Systems e (a) An automated drug delivery system, as defined in subdivision (h), may b located in a correctional clinic licensed by the board under this article. If an automated drug delivery system is located in a correctional clinic, the correctional clinic shall implement the statewide Correctional Pharmacy and Therapeutics Committee’s policies and procedures and the statewide Inmate Medical Services Policies and Procedures to ensure safety, accuracy, accountability, security, patient confidentiality, and maintenance of the quality, potency, and purity of drugs. All policies and procedur es shall be maintained either in electronic form or paper form at the location where the automated drug system is being used. (b) Drugs shall be removed from the automated drug delivery system upon authorization by a pharmacist after the pharmacist has rev iewed the prescription and the patient profile for potential contraindications and adverse drug reactions. If the correctional pharmacy is closed and if, in the prescriber’s professional judgment, delay in therapy may cause patient harm, a medication may b e removed from the automated drug delivery system and administered or furnished to a patient under the direction of the prescriber. Where the drug is otherwise unavailable, a medication may be removed and administered or o an approved protocol as identified within furnished to the patient pursuant t the statewide Inmate Medical Services Policies and Procedures. Any removal 142

143 of medication from an automated drug delivery system shall be documented and provided to the correctional pharmacy when it reopens. (c) D rugs removed from the automated drug delivery system shall be provided to the patient by a health professional licensed pursuant to this division who is lawfully authorized to perform that task. (d) The stocking of an automated drug delivery system shall b e performed by either: (1) A pharmacist. (2) An intern pharmacist or pharmacy technician, acting under the supervision of a pharmacist. (e) Review of the drugs contained within, and the operation and maintenance of, the automated drug delivery system shall be the responsibility of the correctional clinic. The review shall be conducted on a monthly basis by a pharmacist and shall include a physical inspection of the drugs in the automated drug delivery system, an inspection of the automated drug delivery sys tem machine for cleanliness, and a review of all transaction records in order to verify the security and accountability of the system. (f) The automated drug delivery system shall be operated by a licensed correctional pharmacy. Any drugs within an automat ed drug delivery system are considered owned by the licensed correctional pharmacy until they are dispensed from the automated drug delivery system. (g) Drugs from the automated drug delivery system in a correctional clinic shall only be removed by a perso n lawfully authorized to administer or dispense the drugs. (h) For purposes of this section, an “automated drug delivery system” means a mechanical system controlled remotely by a pharmacist that performs operations or activities, other than compounding or administration, relative to the storage, dispensing, or distribution of prepackaged dangerous drugs or dangerous devices. An automated drug delivery system shall collect, control, and maintain all transaction information to accurately track the movement o f drugs into and out of the system for security, accuracy, and accountability. Article 14. Clinics 4190. Clinic Defined; License Required; Purchase of Drugs at Wholesale: Drug Distribution Service of a Clinic; Information Reported to the Board r the purposes of this article, "clinic" means a surgical clinic licensed (a) Fo pursuant to paragraph (1) of subdivision (b) of Section 1204 of the Health and Safety Code, an outpatient setting accredited by an accreditation agency, as defined in Section 1248 of the Health and Safety Code, or an ambulatory surgical center certified to participate in the Medicare Program under Title XVIII of the federal Social Security Act (42 U.S.C. Sec. 1395 et seq.). (b) A clinic licensed by the board may purchase drugs at w holesale for administration or dispensing, under the direction of a physician and surgeon, to patients registered for care at the clinic, as provided in subdivision (c). A separate license shall be required for each clinic location. A clinic licensed by 143

144 th e board shall notify the board of any change in the clinic's address on a form furnished by the board. The clinic shall keep records of the kind and amounts of drugs purchased, administered, and dispensed, and the records shall be available and maintained for a minimum of three years for inspection by all properly authorized personnel. (c) The drug distribution service of a clinic shall be limited to the use of drugs for administration to the patients of the clinic and to the dispensing of drugs for the control of pain and nausea for patients of the clinic. Drugs shall not be dispensed in an amount greater than that required to meet the patient's needs for 72 hours. Drugs for administration shall be those drugs directly applied, whether by injection, inha lation, ingestion, or any other means, to the body of a patient for his or her immediate needs. (d) No clinic shall be entitled to the benefits of this section until it has obtained a license from the board. (e) If a clinic is licensed by the board, any proposed change in ownership or beneficial interest in the licensee shall be reported to the board, on a form to be furnished by the board, at least 30 days prior to the execution of any agreement to purchase, sell, exchange, gift or otherwise transfer any ownership or beneficial interest or prior to any transfer of ownership or beneficial interest, whichever occurs earlier. (f) Nothing in this section shall limit the ability of a physician and surgeon to rugs at a clinic as provided in prescribe, dispense, administer, or furnish d Sections 2241.5, 2242, and 4170. Compliance With Department of Public Health Requirements; Who 4191. May Dispense Drugs (a) Prior to the issuance of a clinic license authorized under this article, the clinic shall comply with all applicable laws and regulations of the State Department of Public Health and the board relating to drug distribution to ensure that inventories, security procedures, training, protocol development, recordkeeping, packaging, labeling, dispensing, and patient consultation are carried out in a manner that is consistent with the promotion and protection of the health and safety of the public. The policies and procedures to implement the laws and regulations shall be developed and approved by the consu lting pharmacist, the professional director, and the clinic administrator. (b) The dispensing of drugs in a clinic that has received a license under this article shall be performed only by a physician, a pharmacist, or other person dispense drugs, and only in compliance with all lawfully authorized to applicable laws and regulations. 4192. Duties of Professional Director; Providing Information to Board (a) Each clinic that makes an application for a license under this article shall the professional director is responsible for the safe, orderly, show evidence that and lawful provision of pharmacy services. In carrying out the professional director's responsibilities, a consulting pharmacist shall be retained to approve the policies and procedures in co njunction with the professional director and 144

145 the administrator. In addition, the consulting pharmacist shall be required to visit the clinic regularly and at least quarterly. However, nothing in this section siting more than quarterly to shall prohibit the consulting pharmacist from vi review the application of policies and procedures based on the agreement of all the parties approving the policies and procedures. (b) The consulting pharmacist shall certify in writing quarterly that the clinic t, operating in compliance with the requirements of this article. Each is, or is no completed written certification shall be kept on file in the clinic for three years and shall include recommended corrective actions, if appropriate. cle, "professional director" means a physician (c) For the purposes of this arti and surgeon acting in his or her capacity as medical director or a dentist or podiatrist acting in his or her capacity as a director in a clinic where only dental or podiatric services are provided. (d) Lice nsed clinics shall notify the board within 30 days of any change in professional director on a form furnished by the board. 4193. Clinic Not Eligible for Professional Dispensing Fee; Ban on Offering Drugs for Sale o this article shall be eligible for any No clinic holding a license pursuant t - Cal program professional dispensing fee that may be authorized under the Medi (Chapter 7 (commencing with Section 14000) of Part 3 of Division 9 of the Welfare and Institutions Code). No clinic holding a license pu rsuant to this article shall offer drugs for sale or shall charge or bill for professional services for the dispensing or administering of drugs. Dispensing of Schedule II Substance by Clinic Prohibited; Physician 4194. May Dispense; Administration Autho rized in Clinic No Schedule II controlled substance shall be dispensed in the clinic. This limitation does not prohibit a physician from dispensing a Schedule II drug to the extent permitted by subdivision (b) of Section 11158 of the Health and ode and all other provisions of law, nor does it prevent the lawful Safety C administration of Schedule II drugs on the premises of the clinic. 4195. Inspection Authorized The board shall have the authority to inspect a clinic that is licensed pursuant article at any time in order to determine whether the clinic is, or is not, to this operating in compliance with this article and all other provisions of the law. 145

146 - Animal Drug Retailers Article 15. Veterinary Food License Required: Temporary License Per sons Authorized in 4196. s; ; Board Approval of Designated ; Other Requirements Storage Area - in - Charge Representative (a) No person shall conduct a veterinary food - animal drug retailer in the State d. A license of California unless he or she has obtained a license from the boar - animal drug retailer owned or shall be required for each veterinary food operated by a specific person. A separate license shall be required for each of the premises of any person operating a veterinary food animal drug retailer in - more than o ne location. The license shall be renewed annually and shall not be transferable. (b) The board may issue a temporary license, upon conditions and for periods of time as the board determines to be in the public interest. A temporary license fee shall be fixed by the board at an amount not to exceed the annual fee for renewal of a license to conduct a veterinary food - animal drug retailer. (c) No person other than a pharmacist, an intern pharmacist, a designated e law, or a person authorized to representative, an authorized officer of th prescribe, shall be permitted in that area, place, or premises described in the permit issued by the board - pursuant to Section 4041, wherein veterinary food animal drugs are stored, possessed, or repacked. A pharmacist or d esignated representative shall be responsible for any individual who enters the veterinary food animal drug retailer for the purpose of performing clerical, inventory - control, housekeeping, delivery, maintenance, or similar functions relating to the veteri nary food - animal drug retailer. (d) Every veterinary food - animal drug retailer shall be supervised or managed - in - representative by a designated representative - in - charge. The designated charge shall be responsible for the veterinary - animal drug retai ler's food - animal drug compliance with state and federal laws governing veterinary food initial application for a license, and for each renewal, retailers. As part of its each - animal drug retailer shall, on a form designed by the veterinary food board, provide identifying information and the California license number for a designated representative or pharmacist proposed to serve as the designated designated representative representative - charge. The proposed in - in - charge - shall be subject to approval by the board . The board shall not issue or renew a veterinary food - animal drug retailer license without identification of an charge for the veterinary approved designated representative - in - food - animal drug retailer. - animal drug retailer sha ll notify the board in (e) Every veterinary food writing, on a form designed by the board, within 30 days of the date when a designated representative - in - charge who ceases to act as the designated representative - in - charge, and shall on the same form propose another designated repre over as the designated sentative or pharmacist to take representative - in - charge. The proposed replacement designated representative - in charge shall be subject to approval by the board. If disapproved, the - another replacement within - animal drug retailer shall propose veterinary food date of disapproval, and shall continue to name proposed 15 days of the 146

147 - in - charge is approved by the replacements until a designated representative board. (f) For purposes of this section, designated in representative - - charge m eans a representative license pursuant to Section 4053, or person granted a designated pharmacist, who is the supervisor or manager of the facility. a registered 4197. Minimum Standards: Security; Sanitation; Board Regulations; Waivers (a) The following minimum standards shall apply to all veterinary food - animal drug retailers licensed by the board: (1) Each retailer shall store veterinary food - animal drugs in a secure, lockable area. (2) Each retailer shall maintain on the premises fixtures and equipm ent in a clean and orderly condition. The premises shall be dry, well ventilated, and - have adequate lighting. (b) The board may, by regulation, impose any other minimum standards pertaining to the acquisition, storage, and maintenance of veterinary food - animal drugs, or other goods, or to the maintenance or condition of the licensed premises of any veterinary food - animal drug retailer as the board determines are reasonably necessary. y (c) When, in the opinion of the board, a high standard of patient safet consistent with good animal safety and care in the case of an animal patient can be provided by the licensure of a veterinary food animal drug retailer that does - - not meet all of the requirements for licensure as a veterinary food animal drug e board may waive any licensing requirements. retailer, th Written Policies and Procedures Required: Contents; Training of 4198. Personnel; Quality Assurance; Consulting Pharmacist (a) Each veterinary food - animal drug retailer shall have written policies and procedu - animal res related to the handling and dispensing of veterinary food drugs by veterinary food - animal drug retailers. These written policies and procedures shall include, but not be limited to, the following: (1) Training of staff. (2) Cleaning, storage, and maintenance of veterinary food - animal drugs and equipment. (3) Recordkeeping requirements. (4) Storage and security requirements. (5) Quality assurance. (b) Each retailer shall prepare and maintain records of training and demonstrated competence f or each individual employed or retained by the retailer. These records shall be maintained for three years from and after the last date of employment. (c) Each retailer shall have an ongoing, documented quality assurance program which includes, but is no t limited to: (1) Monitoring personnel performance. (2) Storage, maintenance, and dispensing of veterinary food - animal drugs. 147

148 (d) The records and documents specified in subdivisions (a) and (b) shall be maintained for three years from the date of makin g. The records and documents in subdivisions (a), (b), and (c) shall be, at all times during business hours, open to inspection by authorized officers of the law. (e) To assure compliance with the requirements of this chapter regarding veterinary food - operations of the animal drug retailer, a consulting pharmacist shall visit the veterinary food - animal drug retailer regularly and at least quarterly. The consulting pharmacist shall be retained either on a volunteer or paid basis to review, approve, and r evise the policies and procedures of the animal drug retailer, and assure compliance with California and veterinary food - federal law regarding the labeling, storage, and dispensing of veterinary food - animal drugs. The consulting pharmacist shall certify in writing at least twice a year whether - animal drug retailer is operating in compliance with or not the veterinary food the requirements of this chapter. The most recent of the written certifications shall be submitted with the annual renewal application of a veterinary food - animal drug retailer license. 4199. Labeling Requirements; Maintaining Prescription Records animal drug dispensed pursuant to a prescription from (a) Any veterinary food - a licensed veterinarian for food producing animals from a ve - terinary food animal drug retailer pursuant to this chapter is subject to the labeling requirements of Sections 4076 and 4077. (b) All prescriptions filled by a veterinary food - animal drug retailer shall be kept on file and maintained for at least three years in accordance with Section 4333. Article 16. Applications 4200. Pharmacist License Requirements: Age; Education; Experience; Examination; Proof of Qualifications; Fees (a) The board may license as a pharmacist an applicant who meets all the foll owing requirements: (1) Is at least 18 years of age. (2) (A) Has graduated from a college of pharmacy or department of pharmacy of a university recognized by the board; or (B) If the applicant graduated from a foreign pharmacy school, the foreign - educat ed applicant has been certified by the Foreign Pharmacy Graduate Examination Committee. (3) Has completed at least 150 semester units of collegiate study in the United States, or the equivalent thereof in a foreign country. No less than 90 of those semest er units shall have been completed while in resident attendance at a school or college of pharmacy. (4) Has earned at least a baccalaureate degree in a course of study devoted to the practice of pharmacy. ice experience or the (5) Has completed 1,500 hours of pharmacy pract equivalent in accordance with Section 4209. 148

149 (6) Has passed the North American Pharmacist Licensure Examination and the California Practice Standards and Jurisprudence Examination for Pharmacists on or after January 1, 2004. (b) Proof of the qualifications of an applicant for licensure as a pharmacist shall be made to the satisfaction of the board and shall be substantiated by affidavits or other evidence as may be required by the board. (c) Each person, upon application for li censure as a pharmacist under this chapter, shall pay to the executive officer of the board the fees provided by this chapter. The fees shall be compensation to the board for investigation or examination of the applicant. 200.1 Multiple Failures of Lic ense Examination; Additional Education 4 Requirements (a) Notwithstanding Section 135, an applicant may take the North American Pharmacist Licensure Examination four times, and may take the California Practice Standards and Jurisprudence Examination for Ph armacists four times. (b) Notwithstanding Section 135, an applicant may take the North American Pharmacist Licensure Examination and the California Practice Standards and Jurisprudence Examination for Pharmacists four additional times each if he or uccessfully completes, at minimum, 16 additional semester units of she s education in pharmacy as approved by the board. (c) The applicant shall comply with the requirements of Section 4200 for each application for reexamination made pursuant to subdivision (b ). (d) An applicant may use the same coursework to satisfy the additional educational requirement for each examination under subdivision (b), if the coursework was completed within 12 months of the date of his or her application for reexamination. (e) For purposes of this section, the board shall treat each failing score on the pharmacist licensure examination administered by the board prior to January 1, 2004, as a failing score on both the North American Pharmacist Licensure Examination and the Califo rnia Practice Standards and Jurisprudence Examination for Pharmacists. 4200.2. California Practice Standards and Jurisprudence Examination for Pharmacists; Required Inclusions When developing the California Practice Standards and Jurisprudence Examinat ion for Pharmacists, the board shall include all of the following: (a) Examination items to demonstrate the candidate's proficiency in patient communication skills. (b) Aspects of contemporary standards of practice for pharmacists in ing, but not limited to, the provision of pharmacist care and California, includ the application of clinical knowledge to typical pharmacy practice situations that are not evaluated by the North American Pharmacy Licensure Examination. 149

150 Examination Process to be R eviewed Regularly; Required 4200.3. Standards (a) The examination process shall be regularly reviewed pursuant to Section 139. (b) The examination process shall meet the standards and guidelines set forth in the Standards for Educational and Psychological Test ing and the Federal Uniform Guidelines for Employee Selection Procedures. The board shall work of the department or with Professional Examination Services with the Office of an equivalent organization who shall certify at minimum once every five years tha t the examination process meets these national testing standards. If the department determines that the examination process fails to meet these standards, the board shall terminate its use of the North American Pharmacy Licensure Examination and shall use only the written and practical examination developed by the board. (c) The examination shall meet the mandates of subdivision (a) of Section 12944 of the Government Code. (d) The board shall work with the Office of Professional Examination Services or with an equivalent organization to develop the state jurisprudence examination to ensure that applicants for licensure are evaluated on their knowledge of applicable state laws and regulations. s for the pharmacist's (e) The board shall annually publish the pass and fail rate licensure examination administered pursuant to Section 4200, including a comparison of historical pass and fail rates before utilization of the North American Pharmacist Licensure Examination. (f) The board shall report to the Join t Committee on Boards, Commissions, and Consumer Protection and the department as part of its next scheduled review, the pass rates of applicants who sat for the national examination compared with the pass rates of applicants who sat for the prior state ex amination. This report shall be a component of the evaluation of the examination process that is based on psychometrically sound principles for establishing minimum qualifications and levels of competency. 4200.4. Retaking National Examination After Fai lure; Waiting Period either the North American Pharmacist Licensure An applicant who fails Examination or the California Practice Standards and Jurispruden ce examination for at least 45 Examination for Pharmacists may not retake that days. The board may, in consultation with the Office of Professional Examination Services of the department, adopt a regulation establishing a different waiting period to retake the examination. 4200.5. Retired Licensee: Eligibility; Bar on Practice; Requirement for Restor ation to Active Status (a) The board shall issue, upon application and payment of the fee established by Section 4400, a retired license to a pharmacist who has been licensed by the board. The board shall not issue a retired license to a pharmacist whos e license has been revoked. 150

151 (b) The holder of a retired license issued pursuant to this section shall not engage in any activity for which an active pharmacist's license is required. A itles "retired pharmacist holding a retired license shall be permitted to use the t pharmacist" or "pharmacist, retired." (c) The holder of a retired license shall not be required to renew that license. (d) In order for the holder of a retired license issued pursuant to this section to restore his or her license to acti ve status, he or she shall pass the examination that is required for initial licensure with the board. 4201. Application Form: Required Information; Authority Granted by License; Reporting Changes in Beneficial Ownership (a) Each application to conduct a pharmacy, wholesaler, third - party logistics provider, veterinary food animal drug retailer , or outsourcing facility shall be - made on a form furnished by the board and shall state the name, address, usual occupation, and professional qualifications, if a ny, of the applicant. If the applicant is other than a natural person, the application shall state the information as to each person beneficially interested therein or any person with management or control over the license . (b) As used in this section, a nd subject to subdivision (c), the term “person beneficially interested” means and includes: (1) If the applicant is a partnership or other unincorporated association, each partner or member. (2) If the applicant is a corporation, each of its officers, directors, and stockholders, provided that a natural person shall not be deemed to be beneficially interested in a nonprofit corporation. (3) If the applicant is a limited liability company, each officer, manager, or member. (c) If the applicant is a partnership or other unincorporated association, a limited liability company, or a corporation, and the number of partners, members, or stockholders, as the case may be, exceeds five, the application shall so state, and shall further state the information required by subdivision (a) as to each of the five partners, members, or stockholders who own the five largest interests in the applicant entity. Upon request by the executive officer, the applicant shall furnish the board with the information required by subdivision (a) as to partners, members, or stockholders not named in the application, or shall refer the board to an appropriate source of that information. (d) The application shall contain a statement to the effect that the applicant has icted of a felony and has not violated any of the provisions of this not been conv chapter. If the applicant cannot make this statement, the application shall contain a statement of the violation, if any, or reasons which will prevent the applicant from being able to co mply with the requirements with respect to the statement. (e) Upon the approval of the application by the board and payment of the fee required by this chapter for each pharmacy, wholesaler, third - party logistics retailer, the executive officer of the provider, or veterinary food - animal drug party - board shall issue a license to conduct a pharmacy, wholesaler, third 151

152 - animal drug retailer , or outsourcing facility logistics provider, veterinary food if all of the provisions of this chapter have been complied with. (f) Notwithstanding any other law, the pharmacy license shall authorize the holder to conduct a pharmacy. The license shall be renewed annually and shall not be transferable. (g) ze the Notwithstanding any other law, the wholesaler license shall authori holder to wholesale dangerous drugs and dangerous devices. The license shall be renewed annually and shall not be transferable. party logistics provider license - (h) Notwithstanding any other law, the third coordinate warehousing, distribution, or shall authorize the holder to provide or other similar services of dangerous drugs and dangerous devices. The license shall be renewed annually and shall not be transferable. - (i) Notwithstanding any other law, the veterinary food animal drug retailer lic ense shall authorize the holder to conduct a veterinary food - animal drug retailer and to sell and dispense veterinary food - animal drugs as defined in Section 4042. For licenses referred to in subdivisions (f), (g), (h), and (i), any change in (j) the pro posed beneficial ownership interest shall be reported to the board within 30 days thereafter upon a form to be furnished by the board. (Amended by Stats. 2015, Ch. 303, Sec. 7. Effective January 1, 2016.) Pharmacy Technician: License Requirements f or Education, 4202. Experience; Board Regulations; Criminal Background Check; Discipline (a) The board may issue a pharmacy technician license to an individual if he or she is a high school graduate or possesses a general educational development certificate equ ivalent, and meets any one of the following requirements: (1) Has obtained an associate's degree in pharmacy technology. (2) Has completed a course of training specified by the board. (3) Has graduated from a school of pharmacy recognized by the board. (4) Is certified by a pharmacy technician certifying organization offering a pharmacy technician certification program accredited by the National Commission for Certifying Agencies that is approved by the board. (b) The board shall adopt regulations purs uant to this section for the licensure of pharmacy technicians and for the specification of training courses as set out in paragraph (2) of subdivision (a). Proof of the qualifications of any applicant for licensure as a pharmacy technician shall be made t o the satisfaction of the board and shall be substantiated by any evidence required by the board. (c) The board shall conduct a criminal background check of the applicant to determine if an applicant has committed acts that would constitute grounds for de nial of licensure, pursuant to this chapter or Chapter 2 (commencing with Section 480) of Division 1.5. (d) The board may suspend or revoke a license issued pursuant to this section on any ground specified in Section 4301. licen sed as a pharmacist, the pharmacy technician (e) Once an individual is registration is no longer valid and the pharmacy technician license shall be returned to the board within 15 days. 152

153 4202.5 Designated Paramedic License ; Fee (a) The board may issue a designated paramedic licen se to an individual if he or she holds a license as a paramedic in this state and meets the criteria of this section. (b) The board shall conduct a criminal background check of the applicant to itute grounds for determine if the applicant has committed acts that would const denial of licensure, pursuant to this chapter or Chapter 2 (commencing with Section 480) of Division 1.5. (c) The board may suspend or revoke a license issued pursuant to this section on any ground specified in Section 4301. (d) A license issued under this section is dependent on the validity of the holder’s paramedic license and shall be automatically suspended if the individual’s paramedic license is expired, revoked, or otherwise invalidated by the issuing authority. (e) The fee for app lication and issuance of an initial license as a designated paramedic shall be one hundred forty dollars ($140) for a two - year license. The biennial renewal shall be one hundred forty dollars ($140). The penalty fee for - five dollars failure to renew an authorized param edic license shall be sixty ($65). - Profit Clinic License Application: Form; Investigation 4203. Non (a) Each application for a license under Section 4180 shall be made on a form furnished by the board. The form of application for a license under Section 4180 shall contain the name and address of the applicant, whether the applicant is licensed as a primary care clinic as defined in this code, the name of its professional director, the name of its administrator, and the name of its consulting pharmacist. (b) Upon the filing of the application and payment of the fee prescribed in subdivision (s) of Section 4400, the board shall make a thorough investigation to determine whether the applicant and the premises for which application for a permit is made qualify for a license. The board shall also determine whether this article has been complied with, and shall investigate all matters directly related to the issuance of the license. The board shall not, however, investigate any matters connected wi th the operation of a premises, including operating hours, parking availability, or operating noise, except those matters relating to the furnishing, sale, or dispensing of drugs or devices. The board shall deny an application for a license if either the a pplicant or the premises for which application for a license is made do not qualify for a license under this article. (c) If the board determines that the applicant and the premises for which application for a license is made qualify for a license under t his article, the executive officer of the board shall issue a license authorizing the clinic to which it is issued to purchase drugs at wholesale pursuant to Section 4180. The license shall be renewed annually on or before December 31 of each year upon pay ment of the renewal fee prescribed in subdivision (s) of Section 4400 and shall not be transferable. 153

154 4203.5. Clinic Application (a) Notwithstanding any other law, when a clinic applicant submits either type of application described in subdivision (b), th e board shall issue a license or incorporate the reported changes, as appropriate, within 30 days of receipt of a completed application and payment of any prescribed fees. (b) This section applies to the following types of applications: (1) A new clinic license application filed under Section 4180. (2) Applications to report changes to an existing site licensed under Section 4180, including, but not limited to, changes in professional director, clinic administrator, corporate officers, change of location , or change of address. (c) This section shall not be construed to limit the board’s authority to conduct an investigation to determine whether applicants and the premises for which an application is made qualify for a license. Correctional Clinic 4203.6 s: License Application (a) Each application for a license as a correctional clinic under Article 13.5 (commencing with Section 4187) shall be made on a form furnished by the board. The application form shall contain the name and address of the applicant, t he name of its chief executive officer, as defined in Section 4187, and the name of the pharmacist charge of the correctional pharmacy that - in - provides drugs to the clinic. (b) Upon the filing of the application and payment of the fee prescribed in Section 4400, where applicable, the board shall make a thorough investigation to determine whether the applicant and the premises for which application for a license is made qualify for licensure. The board shall also determine whether this article has been compl ied with and shall investigate all matters directly related to the issuance of the license. The board shall not, however, investigate any matters connected with the operation of a premises, including, but not limited to, operating hours, parking availabili ty, or operating noise, except those matters relating to the furnishing or dispensing of drugs or devices. The board shall deny an application for a license if either the applicant or the y for a premises for which application for a license is made does not qualif license under this article. (c) If the board determines that the applicant and the premises for which application for a license is made qualify for a license under this article, the executive officer of the board shall issue a license authorizing t he correctional clinic to which it is issued to obtain drugs pursuant to Article 13.5 (commencing with Section 4187). The license shall be renewed annually on or before December 31 of each year upon payment of the renewal fee prescribed in Section 4400, if applicable. A license shall not be transferable. 4204. Surgical Clinic Application: Form; Investigation ( a) Each application for a license under Section 4190 shall be made on a form furnished by the board. The form of application for a license under th is article shall contain the name and address of the applicant, whether the applicant is licensed, the type of services the facility will offer, the name of its professional 154

155 director, the name of its administrator, and the name of its consulting pharmacist . (b) Each initial application shall contain a statement from a consulting pharmacist certifying that the policies and procedures of the clinic's drug distribution service, relative to inventories, security procedures, training, protocol development, reco rdkeeping, packaging, labeling, dispensing, and patient consultation are consistent with the promotion and protection of health and safety of the public. Upon the filing of the application and the payment of a ard shall make a thorough (s) of Section 4400, the bo fee in subdivision investigation to determine whether the applicant and the premises for which application for a license is made qualify for a license. The board shall also determine whether this article has been complied with, and shall investigate all matters directly related to the issuance of the license. The board shall not however, investigate any matters connected with the operation of a premises, including operating hours, parking availability, or operating noise, except those matters relatin g to the furnishing, sale, or dispensing of drugs or devices. The board shall deny an application for a license if either the applicant or the premises for which application for a license is made do not qualify for a license under this article. board determines that the applicant and the premises for which (c) If the application for a license is made qualify for a license under Section 4190, the executive officer of the board shall issue a license authorizing the clinic to ugs at wholesale pursuant to Section 4190. The which it is issued to purchase dr license shall be renewed annually upon payment of a renewal fee prescribed in subdivision (s) of Section 4400 and shall not be transferable. 4205. Sale or Dispensing of Hypodermic Syringes and Needles: When Separate License Required; Form and Content of Application; Renewability; Discipline (a) A license issued pursuant to Section 4110, 4120, 4160, or 4161 shall be considered a license within the meaning of Section 4141. tion, issue a license to any person authorizing (b) The board may, in its discre the sale and dispensing of hypodermic syringes and needles for animal use. (c) The application for a license shall be made in writing on a form to be furnished by the board. The board may require any infor mation as the board deems reasonably necessary to carry out the purposes of Article 9 (commencing with Section 4140) of this chapter. (d) A separate license shall be required for each of the premises of any person who sells or dispenses hypodermic syrin ges or needles at more than one location. (e) A license shall be renewed annually and shall not be transferable. (f) The board may deny, revoke, or suspend any license issued pursuant to this article for any violation of this chapter. 155

156 4207. Investi gation by Board (a) Upon receipt of an application for a license and the applicable fee, the board shall make a thorough investigation to determine whether the applicant is qualified for the license being sought. The board shall also determine whether t his article has been complied with, and shall investigate all matters directly related to the issuance of the license that may affect the public welfare. (b) The board shall not investigate matters connected with the operation of a premises other than t hose matters solely related to the furnishing of dangerous drugs or dangerous devices that might adversely affect the public welfare. (c) The board shall deny an application for a license if the applicant does not qualify for the license being sought. (d) Notwithstanding any other provision of law, the board may request any information it deems necessary to complete the application investigation required by this section, and a request for information that the board deems section in any application or related form devised necessary in carrying out this by the board shall not be required to be adopted by regulation pursuant to the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Governmen t Code). 4208. Intern Pharmacist License (a) At the discretion of the board, an intern pharmacist license may be issued for a period of: (1) One to six years to a person who is currently enrolled in a school of pharmacy recognized by the board. (2) Two years to a person who is a graduate of a school of pharmacy recognized by the board and who has applied to become licensed as a pharmacist in California. (3) Two years to a foreign graduate who has met educational requirements described in para graphs (1) and (2) of subdivision (a) of Section 4200. (4) One year to a person who has failed the pharmacist licensure examination four times and has reenrolled in a school of pharmacy to satisfy the requirements of Section 4200.1. (b) The board may issue an intern pharmacist license to an individual for the period of time specified in a decision of reinstatement adopted by the board. (c) An intern pharmacist shall notify the board within 30 days of any change of address. (d) An intern pharmaci st whose license has been issued pursuant to paragraph (1) or (4) of subdivision (a) shall return his or her license, by registered mail, within 30 days of no longer being enrolled in a school of pharmacy. The intern pharmacist license shall be canceled by the board. Notwithstanding subdivision (c), an intern pharmacist license may be reinstated if the student reenrolls in a school of pharmacy recognized by the board to fulfill the education requirements of paragraphs (1) to (4), inclusive, of subdivision ( a) of Section 4200. (e) A person who has not completed the experience requirements necessary to be eligible for the licensure examination may have his or her intern license extended for a period of up to two years at the discretion of the board if he or 156

157 she is able to demonstrate his or her inability to exercise the privileges of the intern license during the initial license period. 4209. Intern Pharmacist; Minimum Hours of Practice to Apply for Pharmacist Exam (a) (1) mplete 1,500 hours of pharmacy practice An intern pharmacist shall co experience before applying for the pharmacist licensure examination. (2) This pharmacy practice experience shall comply with the Standards of Curriculum established by the Accreditation Council for Pharmacy Educati on (ACPE) or with regulations adopted by the board. This pharmacy practice experience shall include 900 hours of pharmacy (3) practice experience in a pharmacy as a pharmacist and shall include pharmacy practice experience in both a community and institu tional pharmacy practice setting. (b) An intern pharmacist shall submit proof of his or her pharmacy practice experience on board approved affidavits, or another form specified by the - board, which shall be certified under penalty of perjury by a pharmaci st under whose supervision the experience was obtained or by the pharmacist - in - charge at the pharmacy while the pharmacist intern obtained the experience. Pharmacy practice experience earned in another state may be certified by the licensing agency of that state to document proof of those hours. An applicant for the examination who has been licensed as a pharmacist in (c) any state for at least one year, as certified by the licensing agency of that state, may submit this certification to satisfy the requi red 1,500 hours of pharmacy practice experience, provided that the applicant has obtained a minimum of 900 hours of pharmacy practice experience in a pharmacy as a pharmacist and has pharmacy practice experience in both a community and institutional pharma cy practice setting. Certification of an applicant’s licensure in another state shall be submitted in writing and signed, under oath, by a duly authorized official of the state in which the license is held. (d) An applicant for the examination who has gr aduated after January 1, 2016, from an ACPE accredited college of pharmacy or school of pharmacy recognized by the board shall be deemed to have satisfied the pharmacy practice experience requirements specified in subdivisions (a) and (b). s. 2015, Ch. 147, Sec. 1. Effective January 1, 2016.) (Amended by Stat 4210. Advanced Practice Pharmacist License (a) A person who seeks recognition as an advanced practice pharmacist shall meet all of the following requirements: (1) Hold an active license to practice pharmacy issued pursuant to this chapter that is in good standing. (2) Satisfy any two of the following criteria: (A) Earn certification in a relevant area of practice, including, but not limited to, ambulatory care, critical care, geriatric pharmacy, nuclear pharmacy, nutrition support pharmacy, oncology pharmacy, pediatric pharmacy, pharmacotherapy, or psychiatric pharmacy, from an organization recognized by 157

158 the Accreditation Council for Pharmacy Education or another entity recognized by the board. Complete a postgraduate residency through an accredited postgraduate (B) institution where at least 50 percent of the experience includes the provision of direct patient care services with interdisciplinary teams. Have provided clinical services to patients for at least one year under a (C) collaborative practice agreement or protocol with a physician, advanced practice pharmacist, pharmacist practicing collaborative drug therapy management, or health system. (3) File an application with the board for recognition as an advanced practice pharmacist. (4) Pay the applicable fee to the board. (b) An advanced practice pharmacist recognition issued pursuant to this section shall be valid for two years, coterminous with the certificate holder’s license to practice pharmacy. (c) The board shall adopt regulations establishing the means of documenting completion of the requirements in this section. (d) The board shall, by regulation, set the fee for the issuance and renewal of advanced practice pharmacist recognition at the reasonable cost of regulating advanced practice pharmacists pursuant to this chapter. The fee shall not exceed three hundred dollars ($300). Article 17. Continuing Education Requirements for Renewal of Pharmacist License: Clock 4231. Hours; Exemption for New Licensee (a) The board shall not renew a pharmacist license unless the applicant submits proof satisfactory to the board that he or she has successfully completed 30 hours of approved courses of continuing pharmacy education d uring the two years preceding the application for renewal. (b) Notwithstanding subdivision (a), the board shall not require completion of continuing education for the first renewal of a pharmacist license. (c) If an applicant for renewal of a pharmac ist license submits the renewal application and payment of the renewal fee but does not submit proof satisfactory to the board that the licensee has completed 30 hours of continuing pharmacy education, the board shall not renew the license and shall issue the applicant an inactive pharmacist license. A licensee with an inactive pharmacist license issued pursuant to this section may obtain an active pharmacist license by paying the renewal fees due and submitting satisfactory proof to the board that the lice nsee has completed 30 hours of continuing pharmacy education. (d) If, as part of an investigation or audit conducted by the board, a pharmacist fails to provide documentation substantiating the completion of continuing education as required in subdivisi on (a), the board shall cancel the active pharmacist license and issue an inactive pharmacist license in its place. A licensee with an inactive pharmacist license issued pursuant to this section may obtain an active pharmacist license by paying the renewal fees due and 158

159 submitting satisfactory proof to the board that the licensee has completed 30 hours of continuing pharmacy education. 4232. Content of Courses (a) The courses shall be in the form of postgraduate studies, institutes, nferences, workshops, extension studies, correspondence seminars, lectures, co courses, and other similar methods of conveying continuing professional pharmacy education. (b) The subject matter shall be pertinent to the socioeconomic and legal ties and actions of drugs and dosage forms and aspects of health care, the proper the etiology, and characteristics and therapeutics of the disease state. (c) The subject matter of the courses may include, but shall not be limited to, the following: pharmacology, biochemistry, physiology, pharmaceutical chemistry, pharmacy administration, pharmacy jurisprudence, public health and communicable diseases, professional practice management, anatomy, histology, and any other subject matter as represented in curricula of accredited colleges of pha rmacy. 4233. Advanced Practice Pharmacist; Continuing Education Requirement A pharmacist who is recognized as an advanced practice pharmacist shall complete 10 hours of continuing education renewal cycle in addition to each the more or requirements of Section 4 231. The subject matter shall be in one the of practice relevant to areas pharmacist’s clinical practice. 4234. Exceptions: Emergencies; Hardship The board may, in accordance with the intent of this article, make exceptions s of this article in emergency or hardship cases. from the requirement Article 18. Poisons 4240. California Hazardous Substances Act; Application of Act (a) The California Hazardous Substances Act, Chapter 4 (commencing with Section 108100) of Part 3 of Division 104 of t he Health and Safety Code, applies to pharmacies and pharmacists and any other person or place subject to the jurisdiction of the board. (b) The board may enforce that act when necessary for the protection of the health and safety of the public if prior regulatory notice is given in accordance with the rulemaking provisions of the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code). Board enforcement shall focus on those haza rdous substances that relate significantly to or overlap the practice of pharmacy. (c) "Poison" as used in this chapter refers to a category of hazardous substances defined in Section 108125 of the Health and Safety Code. The e the category more specific. board may by regulation mak 159

160 Article 19. Disciplinary Proceedings 4300. Revocation and Suspension: Authority; Conditions; Issuance of Probationary License; Application of Administrative Procedure Act; Judicial Review (a) Every license issued may be suspended or revoked. (b) The board shall discipline the holder of any license issued by the board, whose default has been entered or whose case has been heard by the board and found guilty, by any of the following methods: (1) Suspending judgment. (2) Placing him or her upon probation. (3) Suspending his or her right to practice for a period not exceeding one year. (4) Revoking his or her license. (5) Taking any other action in relation to disciplining him or her as the board in its discretion may de em proper. (c) The board may refuse a license to any applicant guilty of unprofessional conduct. The board may, in its sole discretion, issue a probationary license to any applicant for a license who is guilty of unprofessional conduct and who has met a ll other requirements for licensure. The board may issue the license subject to any terms or conditions not contrary to public policy, including, but not limited to, the following: (1) Medical or psychiatric evaluation. (2) Continuing medical or psychia tric treatment. (3) Restriction of type or circumstances of practice. (4) Continuing participation in a board - approved rehabilitation program. (5) Abstention from the use of alcohol or drugs. (6) Random fluid testing for alcohol or drugs. (7) Complian ce with laws and regulations governing the practice of pharmacy. (d) The board may initiate disciplinary proceedings to revoke or suspend any probationary certificate of licensure for any violation of the terms and conditions of probation. Upon satisfact ory completion of probation, the board shall convert the probationary certificate to a regular certificate, free of conditions. (e) The proceedings under this article shall be conducted in accordance with Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of the Government Code, and the board shall have all the powers granted therein. The action shall be final, except that the propriety of the action is subject to review by the superior court pursuant to Section 1094.5 of the Code of Civil Procedure. 4300.1. Board Authority to Render a Decision on a License The expiration, cancellation, forfeiture, or suspension of a board - issued license by operation of law or by order or decision of the board or a court of law, the placement of a licen se on a retired status, or the voluntary surrender of a license by a licensee shall not deprive the board of jurisdiction to commence or proceed with any investigation of, or action or disciplinary proceeding uspending or revoking the license. against, the licensee or to render a decision s 160

161 4301. Obtaining License by Fraud or Misrepresentation ; Unprofessional Conduct The board shall take action against any holder of a license who is guilty of take. unprofessional conduct or whose license has been issued by mis Unprofessional conduct shall include, but is not limited to, any of the following: (a) Procurement of a license by fraud or misrepresentation. (b) Incompetence. (c) Gross negligence. (d) The clearly excessive furnishing of controlled substances in vi olation of subdivision (a) of Section 11153 of the Health and Safety Code. (e) The clearly excessive furnishing of controlled substances in violation of subdivision (a) of Section 11153.5 of the Health and Safety Code. Factors to be considered in determini ng whether the furnishing of controlled substances is clearly excessive shall include, but not be limited to, the amount of controlled substances furnished, the previous ordering pattern of the customer (including size and frequency of orders), the type an d size of the customer, and where and to whom the customer distributes its product. (f) The commission of any act involving moral turpitude, dishonesty, fraud, deceit, or corruption, whether the act is committed in the course of relations as otherwise, and whether the act is a felony or misdemeanor or not. a licensee or (g) Knowingly making or signing any certificate or other document that falsely represents the existence or nonexistence of a state of facts. (h) The administering to oneself, of any controll ed substance, or the use of any dangerous drug or of alcoholic beverages to the extent or in a manner as to be dangerous or injurious to oneself, to a person holding a license under this chapter, or to any other person or to the public, or to the extent th at the use impairs the ability of the person to conduct with safety to the public the practice authorized by the license. (i) Except as otherwise authorized by law, knowingly selling, furnishing, giving give away, or administer, away, or administering, or offering to sell, furnish, any controlled substance to an addict. (j) The violation of any of the statutes of this state, of any other state, or of the United States regulating controlled substances and dangerous drugs. (k) The conviction of more than one misdemeanor or any felony involving the administration of any dangerous drug or alcoholic use, consumption, or self - beverage, or any combination of those substances. (l) The conviction of a crime substantially related to the qualifications, functions, and duties of a licensee under this chapter. The record of conviction of a violation of Chapter 13 (commencing with Section 801) of Title 21 of the United States Code regulating controlled substances or of a violation of the statutes of this state regulating c ontrolled substances or dangerous drugs shall be conclusive evidence of unprofessional conduct. In all other cases, the record of conviction shall be conclusive evidence only of the fact that the conviction occurred. The board may inquire into the circumst ances surrounding the commission of the crime, in order to fix the degree of discipline or, in the case 161

162 of a conviction not involving controlled substances or dangerous drugs, to determine if the conviction is of an offense substantially related to the qua lifications, functions, and duties of a licensee under this chapter. A plea or verdict of guilty or a conviction following a plea of nolo contendere is deemed to be a conviction within the meaning of this provision. The board may take action when the time for appeal has elapsed, or the judgment of conviction has been affirmed on appeal or when an order granting probation is made suspending the imposition of sentence, irrespective of a subsequent order under Section 1203.4 of the Penal Code allowing the pers on to withdraw his or her plea of guilty and to enter a plea of not guilty, or setting aside the verdict of guilty, or dismissing the accusation, information, or indictment. (m) The cash compromise of a charge of violation of Chapter 13 (commencing ction 801) of Title 21 of the United States Code regulating controlled with Se substances or of Chapter 7 (commencing with Section 14000) of Part 3 of Division 9 of the Welfare and Institutions Code relating to the Medi - Cal program. (n) The revocation, suspension, or other discipline by another state of a license to practice pharmacy, operate a pharmacy, or do any other act for which a license is required by this chapter that would be grounds for revocation, suspension, or other discipline under this chapter. Any d isciplinary action taken by the board pursuant to this section shall be coterminous with action taken by another state, except that the term of any discipline taken by the board may exceed that of another state, consistent with the board’s enforcement elines. The evidence of discipline by another state is conclusive proof of guid unprofessional conduct. (o) Violating or attempting to violate, directly or indirectly, or assisting in or abetting the violation of or conspiring to violate any provision or term o f this chapter or of the applicable federal and state laws and regulations governing pharmacy, including regulations established by the board or by any other state or federal regulatory agency. (p) Actions or conduct that would have warranted denial of a l icense. (q) Engaging in any conduct that subverts or attempts to subvert an investigation of the board. (r) The selling, trading, transferring, or furnishing of drugs obtained pursuant to Section 256b of Title 42 of the United States Code to any person a l icensee knows or reasonably should have known, not to be a patient of a covered entity, as defined in paragraph (4) of subsection (a) of Section 256b of Title 42 of the United States Code. aler to a (s) The clearly excessive furnishing of dangerous drugs by a wholes pharmacy that primarily or solely dispenses prescription drugs to patients of long - term care facilities. Factors to be considered in determining whether the furnishing of dangerous drugs is clearly excessive shall include, but not be limited to, the amount of dangerous drugs furnished to a pharmacy that term care - primarily or solely dispenses prescription drugs to patients of long facilities, the previous ordering pattern of the pharmacy, and the general patient population to whom the pharmacy dis tributes the dangerous drugs. That a wholesaler has established, and employs, a tracking system that complies with 162

163 the requirements of subdivision (b) of Section 4164 shall be considered in determining whether there has been a violation of this subdivision . This provision shall not be interpreted to require a wholesaler to obtain personal medical information or be authorized to permit a wholesaler to have access to personal medical information except as otherwise authorized by Section 56 and following of th e Civil Code. For purposes of this section, “lon g - term care facility” has the same meaning given the term in Section 1418 of the Health and Safety Code. (t) The acquisition of a nonprescription diabetes test device from a person that the licensee knew or s hould have known was not the nonprescription diabetes cturer’s authorized distributor as test device’s manufacturer or the manufa identified in Section 4160.5. (u) The submission of a reimbursement claim for a nonprescription diabetes test aceutical benefit manager, health insurer, government agency, device to a pharm or other third - party payor when the licensee knew or reasonably should have known that the diabetes test device was not purchased either directly from the manufacturer or from the nonprescriptio n diabetes test device manufacturer’s authorized distributors as identified in Section 4160.5. Greatest Threat of Patient Harm 4301.1. Investigation Priority – In order to ensure that the board’s resources are maximized for the protection of the public health and safety, the board shall prioritize its investigative and prosecutorial resources to ensure that pharmacists representing the greatest threat of patient harm are identified and disciplined expeditiously. 4301.5. Pharmacist License; Out - of - Stat e Suspension or Revocation to Apply to California License (a) If a pharmacist possesses a license or is otherwise authorized to practice pharmacy in any other state or by an agency of the federal government, and that license or authority is suspended or r evoked, the pharmacist's license shall be suspended automatically for the duration of the suspension or revocation, unless terminated or rescinded as provided in subdivision (c). The board shall notify the pharmacist of the license suspension and of his or her right to have the issue of penalty heard as provided in this section. (b) Upon its own motion or for good cause shown, the board may decline to impose or may set aside the suspension when it appears to be in the interest of justice to do so, with due regard to maintaining the integrity of and confidence in the pharmacy profession. (c) The issue of penalty shall be heard by an administrative law judge sitting alone, by a committee of the board sitting with an administrative law judge, or sitting with an administrative law judge, at the board's discretion. by the board A pharmacist may request a hearing on the penalty and that hearing shall be held within 90 days from the date of the request. If the order suspending or revoking the pharmacist's license or authority to practice pharmacy is overturned on appeal, any discipline ordered pursuant to this section shall automatically cease. Upon the showing to the administrative law judge, board, 163

164 - of - state action is not a or committee of the board by the pharmacist that the out basis for discipline in California, the suspension shall be rescinded. If an accusation for permanent discipline is not filed within 90 days of the suspension imposed pursuant to this section, the suspension shall automatically terminate. (d) The record of the proceedings that resulted in the suspension or revocation of the pharmacist's license or authority to practice pharmacy, including a transcript of the testimony therein, may be received in evidence. been issued pursuant to this section, the (e) If a summary suspension has pharmacist may request that the hearing on the penalty conducted pursuant to subdivision (c) be held at the same time as a hearing on the accusation. 4302. Discipline of Corporate Licensee for Conduct of Officer, Director, Shareholder The board may deny, suspend, or revoke any license where conditions exist in relation to any person holding 10 percent or more of the ownership interest , or where conditions e xist in relation to any officer, director, or other pers on with management or control of the license that would constitute grounds for disciplinary action against a licensee. 4303. Nonresident Pharmacy: Grounds for Discipline The board may report any violation by a nonresident pharmacy of the laws (a) and r egulations of this state, any other state, or of the United States, including, but not limited to, any violation of this chapter or of the regulations established by the board, to any appropriate state or federal regulatory or licensing agency, including, but not limited to, the regulatory or licensing agency of the state in which the nonresident pharmacy is a resident or in which the pharmacist is licensed. (b) The board may cancel, deny, revoke, or suspend a nonresident pharmacy registration, issue a ci tation or letter of admonishment to a nonresident pharmacy, or take any other action against a nonresident pharmacy that the board may take against a resident pharmacy license, on any of the same dent pharmacy, grounds upon which such action might be taken against a resi provided that the grounds for the action are also grounds for action in the state in which the nonresident pharmacy is permanently located. (c) If the home state pharmacy license of a nonresident pharmacy is canceled, revoked, or suspended for any reason, any license issued pursuant to Section 4112 or 4127.2 shall be immediately canceled, revoked, or suspended by operation of law. – 4303.1. Outsourcing Facility License Canceled, Revoked or Suspended by Operation of Law od and Drug Administration (FDA) cancels, revokes, or If the federal Fo suspends an outsourcing facility’s registration for any reason, any license issued pursuant to Section 4129.2 shall be immediately canceled, revoked, or suspended by operation of law. 164

165 t Wholesaler; Authority to Discipline 4304. Nonresiden The board may deny, revoke, or suspend any license issued pursuant to Section 4161 for any violation of this chapter or for any violation of Part 5 (commencing with Section 109875) of Division 104 of the Health and S afety Code. 4305. Disciplinary Grounds: Failure of Pharmacy or Pharmacist to Notify Board of Termination of Pharmacist in - Charge; Continuing - to Operate Without Pharmacist has Failure by any pharmacist to notify the board in writing that he or she (a) in - charge of a pharmacy, or by any pharmacy to ceased to act as the pharmacist - - - charge is no longer acting in notify the board in writing that a pharmacist in - that capacity, within the 30 day period specified in Sections 4101 and 4113 shall constitute groun ds for disciplinary action. (b) Operation of a pharmacy for more than 30 days without supervision or management by a pharmacist - - charge shall constitute grounds for disciplinary in action. Any person who has obtained a license to conduct a pharmacy, who (c) timely that the pharmacist - in - charge of the willfully fails to notify the board and who continues to permit the pharmacy has ceased to act in that capacity, compounding or dispensing of prescriptions, or the furnishing of drugs or poisons, in his or subject to the her pharmacy, except by a pharmacist - charge, shall - supervision and management of a responsible pharmacist be in subject to summary suspension or revocation of his or her license to conduct a pharmacy . , Disciplinary Grounds: Failu - Veterinary Food 4305.5. re of Wholesaler Animal Drug Retailer or Third Party Logistics Provider to Notify - - in Board of Termination of Designated Representative Charge or - Responsible Manager ; Continuing to Operate Without Designated Representative - in - Charge or Resp onsible Manager A person that is licensed as a wholesaler, third - party logistics provider, or (a) veterinary food - animal drug retailer, shall notify the board within 30 days of the termination of employment of the designated representative - in - charge or r esponsible manager. Failure to notify the board within the 30 - day period shall constitute grounds for disciplinary action. A person that is licensed as a wholesaler, third - party logistics provider, or (b) - animal drug retailer, that willfu lly fails to notify the board of veterinary food - in - charge or the termination of employment of the designated representative responsible manager at its licensed place of business, and that continues to operate the place of business in the absence of the designated represe ntative - in - charge or responsible manager for that place of business shall be subject to summary suspension or revocation of its license as a wholesaler, third - party logistics provider, or veterinary food - animal drug retailer at that place of business. - (c ) A designated representative - in - charge of a wholesaler or veterinary food - animal drug retailer, or a responsible manager of a third party logistics 165

166 provider, who terminates his or her employment at the licensed place of business, shall notify the board wi thin 30 days of the termination of employment. Failure to notify the board within the 30 - day period shall constitute grounds for disciplinary action. 4306. Violation of Professional Corporation Act as Unprofessional Conduct It shall constitute unprofe ssional conduct and a violation of this chapter for any person licensed under this chapter to violate, attempt to violate, directly or indirectly, or assist in or abet the violation of, or conspire to violate, any - Knox Professional Corporation provision or term of this article, the Mos cone Act, or any regulations duly adopted under those laws. 4306.5. Acts or Omissions by Pharmacist: Unprofessional Conduct Unprofessional conduct for a pharmacist may include any of the following: (a) Acts or omissions that involve, in whole or in part, the inappropriate exercise of his or her education, training, or experience as a pharmacist, whether or not the act or omission arises in the course of the practice of , or operation of a pharmacy or the ownership, management, administration pharmacy or other entity licensed by the board. (b) Acts or omissions that involve, in whole or in part, the failure to exercise or implement his or her best professional judgment or corresponding responsibility with regard to the dis pensing or furnishing of controlled substances, dangerous drugs, or dangerous devices, or with regard to the provision of services. (c) Acts or omissions that involve, in whole or in part, the failure to consult er records pertaining to the appropriate patient, prescription, and oth performance of any pharmacy function. (d) Acts or omissions that involve, in whole or in part, the failure to fully - specific information pertaining to the maintain and retain appropriate patient nction. performance of any pharmacy fu 4306.6. Mitigating Factors for Pharmacist - in - Charge Reporting Violations of Others charge for the violation of a state or If the board disciplines a pharmacist - in - federal law or regulation committed by another person and the pharmacist - in - ge reported to the board that violation or suspected violation, the board char shall use the report as a mitigating factor if all of the following conditions are met: - (a) The pharmacist - in charge did not engage, either directly or indirectly, in any conduct t hat violated any state or federal law or regulation pertaining to the practice of pharmacy. charge did not permit, encourage, approve of, either (b) The pharmacist - in - tacitly or implicitly or through willful ignorance, any conduct committed by rson that violated state or federal law or regulation pertaining to the another pe practice of pharmacy. 166

167 (c) The pharmacist - in - charge reported the violation, or suspected violation, of any state or federal law or regulation pertaining to the practice of pharmacy to the board as soon as reasonably possible following the discovery of the violation. (d) The pharmacist - in - charge took all actions reasonably necessary to stop and remedy the violation, or suspected violation, of any state or federal law or taining to the practice of pharmacy as soon as reasonably possible regulation per following the discovery of the violation. 4307. Individuals with Denied, Revoked, Suspended, etc. Licenses Prohibited From Pharmacy Ownership or Association with Board Licensed Entities (a) Any person who has been denied a license or whose license has been revoked or is under suspension, or who has failed to renew his or her license while it was under suspension, or who has been a manager, administrator, owner, member, officer, director, associate, partner, or any other person with firm, or management or control of any partnership, corporation, trust, association whose application for a license has been denied or revoked, is under g as the manager, suspension or has been placed on probation, and while actin partner, or any other administrator, owner, member, officer, director, associate, person with management or control had knowledge of or knowingly participated in any conduct for which the license was denied, revoked, suspended, or placed on probation, shall be prohibited from serving as a manager, administrator, owner, member, officer, director, associate, partner, or in any other position with management or control of a licensee as follows: (1) Where a probationary license is issued or w here an existing license is placed on probation, this prohibition shall remain in effect for a period not to exceed five years. (2) Where the license is denied or revoked, the prohibition shall continue until the license is issued or reinstated. ager, administrator, owner, member, officer, director, associate, (b) "Man as used partner, or any other person with management or control of a license” in this section and Section 4308, may refer to a pharmacist or to any other person who serves in such capacity i n or for a licensee. (c) The provisions of subdivision (a) may be alleged in any pleading filed pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of the Government Code. However, no order may be issued in that case except as t o a person who is named in the caption, as to whom the pleading alleges the applicability of this section, and where the person has been given notice of the proceeding as required by Chapter 5 (commencing with Section 11500) of Part Government Code. The authority to proceed as provided 1 of Division 3 of the by this subdivision shall be in addition to the board's authority to proceed under Section 4339 or any other provision of law. 167

168 4308. Prohibited Association: Notification of Affected Licensees Known to Board Whenever a person is prohibited from serving as a manager, administrator, owner, member, officer, director, associate, partner, or in any other position of management or control of a licensee as provided by Section 4307, the board shall, in eac h case where it has that information, notify in writing each licensee for whom the person is a manager, administrator, owner, member, officer, director, associate, partner, or in any other position with management or control hall send the notification to the licensee's address of the prohibition. The board s of record. The licensee shall have 30 days from the date that the notice is sent to remove and replace the prohibited person and, where appropriate, file a change of permit to reflect that change. 4309 . Petition for Reinstatement, etc. of Disciplined License: Time for Filing; Contents; Investigation; Hearing; Factors to be Considered; Effect of Ongoing Criminal Sentence, Accusation, or Petition to Revoke Probation (a) A person whose license has been r evoked or suspended or who has been placed on probation may petition the board for reinstatement or modification of penalty, including modification or termination of probation, after not less than the following minimum periods have elapsed from the effecti ve date of the decision ordering disciplinary action: (1) At least three years for reinstatement of a revoked license. (2) At least two years for early termination of probation of three years or more. (3) At least one year for modification of a conditio n, or reinstatement of a license revoked for mental or physical illness, or termination of probation of less than three years. (b) The petition shall state any facts required by the board, and the petition shall be accompanied by two or more verified reco mmendations from holders of licenses issued by the board to which the petition is addressed, and two or more recommendations from citizens, each having personal knowledge of the disciplinary penalty imposed by the board and the activities of the petitioner since the disciplinary penalty was imposed. (c) The petition may be heard by the board sitting with an administrative law judge, or a committee of the board sitting with an administrative law judge, or ve law judge. Where the the board may assign the petition to an administrati petition is heard by a committee of the board sitting with an administrative law judge or by an administrative law judge sitting alone, the decision shall be subject to review by the board pursuant to Section 11517 of the Governmen t Code. (d) In considering reinstatement or modification of penalty, the board, committee of the board, or the administrative law judge hearing the petition may consider factors including, but not limited to, all of the following: (1) All the activities of the petitioner since the disciplinary action was taken. (2) The offense for which the petitioner was disciplined. (3) The petitioner's activities during the time the license was in good standing. 168

169 (4) The petitioner's documented rehabilitative efforts . (5) The petitioner's general reputation for truth and professional ability. (e) The hearing may be continued from time to time as the board, committee of the board, or the administrative law judge designated in Section 11371 of the s necessary. Government Code find (f) The board, committee of the board, or administrative law judge may impose necessary terms and conditions on the licensee in reinstating the license. (g) No petition under this section shall be considered while the petitioner is under sen tence for any criminal offense, including any period during which the petitioner is on court imposed probation or parole. No petition shall be - considered while there is an accusation or petition to revoke probati on pending against the person. The board ma y deny without a hearing or argument any petition filed pursuant to this section within a period of two years from the effective date of the prior decision following a hearing under this section. (h) Nothing in this section shall be deemed to amend or oth erwise change the effect or application of Sections 822 and 823. (i) The board may investigate any and all matters pertaining to the petition and documents submitted with or in connection with the application. 4310. tion for Licensure; Application Notice of Denial of Application: Peti of Administrative Procedure Act Immediately upon the denial of any application for a license the board shall notify the applicant in writing. Within 10 days after the board mails the notice, her written petition for a license to the board. the applicant may present his or Upon receipt by the board of the written petition, proceedings shall be conducted in accordance with Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code. 43 11. Suspension of License for Felony Conviction: Automatic Suspension; Summary Suspension; Other Suspensions; Applicable Proceedings (a) Any license issued by the board, or the holder thereof, shall be suspended automatically during any time that the per son is incarcerated after conviction of a felony, regardless of whether the conviction has been appealed. The board, immediately upon receipt of a certified copy of a record of a criminal conviction, shall determine whether the person has been automatical ly suspended by virtue of incarceration pursuant to a felony conviction and, if so, the duration of that suspension. The board shall notify the person so suspended of the suspension and that the person has a right to request a hearing, solely as to whether he or she is incarcerated pursuant to a felony conviction, in writing at that person's address of record with the board and at the facility in which the person is incarcerated. (b) In addition to any suspension under subdivision (a), the board shall summ arily suspend any license issued by the board where a conviction of the holder of the license meets the requirements of paragraphs (1) and (2). (1) A felony that was either of the following: 169

170 (A) Committed in the course of a business or practice for which the board issues a license. (B) Committed in a manner that a client, customer, or patient of the licensee was a victim. (2) Where an element of the offense involves either of the following: (A) The specific intent to deceive, defraud, steal, or make a false statement. (B) The illegal sale or possession for sale of or trafficking in any controlled substance. (3) The suspension shall continue until the time for appeal has elapsed, if no appeal is taken, or until the judgment of conviction has been affir med on appeal or has otherwise become final, and until further order of the board. (4) The board shall immediately send notice in writing of the suspension to the licensee, or the holder of any other board - issued license, at his or her address of record and, if incarcerated at the time, at the facility in which the person is incarcerated. The notice shall include notification of that person's right to elect to have the issue of penalty heard as provided in paragraph (2) of subdivision (d), and of the rig ht to request a hearing to contest the summary suspension. Any request for a hearing under this paragraph must be received by the board within 15 days following receipt of the notice provided for by this paragraph. inistrative law judge, a committee of (5) The hearing shall be before an adm the board sitting with an administrative law judge, or the board sitting with an administrative law judge, at the board's discretion, and shall be subject to e limited to (A) review by the board, at its discretion. The hearing shall b whether there has been a felony conviction as stated in the board's notice, and (B) whether the conviction meets the criteria of this subdivision, except where the licensee chooses to proceed as provided by paragraph (2) of subdivision (d) , or where the board has also filed and served an accusation as provided in Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code and given notice of the hearing as required by that accusation under Chapter 5 (commencing with chapter; provided that if an Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code is also to be heard, only an administrative law judge sitting alone or the board, sitting with an administrative law judge, may hear the c ase. (c) In addition to any suspension under subdivision (a), the board shall also suspend any license issued by the board, or the holder thereof, if the board determines that the felony conviction of the holder of the license is substantially related to the qualifications, functions, or duties of the licensee. (1) Notice of the board's determination shall be sent to the licensee, or the holder thereof, at that person's address of record with the board and, if the person is incarcerated at the time, the facility in which the person is incarcerated. The notice shall advise the person that the license shall be suspended without hearing unless, within 15 days following receipt of the notice, a written request for hearing is delivered to the board. (2) Up on receipt of a timely request for hearing, a notice of hearing shall be sent to the person at least 10 days before the date scheduled for the hearing. The notice of hearing shall include notification of that person's right to elect to have the issue of p enalty heard as provided in paragraph (2) of subdivision (d). 170

171 (3) The hearing to determine whether a felony conviction is substantially related for purposes of an interim suspension under this subdivision shall be separate from any hearing on an accusati on under the Administrative Procedure Act, except where the licensee elects to proceed under paragraph (2) of subdivision (d), or where the board has filed and served an accusation as provided by Chapter 5 (commencing with Section 11500) of Part 1 of Divis ion 3 of Title 2 of the Government Code and given notice of hearing as required by that chapter. The hearing on whether the felony conviction is substantially related shall be heard either by an administrative law judge sitting alone, by a committee of th e board sitting with an administrative law judge, or by the board sitting with an administrative law judge, at the board's discretion, and shall be subject to review by the board, at its discretion. However, if an accusation th Section 11500) of Part 1 of Division 3 of under Chapter 5 (commencing wi Title 2 of the Government Code is also to be heard, only an administrative law judge sitting alone or the board, sitting with an administrative law judge, may hear the case. Except where a person proceeds under paragraph (2) of subdivision (d), or the board proceeds with an accusation at the same time, any suspension imposed under this subdivision shall continue until an accusation is filed under Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code and a final decision is rendered by the board. (4) A conviction of any crime referred to in Section 4301, or for violation of Section 187, 261, or 288 of the Penal Code, shall be conclusively presumed to be substantially related to the qualifications, functions, or duties of a licensee of the board. Upon its own motion or for good cause shown the board may decline to impose a suspension under this subdivision or may set aside a suspension previously imposed when it appear s to be in the interest of justice to do so, with due regard to maintaining the integrity of and confidence in the practice of pharmacy and the handling of dangerous drugs and devices. (d) (1) Discipline may be ordered in accordance with Section 4300 or an application denied when the time for appeal has elapsed, the judgment of conviction has been affirmed on appeal, or an order granting probation is made suspending the imposition of sentence, irrespective of a subsequent order under Penal Code allowing the person to withdraw his or her Section 1203.4 of the plea of guilty and to enter a plea of not guilty, setting aside the verdict of guilty, or dismissing the accusation, complaint, information, or indictment. an administrative law judge sitting (2) The issue of penalty shall be heard by alone or with a committee of the board or with the board itself, at the board's discretion, and any decision shall be subject to review by the board, at its discretion. The hearing shall not be held until the judgment o f conviction has become final or, irrespective of a subsequent order under Section 1203.4 of the Penal Code, an order granting probation has been made suspending the imposition of sentence, provided that a licensee may, at his or her option, elect the issue of penalty decided before those time periods have elapsed. to have Where the licensee so elects, the issue of penalty shall be heard in the manner described in this section at the hearing to determine whether the conviction was the qualifications, functions, or duties of the licensee. If substantially related to 171

172 the conviction of a licensee who has made this election is overturned on appeal, any discipline ordered pursuant to this section shall automatically cease. Nothing in this subdivision shall proh ibit the board from pursuing disciplinary action based on any cause, including the facts underlying the conviction, other than the overturned conviction. (3) The record of the proceedings resulting in the criminal conviction, including a transcript of an y testimony taken in connection with the proceeding, may be received in evidence in any administrative proceeding to the extent the testimony would otherwise be admissible under Chapter 5 (commencing with f the Government Code. A Section 11500) of Part 1 of Division 3 of Title 2 o certified copy of the criminal conviction shall be conclusive proof of the fact of the conviction. (e) Other provisions of this chapter setting forth procedures for the suspension or revocation of a license issued by the board s hall not apply to proceedings conducted pursuant to this section, except as specifically provided in this section. (f) For purposes of this section, a crime is a felony if it is specifically declared to be so or is made a felony by subdivision (a) of Sec tion 17 of the Penal Code, unless it is charged as a misdemeanor pursuant to paragraph (4) or (5) of subdivision (b) of Section 17 of the Penal Code, irrespective of whether in a particular case the crime may be considered a misdemeanor as a result of post conviction proceedings. For purposes of this section, a felony also includes a conviction under federal law, or the law of any other state of the United States, of the District of Columbia, or of any territory or possession of the tion includes a plea or verdict of guilty or a conviction United States. A convic following a plea of nolo contendere. (g) The board may delegate the authority to issue a suspension under subdivision (a) or (b) or a notice of suspension under subdivision (c) to the executive of ficer of the board. 4312. Voiding License of Entity Remaining Closed: Notice; Disposition of Stock; Distribution of Proceeds Where Board Sells Stock - party logistics (a) The board may cancel the license of a wholesaler, third ary food - animal drug retailer , or outsourcing provider, pharmacy, veterin if the licensed premises remain closed, as defined in subdivision (e), facility other than by order of the board. For good cause shown, the board may cancel a license after a shorter period of closure. To cance l a license pursuant to this subdivision, the board shall make a diligent, good faith effort to give notice by personal service on the licensee. If a written objection is not received within 10 days after personal service is made or a diligent, good faith effort to give notice by personal service on the licensee has failed, the board may cancel the license without the necessity of a hearing. If the licensee files a written objection, the board shall file an accusation based on the licensee remaining closed. Proceedings shall be conducted in accordance with Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code, and the board shall have all the powers granted in that chapter. 172

173 party logistics provider, pharmacy, If the license of a wholesaler, t hird - (b) veter inary food - animal drug retailer, or outsourcing facility is canceled pursuant to subdivision (a) or revoked pursuant to Article 19 (commencing with Section 4300), or a wholesaler, third , pharmacy, - party logistics provider animal drug retailer notifies the board - veterinary food , or outsourcing facility of its intent to remain closed or to discontinue business, the licensee shall, within 10 days thereafter, arrange for the transfer of all dangerous drugs and olled substances or dangerous devices to another licensee authorized to contr possess the dangerous drugs and controlled substances or dangerous devices. The licensee transferring the dangerous drugs and controlled substances or ly confirm in writing to the board that the dangerous devices shall immediate transfer has taken place. (c) If a wholesaler, third - party logistics provider, pharmacy, veterinary food - , or outsourcing facility fails to comply with subdivision animal drug retailer d obtain an order from the superior court in the (b), the board may seek an - county in which the wholesaler, third party logistics provider, pharmacy, inary food - animal drug retailer, or outsourcing facility veter is located, authorizing the board to enter the wholesaler, third - party logistics provider, animal drug retailer pharmacy, veterinary food and , or outsourcing facility - inventory and store, transfer, sell, or arrange for the sale of, all dangerous drugs - ird and controlled substances and dangerous devices found in the wholesaler, th - animal drug retailer , or party logistics provider, pharmacy, veterinary food . outsourcing facility (d) If the board sells or arranges for the sale of any dangerous drugs, controlled substances, or dangerous devices pursuant to subdivision (c), the bo ard may retain from the proceeds of the sale an amount equal to the cost to the board of obtaining and enforcing an order issued pursuant to subdivision (c), including the cost of disposing of the dangerous drugs, controlled substances, or dangerous device s. The remaining proceeds, if any, shall be returned to the licensee from whose premises the dangerous drugs or controlled substances or dangerous devices were removed. (1) The licensee shall be notified of his or her right to the remaining proceeds by p ersonal service or by certified mail, postage prepaid. (2) If a statute or regulation requires the licensee to file with the board his or her address, and any change of address, the notice required by this subdivision may be sent by certified mail, posta ge prepaid, to the latest address on file with the board and service of notice in this manner shall be deemed completed on the 10th day after the mailing. (3) If the licensee is notified as provided in this subdivision, and the licensee fails to contact the board for the remaining proceeds within 30 calendar days after personal service has been made or service by certified mail, postage prepaid, is deemed completed, the remaining proceeds shall be deposited by the board into the Pharmacy Board Contingent Fund. These deposits shall be deemed to have been received pursuant to Chapter 7 (commencing with Section 1500) of Title 10 of Part 3 of the Code of Civil Procedure and shall be subject to claim or other disposition as provided in that chapter. 173

174 (e) For t he purposes of this section, “closed” means not engaged in the ordinary activity for which a license has been issued for at least one day each - calendar week during any 120 day period. (f) Nothing in this section shall be construed as requiring a pharmacy to be open seven days a week. 4313. Evidence of Rehabilitation; Priority of Public Protection In determining whether to grant an application for licensure or whether to discipline or reinstate a license, the board shall give consideration to evidence of rehabilitation. However, public protection shall take priority over rehabilitation and, where evidence of rehabilitation and public protection are in conflict, public protection shall take precedence. 4314. Orders of Abatement (a) The board may iss ue citations containing fines and orders of abatement for any violation of Section 733, for any violation of this chapter or regulations adopted pursuant to this chapter, or for any violation of Division 116 nd Safety Code, in (commencing with Section 150200) of the Health a accordance with Sections 125.9, 148, and 4005 and the regulations adopted pursuant to those sections. (b) Where appropriate, a citation issued by the board, as specified in this section, may subject the person or entity to whom the cit ation is issued to an administrative fine. (c) Notwithstanding any other provision of law, where appropriate, a citation issued by the board may contain an order of abatement. The order of abatement shall fix a reasonable time for abatement of the violat ion. It may also require the person or entity to whom the citation is issued to demonstrate how future compliance with the Pharmacy Law, and the regulations adopted pursuant thereto, will be accomplished. A demonstration may include, but is not limited to , submission of a corrective action plan, and requiring completion of up to six hours of continuing education courses in the subject matter specified in the order of abatement. Any continuing education courses required by the order of addition to those required for license renewal. abatement shall be in (d) Nothing in this section shall in any way limit the board from issuing a citation, fine, and order of abatement pursuant to Section 4067 or Section 56.36 of the Civil Code, and the regulations adopted p ursuant to those sections. 4315. Letter of Admonishment (a) The executive officer, or his or her designee, may issue a letter of admonishment to a licensee for failure to comply with Section 733, for failure to comply with this chapter or regulations a dopted pursuant to this chapter, or for failure to comply with Division 116 (commencing with Section 150200) of the Health and Safety Code, directing the licensee to come into compliance. The executive officer, or his or her designee, may issue a let ter of (b) admonishment to an applicant for licensure who has committed any violation of law that the board deems, in its discretion, does not merit the denial of a license 174

175 or require probationary status under Section 4300. The letter of admonishment may be is sued concurrently with a license. (c) The letter of admonishment shall be in writing and shall describe in detail the nature and facts of the violation, including a reference to the statutes or regulations violated. (d) The letter of admonishment shall inform the licensee or applicant that within 30 days of service of the order of admonishment the licensee or applicant may do either of the following: (1) Submit a written request for an office conference to the executive officer of the board to contest the letter of admonishment. (A) Upon a timely request, the executive officer, or his or her designee, shall hold an office conference with the licensee or applicant or his or her legal counsel or authorized representative. Unless so authorized by the ex ecutive officer, or his or her designee, no individual other than the legal counsel or authorized representative of the licensee or applicant may accompany the licensee or applicant to the office conference. (B) Prior to or at the office conference, the licensee or applicant may submit to the executive officer declarations and documents pertinent to the subject matter of the letter of admonishment. The office conference is intended to be an informal proceeding and shall (C) not be subject to the Adminis trative Procedure Act (Chapter 3.5 (commencing with Section 11340), Chapter 4 (commencing with Section 11370), Chapter 4.5 (commencing with Section 11400), or Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Co de). (D) The executive officer, or his or her designee, may affirm, modify, or withdraw the letter of admonishment. Within 14 calendar days from the date of the office conference, the executive officer, or his or her designee, shall personally serve or s end the board’s written decision by certified mail to the licensee’s or applicant’s address of record. This decision shall be deemed the final administrative decision concerning the letter of admonishment. Judicial review of the decision may be had b (E) y filing a petition for a writ of mandate in accordance with the provisions of Section 1094.5 of the Code of Civil Procedure within 30 days of the date the decision was personally served or sent by certified mail. The judicial review shall extend to the qu estion of whether or not there was a prejudicial abuse of discretion in the issuance of the letter of admonishment. Comply with the letter of admonishment and, if required, submit a written (2) corrective action plan to the executive officer documenting compliance. If an office conference is not requested pursuant to this section, compliance with the letter of admonishment shall not constitute an admission of the violation noted in the letter of admonishment. ed upon the licensee or applicant The letter of admonishment shall be serv (e) personally or by certified mail at his or her address of record with the board. If the licensee or applicant is served by certified mail, service shall be effective upon deposit in the United States mail. 175

176 (f) The license e or applicant shall maintain and have readily available a copy of the letter of admonishment and corrective action plan, if any, for at least three years from the date of issuance of the letter of admonishment. Nothing in this section shall in any w ay limit the board’s authority or (g) ability to do either of the following: (1) Issue a citation pursuant to Section 125.9, 148, or 4067, or pursuant to Section 1775 of Title 16 of the California Code of Regulations. (2) Institute disciplinary proceedings pursuant to this article. (h) The issuance of a letter of admonishment pursuant to subdivision (b) shall not be construed as a disciplinary action or discipline for purposes of licensure or the reporting of discipline for licensure. Board Authori zed to 4316. Issue Cease and Desist Orders is authorized to issue a cease and , through its executive officer, (a) The board desist order for operating any facility under this chapter that requires licensure without obtaining that licensure. (b) Whenever the board issues a cease and desist order pursuant to subdivision (a), the board shall immediately issue the facility a notice setting forth the acts or omissions with which it is charged, specifying the pertinent code section or sections and any regulations. (c) The order shall provide that the facility, within 15 days of receipt of the notice, may request a hearing before the president of the board to contest the cease and desist order. Consideration of the facility’s contest of the cease and desist order s hall comply with the requirements of Section 11425.10 of the Government Code. The hearing shall be held no later than five days from the date the request of the owner is received by the board. The president shall render a written decision within five days of the hearing. In the absence of the president of the board, the vice president of the board may conduct the hearing permitted by this subdivision. Review of the decision of the president of the control of the board may be sought by the owner or person in possession or pursuant to Section 1094.5 of the Code of Civil Procedure. facility Article 20. Prohibitions and Offenses 4320. Penalties for Violation of Pharmacy Law: Actions Authorized; Who May File Actions (a) The penalties prescribed in this chap ter may be recovered in any court having jurisdiction, by a civil action instituted by the board in the name of the State of California, or by criminal prosecution upon complaint being made. (b) The district attorney of the county wherein violations of t his chapter occur shall conduct all felony prosecutions at the request of the board. The district attorney of the county or city attorney of the city wherein violations of this chapter occur shall conduct all other actions and prosecutions at the request of the board. 176

177 4321. Penalties: Misdemeanors; Infractions (a) Any person who knowingly violates any of the provisions of this chapter, when no other penalty is provided, is guilty of a misdemeanor, and upon conviction thereof shall be punished by a fi ne of not less than two hundred dollars ($200), and not more than two thousand dollars ($2,000), or by imprisonment of not less than 30 days nor exceeding six months, or by both that fine and imprisonment. tes any of the provisions of this (b) In all other instances, any person who viola chapter, when no other penalty is provided, is guilty of an infraction, and upon conviction thereof may be punished by a fine not to exceed one thousand dollars ($1,000). Misdemeanor or Infraction: False Representa 4322. tions to Secure License for Self or Others; False Representation of Licensure; Penalties Any person who attempts to secure or secures licensure for himself or herself or any other person under this chapter by making or causing to be made any false repres entations, or who fraudulently represents himself or herself to be registered, is guilty of a misdemeanor, and upon conviction thereof shall be punished by a fine not exceeding five thousand dollars ($5,000), or by imprisonment not exceeding 50 days, or by both that fine and imprisonment. 4323. Misdemeanor; False Representation of Self as a Physician, Agent of Physician, etc. to Obtain Drug Every person who, in order to obtain any drug, falsely represents himself or rson who can lawfully prescribe the drug, or herself to be a physician or other pe falsely represents that he or she is acting on behalf of a person who can lawfully prescribe the drug, in a telephone or electronic communication with a pharmacist, shall be punished by imprisonment in the count y jail for not more than one year. Felony or Misdemeanor: Forgery of Prescription; Possession of 4324. Drugs Obtained Through Forged Prescription (a) Every person who signs the name of another, or of a fictitious person, or falsely makes, alters, forge s, utters, publishes, passes, or attempts to pass, as genuine, any prescription for any drugs is guilty of forgery and upon conviction pursuant to subdivision (h) of thereof shall be punished by imprisonment nt in a Section 1170 of the Penal Code, or by imprisonme county jail for not more than one year. (b) Every person who has in his or her possession any drugs secured by a forged prescription shall be punished by imprisonment pursuant to subdivision (h) of Section 1170 of the Penal Code, or by imprisonme nt in the county jail for not more than one year. 4325. Misdemeanor: Manufacture, Possession, etc. of False Prescription Blank (a) No person other than a physician, dentist, podiatrist, veterinarian, pharmacist, or other person authorized by law to dis pense, administer, or 177

178 prescribe controlled substances, or the person's agent acting under authorization by the person to print prescription blanks, and acting in the regular practice of py, the person's profession, shall knowingly and willfully manufacture, co reproduce, or possess, or cause to be manufactured, copied, reproduced, or possessed, any prescription blank that purports to bear the name, address, and federal registry or other identifying information of a physician, dentist, podiatrist, veterinaria n, or other person authorized by law to dispense, administer, or prescribe controlled substances. (b) Every person who violates this section shall be guilty of a misdemeanor. 4326. Misdemeanor: Obtaining Needle or Syringe by Fraud, etc.; Unlawful Use o f Needle or Syringe Obtained from Another (a) Any person who obtains a hypodermic needle or hypodermic syringe by a false or fraudulent representation or design or by a forged or fictitious name, or contrary to, or in violation of, any of the provisions of this chapter, is guilty of a misdemeanor. (b) Any person who has obtained a hypodermic needle or hypodermic syringe from any person to whom a permit has been issued as provided in Article 9 (commencing with Section 4140) and who uses, or permits or ca uses, directly or indirectly, the hypodermic needle or hypodermic syringe to be used for any purpose other than that for which it was obtained is guilty of a misdemeanor and upon conviction thereof shall be punished by a fine not exceeding one lars ($1,000), or by imprisonment in a county jail not exceeding thousand dol one year, or both a fine and imprisonment. 4327. Misdemeanor: Sale, Dispensing, or Compounding While Under the Influence of Drugs or Alcoholic Beverages ls, dispenses or compounds any drug while Any person who, while on duty, sel under the influence of any dangerous drug or alcoholic beverages shall be guilty of a misdemeanor. 4328. Misdemeanor: Permitting Compounding, Dispensing, or Furnishing by Non - Pharmacist Except as otherwise prov ided in this chapter, any person who permits the compounding or dispensing of prescriptions, or the furnishing of dangerous drugs in his or her pharmacy, except by a pharmacist, is guilty of a misdemeanor. - Pharmacist Acting as Mana ger, Compounding, 4329. Misdemeanor: Non Dispensing or Furnishing Drugs Any non - pharmacist who takes charge of or acts as supervisor, manager , or pharmacist - in - charge of any pharmacy , or who compounds or dispenses a prescription or furnishes dangerous drugs except as otherwise provided in this is guilty of a misdemeanor. chapter , 178

179 4330. Misdemeanor: Non - Pharmacist Owner Failing to Place Pharmacist in Charge, Dispensing or Compounding Except by Pharmacist, Interfering with Pharmacist - in - Charge license to conduct a pharmacy, who fails to (a) Any person who has obtained a place in charge of the pharmacy a pharmacist, or any person, who by himself or herself, or by any other person, permits the compounding or dispensing of prescriptions, or the furnishing of dangerous drugs, in hi s or her pharmacy, except by a pharmacist, or as otherwise provided in this chapter, is guilty of a misdemeanor. owner who commits any act that would subvert or tend to (b) Any pharmacy subvert the efforts of the pharmacist in - charge to comply with the l aws - governing the operation of the pharmacy is guilty of a misdemeanor. 4331. Misdemeanor: Wholesaler, Veterinary Food - Animal Drug Retailer Failing to Place Pharmacist or Designated Representative in Charge, Permitting Dispensing or Compounding Except by Pharmacist or Designated Representative who takes charge of a A person not authorized under this chapter (a) - animal drug retailer or who dispenses a wholesaler or veterinary food prescription or furnishes dangerous devices, except as otherwise provided in this chapter, is guilty of a misdemeanor. (b) A person who is not a responsible manager or a designated representative - - party logistics provider or coordinates the 3PL who takes charge of a third warehousing or distribution of dangerous drugs or danger ous devices within a third - party logistics provider, except as otherwise provided in this chapter, is guilty of a misdemeanor. (c) A person licensed as a veterinary food - animal drug retailer that fails to place in charge of that veterinary food - animal dr ug retailer a pharmacist or designated representative, or any person who, by himself or herself, or by any other person, permits the dispensing of prescriptions, except by a pharmacist or designated representative, or as otherwise provided in this chapter, is guilty of a misdemeanor. (d) A person licensed as a wholesaler that fails to place in charge of that wholesaler a pharmacist or designated representative, or any person who, by himself or herself, or by any other person, permits the furnishing of dan gerous drugs or dangerous devices, except by a pharmacist or designated representative, or as otherwise provided in this chapter, is guilty of a misdemeanor. party logistics provider that fails to place in (e) A person licensed as a third - charge of a lic ensed place of business of the third - party logistics provider a responsible manager, or any person who, by himself or herself, or by any other person, permits the furnishing of dangerous drugs or dangerous devices, except wise provided in this chapter, is guilty of a by a facility manager, or as other misdemeanor. 179

180 Misdemeanor: Failure or Refusal to Maintain or Produce Required 4332. Drug or Device Records; Willful Production of False Reports Any person who fails, neglects, or refuses to maintain the rec ords required by Section 4081 or who, when called upon by an authorized officer or a member of the board, fails, neglects, or refuses to produce or provide the records within a reasonable time, or who willfully produces or furnishes records that are false, is guilty of a misdemeanor. 4333. Maintaining Prescriptions, Other Drug Records on Premises, Open to Inspection; Waiver; Willful Failure to Keep or Permit Inspection of Records o f Prescriptions, Other Records i s Misdemeanor d by a pharmacy and all other records required by (a) All prescriptions fille Section 4081 shall be maintained on the premises and available for inspection by authorized officers of the law for a period of at least three years. In cases where the pharmacy discontinues business, thes e records shall be maintained in a board - licensed facility for at least three years. (b) Any person who willfully fails to comply with subdivision (a) is guilty of a misdemeanor, and upon conviction thereof, shall be punished by a fine not exceeding two hundred dollars ($200). Any person convicted of a second or subsequent offense shall be punished by a fine of not less than two hundred dollars ($200) and not more than four hundred dollars ($400). oard may, upon written (c) (1) Notwithstanding subdivisions (a) and (b), the b request, grant a waiver of the requirement that the records described in subdivisions (a) and (b) be maintained on the licensed premises or, in the event the pharmacy discontinues business, that the records be maintained in a board l icensed facility. A person who maintains records in compliance with that waiver is not subject to the penalties set forth in subdivision (b). (2) A waiver granted pursuant to this subdivision shall not affect the board's authority under this section or a ny other provision of this chapter. Knowingly Failing to Arrange for Disposition of Stock of Closed or 4335. Discontinued Business : Misdemeanor Any person who knowingly violates subdivision (b) of Section 4312 is guilty of a misdemeanor. 4336. Felony : Knowing or Willful Use of Minor to Violate Specified Sections of Pharmacy Law: Exception for Pharmacist Furnishing Pursuant to a Prescription (a) Every person who knowingly or willfully violates Section 4055, 4059, 4060, 4061, 4062, 4063, 4064, 4065, 4 077, 4080, 4081, 4083, or 4332 with respect to dangerous drugs by use of a minor as an agent is guilty of a felony. (b) Nothing contained in this section shall apply to a pharmacist furnishing dangerous drugs pursuant to a prescription. 4337. Distribut ion of Fines Collected Except as otherwise specified, all fines collected for violations of this chapter - shall be paid as follows: one half into the State Treasury to the credit of the 180

181 Contingent Fund of the Board of Pharmacy of the State of California and one - half to the treasurer of the jurisdiction in which the misdemeanor is prosecuted, to be deposited in the same fund as fines for other misdemeanors occurring in that jurisdiction are deposited. 4338. Additional Fines May be Assessed In addition to any fine assessed under Section 4321, the judge may assess a fine not to exceed seventy dollars ($70) against any person who violates Section 4140 or 4142, with the proceeds of this fine to be used in accordance The court shall, however, take into with Section 1463.23 of the Penal Code. consideration the defendant's ability to pay and no defendant shall be denied probation because of his or her inability to pay the fine permitted under this section. 4339. Board Action to Enjoin Violation of Pharmacy L aw; Exception for Certain Drugs and Devices (a) The board may bring an action to enjoin the violation of any provision of this chapter in any superior court in and for the county in which the violation has occurred. Any action shall conform to the requi rements of Chapter 3 (commencing with Section 525) of Title 7 of Part 2 of the Code of Civil Procedure, except that the board shall not be required to allege facts necessary to show or tending to show lack of adequate remedy at law or irreparable loss. The action shall be brought in the name of the people of the damage or State of California. (b) Nothing in this section shall permit the bringing of any action with respect to any drug or product not subject to Section 4022 that is packaged or bottled in t he manufacturer's or distributor's container and labeled in accordance with applicable federal and state drug labeling requirements. (c) The authority granted by this section is in addition to the authority of the board to institute any other administrat ive, civil, or criminal action. Unlawful Advertising by Nonresident Pharmacy Not Registered 4340. with Board It is unlawful for any nonresident pharmacy that is not registered pursuant to o advertise the Section 4112 or for any person who is a resident of this state t pharmacy services of any pharmacy, with the knowledge that the advertisement will or is likely to induce members of the public in this state to use the pharmacy to fill prescriptions. 4341. Advertisement of Prescription Drugs or Devices Notwithstanding any other provision of law, prescription drugs or devices may be advertised if the advertisement conforms with the requirements of Section 651. 181

182 4342. Actions by Board to Prevent Sales of Preparations or Drugs Lacking Quality of Strength; Penalties for Knowing or Willful Violation of Regulations Governing Those Sales (a) The board may institute any action or actions as may be provided by law and that, in its discretion, are necessary, to prevent the sale of pharmaceutical preparations an d drugs that do not conform to the standard and tests as to quality and strength, provided in the latest edition of the United States Pharmacopoeia or the National Formulary, or that violate any provision of the Sherman Food, Drug, and Cosmetic Law (Part 5 (commencing with Section 109875) of Division 104 of the Health and Safety Code). (b) Any knowing or willful violation of any regulation adopted pursuant to Section 4006 shall be subject to punishment in the same manner as is provided in Sections 4321 an d 4336. 4343. Buildings: Prohibition Against the Use of Certain Signs Unless Licensed Pharmacy Within No building shall have upon it or displayed within it or affixed to or used in macy," connection with it a sign bearing the word or words "Pharmacist," "Phar "Apothecary," "Drugstore," "Druggist," "Drugs," "Medicine," "Medicine Store," "Drug Sundries," "Remedies," or any word or words of similar or like import; or the characteristic symbols of pharmacy; or the characteristic ilar design, unless there is upon or within the prescription sign (Rx) or sim building a pharmacy holding a license issued by the board pursuant to Section 4110. Article 21. Pharmacists Recovery Program 4360. Impaired Pharmacists: Legislative Intent The board shall operate a phar macists recovery program to rehabilitate pharmacists and intern pharmacists whose competency may be impaired due to abuse of alcohol, drug use, or mental illness. The intent of the pharmacists recovery program is to return these pharmacists and intern phar macists to the practice of pharmacy in a manner that will not endanger the public health and safety. 4361. Definitions (a) "Participant" means a pharmacist or intern pharmacist who has entered the pharmacists recovery program. (b) "Pharmacists recove ry program" means the rehabilitation program created by this article for pharmacists and intern pharmacists. 4362. Function of Program: Board Referrals; Voluntary, Confidential Participation (a) A pharmacist or intern pharmacist may enter the pharmacist s recovery program if: (1) The pharmacist or intern pharmacist is referred by the board instead of, or in addition to, other means of disciplinary action. 182

183 (2) The pharmacist or intern pharmacist voluntarily elects to enter the pharmacists recovery progra m. (b) A pharmacist or intern pharmacist who enters the pharmacists recovery program pursuant to paragraph (2) of subdivision (a) shall not be subject to discipline or other enforcement action by the board solely on his or her entry ecovery program or on information obtained from the into the pharmacists r pharmacist or intern pharmacist while participating in the program unless the pharmacist or intern pharmacist would pose a threat to the health and safety of the public. However, if the board receives inf ormation regarding the conduct of the pharmacist or intern pharmacist, that information may serve as a basis for discipline or other enforcement by the board. 4364. Criteria for Participation to be Established by Board teria for the participation of pharmacists and (a) The board shall establish cri intern pharmacists in the pharmacists recovery program. (b) The board may deny a pharmacist or intern pharmacist who fails to meet the criteria for participation entry into the pharmacists recovery program. (c) The establishment of criteria for participation in the pharmacists recovery program shall not be subject to the requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code. 4365. Contracting with Employee Assistance Program: Selection The board shall contract with one or more qualified contractors to administer the pharmacists recovery program. 4366. Function of the Employee Assistance Program ng the pharmacists recovery The functions of the contractor administeri program shall include, but not be limited to, the following: (a) To evaluate those pharmacists and intern pharmacists who request participation in the program. pharmacists (b) To develop a treatment contract with each participant in the recovery program. (c) To monitor the compliance of each participant with their treatment contract. (d) To prepare reports as required by the board. (e) To inform each participant of the procedures followed in the program. (f) To inform each participant of their rights and responsibilities in the program. (g) To inform each participant of the possible consequences of noncompliance with the program. 4369. Board Referrals to Program: Written Information Provided to Licensee; Terminatio n for Non - Compliance; Report to Board of Termination ; Authority to Discipline (a) Any failure to comply with the treatment contract, determination that the participant is failing to derive benefit from the program, or other requirements of the pharmacist s recovery program may result in the termination of the 183

184 pharmacist's or intern pharmacist's participation in the pharmacists recovery program. The name and license number of a pharmacist or intern pharmacist who is terminated from the pharmacists recovery program and the basis for the termination shall be reported to the board. (b) Participation in the pharmacists recovery program shall not be a defense to any disciplinary action that may be taken by the board. (c) No provision of this article shall pre clude the board from commencing disciplinary action against a licensee who is terminated from the pharmacists recovery program. 4371. Review of Program Activities (a) The executive officer of the board shall designate a program manager of the pharmacis ts recovery program. The program manager shall have background experience in dealing with substance abuse issues. (b) The program manager shall review the pharmacists recovery program on a quarterly basis. As part of this evaluation, the program manager shall review files of all participants in the pharmacists recovery program. (c) The program manager shall work with the contractor administering the pharmacists recovery program to evaluate participants in the program according and to develop treatment contracts and evaluate to established guidelines participant progress in the program. 4372. Confidential Records; Exception for Disciplinary Proceeding All board records and records of the pharmacists recovery program pertaining to the treatment of a ph armacist or intern pharmacist in the program shall be kept confidential and are not subject to discovery, subpoena, or disclosure pursuant to Chapter 3.5 (commencing with Section 6250) of Division 7 of Title 1 of the Government Code. However, board record s and records of the pharmacists recovery program may be disclosed and testimony provided in connection with participation in the pharmacists recovery program, but only to the extent those records or testimony are relevant to the conduct for which the phar macist or intern pharmacist was terminated from the pharmacists recovery program. 4373. Immunity from Civil Liability No member of the board shall be liable for any civil damages because of acts or omissions that may occur while acting in good faith pu rsuant to this article. Article 22. Unfair Trade Practices 4380. Resale of Preferentially Priced Drugs: Prohibition; Exceptions (a) The resale, by any person, of drugs acquired at preferentially low prices permitted under federal law only because of the Nonprofit Institutions Act (15 U.S.C. Sec. 13c) is prohibited except in any of the following instances: (1) When for the person's own use, as defined by the federal courts in Abbott Labs. v. Portland Retail Druggists (425 U.S. 1, 47 L. Ed. 2d 537) and DeModena v. Kaiser Foundation Health Plan, Inc. (743 F. 2d 1388). 184

185 (2) When sold to a purchaser also eligible for those prices under the Nonprofit Institutions Act, that controls, is controlled by, or is under common control with, the seller, and that pur chases the products for its own use, as defined in paragraph (1). (3) When sold to a walk - in customer pursuant to a prescription, provided that those sales represent less than 1 percent of the drugs purchased by the seller for its own use in this state. (b) Nothing in this article prohibits the resale of drugs to any person in the occasional emergency situation where no other sources are readily available in the community to meet the emergency need. 4381. Violation of Article as Unfair Competition; Priv ate Actions Authorized; Triple Damages and Attorneys’ Fees; Proof Required (a) A violation of this article is an act of unfair competition within the meaning of Chapter 5 (commencing with Section 17200) of Part 2 of Division 7, and this article is enforc eable as provided in that chapter. (b) In addition thereto, any person or trade association may bring an action to enjoin and restrain any violation of this article and to recover actual damages, if any. (c) In an action for injunctive relief under thi s article, it is not necessary to allege or prove actual damages or the threat thereof, or actual injury or the threat thereof, to the plaintiff. In addition to injunctive relief, the plaintiff in any action shall recover three times the amount of his or h er actual damages, if any, as well as three times the actual damages, if any, sustained by any person who has assigned to the plaintiff a claim for damages resulting from a violation of ntered this section. In any action under this article in which judgment is e against the defendant, the plaintiff shall be awarded reasonable attorneys' fees together with the costs of suit. (d) In issuing an injunction against a violation under this article, the court deems expedient in order to may, in its discretion, include any other restraint it deter the defendant from and ensure against future violations of this article. (e) Proof of malice or intent to harm competition is immaterial to sustain a cause of action under this article. - In Customers 4382. Board May Audit Sales to Walk The board may audit persons for compliance with the limits established in paragraph (3) of subdivision (a) of Section 4380 except that in the case of a facility or pharmacy that predominately serves members of a prepaid group practice h ealth care service plan, those audits may be undertaken solely by the Department of Managed Health Care pursuant to its authority to audit those plans. 85 1

186 Article 23. Revenue and Renewal 4400. Fees The amount of fees and penalties prescribed by this chapter, except as otherwise provided, is that fixed by the board according to the following schedule: The fee for a nongovernmental pharmacy license shall be five hundred (a) twenty dollars ($520) and may be increased to five hundred seventy dollars ($ 570). The fee for the issuance of a temporary nongovernmental pharmacy permit shall be two hundred fifty dollars ($250) and may be increased to three hundred twenty - five dollars ($325). all be (b) The fee for a nongovernmental pharmacy license annual renewal sh six hundred sixty - five dollars ($665) and may be increased to nine hundred thirty dollars ($930). (c) The fee for the pharmacist application and examination shall be two - five hundred sixty dollars ($260) and may be increased to two hundred eighty dollars ($285). (d) The fee for regrading an examination shall be ninety dollars ($90) and may be increased to one hundred fifteen dollars ($115). If an error in grading is found and the applicant passes the examination, the regrading fee shall be refund ed. five dollars (e) The fee for a pharmacist license shall be one hundred ninety - ($195) and may be increased to two hundred fifteen dollars ($215). The fee for a pharmacist biennial renewal shall be three hundred sixty dollars ($360) and d to five hundred five dollars ($505). may be increase The fee for a nongovernmental wholesaler or third - party logistics provider (f) license and annual renewal shall be seven hundred eighty dollars ($780) and application fee may be increased to eight hundred twenty dollars ($820). The for any additional location after licensure of the first 20 locations shall be three hundred dollars ($300) and may be decreased to no less than two hundred - five dollars ($225). A temporary license fee shall be seven hundred twenty fifteen dollars ($715) and may be decreased to no less than five hundred fifty dollars ($550). (g) The fee for a hypodermic license shall be one hundred seventy dollars ($170) and may be increased to two hundred forty dollars ($240). The fee for a hypodermic li cense renewal shall be two hundred dollars ($200) and may be increased to two hundred eighty dollars ($280). (h) The fee for application, investigation, and issuance of a license as a (1) as a designate d ive pursuant to Section 4053, designated representat 3PL pursuant to Section 4053.1, representative - or as a designated representative - reverse distributor pursuant to section 4053.2 shall be one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210). (2) The fee for the annual r enewal of a license as a designated representative , or designated representative reverse distributor designated representative - 3PL - shall be two hundred fifteen dollars ($215) and may be increased to three hundred dollars ($300). 186

187 The fee for the (1) (i) application, investigation, and issuance of a license as a designated representative for a veterinary food - animal drug retailer pursuant to Section 4053 shall be one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210). (2) The fee for the annual renewal of a license as a designated representative - animal drug retailer shall be two hundred fifteen dollars for a veterinary food ($215) and may be increased to three hundred dollars ($300). - esident wholesaler or third (j) (1) The application fee for a nonr party logistics provider license issued pursuant to Section 4161 shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820). (2) For nonresident wholesalers or third - party logistics providers that have 21 or more facilities operating nationwide the application fees for the first 20 locations shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820). The application fee for any additional location after licensure of the first 20 locations shall be three hundred dollars ($300) and may be decreased to no less than two hundred twenty - five dollars ($225). A temporary license fee shall be seven hundred fifteen dollars ($715) d to no less than five hundred fifty dollars ($550). and may be decrease party (3) The annual renewal fee for a nonresident wholesaler license or third - logistics provider license issued pursuant to Section 4161 shall be seven d to eight hundred twenty hundred eighty dollars ($780) and may be increase dollars ($820). The fee for evaluation of continuing education courses for accreditation (k) shall be set by the board at an amount not to exceed forty dollars ($40) per course hour. (l) The fee for an intern pharmacist licens e shall be one hundred sixty - five dollars ($165) and may be increased to two hundred thirty dollars ($230). The fee for transfer of intern hours or verification of licensure to another state shall be twenty - five dollars ($25) and may be increased to thirty dollars ($30). (m) The board may waive or refund the additional fee for the issuance of a license where the license is issued less than 45 days before the next regular renewal date. has been (n) The fee for the reissuance of any license, or renewal thereof, that lost or destroyed or reissued due to a name change shall be thirty five dollars - ($35) and may be increased to forty - five dollars ($45). (o) The fee for the reissuance of any license, or renewal thereof, that must be reissued because of a change in the information, shall be one hundred dollars ($100) and may be increased to one hundred thirty dollars ($130). It is the intent of the Legislature that, in setting fees pursuant to this (p) section, the board shall seek to maintain a reserve in the Pharmacy Board Contingent Fund equal to approximately one year’s operating expenditures. (q) The fee for any applicant for a nongovernmental clinic license shall be five hundred twenty dollars ($520) for each license and may be increased to five hundred seventy dollars ($570). The annual fee for renewal of the license shall - five dollars ($325) for each license and may be be three hundred twenty increased to three hundred sixty dollars ($360). 187

188 (r) The fee for the issuance of a pharmacy technician license shall be one hundred forty dollars ($140) and may be increased to one hundred ninety - five dollars ($195). The fee for renewal of a pharmacy technician license shall be one hundred forty dollars ($140) and may be increased to one hundred ninety - s ($195). five dollar (s) - The fee for a veterinary food animal drug retailer license shall be four hundred thirty five dollars ($435) and may be increased to six hundred ten - dollars ($610). The annual renewal fee for a veterinary food - animal drug retailer license sh all be three hundred thirty dollars ($330) and may be increased to four hundred sixty dollars ($460). (t) The fee for issuance of a retired license pursuant to Section 4200.5 shall be - thirty - five dollars ( $45). five dollars ($35) and may be increased to forty (u) The fee for issuance of a nongovernmental sterile compounding pharmacy license or a hospital satellite compounding pharmacy shall be one thousand six hundred forty - five dollars ($1,645) and may be increased to two thousand three hundred five do llars ($2,305). The fee for a temporary license shall be five hundred fifty dollars ($550) and may be increased to seven hundred fifteen dollars ($715). The annual renewal fee of the license shall be one thousand and may be increased to one five dollars ($1,325) - three hundred twenty thousand eight hundred fifty - five dollars ($1,855). The fee for the issuance of a nonresident sterile compounding pharmacy (v) license shall be two thousand three hundred eighty dollars ($2,380) and may be housand three hundred thirty - five dollars ($3,335). The increased to three t annual renewal of the license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to three thousand one hundred eighty ion fee, the nonresident dollars ($3,180). In addition to paying that applicat sterile compounding pharmacy shall deposit, when submitting the application, a reasonable amount, as determined by the board, necessary to cover the board’s estimated cost of performing the inspection required by Section 4127.2. If the required deposit is not submitted with the application, the application shall be deemed to be incomplete. If the actual cost of the inspection exceeds the amount deposited, the board shall provide to the applicant a written invoice for mount and shall not take action on the application until the full the remaining a amount has been paid to the board. If the amount deposited exceeds the amount of actual and necessary costs incurred, the board shall remit the difference to the applicant. (w) the issuance of an outsourcing facility license shall be two The fee for thousand two hundred seventy dollars ($2,270) and may be increased to up to three thousand one hundred eighty dollars ($3,180) by the board. The fee for the renewal of an outsourcing facility li cense shall be one thousand three hundred twenty - five dollars ($1,325) and may be increased to up to one thousand eight hundred fifty - five dollars ($1,855) by the board. The fee for a temporary outsourcing facility license shall be seven hundred fifteen do llars ($715). The fee for the issuance of a nonresident outsourcing facility license shall (x) be two thousand three hundred eighty dollars ($2,380) and may be increased to - up to three thousand three hundred thirty five dollars ($3,335) by the board. 188

189 The fee for the renewal of a nonresident outsourcing facility license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to up to three thousand one hundred eighty dollars ($3,180) by the board. In addition to paying that applicat ion fee, the nonresident outsourcing facility shall deposit, when submitting the application, a reasonable amount, as determined by the board, necessary to cover the board’s estimated cost of performing the inspection required by Section 4129.2. If the req uired deposit is not submitted with the application, the application shall be deemed to be incomplete. If the actual cost of the inspection exceeds the amount deposited, the board shall provide to the applicant a written invoice for the remaining amount an d shall not take action on the application until the full amount has been paid to the board. If the amount deposited exceeds the amount of actual and necessary costs incurred, the board shall remit the difference to the applicant. (y) The fee for the iss uance of a centralized hospital packaging license shall be eight hundred twenty dollars ($820) and may be increased to one thousand one hundred fifty dollars ($1,150). The annual renewal of the license shall be eight hundred five dollars ($805) and may be increased to one thousand one hundred twenty - five dollars ($1,125). (z) The fee for the issuance of a license to a correctional clinic pursuant to Article 13.5 (commencing with Section 4187) that is not owned by the state shall be five hundred twenty dol lars ($520) and may be increased to five hundred seventy dollars ($570). The annual renewal fee for that correctional - five dollars ($325) and may be clinic license shall be three hundred twenty increased to three hundred sixty dollars ($360). (aa) Beginnin g on and after July 1, 2019, the fee for an ADDS license shall be two hundred dollars ($200) and may be increased to two hundred fifty dollars ($250). The fee for the annual renewal of the license shall be two hundred dollars ($200) and may be increased to two hundred fifty dollars ($250). 4401. Pharmacist: Biennial Renewal Every pharmacist who desires to retain his or her license on the books of the board shall biennially pay to the executive officer of the board the renewal fee, established by the boa rd, within the limits prescribed by this chapter. In return for the payment of the renewal fee, a certificate of renewal shall be issued. Cancellation: Of 4402. hree Years; Renewal for T Pharmacist a fter Non - fter 60 Days All Other Licenses a (a) Any phar macist license that is not renewed within three years following its expiration may not be renewed, restored, or reinstated and shall be canceled by operation of law at the end of the three - year period. (b) (1) Any pharmacist whose license is canceled purs uant to subdivision (a) may obtain a new license if he or she takes and passes the examination that is required for initial license with the board. (2) The board may impose conditions on any license issued pursuant to this section, as it deems necessary. 189

190 (c) A license that has been revoked by the board under former Section 4411 shall be deemed canceled three years after the board's revocation action, unless the board has acted to reinstate the license in the interim. authority of the board to proceed with any (d) This section shall not affect the accusation that has been filed prior to the expiration of the three - year period. (e) Any other license issued by the board may be canceled by the board if the license is not renewed within 60 days after its expi ration. Any license canceled under this subdivision may not be reissued. Instead, a new application will be required. 4403. Reissuance without Payment of Fees Prohibited The board shall not reissue or renew any license without the payment of the fees re quired by this chapter and the payment of all fees that are delinquent at the time that the application is made. 4404. Reissuance of Lost or Destroyed License; Proof of Loss, etc. If any license issued under this chapter is lost or destroyed, or if any p erson desires a reissuance of his or her license, the board may reissue it, subject to Section 4403, upon application therefor, and the submission of satisfactory proof, if required by the board, that the license has been lost or destroyed, or if se has not been lost or destroyed, upon the surrender of the old license. the licen 4405. Disposition of Fines All fines recoverable under this chapter shall be paid by the magistrate receiving the same to the board, except where other provision is made in this chapter for the disposition thereof. 4406. Report of Fees Collected All fees collected on behalf of the board and all receipts of every kind and nature shall be reported each month for the month preceding to the Controller and at the same time the enti re amount shall be paid into the State Treasury and shall be credited to the Pharmacy Board Contingent Fund which is hereby available, upon appropriation of the created. This contingent fund shall be . Legislature, for the use of the board 4407. Compensa tion of Members All compensation of members and all other expenses of the board shall be paid out of the examination and registration fees and fines. 4409. Contribution to California Pharmacist Scholarship and Repayment Program at License Renewal At t he time a pharmacy license is renewed pursuant to subdivision (a) of Section 4110 or a pharmacist license is renewed pursuant to Section 4401, the pharmacy or pharmacist may make a contribution of at least twenty five dollars - ($25), to be submitted to the board, for the sole purpose of funding the California Pharmacist Scholarship and Loan Repayment Program established pursuant to Article 2 (commencing with Section 128198) of Chapter 3 of Part 3 190

191 on submitted of Division 107 of the Health and Safety Code. The contributi pursuant to this section shall be paid into the State Treasury and credited to the California Pharmacist Scholarship and Loan Repayment Program Fund established pursuant to Section 128198.5 of the Health and Safety Code. Article 24. Prescrip tion Rates for Medicare Beneficiaries 4425. - Cal Program; Conditions; Pharmacy Participation in Medi Department of Health Care Services Utilization Review and Monitoring (a) As a condition for the participation of a pharmacy in the Medi - Cal program purs uant to Chapter 7 (commencing with Section 14000) of Division 9 of the Welfare and Institutions Code, the pharmacy, upon presentation of a valid prescription for the patient and the patient's Medicare card, shall charge Medicare beneficiaries a price that does not exceed the Medi - Cal reimbursement rate for prescription medicines, and an amount, as set by the State Department of Health Care Services to cover electronic transmission charges. However, Medicare beneficiaries shall not be allowed to use the Med i - Cal reimbursement rate for over - the - counter medications or compounded prescriptions. Health (b) The State Department of shall provide a mechanism Care Services to calculate and transmit the price to the pharmacy, but shall not apply the Cal drug u tilization review process for purposes of this section. - Medi (c) The State Department of Health Care Services shall monitor pharmacy participation with the requirements of subdivision (a). (d) The State Department of Health Care Services shall conduct an ou treach program to inform Medicare beneficiaries of their right to participate in the program described in subdivision (a), including, but not limited to, the following: Cal reimbursement rate for, at (1) Including on its Internet Web site the Medi - minimum , 200 of the most commonly prescribed medicines and updating this information monthly. (2) Providing a sign to participating pharmacies that the pharmacies shall prominently display at the point of service and at the point of sale, reminding the Medicare beneficiaries to ask that the charge for their prescription be the same amount as the Medi - Cal reimbursement rate and providing the mail address, and Internet Web site address department's telephone number, e - to access information about the program. (e) If prescription drugs are added to the scope of benefits available under the federal Medicare program, the Senate Office of Research shall report that fact to the appropriate committees of the Legislature. It is the intent of the Legislature to evaluate t he need to continue the implementation of this article under those circumstances. (f) This section shall not apply to a prescription that is covered by insurance. 191

192 4426. Department of Public Health to Study Reimbursement Rates Health shall conduct a study of the adequacy Public The State Department o f of Medi - Cal pharmacy reimbursement rates including the cost of providing prescription drugs and services. Article 25. Automated Drug Delivery System Definitions of Drugs and Devices 4427. As used in t his article, “drugs” or “dangerous drugs” shall have the same meaning as “dangerous drug” as provided in Section 4022 and “devices” or “dangerous devices” shall have the same meaning as “dangerous device” as provided in Section 4022. 4427.1. Requirements for Installation or Operation An ADDS shall not be installed or operated in California unless it meets the requirements of this article. Licensing Requirements 4427.2. (a) An ADDS installed, leased, owned, or operated in California shall be licensed by th e board. (b) An ADDS license shall only be issued to the holder of a current, valid, and active pharmacy license of a pharmacy located and licensed in California. (c) A separate application and license shall be required for each ADDS. (d) An ADDS license s hall only be issued when the following conditions are met: (1) Use of the ADDS is consistent with legal requirements. (2) The proposed location for installation of the ADDS meets the requirements of Section 4427.3 and the ADDS is secure from access and rem oval by unauthorized individuals. (3) The pharmacy’s policies and procedures related to the ADDS include appropriate security measures and monitoring of the inventory to prevent theft and diversion. ions for reporting to (4) The pharmacy’s policies and procedures include provis the board drug losses from the ADDS inventory, as required by law. (e) Prior to issuance of the license, the board shall conduct a prelicensure inspection, within 30 days of a completed application for an ADDS license, at the proposed location of the ADDS. Relocation of the ADDS shall require a new application for licensure. Replacement of an ADDS shall require notification to the board within 30 days. (f) The ADDS license shall be canceled by operation of law if the underlying pharmac y license is not current, valid, and active. Upon reissuance or reinstatement of the underlying pharmacy license, a new application for an ADDS license may be submitted to the board. (g) The holder of an ADDS license shall advise the board in writing withi n 30 days if use of the ADDS is discontinued. (h) The ADDS license shall be renewed annually, and the renewal date shall be the same as the underlying pharmacy license. 192

193 (i) An AUDS operated by a licensed hospital pharmacy, as defined in Section 4029, and u sed solely to provide doses administered to patients while in a licensed general acute care hospital facility or a licensed acute psychiatric hospital facility, as defined in subdivisions (a) and (b) of Section 1250 of the Health and Safety Code, shall be exempt from the requirement of obtaining an ADDS license pursuant to this section if the licensed hospital pharmacy owns or leases the AUDS and owns the dangerous drugs and dangerous devices in the AUDS. The AUDS shall comply with all other requirements fo r an ADDS in this article. The licensed hospital pharmacy shall maintain a list of the locations of each AUDS it operates and shall make the list available to the board upon request. (j) An ADDS license is not required for technology, installed within the secured licensed premises area of a pharmacy, used in the selecting, counting, packaging, and labeling of dangerous drugs and dangerous devices. 4427.3. Location Requirements (a) An ADDS shall be placed and operated inside an enclosed building, with a pre mises address, at a location approved by the board. (b) An ADDS shall be placed and operated in one of the following locations: (1) Adjacent to the secured pharmacy area of the pharmacy holding the ADDS license. ection 1250 of the Health and Safety (2) A health facility licensed pursuant to S Code that complies with Section 1261.6 of the Health and Safety Code. (3) A clinic licensed pursuant to Section 1204 or 1204.1 of the Health and Safety Code, or Section 4180 or 4190 of this code. (4) A correctional clin ic licensed pursuant to Section 4187.1. (5) If the ADDS is an APDS, in a location as provided in Section 4427.6. (c) Prior to installation, the pharmacy holding the ADDS license and the intly location where the ADDS is placed pursuant to subdivision (b) shall jo develop and implement written policies and procedures to ensure safety, accuracy, accountability, security, patient confidentiality, and maintenance of the ADDS, as well as quality, potency, and purity of the drugs and devices. These policies and pro cedures shall be maintained at the location of the ADDS and at the pharmacy holding the ADDS license. Ownership and Operation by Pharmacy 4427.4. (a) The ADDS shall be owned or leased by the pharmacy holding the license for the ADDS. (b) Each ADDS shall o nly be operated under the supervision of the pharmacy holding the ADDS license. (c) An ADDS shall be considered an extension and part of the pharmacy holding the ADDS license, regardless of the ADDS location, and shall be subject to inspection pursuant to Section 4008. (d) Drugs and devices stored in an ADDS shall be deemed part of the inventory and the responsibility of the pharmacy holding the ADDS license, and drugs and devices dispensed from the ADDS shall be considered to have been armacy. dispensed by that ph 193

194 (e) (1) The stocking and restocking of an ADDS shall be performed by a pharmacist, or by a pharmacy technician or intern pharmacist under the supervision of a pharmacist, except for an ADDS located in a health facility licensed pursuant to Section 1250 of the Health and Safety Code, where the stocking and restocking of the ADDS may be performed in compliance with Section 1261.6 of the Health and Safety Code. (2) Access to the ADDS shall be controlled and tracked using an identification or password s ystem or biosensor. (3) The ADDS shall make a complete and accurate record of all transactions that includes all users accessing the system and all drugs added to, or removed from, the system. (f) If drugs or devices are not immediately transferred into an ADDS upon arrival at the ADDS location, the drugs and devices shall be stored for no longer than 48 hours in a secured room within the ADDS location approved by the board under Section 4427.3. Upon retrieval of these drugs and devices from , an inventory shall be taken to detect any losses or overages. secured storage Personnel Training Required 4427.5. Prior to installation, and annually thereafter, the pharmacy holding the ADDS license shall provide training on the operation and use of the ADDS to pharma cy personnel and to personnel using the ADDS at the location where the ADDS is placed pursuant to subdivision (b) of Section 4427.3. Requirements for 4427.6. APDS Using In addition to any other requirements imposed by this article, an APDS shall additiona lly meet the following requirements: (a) The pharmacy shall develop and implement, and review annually, written policies and procedures pertaining to the APDS, including all of the following: (1) Maintaining the security of the APDS and the dangerous drugs and dangerous devices within that APDS. (2) Determining and applying inclusion criteria regarding which drugs and devices are appropriate for placement in the APDS and for which patients. acist is (3) Ensuring that patients are aware that consultation with a pharm available for any prescription medication, including for those delivered via the APDS. (4) Describing assignment of responsibilities to, and training of, pharmacy personnel, and other personnel using the APDS at the location where the APDS is plac ed pursuant to subdivision (b) of Section 4427.3, regarding maintenance and filing procedures for the APDS. (5) Orienting participating patients on the use of the APDS, notifying patients when expected prescription medications are not available in the APDS , and ensuring that patient use of the APDS does not interfere with delivery of drugs and devices. (6) Ensuring delivery of drugs and devices to patients expecting to receive them from the APDS in the event the APDS is disabled or malfunctions. (b) The APD S shall only be used for patients who have signed a written consent form demonstrating their informed consent to receive prescribed drugs 194

195 and devices from an APDS, and whose use of the APDS meets inclusion criteria established pursuant to subdivision (a). (c) The APDS shall have a means to identify each patient and only release the identified patient’s drugs and devices to the patient or the patient’s agent. (d) A pharmacist licensed by the board shall perform all clinical services conducted as part of the dispensing process, including, but not limited to, drug utilization review and consultation. (e) Drugs shall be dispensed from the APDS only upon authorization by a licensed pharmacist after the pharmacist has reviewed the prescription and the ofile for potential contraindications and adverse drug reactions. patient’s pr (f) All prescribed drugs and devices dispensed to a patient from an APDS for the first time shall be accompanied by a consultation conducted by a pharmacist licensed by the board via a telec ommunications link that has two - way audio and video. (g) The APDS shall include a notice, prominently posted on the APDS, providing the name, address, and phone number of the pharmacy that holds the ADDS license for that APDS. (h) The labels on all drugs a nd devices dispensed by the APDS shall comply with Section 4076 and with Section 1707.5 of Title 16 of the California Code of Regulations. (i) Any incident involving the APDS where a complaint, error, or omission has he pharmacy’s quality assurance program occurred shall be reviewed as part of t pursuant to Section 4125. (j) An APDS may be located and operated in a medical office or other location where patients are regularly seen for purposes of diagnosis and treatment, and dangerous drugs and dangerous devices to the APDS is only used to dispense patients of the practice. (k) The board shall not issue a pharmacy more than 15 ADDS licenses for APDS units. Consistent with Section 4001.1, the board, by regulation, may reduce the number of ADDS licenses a pharm acy may be issued for APDS units. (l) The pharmacy holding the ADDS license for an APDS shall maintain the policies and procedures developed pursuant to subdivision (a) for three years after the last date of use of that APDS. Self 4427.7. ecordkeeping Requirements Assessment and R - (a) A pharmacy holding an ADDS license shall complete an annual self - assessment, performed pursuant to Section 1715 of Title 16 of the California Code of Regulations, evaluating the pharmacy’s compliance with pharmacy to the use of the ADDS. All information regarding operation, law relating maintenance, compliance, error, omissions, or complaints pertaining to the ADDS shall be included in the self - assessment. ce (b) The pharmacy shall comply with all recordkeeping and quality assuran requirements established in pharmacy law and regulation, and shall maintain those records within the licensed pharmacy holding the ADDS license and separate from other pharmacy records. 195

196 4427.8. Report to the Legislature During Sunset Evaluation (a) Thi s article shall become operative on July 1, 2019. (b) On or before January 1, 2024, as part of the board’s sunset evaluation process, and notwithstanding Sections 9795 and 10231.5 of the Government Code, the board shall report to the appropriate committees of the Legislature on the regulation of ADDS units as provided in this article. At a minimum, this report shall require all of the following: (1) The use and dispersion of ADDS throughout the health care system. d by the board each year and the (2) The number of ADDS inspections conducte findings from the inspections. (3) Public safety concerns relating to the use of ADDS as identified by the board. OTHER IMPORTANT SECTIONS OF THE BUSINESS & PROFESSIONS CODE 31. Licensee or Applicant Name on Tax Delinquen cies List (a) As used in this section, "board" means any entity listed in Section 101, the entities referred to in Sections 1000 and 3600, the State Bar, the Department of Real Estate, and any other state agency that issues a license, certificate, or istration authorizing a person to engage in a business or profession. reg (b) Each applicant for the issuance or renewal of a license, certificate, registration, or other means to engage in a business or profession regulated by a board who is not in complian ce with a judgment or order for support shall be subject to Section 17520 of the Family Code. (c) "Compliance with a judgment or order for support" has the meaning given in paragraph (4) of subdivision (a) of Section 17520 of the Family Code. (d) Each licensee or applicant whose name appears on a list of the 500 largest tax delinquencies pursuant to Section 7063 or 19195 of the Revenue and Taxation Code shall be subject to Section 494.5. (e) Each application for a new license or renewal of a license s hall indicate on the application that the law allows the State Board of Equalization and the Franchise Tax Board to share taxpayer information with a board and requires the licensee to pay his or her state tax obligation and that his or her license may be suspended if the state tax obligation is not paid. (f) For purposes of this section, "tax obligation" means the tax imposed under, or in accordance with, Part 1 (commencing with Section 6001), Part 1.5 (commencing with Section 7200), Part 1.6 (commencing with Section 7251), Part 1.7 (commencing with Section 7280), Part 10 (commencing with Section 17001), or Part 11 (commencing with Section 23001) of Division 2 of the Revenue and Taxation Code. 40. Expert Consultant Agreement (a) Subject to the standar ds described in Section 19130 of the Government Code, any board, as defined in Section 22, the State Board of Chiropractic Examiners, or the Osteopathic Medical Board of California may enter into an agreement with an expert consultant to do any of the foll owing: 196

197 (1) Provide an expert opinion on enforcement - related matters, including providing testimony at an administrative hearing. (2) Assist the board as a subject matter expert in examination development, examination validation, or occupational analyses. (3) Evaluate the mental or physical health of a licensee or an applicant for a license as may be necessary to protect the public health and safety. (b) An executed contract between a board and an expert consultant shall be Part 2 (commencing with Section 10100) of exempt from the provisions of Division 2 of the Public Contract Code. (c) Each board shall establish policies and procedures for the selection and use of expert consultants. e of practice (d) Nothing in this section shall be construed to expand the scop of an expert consultant providing services pursuant to this section. [Edit. To protect and safeguard consumers and the public in this state, it is necessary that this act take September 26, 2011] effect immediately — . Applicants; Milita ry Service Inquiry 114 .5 Commencing January 1, 2015, each board shall inquire in every application for licensure if the individual applying for licensure is serving in, or has previously served in, the military. 115.4. Expedited Licensure For Honorably Discha rged Member of the Armed Forces within (a) any other law, on and after July 1, 2016, a board Notwithstanding the department shall expedite, and may the initial licensure process for assist, the who applicant an applicant supplies satisfactory evidence to the board that Armed served as an active duty member of the has Forces of the United States and was honorably discharged. may adopt (b) A board section. regulations necessary to administer this 115.5 . Expedited Licensure Process (a) A board within the d epartment shall expedite the licensure process for an applicant who meets both of the following requirements: (1) Supplies evidence satisfactory to the board that the applicant is married to, or in a domestic partnership or other legal union with, an acti ve duty member of the Armed Forces of the United States who is assigned to a duty station in this state under official active duty military orders. (2) Holds a current license in another state, district, or territory of the United States in the profession or vocation for which he or she seeks a license from the board. (b) A board may adopt regulations necessary to administer this section. 125.3. Recovery of Investigation and Enforcement Costs: Procedures; Proof; Enforcement provided by law, in any order issued in resolution of a (a) Except as otherwise disciplinary proceeding before any board within the department or before the Osteopathic Medical Board, upon request of the entity bringing the proceeding, 197

198 the administrative law judge may direct a li centiate found to have committed a violation or violations of the licensing act to pay a sum not to exceed the reasonable costs of the investigation and enforcement of the case. (b) In the case of a disciplined licentiate that is a corporation or a partn ership, the order may be made against the licensed corporate entity or licensed partnership. (c) A certified copy of the actual costs, or a good faith estimate of costs where its actual costs are not available, signed by the entity bringing the proceeding or designated representative shall be prima facie evidence of reasonable costs of investigation and prosecution of the case. The costs shall include the amount of investigative and enforcement costs up to the date of the hearing, including, but not limit ed to, charges imposed by the Attorney General. (d) The administrative law judge shall make a proposed finding of the amount of reasonable costs of investigation and prosecution of the case when requested pursuant to subdivision (a). The finding of the a dministrative law judge with regard to costs shall not be reviewable by the board to increase the cost award. The board may reduce or eliminate the cost award, or remand to the administrative law judge if the proposed decision fails to make a finding on co sts requested pursuant to subdivision (a). (e) If an order for recovery of costs is made and timely payment is not made as directed in the board's decision, the board may enforce the order for shall be in repayment in any appropriate court. This right of enforcement addition to any other rights the board may have as to any licentiate to pay costs. (f) In any action for recovery of costs, proof of the board's decision shall be conclusive proof of the validity of the order of payment and the terms for pay ment. (g) (1) Except as provided in paragraph (2), the board shall not renew or reinstate the license of any licentiate who has failed to pay all of the costs ordered under this section. (2) Notwithstanding paragraph (1), the board may, in its discretion , conditionally renew or reinstate for a maximum of one year the license of any licentiate who demonstrates financial hardship and who enters into a formal year period for - agreement with the board to reimburse the board within that one the unpaid costs. (h) All costs recovered under this section shall be considered a reimbursement for costs incurred and shall be deposited in the fund of the board recovering the costs to be available upon appropriation by the Legislature. (i) Nothing in this section shal l preclude a board from including the recovery of the costs of investigation and enforcement of a case in any stipulated settlement. (j) This section does not apply to any board if a specific statutory provision in that board's licensing act provides for recovery of costs in an administrative disciplinary proceeding. (k) Notwithstanding the provisions of this section, the Medical Board of California shall not request nor obtain from a physician and surgeon, iplinary proceeding against the investigation and prosecution costs for a disc licentiate. The board shall ensure that this subdivision is revenue neutral with 198

199 regard to it and that any loss of revenue or increase in costs resulting from this subdivision is offset by an increase in the amount of the i nitial license fee and the biennial renewal fee, as provided in subdivision (e) of Section 2435. 125.9. Citation and Fine (a) Except with respect to persons regulated under Chapter 11 (commencing with Section 7500), and Chapter 11.6 (commencing with Se ction 7590) of Division 3, any board, bureau, or commission within the department, the board created by the Chiropractic Initiative Act, and the Osteopathic Medical Board of California, may establish, by regulation, a system for the issuance to a licensee of a citation which may contain an order of abatement or an order to pay an administrative fine assessed by the board, bureau, or commission where the licensee is in violation of the applicable licensing act or any regulation adopted pursuant thereto. (b) The system shall contain the following provisions: (1) Citations shall be in writing and shall describe with particularity the nature of the violation, including specific reference to the provision of law determined to have been violated. (2) Whenever a ppropriate, the citation shall contain an order of abatement fixing a reasonable time for abatement of the violation. (3) In no event shall the administrative fine assessed by the board, bureau, or commission exceed five thousand dollars ($5,000) for each inspection or each investigation made with respect to the violation, or five thousand dollars ($5,000) for each violation or count if the violation involves fraudulent billing submitted to an insurance company, the Medi - Cal program, or Medicare. In ing a fine, the board, bureau, or commission shall give due consideration assess to the appropriateness of the amount of the fine with respect to factors such as the gravity of the violation, the good faith of the licensee, and the history of previous violations. (4) A citation or fine assessment issued pursuant to a citation shall inform the licensee that if he or she desires a hearing to contest the finding of a violation, that hearing shall be requested by written notice to the board, bureau, or hin 30 days of the date of issuance of the citation or assessment. commission wit If a hearing is not requested pursuant to this section, payment of any fine shall not constitute an admission of the violation charged. Hearings shall be held ncing with Section 11500) of Part 1 of Division 3 pursuant to Chapter 5 (comme of Title 2 of the Government Code. (5) Failure of a licensee to pay a fine within 30 days of the date of assessment, unless the citation is being appealed, may result in disciplinary action being taken by the board, bureau, or commission. Where a citation is not contested and a fine is not paid, the full amount of the assessed fine shall be added to the fee for renewal of the license. A license shall not be renewed without payment of the renewal fee and fi ne. (c) The system may contain the following provisions: (1) A citation may be issued without the assessment of an administrative fine. (2) Assessment of administrative fines may be limited to only particular violations of the applicable licensing act. 199

200 (d) Notwithstanding any other provision of law, if a fine is paid to satisfy an assessment based on the finding of a violation, payment of the fine shall be represented as satisfactory resolution of the matter for purposes of public disclosure. (e) Admin istrative fines collected pursuant to this section shall be deposited in the special fund of the particular board, bureau, or commission. 144.5. Authority To Receive Certified Records quest, Notwithstanding any other law, a board described in Section 144 may re and is authorized to receive, from a local or state agency certified records of all arrests and convictions, certified records regarding probation, and any and all other related documentation needed to complete an applicant or licensee investigation . A local or state agency may provide those records to the board upon request. 148. Unlicensed Activity Any board, bureau, or commission within the department may, in addition to the administrative citation system authorized by Section 125.9, also estab lish, by regulation, a similar system for the issuance of an administrative citation to an unlicensed person who is acting in the capacity of a licensee or registrant under the jurisdiction of that board, bureau, or commission. The administrative system authorized by this section shall meet the requirements of citation Section 125.9 and may not be applied to an unlicensed person who is otherwise exempted from the provisions of the applicable licensing act. The ystem for unlicensed activity does establishment of an administrative citation s not preclude the use of other enforcement statutes for unlicensed activities at the discretion of the board, bureau, or commission. 208 . CURES Fee Assessment ( a) Beginning April 1, 2014, a Controlled Substance Utilizati on Review and Evaluation System (CURES) fee of six dollars ($6) shall be assessed annually on each of the licensees specified in subdivision (b) to pay the reasonable costs associated with operating and maintaining CURES for the purpose of regulating those licensees. The fee assessed pursuant to this subdivision shall be billed and collected by the regulating agency of each licensee at the time of the licensee’s license renewal. If the reasonable regulatory cost of operating and maintaining CURES is less th an six dollars ($6) per licensee, the Department of Consumer Affairs may, by regulation, reduce the fee established by this section to the reasonable regulatory cost. (b) (1) Licensees authorized pursuant to Section 11150 of the Health and Safety Code to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances or pharmacists licensed pursuant to Chapter 9 (commencing with Section 4000) of Division 2. (2) Beginning July 1, 2017, licensees issued a l icense that has been placed in a retired or inactive status pursuant to a statute or regulation are exempt from the CURES fee requirement in subdivision (a). This exemption shall not apply to licensees whose license has been placed in a retired or inactive status if the 200

201 licensee is at any time authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances. (3) Wholesalers, third - party logistics providers, nonresident wholesalers, and nonresi dent third - party logistics providers of dangerous drugs licensed pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2. (4) Nongovernmental clinics licensed pursuant to Article 13 (commencing with Section 4180) and Article 14 (c ommencing with Section 4190) of Chapter 9 of Division 2. (5) Nongovernmental pharmacies licensed pursuant to Article 7 (commencing with Section 4110) of Chapter 9 of Division 2. (c) The funds collected pursuant to subdivision (a) shall be deposited in th e CURES Fund, which is hereby created within the State Treasury. Moneys in the CURES Fund shall, upon appropriation by the Legislature, be available to the Department of Consumer Affairs to reimburse the Department of Justice for costs to operate and maint ain CURES for the purposes of regulating the licensees specified in subdivision (b). (d) The Department of Consumer Affairs shall contract with the Department of Justice on behalf of the Medical Board of California, the Dental Board of ifornia State Board of Pharmacy, the Veterinary Medical California, the Cal Board, the Board of Registered Nursing, the Physician Assistant Board of the Medical Board of California, the Osteopathic Medical Board of California, the athic Medical Board, the State Naturopathic Medicine Committee of the Osteop Board of Optometry, and the California Board of Podiatric Medicine to operate and maintain CURES for the purposes of regulating the licensees specified in subdivision (b). plication and 209. CURES Prescription Drug Monitoring Program; Ap Approval Process The Department of Justice, in conjunction with the Department of Consumer Affairs and the boards and committees identified in subdivision (d) of Section 208, shall do all of the following: eamlined application and approval process to (a) Identify and implement a str provide access to the CURES Prescription Drug Monitoring Program (PDMP) database for licensed health care practitioners eligible to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, o r Schedule IV controlled substances and for pharmacists. Every reasonable effort shall be made to implement a streamlined application and approval process that a licensed health care practitioner or pharmacist can complete at the time that he lying for licensure or renewing his or her license. or she is app (b) Identify necessary procedures to enable licensed health care practitioners and pharmacists with access to the CURES PDMP to delegate their authority to order reports from the CURES PDMP. Devel op a procedure to enable health care practitioners who do not have a (c) federal Drug Enforcement Administration (DEA) number to opt out of applying for access to the CURES PDMP. 201

202 315.2 Violation of Probation; Order for Licensee to Cease Practice (a) A board , as described in Section 315, shall order a licensee of the board to cease practice if the licensee tests positive for any substance that is prohibited under the terms of the licensee’s probation or diversion program. (b) An order to cease practice under this section shall not be governed by the provisions of Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code. (c) A cease practice order under this section shall not constitute disciplinary action. (d) This section shall have no effect on the Board of Registered Nursing pursuant to Article 3.1 (commencing with Section 2770) of Chapter 6 of Division 2. 315.4 . Order Clinical Diagnostic Evaluation for Licensee (a) A board, as described in Section 315, may ad opt regulations authorizing the board to order a licensee on probation or in a diversion program to cease practice for major violations and when the board orders a licensee to undergo a clinical diagnostic evaluation pursuant to the uniform and specific st andards adopted and authorized under Section 315. (b) An order to cease practice under this section shall not be governed by the provisions of Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code. (c) A ceas e practice order under this section shall not constitute disciplinary action. (d) This section shall have no effect on the Board of Registered Nursing pursuant to Article 3.1 (commencing with Section 2770) of Chapter 6 of Division 2. 460. Licensed Depart ment of Consumer Affairs Businesses (a) No city, county, or city and county shall prohibit a person or group of persons, authorized by one of the agencies in the Department of Consumer Affairs or an entity established pursuant to this code by a license, c ertificate, or other means to engage in a particular business, from engaging in that business, occupation, or profession or any portion of that business, occupation, or profession. (b) (1) No city, county, or city and county shall prohibit a healing arts professional licensed with the state under Division 2 (commencing with Section 500) or licensed or certified by an entity established pursuant to this code from engaging in any act or performing any procedure that falls within the professionally recognized scope of practice of that licensee. (2) This subdivision shall not be construed to prohibit the enforcement of a local ordinance in effect prior to January 1, 2010, related to any act or practice of a procedure that falls within the professionally recognized scope of healing arts professional licensed under Division 2 (commencing with Section 500). 202

203 (c) This section shall not be construed to prevent a city, county, or city and county from adopting or enforcing any local ordinance governing zoning, s licensing, or reasonable health and safety requirements for busines establishments or businesses of a healing arts professional licensed under Division 2 (commencing with Section 500) or licensed or certified by an entity or group of persons described in established under this code or a person subdivision (a). Nothing in this section shall prohibit any city, county, or city and county (d) from levying a business license tax solely for revenue purposes, nor any city or county from levying a license tax solely for the purpose of covering the cost of regulation. Licensure/Registration Related to Section 31 476. (a) Except as provided in subdivision (b), nothing in this division shall apply ncing to the licensure or registration of persons pursuant to Chapter 4 (comme with Section 6000) of Division 3, or pursuant to Division 9 (commencing with Section 23000) or pursuant to Chapter 5 (commencing with Section 19800) of Division 8. (b) Section 494.5 shall apply to the licensure of persons authorized to practice law pursuant to Chapter 4 (commencing with Section 6000) of Division 3, and the licensure or registration of persons pursuant to Chapter 5 (commencing with Section 19800) of Division 8 or pursuant to Division 9 (commencing with Section 23000). 480. Denial o f Licenses A board may deny a license regulated by this code on the grounds that the (a) applicant has one of the following: (1) Been convicted of a crime. A conviction within the meaning of this section means a plea or verdict of guilty or a conviction following a plea of nolo contendere. Any action that a board is permitted to take following the establishment of a conviction may be taken when the time for appeal has elapsed, or the judgment of conviction has been affirmed on appeal, or when an order gra nting probation is made suspending the imposition of sentence, irrespective of a subsequent order under the provisions of Section 1203.4, 1203.4a, or 1203.41 of the Penal Code. (2) Done any act involving dishonesty, fraud, or deceit with the intent to stantially benefit himself or herself or another, or substantially injure sub another. (3) (A) Done any act that if done by a licentiate of the business or profession in question, would be grounds for suspension or revocation of license. (B) The board may de ny a license pursuant to this subdivision only if the crime or act is substantially related to the qualifications, functions, or duties of the business or profession for which application is made. rson shall not be Notwithstanding any other provision of this code, a pe (b) denied a license solely on the basis that he or she has been convicted of a felony if he or she has obtained a certificate of rehabilitation under Chapter 3.5 (commencing with Section 4852.01) of Title 6 of Part 3 of the Penal Code or 203

204 tha t he or she has been convicted of a misdemeanor if he or she has met all applicable requirements of the criteria of rehabilitation developed by the board to evaluate the rehabilitation of a person when considering the denial of a license under subdivision (a) of Section 482. (c) Notwithstanding any other provisions of this code, a person shall not be denied a license solely on the basis of a conviction that has been dismissed pursuant to Section 1203.4, 1203.4a, or 1203.41 of the Penal Code. An applicant w ho has a conviction that has been dismissed pursuant to Section 1203.4, 1203.4a, or 1203.41 of the Penal Code shall provide proof of the dismissal. A board may deny a license regulated by this code on the ground that the (d) applicant knowingly made a fal se statement of fact that is required to be revealed in the application for the license. 494.5. License Shall Not be Issued, Reactivated, Reinstated, or Renewed and be Suspended if Named on Certified Tax Delinquencies List (a) (1) Except as provided in paragraphs (2), (3), and (4), a state governmental licensing entity shall refuse to issue, reactivate, reinstate, or renew a license and shall suspend a license if a licensee's name is included on a certified list. ll suspend a license if a licensee's (2) The Department of Motor Vehicles sha name is included on a certified list. Any reference in this section to the issuance, reactivation, reinstatement, renewal, or denial of a license shall not apply to the Department of Motor Vehicles. (3) The State Bar o f California may recommend to refuse to issue, reactivate, reinstate, or renew a license and may recommend to suspend a license if a licensee's name is included on a certified list. The word "may" shall be substituted for the word "shall" relating to the i ssuance of a temporary license, refusal to issue, reactivate, reinstate, renew, or suspend a license in this section for licenses under the jurisdiction of the California Supreme Court. (4) The Alcoholic Beverage Control Board may refuse to issue, reacti vate, reinstate, or renew a license, and may suspend a license, if a licensee's name is included on a certified list. (b) For purposes of this section: (1) "Certified list" means either the list provided by the State Board of Equalization or the list pro vided by the Franchise Tax Board of persons whose names appear on the lists of the 500 largest tax delinquencies pursuant to Section 7063 or 19195 of the Revenue and Taxation Code, as applicable. (2) "License" includes a certificate, registration, or any other authorization to engage in a profession or occupation issued by a state governmental licensing entity. "License" includes a driver's license issued pursuant to Chapter 1 (commencing with Section 12500) of Division 6 of the Vehicle Code. "License" exc ludes a vehicle registration issued pursuant to Division 3 (commencing with Section 4000) of the Vehicle Code. (3) "Licensee" means an individual authorized by a license to drive a motor vehicle or authorized by a license, certificate, registration, or ot her 204

205 authorization to engage in a profession or occupation issued by a state governmental licensing entity. (4) "State governmental licensing entity" means any entity listed in Section of 101, 1000, or 19420, the office of the Attorney General, the Department Insurance, the Department of Motor Vehicles, the State Bar of California, the Department of Real Estate, and any other state agency, board, or commission that issues a license, certificate, or registration authorizing an individual to engage in a profe ssion or occupation, including any certificate, business or occupational license, or permit or license issued by the Department of Motor Vehicles or the Department of the California Highway Patrol. "State governmental licensing entity" shall not include th e Contractors' State License Board. (c) The State Board of Equalization and the Franchise Tax Board shall each submit its respective certified list to every state governmental licensing entity. The certified lists shall include the name, social security number or taxpayer identification number, and the last known address of the persons identified on the certified lists. (d) Notwithstanding any other law, each state governmental licensing entity shall collect the social security number or the federal tax payer identification number from all applicants for the purposes of matching the names of the certified lists provided by the State Board of Equalization and the Franchise Tax Board to applicants and licensees. ntity shall determine whether an (e) (1) Each state governmental licensing e applicant or licensee is on the most recent certified list provided by the State Board of Equalization and the Franchise Tax Board. (2) If an applicant or licensee is on either of the certified lists, the state governmenta l licensing entity shall immediately provide a preliminary notice to the applicant or licensee of the entity's intent to suspend or withhold issuance or renewal of the license. The preliminary notice shall be delivered personally or by mail to the applican t's or licensee's last known mailing address on file with the state governmental licensing entity within 30 days of receipt of the certified list. Service by mail shall be completed in accordance with Section 1013 of the Code of Civil Procedure. tate governmental licensing entity shall issue a temporary license (A) The s valid for a period of 90 days to any applicant whose name is on a certified list if the applicant is otherwise eligible for a license. (B) The 90 - day time period for a temporary license sh all not be extended. Only one temporary license shall be issued during a regular license term and the term of the temporary license shall coincide with the first 90 days of the regular license term. A license for the full term or the remainder of the licen se term may be issued or renewed only upon compliance with this section. (C) In the event that a license is suspended or an application for a license or the renewal of a license is denied pursuant to this section, any funds paid by the ee shall not be refunded by the state governmental licensing applicant or licens entity. (f) (1) A state governmental licensing entity shall refuse to issue or shall suspend a license pursuant to this section no sooner than 90 days and no later 205

206 than 120 days of the mailing of the preliminary notice described in paragraph (2) of subdivision (e), unless the state governmental licensing entity has received a release pursuant to subdivision (h). The procedures in the administrative adjudication provisions of the Administrative P rocedure Act (Chapter 4.5 (commencing with Section 11400) and Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code) shall not apply to the denial or suspension of, or refusal to renew, a license or the issuanc e of a temporary license pursuant to this section. (2) Notwithstanding any other law, if a board, bureau, or commission listed in Section 101, other than the Contractors' State License Board, fails to take partment of Consumer Affairs action in accordance with this section, the De shall issue a temporary license or suspend or refuse to issue, reactivate, reinstate, or renew a license, as appropriate. (g) Notices shall be developed by each state governmental licensing entity. For an applicant or license e on the State Board of Equalization's certified list, the notice shall include the address and telephone number of the State Board of Equalization, and shall emphasize the necessity of obtaining a release from the State Board of Equalization as a conditio n for the issuance, renewal, or continued valid status of a license or licenses. For an applicant or licensee on the Franchise Tax Board's certified list, the notice shall include the address and size the telephone number of the Franchise Tax Board, and shall empha necessity of obtaining a release from the Franchise Tax Board as a condition for the issuance, renewal, or continued valid status of a license or licenses. (1) The notice shall inform the applicant that the state governmental licensing entity shall issue a temporary license, as provided in subparagraph (A) of paragraph (2) of subdivision (e), for 90 calendar days if the applicant is otherwise eligible and that upon expiration of that time period, the license will be denied unless the state gove rnmental licensing entity has received a release from the State Board of Equalization or the Franchise Tax Board, whichever is applicable. (2) The notice shall inform the licensee that any license suspended under this section will remain suspended unti l the state governmental licensing entity receives a release along with applications and fees, if applicable, to reinstate the license. (3) The notice shall also inform the applicant or licensee that if an application is denied or a license is suspende d pursuant to this section, any moneys paid by the applicant or licensee shall not be refunded by the state governmental licensing entity. The state governmental licensing entity shall also develop a form that the applicant or licensee shall use to request a release by the State Board of Equalization or the Franchise Tax Board. A copy of this form shall be included with every notice sent pursuant to this subdivision. (h) If the applicant or licensee wishes to challenge the submission of his or her name on a certified list, the applicant or licensee shall make a timely written request for release to the State Board of Equalization or the Franchise Tax Board, whichever is applicable. The send State Board of Equalization or the Franchise Tax Board shall immediately 206

207 a release to the appropriate state governmental licensing entity and the applicant or licensee, if any of the following conditions are met: (1) The applicant or licensee has complied with the tax obligation, either by payment of the unpaid taxes or entry into an installment payment agreement, as described in Section 6832 or 19008 of the Revenue and Taxation Code, to satisfy the unpaid taxes. (2) The applicant or licensee has submitted a request for release not later than s or licensee's receipt of a preliminary notice 45 days after the applicant' described in paragraph (2) of subdivision (e), but the State Board of Equalization or the Franchise Tax Board, whichever is applicable, will be unable to complete the release review and send notice of its fin dings to the applicant or licensee and state governmental licensing entity within 45 days after the State Board of Equalization's or the Franchise Tax Board's receipt of the applicant's or licensee's request for release. Whenever a release is granted under this paragraph, and, notwithstanding that release, the applicable license or licenses have been suspended erroneously, the state governmental licensing entity shall reinstate the applicable licenses with retroactive effect back to the date of the erroneou s suspension and that suspension shall not be reflected on any license record. (3) The applicant or licensee is unable to pay the outstanding tax obligation due to a current financial hardship. "Financial hardship" means financial hardship as determined b y the State Board of Equalization or the Franchise Tax Board, whichever is applicable, where the applicant or licensee is unable to pay any part of the outstanding liability and the applicant or licensee is unable to qualify for an installment payment arra ngement as provided for by Section 6832 or Section 19008 of the Revenue and Taxation Code. In order to establish the existence of a financial hardship, the applicant or licensee shall submit any information, including information related to reasonable busi ness and personal expenses, requested by the State Board of Equalization or the Franchise Tax Board, whichever is applicable, for purposes of making that determination. (i) An applicant or licensee is required to act with diligence in responding to notice s from the state governmental licensing entity and the State Board of Equalization or the Franchise Tax Board with the recognition that the temporary license will lapse or the license suspension will go into effect after 90 days and that the State Board of Equalization or the Franchise Tax Board must have time to act within that period. An applicant's or licensee's delay in acting, without good cause, which directly results in the inability of the State Board of Equalization or the Franchise Tax Board, whic hever is applicable, to complete a review of the applicant's or licensee's request for release shall not constitute the diligence required under this section which would justify the issuance of a release. An applicant or licensee shall have the burden of e stablishing that he or she diligently responded to notices from the state governmental licensing entity or the State Board of Equalization or the Franchise Tax Board and that any delay was not without good cause. e Franchise Tax Board shall create (j) The State Board of Equalization or th release forms for use pursuant to this section. When the applicant or licensee 207

208 has complied with the tax obligation by payment of the unpaid taxes, or entry into an installment payment agreement, or establishing the exist ence of a current financial hardship as defined in paragraph (3) of subdivision (h), the State Board of Equalization or the Franchise Tax Board, whichever is applicable, shall mail a release form to the applicant or licensee and provide a release to the ap propriate state governmental licensing entity. Any state governmental licensing entity that has received a release from the State Board of Equalization and the Franchise Tax Board pursuant to this subdivision shall process the days of its receipt. If the State Board of release within five business Equalization or the Franchise Tax Board determines subsequent to the issuance of a release that the licensee has not complied with their installment payment agreement, the State Board of Equalization or the Franch ise Tax Board, whichever is applicable, shall notify the state governmental licensing entity and the licensee in a format prescribed by the State Board of Equalization or the Franchise Tax Board, whichever is applicable, that the licensee is not in complia nce and the release shall be rescinded. The State Board of Equalization and the Franchise Tax Board may, when it is economically feasible for the state governmental licensing entity to develop an automated process for complying with this subdivision, notif y the state governmental licensing entity in a manner prescribed by the State Board of Equalization or the Franchise Tax Board, whichever is applicable, that the licensee has not complied with the installment payment agreement. Upon receipt of this notice, the state governmental licensing entity shall immediately notify the licensee on a form prescribed by the state governmental licensing entity that the licensee's license will be suspended on a specific date, and this date shall be no longer than 30 days f rom the date the form is mailed. The licensee shall be further notified that the license will remain suspended until a new release is issued in accordance with this subdivision. (k) The State Board of Equalization and the Franchise Tax Board may enter in to interagency agreements with the state governmental licensing entities necessary to implement this section. (l) Notwithstanding any other law, a state governmental licensing entity, with the approval of the appropriate department director or governing body, may impose a fee on a licensee whose license has been suspended pursuant to this section. The fee shall not exceed the amount necessary for the state governmental licensing entity to cover its costs in carrying out the provisions of this section. Fee s imposed pursuant to this section shall be deposited in the fund in which other fees imposed by the state governmental licensing entity are deposited and shall be available to that entity upon appropriation in the annual Budget Act. (m) The process desc ribed in subdivision (h) shall constitute the sole administrative remedy for contesting the issuance of a temporary license or the denial or suspension of a license under this section. o the (n) Any state governmental licensing entity receiving an inquiry as t licensed status of an applicant or licensee who has had a license denied or suspended under this section or who has been granted a temporary license 208

209 under this section shall respond that the license was denied or suspended or the temporary license wa s issued only because the licensee appeared on a list of the 500 largest tax delinquencies pursuant to Section 7063 or 19195 of the Revenue and Taxation Code. Information collected pursuant to this section by any state agency, board, or department shall be subject to the Information Practices Act of 1977 (Chapter 1 (commencing with Section 1798) of Title 1.8 of Part 4 of Division 3 of the Civil Code). Any state governmental licensing entity that discloses on its Internet Web site or other publication that t he licensee has had a license denied or suspended under this section or has been granted a temporary license under this section shall prominently disclose, in bold and adjacent to the e license information regarding the status of the license, that the only reason th was denied, suspended, or temporarily issued is because the licensee failed to pay taxes. (o) Any rules and regulations issued pursuant to this section by any state agency, board, or department may be adopted as emergency regulations in accorda nce with the rulemaking provisions of the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code). The adoption of these regulations shall be deemed an emergency and necessary the immediate preservation of the public peace, health, and safety, or for general welfare. The regulations shall become effective immediately upon filing with the Secretary of State. (p) The State Board of Equalization, the Franchise Tax Board, and state g overnmental licensing entities, as appropriate, shall adopt regulations as necessary to implement this section. (q) (1) Neither the state governmental licensing entity, nor any officer, employee, or agent, or former officer, employee, or agent of a state governmental licensing entity, may disclose or use any information obtained from the State Board of Equalization or the Franchise Tax Board, pursuant to this section, except to inform the public of the denial, refusal to renew, or suspension of a license or the issuance of a temporary license pursuant to this section. The release or other use of information received by a state governmental licensing entity pursuant to this section, except as authorized by this section, is punishable as a misdemeanor. This subdivision may not be interpreted to prevent the State Bar of California from filing a request with the Supreme Court of California to suspend a member of the bar pursuant to this section. f a temporary (2) A suspension of, or refusal to renew, a license or issuance o license pursuant to this section does not constitute denial or discipline of a licensee for purposes of any reporting requirements to the National Practitioner Data Bank and shall not be reported to the National Practitioner Data Bank or the Healthcare Integrity and Protection Data Bank. (3) Upon release from the certified list, the suspension or revocation of the applicant's or licensee's license shall be purged from the state governmental ation within three business licensing entity's Internet Web site or other public days. This paragraph shall not apply to the State Bar of California. 209

210 (r) If any provision of this section or the application thereof to any person or ons or circumstance is held invalid, that invalidity shall not affect other provisi applications of this section that can be given effect without the invalid provision or application, and to this end the provisions of this section are severable. (s) All rights to review afforded by this section to an applicant shall also be affor ded to a licensee. (t) Unless otherwise provided in this section, the policies, practices, and procedures of a state governmental licensing entity with respect to license suspensions under this section shall be the same as those applicable with respect t o suspensions pursuant to Section 17520 of the Family Code. (u) No provision of this section shall be interpreted to allow a court to review and prevent the collection of taxes prior to the payment of those taxes in violation of the California Constituti on. (v) This section shall apply to any licensee whose name appears on a list of the 500 largest tax delinquencies pursuant to Section 7063 or 19195 of the Revenue and Taxation Code on or after July 1, 2012. bited 650. Rebates or Discounts for Referral Prohi (a) Except as provided in Chapter 2.3 (commencing with Section 1400) of Division 2 of the Health and Safety Code, the offer, delivery, receipt, or acceptance by any person licensed under this division or the Chiropractic e, refund, commission, preference, patronage Initiative Act of any rebat dividend, discount, or other consideration, whether in the form of money or otherwise, as compensation or inducement for referring patients, clients, or customers to any person, irrespective of any membership, p roprietary interest or coownership in or with any person to whom these patients, clients, or customers are referred is unlawful. (b) The payment or receipt of consideration for services other than the referral of patients which is based on a percentage o f gross revenue or similar type of contractual arrangement shall not be unlawful if the consideration is commensurate with the value of the services furnished or with the fair rental the value of any premises or equipment leased or provided by the recipient to payer. (c) The offer, delivery, receipt, or acceptance of any consideration between a federally qualified health center, as defined in Section 1396d(l)(2)(B) of Title 42 of the United States Code, and any individual or entity providing goods, items, services, donations, loans, or a combination thereof, to the health center entity pursuant to a contract, lease, grant, loan, or other agreement, if that agreement contributes to the ability of the health center entity to maintain or increase the availabi lity, or enhance the quality, of services provided to a medically underserved population served by the health center, shall be permitted only to the extent sanctioned or permitted by federal law. (d) Except as provided in Chapter 2.3 (commencing with Sec tion 1400) of Division 2 of the Health and Safety Code and in Sections 654.1 and 654.2 of , it shall not be unlawful for any person licensed under this division to this code refer a person to any laboratory, pharmacy, clinic (including entities exempt 210

211 from licensure pursuant to Section 1206 of the Health and Safety Code), or health care facility solely because the licensee has a proprietary interest or coownership in the laboratory, pharmacy, clinic, or health care facility; provided, however, that the licen see's return on investment for that proprietary interest or coownership shall be based upon the amount of the capital investment or proportional ownership of the licensee which ownership interest is not based on the number or value of any patients referred . Any referral excepted under this section shall be unlawful if the prosecutor proves that there was no valid medical need for the referral. (e) Except as provided in Chapter 2.3 (commencing with Section 1400) of of and in Sections 654.1 and 654.2 Division 2 of the Health and Safety Code , it shall not be unlawful to provide nonmonetary remuneration, in the this code form of hardware, software, or information technology and training services, as described in subsections (x) and (y) of Section 1001.952 of T itle 42 of the Code of Federal Regulations, as amended October 4, 2007, as published in the Federal Register (72 Fed. Reg. 56632 and 56644), and subsequently amended versions. (f) "Health care facility" means a general acute care hospital, acute psychiat ric hospital, skilled nursing facility, intermediate care facility, and any other health facility licensed by the State Department of Public Health under Chapter 2 (commencing with Section 1250) of Division 2 of the Health and Safety Code. (g) Notwithsta nding the other subdivisions of this section or any other provision of law, the payment or receipt of consideration for advertising, wherein a licensee offers or sells services through a third party advertiser, shall - not constitute a referral of patients w hen the third - party advertiser does not itself recommend, endorse, or otherwise select a licensee. The fee paid to the third - party advertiser shall be commensurate with the service provided by the third - party advertiser. If the licensee determines, after c onsultation with the purchaser of the service, that the service provided by the licensee is not appropriate for the purchaser or if the purchaser elects not to receive the service for any reason and requests a refund, the purchaser shall receive a refund o f the full purchase price as determined by the terms of the advertising service agreement between the third - party advertiser and the licensee. The licensee shall disclose in the advertisement that a consultation is required and that the purchaser will rece ive a refund if not eligible to receive the service. This subdivision shall not apply to basic health care services, as defined in subdivision (b) of Section 1345 of the Health and Safety Code, or essential health benefits, as defined in Section 1367.005 o f the Health and Safety Code and Section 10112.27 of the Insurance Code. The entity that provides the advertising shall be able to demonstrate that the licensee consented in writing to the requirements of this subdivision. A third - party advertiser shall ma ke available to prospective purchasers advertisements for services of all licensees then advertising through the third - party advertiser in the applicable geographic region. In any advertisement offering a discount price for a service, the licensee so disclose the regular, nondiscounted price for that service. shall al (h) A violation of this section is a public offense and is punishable upon a first conviction by imprisonment in a county jail for not more than one year, or by 211

212 imprisonment pursuant to subdiv ision (h) of Section 1170 of the Penal Code, or by a fine not exceeding fifty thousand dollars ($50,000), or by both that imprisonment and fine. A second or subsequent conviction is punishable by imprisonment pursuant to subdivision (h) of Section 1170 of the Penal Code, or by that imprisonment and a fine of fifty thousand dollars ($50,000). 650.1. Lease Prohibition – Hospitals or Prescribers (a) Any amount payable to any hospital, as defined in Section 4028, or any pharmacy permit ownership by person or corporation prohibited from subdivision (a) of Section 4111 under any rental, lease or service arrangement with respect to the furnishing or supply of pharmaceutical services and products, which is determined as a percentage, fraction, or portion of (1) t he charges to patients or of (2) any measure of hospital or pharmacy revenue or cost, for pharmaceuticals and pharmaceutical services is prohibited. (b) Any lease or rental arrangement existing on the effective date of this section shall be in full compl iance with subdivision (a) by January 1, 1986. (c) Any lease or rental agreement entered into prior to January 1, 1980, that extends beyond the effective date of this section shall be construed to be in compliance with this section until its expiration o r the expiration of any option which is contained in any such lease or rental agreement provided that the lease or rental agreement contains provisions which limit pharmacy charges to the in the amounts not in excess of the prevailing charges in similar hospitals general geographic area. (d) The California State Board of Pharmacy, the Medical Board of California, and the State Department of Health Services shall enforce this section and may require information from any person as is necessary for the enfor cement of this section. It shall be the duty of the licensees of the respective regulatory agencies to produce the requisite evidence to show compliance with this section. Violations of this section shall be deemed to be the mutual lessee and lessor, and shall be grounds for disciplinary responsibility of both action or other sanctions against both. Professional Advertising Requirements . 651 (a) It is unlawful for any person licensed under this division or under any initiative act referred to in this division to disseminate or cause to be disseminated any form of public communication containing a false, fraudulent, misleading, or deceptive statement, claim, or image for the purpose of or likely to induce, directly or indirectly, the rendering of profes sional services or furnishing of products in connection with the professional practice or business for which he or she is licensed. A "public communication" as used in this section includes, but is not limited to, communication by means of mail, televisio n, radio, motion picture, newspaper, book, list or directory of healing arts practitioners, Internet, or other electronic communication. (b) A false, fraudulent, misleading, or deceptive statement, claim, or image ny of the following: includes a statement or claim that does a (1) Contains a misrepresentation of fact. 212

213 (2) Is likely to mislead or deceive because of a failure to disclose material facts. (3) (A) Is intended or is likely to create false or unjustified expectations of favorable results, includ ing the use of any photograph or other image that does not accurately depict the results of the procedure being advertised or that has been altered in any manner from the image of the actual subject depicted in the photograph or image. (B) Use of any phot ograph or other image of a model without clearly stating in a prominent location in easily readable type the fact that the photograph or image is of a model is a violation of subdivision (a). For purposes of this actual patient, who has undergone paragraph, a model is anyone other than an the procedure being advertised, of the licensee who is advertising for his or her services. (C) Use of any photograph or other image of an actual patient that depicts or purports to depict the results of any procedure, o r presents "before" and "after" views of a patient, without specifying in a prominent location in easily readable type size what procedures were performed on that patient is a violation of subdivision (a). Any "before" and "after" views (i) shall be compar able in presentation so that the results are not distorted by favorable poses, lighting, or other features of presentation, and (ii) shall contain a statement that the same "before" and "after" results may not occur for all patients. other than a standard consultation fee or a range of fees for (4) Relates to fees, specific types of services, without fully and specifically disclosing all variables and other material factors. (5) Contains other representations or implications that in reasonable probability will cause an ordinarily prudent person to misunderstand or be deceived. (6) Makes a claim either of professional superiority or of performing services in a superior manner, unless that claim is relevant to the service being performed and can be substant iated with objective scientific evidence. (7) Makes a scientific claim that cannot be substantiated by reliable, peer reviewed, published scientific studies. (8) Includes any statement, endorsement, or testimonial that is likely to mislead or deceive bec ause of a failure to disclose material facts. (c) Any price advertisement shall be exact, without the use of phrases, including, but not limited to, "as low as," "and up," "lowest prices," or words or phrases of similar import. Any advertisement that ref ers to services, or costs for services, and that uses words of comparison shall be based on verifiable data substantiating the comparison. Any person so advertising shall be prepared to provide information sufficient to establish the accuracy of that comp arison. Price advertising shall not be fraudulent, deceitful, or misleading, including statements or advertisements of bait, discount, premiums, gifts, or any statements of a similar nature. In connection with price advertising, the t or service shall be clearly identifiable. The price price for each produc advertised for products shall include charges for any related professional services, including dispensing and fitting services, unless the advertisement specifically and clearly indicates otherwise. 213

214 ( d) Any person so licensed shall not compensate or give anything of value to a representative of the press, radio, television, or other communication medium in anticipation of, or in return for, professional publicity unless the fact of compensation is made known in that publicity. (e) Any person so licensed may not use any professional card, professional announcement card, office sign, letterhead, telephone directory listing, medical ce if it list, medical directory listing, or a similar professional notice or devi includes a statement or claim that is false, fraudulent, misleading, or deceptive within the meaning of subdivision (b). (f) Any person so licensed who violates this section is guilty of a misdemeanor. A bona fide mistake of fact shall be a defe nse to this subdivision, but only to this subdivision. (g) Any violation of this section by a person so licensed shall constitute good cause for revocation or suspension of his or her license or other disciplinary action. (h) Advertising by any person so licensed may include the following: (1) A statement of the name of the practitioner. (2) A statement of addresses and telephone numbers of the offices maintained by the practitioner. ner. (3) A statement of office hours regularly maintained by the practitio (4) A statement of languages, other than English, fluently spoken by the practitioner or a person in the practitioner's office. (5) (A) A statement that the practitioner is certified by a private or public board or agency or a statement that the pra ctitioner limits his or her practice to specific fields. (i) For the purposes of this section, a dentist licensed under Chapter 4 (commencing with Section 1600) may not hold himself or herself out as a specialist, or advertise membership in or specialty r ecognition by an accrediting organization, unless the practitioner has completed a specialty education program approved by the American Dental Association and the Commission on Dental Accreditation, is eligible for examination by a national specialty board recognized by the American Dental Association, or is a diplomate of a national specialty board recognized by the American Dental Association. (ii) A dentist licensed under Chapter 4 (commencing with Section 1600) shall not represent to the public or adve rtise accreditation either in a specialty area of practice or by a board not meeting the requirements of clause (i) unless the dentist has attained membership in or otherwise been credentialed by an accrediting organization that is recognized by the board as a bona fide organization for that area of dental practice. In order to be recognized by the board as a bona fide accrediting organization for a specific area of dental practice other than a specialty area of dentistry authorized under clause (i), the o rganization shall condition membership or credentialing of its members upon all of the following: time advanced education program (I) Successful completion of a formal, full - that is affiliated with or sponsored by a university based dental school and is eyond the dental degree at a graduate or postgraduate level. b 214

215 (II) Prior didactic training and clinical experience in the specific area of dentistry that is greater than that of other dentists. based on (III) Successful completion of oral and written examinations psychometric principles. (iii) Notwithstanding the requirements of clauses (i) and (ii), a dentist who lacks membership in or certification, diplomate status, other similar credentials, by an American or completed advanced training approved as bona fide either Dental Association recognized accrediting organization or by the board, may announce a practice emphasis in any other area of dental practice only if the dentist incorporates in capital letters or some other manner clearly distinguishable fr om the rest of the announcement, solicitation, or advertisement that he or she is a general dentist. (iv) A statement of certification by a practitioner licensed under Chapter 7 (commencing with Section 3000) shall only include a statement that he or she is certified or eligible for certification by a private or public board or parent association recognized by that practitioner's licensing board. (B) A physician and surgeon licensed under Chapter 5 (commencing with lifornia may include a statement that Section 2000) by the Medical Board of Ca he or she limits his or her practice to specific fields, but shall not include a statement that he or she is certified or eligible for certification by a private or public board or parent association, including, but no t limited to, a multidisciplinary board or association, unless that board or association is (i) an American Board of Medical Specialties member board, (ii) a board or association with equivalent requirements approved by that physician and surgeon's licensi ng board, or (iii) a board or association with an Accreditation Council for Graduate Medical Education approved postgraduate training program that provides complete training in that specialty or subspecialty. A physician and surgeon licensed under Chapter 5 (commencing with Section 2000) by the Medical Board of California who is certified by an organization other than a board or association referred to in clause (i), (ii), or (iii) shall not , unless the use the term "board certified" in reference to that certification physician and surgeon is also licensed under Chapter 4 (commencing with Section 1600) and the use of the term "board certified" in reference to that certification is in accordance with subparagraph (A). A physician and surgeon licensed under Chapter 5 (commencing with Section 2000) by the Medical Board of California who is certified by a board or association referred to in clause (i), (ii), or (iii) shall not use the term "board certified" unless the full sed and given comparable prominence name of the certifying board is also u with the term "board certified" in the statement. For purposes of this subparagraph, a "multidisciplinary board or association" means an educational certifying body that has a psychometrically valid testing process, as determined by the Medical Board of California, for certifying medical doctors and other health care professionals that is based on the applicant's education, training, and experience. ph, the For purposes of the term "board certified," as used in this subparagra terms "board" and "association" mean an organization that is an American Board of Medical Specialties member board, an organization with equivalent 215

216 requirements approved by a physician and surgeon's licensing board, or an organization with an Accre ditation Council for Graduate Medical Education approved postgraduate training program that provides complete training in a specialty or subspecialty. The Medical Board of California shall adopt regulations to establish and collect a reasonable fee from ea ch board or association applying for recognition pursuant to this subparagraph. The fee shall not exceed the cost of administering this subparagraph. Notwithstanding Section 2 of Chapter 1660 of the Statutes of 1990, this subparagraph shall become operati ve July 1, 1993. However, an administrative agency or accrediting organization may take any action contemplated by this subparagraph relating to the establishment or approval of specialist requirements on and after January 1, 1991. (C) A doctor of podiat ric medicine licensed under Chapter 5 (commencing with Section 2000) by the Medical Board of California may include a statement that he or she is certified or eligible or qualified for certification by a private or public board or parent association, inclu ding, but not limited to, a multidisciplinary board or association, if that board or association meets one of the following requirements: (i) is approved by the Council on Podiatric Medical Education, rements approved by the (ii) is a board or association with equivalent requi California Board of Podiatric Medicine, or (iii) is a board or association with the Council on Podiatric Medical Education approved postgraduate training programs that provide training in podiatric medicine and podiatric surgery. A doctor of podiatric medicine licensed under Chapter 5 (commencing with Section 2000) by the Medical Board of California who is certified by a board or association referred to in clause (i), (ii), or (iii) shall not use the term "board certified" unless th e full name of the certifying board is also used and given comparable prominence with the term "board certified" in the statement. A doctor of podiatric medicine licensed under Chapter 5 (commencing with Section 2000) by the Medical Board of California wh o is certified by an organization other than a board or association referred to in clause (i), (ii), or (iii) shall not use the term "board certified" in reference to that certification. sociation" For purposes of this subparagraph, a "multidisciplinary board or as means an educational certifying body that has a psychometrically valid testing process, as determined by the California Board of Podiatric Medicine, for certifying doctors of podiatric medicine that is based on the applicant's education, trainin g, and experience. For purposes of the term "board certified," as used in this subparagraph, the terms "board" and "association" mean an organization that is a Council on Podiatric Medical Education approved board, an organization with equivalent requirem ents approved by the California Board of Podiatric Medicine, or an organization with a Council on Podiatric Medical Education approved postgraduate training program that provides training in podiatric medicine and podiatric surgery. The California Board of Podiatric Medicine shall adopt regulations to establish and collect a reasonable fee from each board or association applying for recognition pursuant to this subparagraph, to be deposited in the State 216

217 Treasury in the Podiatry Fund, pursuant to Section 2 499. The fee shall not exceed the cost of administering this subparagraph. (6) A statement that the practitioner provides services under a specified private or public insurance plan or health care plan. (7) A statement of names of schools and postgradua te clinical training programs from which the practitioner has graduated, together with the degrees received. (8) A statement of publications authored by the practitioner. (9) A statement of teaching positions currently or formerly held by the practitione r, together with pertinent dates. (10) A statement of his or her affiliations with hospitals or clinics. (11) A statement of the charges or fees for services or commodities offered by the practitioner. (12) A statement that the practitioner regularly ac cepts installment payments of fees. (13) Otherwise lawful images of a practitioner, his or her physical facilities, or of a commodity to be advertised. (14) A statement of the manufacturer, designer, style, make, trade name, brand ype of commodities advertised. name, color, size, or t (15) An advertisement of a registered dispensing optician may include statements in addition to those specified in paragraphs (1) to (14), inclusive, provided that any statement shall not violate subdivision (a), (b), (c), o r (e) or any other section of this code. (16) A statement, or statements, providing public health information encouraging preventative or corrective care. (17) Any other item of factual information that is not false, fraudulent, misleading, or likely to deceive. (i) Each of the healing arts boards and examining committees within Division 2 shall adopt appropriate regulations to enforce this section in accordance with Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Go vernment Code. Each of the healing arts boards and committees and examining committees within Division 2 shall, by regulation, define those efficacious services to be advertised by businesses or professions under their jurisdiction for the purpose of dete rmining whether advertisements are false or misleading. Until a definition for that service has been issued, no advertisement for that service shall be disseminated. However, if a definition of a service has not been issued by a board or committee within 120 days of receipt of a request from a licensee, all those holding the license may advertise the service. Those boards and committees shall adopt or modify regulations defining what services may be advertised, and advertised, the manner in which defined services may be restricting advertising that would promote the inappropriate or excessive use of health services or commodities. A board or committee shall not, by regulation, unreasonably prevent truthful, nondeceptive price or otherwise lawful forms of advertising of services or commodities, by either outright prohibition or imposition of onerous disclosure requirements. However, any member of a 217

218 board or committee acting in good faith in the adoption or enforcement of any regulation shall be deemed to be acting as an agent of the state. (j) The Attorney General shall commence legal proceedings in the appropriate forum to enjoin advertisements disseminated or about to be disseminated in orce this section. violation of this section and seek other appropriate relief to enf Notwithstanding any other provision of law, the costs of enforcing this section to the respective licensing boards or committees may be awarded against any ot licensee found to be in violation of any provision of this section. This shall n diminish the power of district attorneys, county counsels, or city attorneys pursuant to existing law to seek appropriate relief. (k) A physician and surgeon or doctor of podiatric medicine licensed pursuant to Chapter 5 (commencing with Section 2000) by the Medical Board of California who knowingly and intentionally violates this section may be cited and assessed an administrative fine not to exceed ten thousand dollars ($10,000) per event. Section 125.9 shall govern the issuance of this citation and fine except that the fine limitations prescribed in paragraph (3) of subdivision (b) of Section 125.9 shall not apply to a fine under this subdivision. 652. Violation as Unprofessional Conduct Violation of this article in the case of a licensed person constitutes unprofessional conduct and grounds for suspension or revocation of his or her license by the board by whom he or she is licensed, or if a license has been issued in connection with a place of business, then for the suspension or revocation of the place of business in connection with which the violation occurs. The proceedings for suspension or revocation shall be conducted in accordance with Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code, an d each board shall have all the powers granted therein. However, in the case of a licensee of the State Department of Health Services, the proceedings shall be conducted in accordance with Section 110171 of the Health and Safety Code. In addition, any vi olation constitutes a misdemeanor as to any and all persons offering, delivering, receiving, accepting, or participating in any rebate, refund, commission, preference, patronage dividend, unearned discount, or consideration, whether or not licensed under t his division, and is punishable by imprisonment in the county jail not exceeding six months, by a fine not exceeding two thousand five hundred dollars ($2,500), or by both the imprisonment and fine. 652.5 . Violation as Misdemeanor Except as otherwise p rovided in this article, any violation of this article constitutes a misdemeanor as to any and all persons, whether or not licensed under this division, and is punishable by imprisonment in the county jail not exceeding six months, or by a fine not exceedi ng two thousand five hundred dollars ($2,500), or by both the imprisonment and fine. 218

219 733. Dispensing Prescription Drugs and Devices (a) A licentiate shall not obstruct a patient in obtaining a prescription drug or bed or ordered for that patient. A violation device that has been legally prescri of this section constitutes unprofessional conduct by the licentiate and shall subject the licentiate to disciplinary or administrative action by his or her licensing agency. (b) Notwithstanding any other law, a licentiate shall dispense drugs and devices, as described in subdivision (a) of Section 4024, pursuant to a lawful order or prescription unless one of the following circumstances exists: (1) Based solely on the licentiate’s professional training and j udgment, dispensing pursuant to the order or the prescription is contrary to law, or the licentiate determines that the prescribed drug or device would cause a harmful drug interaction or would otherwise adversely affect the patient’s medical condition. ( 2) The prescription drug or device is not in stock. If an order, other than an order described in Section 4019, or prescription cannot be dispensed because the drug or device is not in stock, the licentiate shall take one of the following actions: (A) Im mediately notify the patient and arrange for the drug or device to be delivered to the site or directly to the patient in a timely manner. Promptly transfer the prescription to another pharmacy known to stock the (B) ear enough to the site from which the prescription drug or device that is n prescription or order is transferred, to ensure the patient has timely access to the drug or device. (C) Return the prescription to the patient and refer the patient. The licentiate shall make a reasonable effort to refer the patient to a pharmacy that stocks the prescription drug or device that is near enough to the referring site to ensure that the patient has timely access to the drug or device. (3) The licentiate refuses on ethical, moral, or religious grounds t o dispense a drug or device pursuant to an order or prescription. A licentiate may decline to dispense a prescription drug or device on this basis only if the licentiate has previously notified his or her employer, in writing, of the drug or class of drugs to which he or she objects, and the licentiate’s employer can, without creating undue hardship, provide a reasonable accommodation of the licentiate’s objection. The licentiate’s employer shall establish protocols that ensure that the patient has timely a ccess to the prescribed drug or device despite the licentiate’s refusal to dispense the prescription or order. For purposes of this section, “reasonable accommodation” and “undue hardship” shall have the same meaning as applied to those terms pursuant to s ubdivision (l) of Section 12940 of the Government Code. (c) For the purposes of this section, “prescription drug or device” has the same meaning as the definition in Section 4022. (d) This section applies to emergency contraception drug therapy and self - administered hormonal contraceptives described in Section 4052.3. This section imposes no duty on a licentiate to dispense a drug or device (e) pursuant to a prescription or order without payment for the drug or device, 219

220 patient or through a third - party payer including payment directly by the accepted by the licentiate or payment of any required copayment by the patient. (f) The notice to consumers required by Section 4122 shall include a statement ents of this section. that describes patients’ rights relative to the requirem Authorization for Out - of - State Health Practitioner to Participate in 901. in California Sponsored Events (a) For purposes of this section, the following provisions apply: (1) “Board” means the applicable healing arts board, unde r this division or an initiative act referred to in this division, responsible for the licensure or regulation in this state of the respective health care practitioners. “Health care practitioner” means any person who engages in acts that are (2) to licensure or regulation under this division or under any initiative act subject referred to in this division. (3) “Sponsored event” means an event, not to exceed 10 calendar days, administered by either a sponsoring entity or a local government, or both, thr ough which health care is provided to the public without compensation to the health care practitioner. (4) “Sponsoring entity” means a nonprofit organization organized pursuant to based - Internal Revenue Code or a community Section 501(c)(3) of the ization. organ (5) “Uninsured or underinsured person” means a person who does not have health care coverage, including private coverage or coverage through a program funded in whole or in part by a governmental entity, or a person who has health but the coverage is not adequate to obtain those health care care coverage, services offered by the health care practitioner under this section. (b) A health care practitioner licensed or certified in good standing in another state, district, or territory of the Unite d States who offers or provides health care services for which he or she is licensed or certified is exempt from the requirement for licensure if all of the following requirements are met: following: (1) Prior to providing those services, he or she does all of the Obtains authorization from the board to participate in the sponsored event (A) after submitting to the board a copy of his or her valid license or certificate from each state in which he or she holds licensure or certification and a photograph ic identification issued by one of the states in which he or she holds licensure or certification. The board shall notify the sponsoring entity, within 20 calendar days of receiving a request for authorization, whether that request is approved or denied, p rovided that, if the board receives a request for authorization less than 20 days prior to the date of the sponsored event, the board shall make reasonable efforts to notify the sponsoring entity whether that of that sponsored event. request is approved or denied prior to the date (B) Satisfies the following requirements: The health care practitioner has not committed any act or been convicted of (i) a crime constituting grounds for denial of licensure or registration under Section 480 and is in good st anding in each state in which he or she holds licensure or certification. 220

221 (ii) The health care practitioner has the appropriate education and experience to participate in a sponsored event, as determined by the board. (iii) The health care practitioner shall agree to comply with all applicable practice requirements set forth in this division and the regulations adopted pursuant to this division. (C) Submits to the board, on a form prescribed by the board, a request for t a license, and pays a fee, in an amount authorization to practice withou determined by the board by regulation, which shall be available, upon appropriation, to cover the cost of developing the authorization process and processing the request. The services are provided under all o f the following circumstances: (2) (A) To uninsured or underinsured persons. calendar On a short - term voluntary basis, not to exceed a 10 - - day period (B) per sponsored event. (C) In association with a sponsoring entity that complies with subdivision (d). Without charge to the recipient or to a third party on behalf of the (D) recipient. (c) The board may deny a health care practitioner authorization to practice without a license if the health care practitioner fails to comply with this section or for a ny act that would be grounds for denial of an application for licensure. A sponsoring entity seeking to provide, or arrange for the provision of, (d) health care services under this section shall do both of the following: (1) - Register with each applica ble board under this division for which an out - state health care practitioner is participating in the sponsored event by of completing a registration form that shall include all of the following: (A) The name of the sponsoring entity. The name of t he principal individual or individuals who are the officers or (B) organizational officials responsible for the operation of the sponsoring entity. (C) The address, including street, city, ZIP Code, and county, of the sponsoring entity’s principal office and each individual listed pursuant to subparagraph (B). (D) The telephone number for the principal office of the sponsoring entity and each individual listed pursuant to subparagraph (B). (E) Any additional information required by the board. (2) Provid e the information listed in paragraph (1) to the county health department of the county in which the health care services will be provided, along with any additional information that may be required by that department. (e) The sponsoring entity shall not ify the board and the county health department described in paragraph (2) of subdivision (d) in writing of any change to the information required under subdivision (d) within 30 calendar days of the change. (f) Within 15 calendar days of the provision of health care services pursuant to this section, the sponsoring entity shall file a report with the board and the county health department of the county in which the health care services were neral description provided. This report shall contain the date, place, type, and ge of the care provided, along with a listing of the health care practitioners who participated in providing that care. 221

222 (g) The sponsoring entity shall maintain a list of health care practitioners associated with the provision of health ca re services under this section. The sponsoring entity shall maintain a copy of each health care practitioner’s current license or certification and shall require each health care practitioner to attest in writing that his or her license or certificate is n ot suspended or revoked pursuant to disciplinary proceedings in any jurisdiction. The sponsoring entity shall maintain these records for a period of at least five years following the provision of health care services under this section and shall, upon requ est, furnish those records to the board or any county health department. (h) A contract of liability insurance issued, amended, or renewed in this state on or after January 1, 2011, shall not exclude coverage of a health care practitioner or a sponsoring entity that provides, or arranges for the provision of, health care services under this section, provided that the practitioner or entity complies with this section. (i) Subdivision (b) shall not be construed to authorize a health care practitioner to r ender care outside the scope of practice authorized by his or her license or certificate or this division. (1) The board may terminate authorization for a health care practitioner to (j) o comply with provide health care services pursuant to this section for failure t this section, any applicable practice requirement set forth in this division, any regulations adopted pursuant to this division, or for any act that would be grounds for discipline if done by a licensee of that board. (2) The board shall pr ovide both the sponsoring entity and the health care practitioner with a written notice of termination including the basis for that termination. The health care practitioner may, within 30 days after the date of the receipt of notice of termination, file a written appeal to the board. The appeal shall include any documentation the health care practitioner wishes to present to the board. (3) A health care practitioner whose authorization to provide health care services pursuant to this section has been ter minated shall not provide health care services pursuant to this section unless and until a subsequent request for authorization has been approved by the board. A health care practitioner who provides health care services in violation of this paragraph shal l be deemed to be practicing health care in violation of the applicable provisions of this division, and be subject to any applicable administrative, civil, or criminal fines, penalties, and other sanctions provided in this division. f this section are severable. If any provision of this section (k) The provisions o or its application is held invalid, that invalidity shall not affect other provisions or applications that can be given effect without the invalid provision or application. (l) This section s hall remain in effect only until January 1, 2018, and as of that date is repealed, unless a later enacted statute, that is enacted before January 1, 2018, deletes or extends that date. 222

223 17500. False or Misleading Statements, Generally It is unlawful for any person, firm, corporation or association, or any employee thereof with intent directly or indirectly to dispose of real or personal property or to perform services, professional or otherwise, or anything of any nature whatsoever or to induce the pu blic to enter into any obligation relating thereto, to make or disseminate or cause to be made or disseminated before the public in this state, or to make or disseminate or cause to be made or any newspaper or disseminated from this state before the public in any state, in other publication, or any advertising device, or by public outcry or proclamation, or in any other manner or means whatever, including over the Internet, any statement, concerning that real or personal property or those services, professi onal or otherwise, or concerning any circumstance or matter of fact connected with the proposed performance or disposition thereof, which is untrue or misleading, and which is known, or which by the exercise of or misleading, or for any person, reasonable care should be known, to be untrue firm, or corporation to so make or disseminate or cause to be so made or disseminated any such statement as part of a plan or scheme with the intent not herwise, so to sell that personal property or those services, professional or ot advertised at the price stated therein, or as so advertised. Any violation of the provisions of this section is a misdemeanor punishable by imprisonment in the county jail not exceeding six months, or by a fine not exceeding two thousand hundred dollars ($2,500), or by both that imprisonment and fine. five 223

224 CALIFORNIA CODE OF REGULATIONS DIVISION 17, TITLE 16 Article 1. General Provisions Section 1702 Pharmacist Renewal Requirements Pharmacy Technician Renewal Requirements 1702.1. 1702. esignated Representative Renewal Requirements 2 . D 1702.5. Disclosure of Discipline, Renewal, Nonresident Wholesaler or Nonresident Pharmacy. Delegation of Certain Functions 1703. Change of Address 1704. Notification of Bankruptcy, Receivership or Liq uidation 1705. Words of Similar Import 1706. 1706.1. Permit Processing Times Abandonment of Application Files 1706.2. Experimental Programs 1706.5. Article 2. Pharmacies Section Waiver Requirements for Off - Site Storage of Records 1707. 1707.1. tain Medication Profiles (Patient Medication Records) Duty to Main 1707.2. Duty to Consult Duty to Review Drug Therapy and Patient Medication Record Prior to 1707.3. Delivery 1707.4. Procedures for Refill Pharmacies Containers ug Dr Prescription 1707.5 Patient - Centered Labels for ; Requirements 1707.6 Notice to Consumers 1708.2. Discontinuance of Business Radioactive Drugs 1708.3. 1708.4. Pharmacist Handling Radioactive Drugs 1708.5. Pharmacy Furnishing Radioactive Drugs 1709. Names of Owners and Pharmacist - in - Cha rge Charge 1709.1. Designation of Pharmacist - in - 1710. Hospital Pharmacy 1711. Quality Assurance Programs 1712. Use of Pharmacist Identifiers 1713. Receipt and Delivery of Prescriptions and Prescription Medications T o or F Must be rom Licensed Pharmacy 1714. Operational Standards and Security 1714.1. Pharmacy Operations d uring Temporary Absence of a Pharmacist 1714.5 Dangerous Drugs and Devices Exempt from Provisions of Chapter 9, Division 2 of the Business and Professions Code 1715. Self - Assessment of a Pharmacy by the Pharmacist - in - Charge 1715.5. Implementation of Electronic Monitoring of Schedule II Prescriptions Reporting Drug Loss 1715.6. 224

225 Section 1715.65. Inventory Reconciliation Report of Controlled Substances rom Prescripti ons 1716. Variation f Pharmac y Practice 1717. 1717.1. Common Electronic Files 3. Preprinted, Multiple Check o ff Prescription Blanks 1717. 1717.4. Electronic Transmission of Prescriptions 1718. Current Inventory Defined 1718.1 Manufacturer’s Expiration Date Article 3. Ph armacist Candidates Section 1719. Recognized Schools of Pharmacy 1720. Application for Pharmacist Examination and Licensure 1720.1. Graduates of Foreign Pharmacy Schools 1721. Dishonest Conduct d uring Examination 1723.1. Confidentiality of Examinatio n Questions 1724. Passing Grade in Pharmacist Examination 1725. Acceptable Pharmacy Coursework for Examination Candidates with Four Failed Attempts 1726. Supervision of Intern Pharmacists dress Not Available on Internet Intern Ad 1727.1 1727.2 nts for Pharmacist Intern Requireme 1728. Requirements for Examination Article 3.5. Advanced Practice Pharmacist Section 1730. Acceptable Certification Programs 1730.1 . Application Requirements for Advanced Practice Pharmacist Licensure 1730.2. Certification Pr ograms 1731. Experimental Programs Article 4. Continuing Education Section 1732. Definitions 1732.05. Accreditation Agencies for Continuing Education 1732.1. Requirements for Accredited Providers 1732.2. Board Accredited Continuing Education R 1732.3. equirements for Continuing Education Courses 1732.4. Provider Audit Requirements 1732.5. Renewal Requirements for Pharmacist 1732.6. Exemptions 1732.7. Complaint Mechanism Article 4.5 Compounding Section 1735. Compounding in Licensed Pharmacies . Compounding Definitions 173 5.1 225

226 . Compounding Limitations and Requirements ; Self - Assessment 1735.2 Section 1735.3 . Record keeping of Compounded Drug Preparations 1735.4 . Labeling of Compounded Drug Preparations 1735.5 Compounding Policies and Procedures . 1735.6 . Compounding Facilities and Equipment 1735.7 . Training of Compounding Staff Compounding Quality Assurance 1735.8 . Article 5. Dangerous Drugs Section 1744. Drug Warnings 1745. Partial Filling of Schedule II Prescriptions 1746. Emergency Contrac eption 1746.1. Protocol for Pharmacists Furnishing Self - Administered Hormonal Contraception 1746.2. Protocol for Pharmacists Furnishing Nicotine Replacement Products 1746.3. Protocol for Pharmacists Furnishing Naloxone Hydrochloride 1746.4. Pharmacists Initiating and Administering Vaccines 1746.5. Pharmacists Furnishing Travel Medications Article 6. Fees Section Fee Schedule 1749. Article 7. Sterile Compounding Section Sterile ; Compounding Area ; Self - Assessment Compounding 1751. Sterile Com pounding Recordkeeping Requirements 1751.1. Compounding Sterile 1751.2. Labeling Requirements 1751.3 Sterile Compounding Policies and Procedures 4 Facility and Equipment Standards for Sterile Compounding 1751. 1751. 5 . Sterile Compounding Attire 6 1751. . Steril e Compounding Consultation; Training of Sterile Compounding Staff Quality Assurance and Process Validation 1751.7. Sterile Compounding 1751. . Beyond Use Dating for Sterile Compounded Drug Preparations 8 1751.9. Single - Dose and Multi - Dose Containers; Limi tations on Use 1751.10. Sterile Compounding Reference Materials Article 7.5. Furnishing for Home Administrations Section 1752. Furnishing to Parenteral Patient at Home 175 3 . Furnishing to Home Health Agencies and Licensed Hospices a Pharmacy Furnishing Portable Containers Obligations of 1754. 226

227 Prohibitions and Discipline Article 8. Section 1760. Disciplinary Guidelines Erroneous or Uncertain Prescriptions 1761. Unauthorized Disclosure of Prescriptions 1764. 1765. es Commissions, Gratuities, and Rebat 1766. False or Misleading Advertising - 1768. Reapplication Denial of Application 1769. Criteria for Rehabilitation 1770. Substantial Relationship Criteria 1771. Posting of Notice of Suspension 1772. Disciplinary Condition of Suspension Dis ciplinary Conditions of Probation of Pharmacist 1773. Ethics Course Required as Condition of Probation 1773.5 1774. Disciplinary Conditions of Probation of Permit Article 9. Citations and Fines Section 1775. Issuing Citations 1775.1 Amount of Fines 1775.2. Factors Considered 1775.3. Compliance w ith Orders of Abatement Contested Citations 1775.4. Article 9 Prescription Drug Take - Back Services . .1 Section Prescription Drug Take - Back Services: Authorization 1776. .1 6 . Pharmacies 177 177 .2. Pharmacies Offer ing Mail Back Envelope or Package Services 6 177 6 .3. Collection Receptacles in Pharmacies 177 6 .4. Drug Take - Back Services in Skilled Nursing Facilities 1776.5. Reverse Distributors 1776.6. Record Keeping Requirements for Board Licensees Providing Drug Tak e - Back Services Article 10. Wholesalers Section 1780. Minimum Standards for Wholesalers 1780.1 - Minimum Standards for Veterinary Food Animal Drug Retailers 1781. Exemption Certificate 1782. Reporting Sales of Drugs Subject to Abuse 1783. Manufacturer o r Wholesaler Furnishing Drugs or Devices - in 1784. Self - Assessment of a Wholesaler by the Designated Representative - Charge 227

228 Article 10.1. Home Dialysis Drugs and Devices Section 1787. Authorization to Distribute Hemodialysis Drugs and Devices 1790. Assemb ling and Packaging 1791. Labeling 1792. Receipt for Shipment Article 11. Ancillary Personnel Section Definitions 1793. Duties of a Pharmacist 1793.1. Duties of a Pharmacy Technician 1793.2. Licensed Pharmacy Personnel 1793.3. Other Non - acy Technician Application 1793.5. Pharm 1793.6. Training Courses Specified by the Board 1793.7. Requirements for Pharmacies Employing Pharmacy Technicians Technicians in Hospitals with Clinical Pharmacy Programs 1793.8. 228

229 CALIFORNIA CODE OF REGULATIONS DIVISION 17, TITLE 16 Article 1. General Provisions 1702. Pharmacist Renewal Requirements (a) A pharmacist applicant for renewal who has not previously submitted fingerprints as a condition of licensure or for whom an electronic record of the licensee's fingerprints does not exist in the Department of Justice's criminal offender record identification database shall successfully complete a state and federal level criminal offender record information search conducted through the Department of Justice by the licensee's or registrant’s renewal date. (1) A pharmacists shall retain for at least three years as evidence of having complied with subdivision (a) either a receipt showing that he or she has electronically transmitted his or her fingerprint images to the Department of Justice or, for those who did not use an electronic fingerprint ing system, a receipt evidencing that his or her fingerprints were recorded and submitted to oard. the b (2) A pharmacist applicant for renewal shall pay the actual cost of ubdivision (a). compliance with s (3) As a condition of petitioning the board for reinstatement of a revoked or surrendered license, or for restoration of a retired license, an applicant shall comply with subdivision (a). (4) The board may waive the requirements of this sec tion for licensees who are actively serving in the United States military. The board may not return a license to active status until the licensee has complied with subdivision (a). (b) As a condition of renewal, a pharmacist applicant shall disclose on the renewal form whether he or she has been convicted, as defined in Section 490 of the Business and Professions Code, of any violation of the law in this or any other state, the United States, or other country, since his or her last renewal. T raffic infracti ons not involving alcohol, dangerous drugs, or controlled substances do not need to be disclosed . (c) As a condition of renewal, a pharmacist applicant shall disclose on the renewal form any disciplinary action against any license issued to the applicant by a government agency. For the purposes of this section, “disciplinary action” means an adverse licensure or certification action that resulted in a restriction or penalty being placed on the license, such as revocation, suspension, probation or public re primand or reproval. ( d ) Failure to provide all of the information required by this section renders an application for renewal incomplete and the board shall not renew the license and shall issue the applicant an inactive pharmacist license. An inactive pharmacist license issued pursuant to this section may only be reactivated after compliance is confirmed for all licensure renewal requirements. Note: Authority cited: Sections 4001.1 and 4005, Business and Professions 490, 4300, 4036, 4200.5, 4207, 4301, 4301.5, Code. Reference: Sections 141, 229

230 4311 and 4400, Business and Professions Code; and Sections 11105(b)(10) and 11105(e), Penal Code. 1702. 1 Pharmacy Technician Renewal Requirements (a) A pharmacy technician applicant for renewal who has not previou sly submitted fingerprints as a condition of licensure or for whom an electronic record of the licensee’s fingerprints does not exist in the Department of Justice’s criminal offender record identification database shall successfully deral level criminal offender record information search complete a state and fe conducted through the Department of Justice by the licensee’s or registrant’s renewal date that occurs on or after January 1, 2018. (1) A pharmacy technician shall retain for at least three years as evidence of having complied with subdivision (a) either a receipt showing that he or she has electronically transmitted his or her fingerprint images to the Department of Justice or, for those who did not use an electronic fingerprinting system, a receipt evidencing that his or her fingerprints were recorded and submitted to the board. (2) A pharmacy technician applicant for renewal shall pay the actual cost of compliance with subdivision (a). nt of a revoked or (3) As a condition of petitioning the board for reinstateme surrendered license an applicant shall comply with subdivision (a). (4) The board may waive the requirements of this section for licensees who are actively serving in the United States military. The board may not return a license to ac tive status until the licensee has complied with subdivision (a). (b) As a condition of renewal, a pharmacy technician applicant shall disclose on the renewal form whether he or she has been convicted, as defined in Section 490 of the Business and Profes sions Code, of any violation of the law in this or any other state, the United States, or other country, since his or her last renewal. Traffic infractions not involving alcohol, dangerous drugs, or controlled substances do not need to be disclosed. As a condition of renewal, a pharmacy technician applicant shall disclose (c) on the renewal form any disciplinary action against any license issued to the applicant by a government agency. For the purposes of this section, “disciplinary action” means an adver se licensure or certification action that resulted in a restriction or penalty against the license or certification such as revocation, suspension, probation or public reprimand or reproval. (d) Failure to provide all of the information required by this section renders an application for renewal incomplete and the board shall not renew the license until the licensee demonstrates compliance with all requirements. Authority cited: Sections 4001.1 and 4005, Business and Professions Code. ns 141, 490, 4038, 4115, 4202, 4207, 4300, 4301 and 4400, Reference: Sectio Business and Professions Code; and Sections 11105(b)(10) and 11105(e), Penal Code. 230

231 1702. 2 Designated Representative Renewal Requirements (a) A designated representative applicant for renewal w ho has not previously submitted fingerprints as a condition of licensure or for whom an electronic record of the licensee’s fingerprints does not exist in the Department of Justice’s criminal offender record identification database shall successfully compl ete a state and federal level criminal offender record information search conducted through the Department of Justice by the licensee’s or registrant’s renewal date that occurs on or after January 1, 2018. at least three years as evidence (1) A designated representative shall retain for of having complied with subdivision (a) either a receipt showing that he or she has electronically transmitted his or her fingerprint images to the Department of Justice or, for those who did not use an electronic fingerpr inting system, a receipt evidencing that his or her fingerprints were recorded and submitted to the board. (2) A designated representative applicant for renewal shall pay the actual cost of compliance with subdivision (a). (3) As a condition of petitio ning the board for reinstatement of a revoked or surrendered license an applicant shall comply with subdivision (a). (4) The board may waive the requirements of this section for licensees who may not return a are actively serving in the United States military. The board license to active status until the licensee has complied with subdivision (a). (b) As a condition of renewal, a designated representative applicant shall disclose on the renewal form whether he or she has been convicted, as defined in Se ction 490 of the Business and Professions Code, of any violation of the law in this or any other state, the United States, or other country, since his or her last renewal. Traffic infractions not involving alcohol, dangerous drugs, or controlled substances do not need to be disclosed. (c) As a condition of renewal, a designated representative applicant shall disclose on the renewal form any disciplinary action against any license issued to the applicant by a government agency. For the purposes of this sec tion, “disciplinary action” means an adverse licensure or certification action that resulted in a restriction or penalty against the license or certification such as revocation, suspension, probation or public reprimand or reproval. e all of the information required by this section renders an (d) Failure to provid application for renewal incomplete and the board shall not renew the license until the licensee demonstrates compliance with all requirements. Authority cited: Sections 4001.1 and 4005, Busines s and Professions Code. Reference: Sections 141, 490, 4022.5, 4022.7, 4053, 4207, 4300, 4301 and 4400, Business and Professions Code; and Sections 11105(b)(10) and 11105(e), Penal Code. 1702.5. Disclosure of Discipline, Renewal, Nonresident Wholesaler or Nonresident Pharmacy. (a) As a condition of renewal, an applicant seeking renewal of a license as a nonresident wholesaler or as a nonresident pharmacy shall report to the board any disciplinary action taken by any government agency since the last renew al 231

232 of the license. An applicant seeking the first renewal of a license as a nonresident wholesaler or a nonresident pharmacy shall report to the board any disciplinary action taken by any government agency since issuance of the license. Failure to provide information required by this section shall render an application for renewal incomplete, and the board shall not renew the license until such time as the information is provided. (b) For purposes of this section, “disciplinary action” means any adverse l icensure or certification action that resulted in a restriction or penalty against the license or certification. Such actions include revocation, suspension, probation or public reprimand or reproval. ns Code. Authority cited: Section 4005, Business and Professio Reference: Sections 141, 4112, 4161, 4300, 4301, 4302, 4303, 4303.1 and 4316, Business and Professions Code. 1703. Delegation of Certain Functions The power and discretion conferred by law upon the board to receive and file accusations; issue notices of hearing, statements to respondent and statements of issues; receive and file notices of defense; determine the time and place of hearings under Section 11508 of the Government Code; set and calendar cases like dispatch - for hearing and perform other functions necessary to the business of the business of the board in connection with proceedings under the provisions of Sections 11500 through 11528 of the Government Code, prior to the hearing of such proceedings; the certification and delivery or ma iling of copies of decisions under Section 11518 of said code; and issue summary suspension orders or notices of suspension under Section 4311 of the Business and Professions Code ; make changes to its regulations without r eg ulatory effect pursuant to Titl e 1, California Code of Regulations Section 1 00; and approve waivers pursuant to Section 4076.5(e) of the Business and Professions Code are hereby delegated to and conferred upon the executive officer, or, in his or , the acting executive officer. her absence from the office of the board Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4003 and 4311, Business and Professions Code. 1704. Change of Address exemption to Each person holding a certificate, license, permit, registration or practice or engage in any activity in the State of California under any and all laws administered by the Board shall file a proper and current residence address with the Board at its office in Sacramento and shall within 30 days notify the Boa rd at its said office of any and all changes of residence address, giving both the old and new address. Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4003 and 4100, Business and Professions Code. 232

233 1705. Notification o f Bankruptcy, Receivership or Liquidation Any pharmacy, wholesaler, or manufacturer who makes any assignment for the benefit of creditors or enters into any creditor compromise arrangement, or inted, or who who files a petition in bankruptcy, or who has a receiver appo enters into any liquidation or other arrangement which may result in the sale or transfer of drugs, devices or appliances which are required to be sold by a registered pharmacist or other licensee, shall notify the Board immediately in writin g of such fact, and shall set forth the following information, if known: (a) Date of sale or transfer of such drugs, devices or appliances; (b) Name and address of purchaser; (c) Inventory of dangerous drugs and devices showing their disposition; ) Location of records of manufacture, sale, purchase, and disposition of (d dangerous drugs and devices. Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4005, 4024, 4080, 4081 and 4332, Business and Professions Code. Words of Similar Import 1706 The words "Prescription," "Prescription Service," "Medication," "Prescribed Medication," and "Medicinals" are words of similar or like import to those enumerated in Section 4343, Business and Professions Code. Authority cited: Sec tion 4005, Business and Professions Code. Reference: Section 4005. 1706.1 Permit Processing Times 233

234 Maximum Maximum Time Actual License "Permit" as defined in Days for by the Permit Reform Time in Days or Processing Notification Act of 1981 means after Filing a Time in Days Complete Based on Two That an - any license, Application in Year certificate, Application Which the registration, permit or Incomplete or Compilation Board Will Deficient; and any other form of Notify What is Needed authorization required by a s to Correct the Applicant of tate agency to Med Min Max Deficiency Decision engage in a particular activity or act. Processing times for the board's various programs are set forth below. The actual processing times apply to those persons who take and pass the first available examination. License or registration type 30 Pharmacist License 30 167 2,192 67 549 Foreign Graduate 154 30 30 1,047 Application 60 Intern Permit 30 4 83 1 72 Pharmacy Permit 30 305 60 6 60 325 Clinic Permit 30 96 20 234

235 Non - R esident 122* 30 56* 60 12* Pharmacy Permit 185 Exemption Certificate 30 60 20 85 258 30 60 7 87 Hypodermic Distributor’s Permit Wholesale Drug 605 30 60 13 88 Permit 60 Medical Device 30 Retailer Permit 30 60 Medical Device Retailer Warehouse Permit - Out - of State 21 30 60 1 265 Distributor Permit *This registration program began January 1, 1989, thus the data are for only one ½ years. Authority cited: Section 4005, Business and Professions Code. Reference: Section 15376, Government Code. 1706.2 Abandonment of Application Files (a) An applicant for a license to conduct a pharmacy, non - resident pharmacy, sterile injectable compounding pharmacy, wholesaler, out - of - state distributor, animal drug retailer, or to furnish hypod clinic, veterinary food - ermic needles and syringes who fails to complete all application requirements within 60 days after being notified by the board of deficiencies in his, her or its file, may be deemed to have abandoned the application and may be required to file a new applic ation and meet all of the requirements in effect at the time of 235

236 reapplication. (b) An applicant for a pharmacy technician license or a designated representative license who fails to complete all application requirements within 60 days after being notifie d by the board of deficiencies in his or her file, may be deemed to have abandoned the application and may be required to file a new application and meet all of the requirements which are in effect at the time of reapplication. to pay the fee for licensure as a pharmacist required (c) An applicant who fails by subdivision (f) of section 1749 of this Division within 12 months after being notified by the board of his or her eligibility be deemed to have ation and be in abandoned the application and must file a new applic compliance with the requirements in effect at the time of reapplication. (d) An applicant to take the pharmacist licensure examinations who fails to take the examinations within 12 months of being deemed eligible, shall be deemed to have abandoned the application and must file a new application in compliance with all of the requirements in effect at the time of reapplication. (e) An applicant for a intern pharmacist license who fails to complete all application requirements within one ye ar after being notified by the board of deficiencies in his or her file, may be deemed to have abandoned the application and may be required to file a new application and meet all of the requirements which are in effect at the time of reapplication. Autho rity cited: Section 4005, Business and Professions Code. Reference: Sections 4022.5, 4029, 4030, 4037, 4042, 4043, 4053, 4110, 4112, 4115,4120, 4127.1, 4141, 4160, 4161, 4180, 4190, 4200, 4201, 4202, 4203, 4204, 4205 and . 4208, Business and Professions Code Article 2. Pharmacies 1707. Waiver Requirements for Off - Site Storage of Records (a) Pursuant to subdivision (e) of Section 4105 of the Business and Professions Code and subdivision (c) of Section 4333 of the Business and Professions Code, a waiver sh all be granted to any entity licensed by the board site storage of the records described in subdivisions (a), (b) and (c) of for off - Section 4105 of the Business and Professions Code unless the applicant has, oduce records pursuant to Section within the preceding five years, failed to pr 4081 of the Business and Professions Code or has falsified records covered by Section 4081 of the Business and Professions Code. (b) An entity that is granted a waiver pursuant to subdivision (a) shall: (1) maintain the storage area so that the records are secure, including from unauthorized access; and (2) be able to produce the records within two business days upon the request of the board or an authorized officer of the law. (c) In the event that a licensee fails to comply with the conditions set forth in subdivision (b), the board may cancel the waiver without a hearing. Upon notification by the board of cancellation of the waiver, the licensee shall maintain all records at the licensed premises. 236

237 (d) A licensee whos e waiver has been cancelled pursuant to the provisions set forth in subsection (c) may reapply to the board when compliance with the conditions set forth in subsection (b) can be confirmed by the board. (e) Notwithstanding any waiver granted pursuant to s ubdivision (a), all prescription records for non controlled substances shall be maintained on the licensed premises for a period of one year from the date of dispensing. (f) Notwithstanding any waiver granted pursuant to subdivision (a), all prescription records for controlled substances shall be maintained on the licensed premises for a period of two years from the date of dispensing. (g) Notwithstanding the requirements of this section, any entity licensed by in subdivisions (a), (b) and (c) of the board may store the records described Section 4105 of the Business and Professions Code in a storage area at the same address or adjoining the licensed premises without obtaining a waiver from the board if the following conditions are met: s are readily accessible to the pharmacist (1) The record in - - charge (or other pharmacist on duty, or designated representative) and upon request to the board or any authorized officer of the law. (2) The storage area is maintained so that the records are secure and s o that related information is maintained. the confidentiality of any patient - Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4081, 4105 and 4333, Business and Professions Code. Duty to Maintain Medication Profil es (Patient Medication 1707.1. Records). (a) A pharmacy shall maintain medication profiles on all patients who have prescriptions filled in that pharmacy except when the pharmacist has reasonable belief that the patient will not continue to obtain prescription me dications from that pharmacy. (1) A patient medication record shall be maintained in an automated data processing or manual record mode such that the following information is readily retrievable during the pharmacy's normal operating hours. (A) The patie nt's full name and address, telephone number, date of birth (or age) and gender; (B) For each prescription dispensed by the pharmacy: (1). The name, strength, dosage form, route of administration, if other than oral, quantity and directions for use of an y drug dispensed; (2). The prescriber's name and where appropriate, license number, DEA registration number or other unique identifier; (3). The date on which a drug was dispensed or refilled; (4). The prescription number for each prescription; and (5) . The information required by section 1717. (C) Any of the following which may relate to drug therapy: patient allergies, idiosyncrasies, current medications and relevant prior medications including ical conditions which nonprescription medications and relevant devices, or med are communicated by the patient or the patient's agent. 237

238 (D) Any other information which the pharmacist, in his or her professional judgment, deems appropriate. (2) The patient medication record shall be maintained for at least one y ear from the date when the last prescription was filled. Authorized cited: Sections 4005, 4121 and 4122, Business and Professions Code. Reference: Sections 4005, 4121 and 4122, Business and Professions Code. 1707.2 Duty to Consult. (a) A pharmacist sh all provide oral consultation to his or her patient or the patient's agent in all care settings: (1) upon request; or (2) whenever the pharmacist deems it warranted in the exercise of his or her professional judgment. (b)(1) In addition to the obligati on to consult set forth in subsection (a), a pharmacist shall provide oral consultation to his or her patient or the patient's agent in any care setting in which the patient or agent is present: (A) whenever the prescription drug has not previously been d ispensed to a patient; or (B) whenever a prescription drug not previously dispensed to a patient in the same dosage form, strength or with the same written directions, is dispensed by the pharmacy. but not limited to a (2) When the patient or agent is not present (including prescription drug that was shipped by mail) a pharmacy shall ensure that the patient receives written notice: of his or her right to request consultation; and a telephone number from which the patient may obtain oral consultation from a pharmacist who has ready access to the patient's record. (3) A pharmacist is not required by this subsection to provide oral consultation to an inpatient of a health care facility licensed pursuant to section 1250 of the Health and Safety Code, or to an inmate of an adult correctional facility or a juvenile detention facility, except upon the patient's discharge. A pharmacist is not obligated to consult about discharge medications if a health facility licensed pursuant to subdivision (a) or (b) of Health and Safety Code Section 1250 has implemented a written policy about discharge medications which meets the requirements of Business and Professions Code Section 4074. (c) When oral consultation is provided, it shall include at least the following: rections for use and storage and the importance of compliance with (1) di directions; and (2) precautions and relevant warnings, including common severe side or adverse effects or interactions that may be encountered. (d) Whenever a pharmacist deems it warrante d in the exercise of his or her professional judgment, oral consultation shall also include: (1) the name and description of the medication; (2) the route of administration, dosage form, dosage, and duration of drug therapy (3) any special directions fo r use and storage; 238

239 (4) precautions for preparation and administration by the patient, including techniques for self - monitoring drug therapy; (5) prescription refill information; (6) therapeutic contraindications, avoidance of common severe side or adver se effects or known interactions, including serious potential interactions with known nonprescription medications and therapeutic contraindications and the action required if such side or adverse effects or interactions or therapeutic contraindications are present or occur; (7) action to be taken in the event of a missed dose. (e) Notwithstanding the requirements set forth in subsection (a) and (b), a pharmacist is not required to provide oral consultation when a patient or the patient's agent refuses suc h consultation. Authority cited: Sections 4005 , 4076 and 4122, Business and Professions Code. Reference: Sections 4005 and 4122, Business and Professions Code. , 4076 1707.3. Duty to Review Drug Therapy and Patient Medication Record Prior to Delivery. Prior to consultation as set forth in section 1707.2, a pharmacist shall review a patient's drug therapy and medication record before each prescription drug is delivered. The review shall include screening for severe potential drug therapy problems. Auth ority cited: Sections 4005, 4121 and 4122, Business and Professions Code. Reference: Sections 4005, 4074, 4121 and 4122, Business and Professions Code. 1707.4. Procedures for Refill Pharmacies. (a) A pharmacy licensed by the board may process a request f or refill of a prescription received by a pharmacy within this state, provided: (1) The pharmacy that is to refill the prescription either has a contract with the pharmacy which received the prescription or has the same owner as the other pharmacy. (2) T he prescription container: (A) is clearly labeled with all information required by Section 4076 of the Business and Professions Code; and (B) clearly shows the name and address of the pharmacy refilling the pharmacy which receives the prescription and/or the name and address of the refilled prescription for dispensing to the patient. (3) The patient is provided with written information, either on the prescription label or with the prescription container, that describes which pharmacy to contact if the pa tient has any questions about the prescription or medication. (4) Both pharmacies maintain complete and accurate records of the refill, including: (A) the name of the pharmacist who refilled the prescription; (B) the name of the pharmacy refilling the p rescription; and (C) the name of the pharmacy that received the refill request. 239

240 (5) The pharmacy which refills the prescription and the pharmacy to which the refilled prescription is provided for dispensing to the patient shall each be responsible for en suring the order has been properly filled. (6) The originating pharmacy is responsible for compliance with the requirements set forth in Section 1707.1, 1707.2 and 1707.3 of the California Code of Regulations. (b) Nothing in this section shall be constru ed as barring a pharmacy from also filling new prescriptions presented by a patient or a patient's agent or transmitted to it by a prescriber. Authority cited: Section 4005, Business & Professions Code. Reference: ess & Professions Code. Sections 4063, 4076, 4081 and 4333, Busin Patient - Centered Labels for Prescription Drug Containers; 1707.5. Requirements (a) Labels on drug containers dispensed to patients in California shall conform to the following format: (1) Each of the following items, and only th ese four items, shall be clustered into one area of the label that comprises at least 50 percent of the label. Each item shall be printed in at least a 12 - point sans serif typeface, and listed in the following order: (A) Name of the patient Name of t he drug and strength of the drug. For the purposes of this (B) section, “name of the drug” means either the manufacturer's trade name of the drug, or the generic name and the statement “generic for _____” where the brand name is inserted, and the name of the m anufacturer. In the professional judgment of the pharmacist, (i) If the brand name is no longer widely used, the label may list only the generic name of the drug, and (ii) The manufacturer’s name may be listed outside of the patient - centered area. The directions for the use of the drug. (C) (D) The condition or purpose for which the drug was prescribed if the condition or purpose is indicated on the prescription. (2) For added emphasis, the label shall also highlight in bold typeface or color, or use blank space to set off the items listed in subdivision (a)(1). (3) The remaining required elements for the label specified in section 4076 of the Business and Professions Code, as well as any other items of information appearing on the label or the conta iner, shall be printed so as not to interfere with the legibility or emphasis of the primary elements specified in paragraph (1) of subdivision (a). These additional elements may appear in any style, font, and size typeface. (4) When applicable, direction s for use shall use one of the following phrases: (A) Take 1 [insert appropriate dosage form] at bedtime (B) Take 2 [insert appropriate dosage form] at bedtime (C) Take 3 [insert appropriate dosage form] at bedtime form] in the morning (D) Take 1 [insert appropriate dosage 240

241 (E) Take 2 [insert appropriate dosage form] in the morning (F) Take 3 [insert appropriate dosage form] in the morning (G) Take 1 [insert appropriate dosage form] in the morning, and Take 1 [insert e appropriate dosage form] at bedtim (H) Take 2 [insert appropriate dosage form] in the morning, and Take 2 [insert appropriate dosage form] at bedtime (I) Take 3 [insert appropriate dosage form] in the morning, and Take 3 [insert appropriate dosage form] at bedtime (J) Take 1 [insert ap propriate dosage form] in the morning, 1 [insert appropriate dosage form] at noon, and l [insert appropriate dosage form] in the evening (K) Take 2 [insert appropriate dosage form] in the morning, 2 [insert appropriate dosage form] in the appropriate dosage form] at noon, and 2 [insert evening (L) Take 3 [insert appropriate dosage form] in the morning, 3 [insert appropriate dosage form] at noon, and 3 [insert appropriate dosage form] in the evening ng, 1 [insert (M) Take 1 [insert appropriate dosage form] in the morni appropriate dosage form] at noon, 1 [insert appropriate dosage form] in the evening, and 1 [insert appropriate dosage form] at bedtime (N) Take 2 [insert appropriate dosage form] in the morning, 2 [insert appropriate dosage form] at noon, 2 [insert appropriate dosage form] in the evening, and 2 [insert appropriate dosage form] at bedtime (O) Take 3 [insert appropriate dosage form] in the morning, 3 [insert appropriate dosage form] at noon, 3 [insert appropriate dosage form] in the evening, a nd 3 [insert appropriate dosage form] at bedtime (P) If you have pain, take __ [insert appropriate dosage form] at a time. Wait at least __ hours before taking again. Do not take more than __ [appropriate dosage form] in one day (b) By October 2011, and updated as necessary, the board shall publish on its Web site translation of the directions for use listed in subdivision (a)(4) into at least five languages other than English, to facilitate the use thereof by Californ ia pharmacies. (c) The board shall collect and publish on its Web site examples of labels conforming to these requirements, to aid pharmacies in label design and compliance. (d) The pharmacy shall have policies and procedures in place to help patients th limited or no English proficiency understand the information on the label wi as specified in subdivision (a) in the patient's language. The pharmacy's policies and procedures shall be specified in writing and shall include, at minimum, the selected means t o identify the patient's language and to provide interpretive services and translation services in the patient's language. The pharmacy shall, at minimum, provide interpretive services in the patient's language, if interpretive services in such language ar e available, during all hours that the pharmacy is open, either in person by pharmacy staff or by use of a third party - interpretive service available by telephone at or adjacent to the pharmacy counter. 241

242 ( e ) As used in this section, “appropriate dosage for m” includes pill, caplet, capsule or tablet. Authority cited: Sections 4005 and 4076.5, Business and Professions Code. Reference: Sections 4005, 4076, and 4076.5, Business and Professions Code. 1707.6 Notice to Consumers (a) In every pharmacy there sh all be prominently posted, in a place conspicuous to and readable by a prescription drug consumer, a notice containing the text in subdivision (b). Each pharmacy shall use the standardized poster the - sized notice provided or made available by the board, unless pharmacy has received prior approval of another format or display methodology from the board. The board may delegate authority to a committee or to the Executive Officer to give the approval. As an alternative to a printed notice, the pharmacy may als o or instead display the notice on a video screen located in a place conspicuous to and readable by prescription drug consumers, so long as: (1) The video screen is at least 24 inches, measured diagonally; (2) rovided by the board; (3) The The pharmacy utilizes the video image notice p text of the notice remains on the screen for a minimum of 60 seconds; and (4) No more than five minutes elapses between displays of any notice on the screen, as measured between the time that a one - screen notice or the final screen notice ceases to display and the time that the first or s creen of a multi - only page of that notice re displays. The pharmacy may seek approval of - another format or display methodology from the board. The board may delegate authority to a committee or to the Executive Officer to give the approval. (b) The notice shall contain the following text: NOTICE TO CONSUMERS California law requires a pharmacist to speak with you every time you get a new prescription. You have the right to ask for and receiv e from any pharmacy point font. prescription drug labels in 12 - Interpreter services are ava ilable to you upon request at no cost. taking your medicine, be sure you know: the name of the Before medicine and what it does; how and when to take it, for how l ong, and what to do if you miss a dose; possible side effects and what you should do if they occur; whether the new medicine will work safely with other medicines or s upple ments; and what foods, drinks, or activities should be avoided while taking the medi cine. Ask the pharmacist if you have any questions. This pharmacy must provide any medicine or device legally prescribed for you, unless it is not covered by your insurance; you are 242

243 unable to pay the cost of a copayment; or the pharmacist determines doing so would be against the law or potentially harmful to health. If a medicine or device is not immediately available, the pharmacy will work with you to help you get your medicine or device in a timely manner. ug cing and use pri You may ask this pharmacy for information on dr of generic drugs. (c) Every pharmacy, in a place conspicuous to and readable by a prescription drug consumer, at or adjacent to each counter in the pharmacy where dangerous drugs are dispensed or furnished, shall ce containing the following text: post or provide a noti Point to your language. Interpreter services will be provided to you upon request at no cost. This text shall be repeated in at least the following languages: Arabic, Armenian, Cambodian, Cantonese, Farsi, Hmong, Korean, Mandarin, Russian, Spanish, Tagalog, and Vietnamese. Each pharmacy shall use the standardized notice provided or made available by the board, unless the pharmacy has received prior approval of another format or display methodology from the board. The boar d may delegate authority to a committee or to the Executive Officer to give the approval. The pharmacy may post this notice in paper form or on a video screen if the posted notice or video screen is positioned so that a consumer can easily point to and tou ch the statement identifying the language in which he or she requests assistance. Otherwise, the notice shall be made available on a flyer or handout clearly visible from and kept within easy reach of each counter in the pharmacy where dangerous drugs are dispensed or furnished, available at all hours that the pharmacy is open. The flyer or handout shall be at least 8 1/2 inches by 11 inches. Note: Authority cited: Sections 4005 and 4122, Business and Professions Code. Reference: Sections and 4122, Business and Professions 733, 4005, 4076.5 Code. 1708.2. Discontinuance of Business. Any permit holder shall contact the board prior to transferring or selling any dangerous drugs, devices or hypodermics inventory as a result of termination of business or bankr uptcy proceedings and shall follow official instructions given by the board applicable to the transaction. Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4080, 4081, 4322 and 4333, Business and Professions Code; and 5, Health and Safety Code. 1120 243

244 1708.3. Radioactive Drugs. A radioactive drug is any substance defined as a drug in Section 201(g)(1) of the Federal Food, Drug and Cosmetic Act or a radioactive biological product as defined in 21 CFR 600.3(ee) which exhibit s spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any such drug or biological product which is intended to be made radioactive. This definition includes non - radioactive reagent kits and nuclide g enerators which are intended to be used in the preparation of any such substance but does containing compounds, potassium not include drugs such as carbon containing - - compounds or potassium - containing salts which contain trace quantities of ing radionuclides. naturally occurr Authority cited: Section 4005, Business and Professions Code. Reference: Section 4025, Business and Professions Code. 1708.4. Pharmacist Handling Radioactive Drugs. A pharmacist handling radioactive drugs must be competent in the prep aration, handling, storage, receiving, dispensing, disposition and pharmacology of radioactive drugs. He must have completed a nuclear pharmacy course and/or acquired experience in programs approved by the - approved pr ograms may be granted Board. Education and experience in non partial or equivalent credit, if, in the opinion of the Board, such programs provide the level of competence as approved programs or the Nuclear Pharmacy Competency Statement adopted by the Board. Authority cited: Section 4005, Busin ess and Professions Code. Reference: Sections 4021, 4022, 4025, 4036 and 4037, Business and Professions Code 1708.5. Pharmacy Furnishing Radioactive Drugs. A pharmacy furnishing radioactive drugs is any area, place or premises described in a permit issue d by the board where radioactive drugs are stored, processed, compounded, repackaged, or dispensed. A pharmacy exclusively furnishing radioactive drugs shall be exempt from the patient consultation area requirements of Title 16 Cal. Code of Regulations Sec tion 1714(a) unless the Board finds that the public health and safety require their application. A pharmacist qualified under Section 1708.4 to furnish radioactive drugs shall be in the pharmacy whenever the furnishing of radioactive drugs occurs. All pers onnel involved in the furnishing of radioactive drugs shall be under the immediate and direct supervision of such a qualified pharmacist. Authority cited: Sections 4005, 4008 and 4008.2, Business and Professions 08.2, Business and Professions Code. Reference: Sections 4005, 4008 and 40 Code. 244

245 1709. Names of Owners and Pharmacist in Charge. (a) Each permit to operate a pharmacy shall show the name and address of the pharmacy, the form of ownership (individual, partnership or corporation) and the pharmacist in - charge. Each pharmacy shall, in its initial application on the - - in - charge, the names of annual renewal form, report the name of the pharmacist all owners and the names of the corporate officers (if a corporation). Any changes in the pharmacist in - charge , or the owners, or corporate officers shall - be reported to the Board within 30 days. (b) Any transfer, in a single transaction or in a series of transactions, of 10 percent or more of the beneficial interest in a business entity licensed by the board to a person or entity who did not hold a beneficial interest at the time the original permit was issued, shall require written notification to the board within 30 days. (c) The following shall constitute a transfer of permit and require application hange of ownership: any transfer of a beneficial interest in a business for a c entity licensed by the board, in a single transaction or in a series of transactions, to any person or entity, which transfer results in the transferee's holding 50% or eficial interest in that license. more of the ben Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4058, 4101, 4111, 4112, 4113, 4120, 4124, 4130, 4133, 4141, 4149, 4160, 4161, 4196, 4201, 4304, 4305 and 4330, Business and Professions Cod e 1709.1. Designation of Pharmacist in Charge. (a) The pharmacist - in - charge of a pharmacy shall be employed at that location and shall have responsibility for the daily operation of the pharmacy. in rge with adequate cha - (b) The pharmacy owner shall vest the pharmacist - authority to assure compliance with the laws governing the operation of a pharmacy. (c) No pharmacist shall be the pharmacist - in - charge of more than two - - in charge at two pharmacies, pharmacies. If a pharmacist serves as pharmacist thos e pharmacies shall not be separated by a driving distance of more than 50 miles. (d) No pharmacist shall be the pharmacist - in - charge of a pharmacy while charge for a wholesaler concurrently serving as the designated representative - in - d - or a veterinary foo animal drug retailer. (e) Notwithstanding subdivision (a), a pharmacy may designate any pharmacist who is an employee, officer or administrator of the pharmacy or the entity which owns the pharmacy and who is actively involved in the management of the pharmacy on a daily basis as the pharmacist - in - charge for a period not to exceed 120 days. The pharmacy, or the entity which owns the pharmacy, shall be prepared during normal business hours to provide a e involvement of a representative of the board with documentation of th pharmacist in - charge designated pursuant to this subdivision with the pharmacy - - in - charge. and efforts to obtain and designate a permanent pharmacist charge at a second - (f) A pharmacist may refuse to act as a pharmacist - in pharmacy if t he pharmacist determines, in the exercise of his or her 245

246 professional judgment, that assuming responsibility for a second pharmacy would interfere with the effective performance of the pharmacist's responsibilities under the Pharmacy Law. A pharmacist who r efuses to become pharmacist - in - charge at a second pharmacy shall notify the pharmacy owner in writing of his or her determination, specifying the circumstances of concern that have led to that determination. (g) A person employing a pharmacist may not d ischarge, discipline, or otherwise discriminate against any pharmacist in the terms and conditions of employment for exercising or attempting to exercise in good faith the right established pursuant to this section. and Professions Code. Reference: Authority cited: Section 4005, Business Sections 4081, 4113, 4305 and 4330, Business and Professions Code. 1710. Hospital Pharmacy. (a) A hospital pharmacy which predominantly furnishes drugs to inpatients of that hospital may furnish drugs to outpatients or employees of that hospital or to walk - in customers, provided that sales to walk - in customers do not exceed one (1) percent of all the pharmacy's prescriptions. (b) A hospital pharmacy may process an order for filling patient cassettes by another pharmacy within this state, provided: (1) The pharmacy that is to fill the cassettes either has a contract with the ordering hospital pharmacy or has the same owner as the ordering inpatient hospital pharmacy, (2) The filled cassette is delivered directly from th e filling pharmacy to the ordering hospital pharmacy, (3) Each cassette or container meets the requirements of Business and Professions Code section 4076, (4) Both pharmacies are responsible for ensuring that the order has been properly filled. pharmacies shall maintain complete and accurate records of each (5) Both cassette fill transaction, including the name of the pharmacist checking the cassettes at each pharmacy. (6) Prescription information shall be electronically transferred between the two phar macies. Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4005, 4029, 4076 and 4380, Business and Professions Code. 1711. Quality Assurance Programs. (a) Each pharmacy shall establish or participate in an established qual ity assurance program which documents and assesses medication errors to determine cause and an appropriate response as part of a mission to improve the quality of pharmacy service and prevent errors. ans any variation from (b) For purposes of this section, “medication error” me a prescription or drug order not authorized by the prescriber, as described in Section 1716. Medication error, as defined in the section, does not include any 246

247 variation that is corrected prior to furnishing the drug to the patient or patient's agent or any variation allowed by law. (c) (1) Each quality assurance program shall be managed in accordance with written policies and procedures maintained in the pharmacy in an immediately retrievable form. (2) When a pharmacist determines t hat a medication error has occurred, a pharmacist shall as soon as possible: (A) Communicate to the patient or the patient’s agent the fact that a medication error has occurred and the steps required to avoid injury or mitigate the error. (B) Communicate to the prescriber the fact that a medication error has occurred. (3) The communication requirement in paragraph (2) of this subdivision shall only apply to medication errors if the drug was administered to or by the patient, or if the medication error re sulted in a clinically significant delay in therapy. (4) If a pharmacist is notified of a prescription error by the patient, the patient’s agent, or a prescriber, the pharmacist is not required to communicate with that individual as required in paragraph (2) of this subdivision. (d) Each pharmacy shall use the findings of its quality assurance program to develop pharmacy systems and workflow processes designed to prevent medication errors. An investigation of each medication error shall commence as soon a s is reasonably possible, but no later than 2 business days from the date the medication error is discovered. All medication errors discovered shall be subject to a quality assurance review. (e) The primary purpose of the quality assurance review shall be to advance error prevention by analyzing, individually and collectively, investigative and other pertinent data collected in response to a medication error to assess the cause and any contributing factors such as system or process failures. A record of th e quality assurance review shall be immediately retrievable in the pharmacy. The record shall contain at least the following: 1. the date, location, and participants in the quality assurance review; 2. the pertinent data and other information relating to the medication error(s) reviewed and documentation of any patient contact required by subdivision (c); 3. the findings and determinations generated by the quality assurance review; and, 4. recommend changes to pharmacy policy, procedure, systems, or processes, if any. The pharmacy shall inform pharmacy personnel of changes to pharmacy policy, procedure, systems, or processes made as a result of recommendations generated in the quality assurance program. (f) The record of the quality assurance revie w, as provided in subdivision (e) shall be immediately retrievable in the pharmacy for at least one year from the date the record was created. (g) The pharmacy's compliance with this section will be considered by the nvestigation and evaluation of a medication board as a mitigating factor in the i error. 247

248 (h) Nothing in this section shall be construed to prevent a pharmacy from contracting or otherwise arranging for the provision of personnel or other with such skill or expertise resources, by a third party or administrative offices, as the pharmacy believes to be necessary to satisfy the requirements of this section. Authority cited: Section 4005, Business and Professions Code; and Section 2 of Chapter 677, Statutes of 2000. Reference: Section 4125, Busi ness and Professions Code. 1712. Use of Pharmacist Identifiers. (a) Any requirement in this division for a pharmacist to initial or sign a prescription record or prescription label can be satisfied by recording the identity of the reviewing pharmacist i n a computer system by a secure means. The computer used to record the reviewing pharmacist’s identity shall not permit such a record to be altered after it is made. (b) The record of the reviewing pharmacist’s identity made in a computer to subdivision (a) of this section shall be immediately system pursuant retrievable in the pharmacy. Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4005 and 4115, Business and Professions Code. Receipt and Delivery of Prescript cations di 1713. ions and Prescription Me Must be To or F rom Licensed Pharmacy (a) Except as otherwise provided in this Division, no licensee shall participate in any arrangement or agreement, whereby prescriptions, or prescription medications, may be left at, pi cked up from, accepted by, or delivered to any place not licensed as a retail pharmacy. (b) A licensee may pick up prescriptions at the office or home of the prescriber or pick up or deliver prescriptions or prescription medications at the office of or a residence designated by the patient or at the hospital, institution, medical office or clinic at which the patient receives health care services. In addition, the Board may, in its sole discretion, waive application of subdivision (a) for good cause shown. (c) A patient or the patient’s agent may deposit a prescription in a secure container that is at the same address as the licensed pharmacy premises. The pharmacy shall be responsible for the security and confidentiality of the prescriptions deposited in the container. (d) A pharmacy may use an automated delivery device to deliver previously dispensed prescription medications provided: (1) Each patient using the device has chosen to use the device and signed a written consent form demonstrating his or he r informed consent to do so. (2) A pharmacist has determined that each patient using the device meets inclusion criteria for use of the device established by the pharmacy prior to delivery of prescription medication to that patient. 248

249 (3) The device has a means to identify each patient and only release that patient’s prescription medications. (4) The pharmacy does not use the device to deliver previously dispensed prescription medications to any patient if a pharmacist determines that such counseling as set forth in section 1707.2(a)(2). patient requires (5) The pharmacy provides an immediate consultation with a pharmacist, - person or via telephone, upon the request of a patient. either in (6) The device is located adjacent to the secure pharmacy area. (7 ) The device is secure from access and removal by unauthorized individuals. (8) The pharmacy is responsible for the prescription medications stored in the device. (9) Any incident involving the device where a complaint, delivery error, or omission has oc curred shall be reviewed as part of the pharmacy's quality assurance program mandated by Business and Professions Code section 4125. (10) The pharmacy maintains written policies and procedures pertaining to the device as described in subdivision (e). (e) Any pharmacy making use of an automated delivery device as permitted by subdivision (d) shall maintain, and on an annual basis review, written policies and procedures providing for: (1) Maintaining the security of the automated delivery device and the ngerous drugs within the device. da (2) Determining and applying inclusion criteria regarding which medications are appropriate for placement in the device and for which patients, including when consultation is needed. (3) Ensuring that patients are aware t hat consultation with a pharmacist is available for any prescription medication, including for those delivered via the automated delivery device. (4) Describing the assignment of responsibilities to, and training of, pharmacy personnel regarding the maint enance and filing procedures for the automated delivery device. (5) Orienting participating patients on use of the automated delivery device , notifying patients when expected prescription medications are not available in ent use of the device does not interfere with the device , and ensuring that pati delivery of prescription medications. (6) Ensuring the delivery of medications to patients in the event the device is disabled or malfunctions. (f) Written policies and procedures shall be maintained at least three years beyond the last use of an automated delivery device. (g) For the purposes of this section only, "previously - dispensed prescription medications" are those prescription medications that do not trigger a non - discretionary duty to consult under s ection 1707.2(b)(1), because they have been previously dispensed to the patient by the pharmacy in the same dosage form, strength, and with the same written directions. Authority cited: Sections 4005, 4075, and 4114 Business and Professions Code. e: Sections 4005, 4052, 4116 and 4117 Business and Professions Referenc Code. 249

250 1714. Operational Standards and Security. (a) All pharmacies (except hospital inpatient pharmacies as defined by y Business and Professions Code section 4029 which solely or predominantl furnish drugs to inpatients of the hospital) shall contain an area which is suitable for confidential patient counseling. (b) Each pharmacy licensed by the board shall maintain its facilities, space, fixtures, and equipment so that drugs are safely and properly prepared, maintained, secured and distributed. The pharmacy shall be of sufficient size and unobstructed area to accommodate the safe practice of pharmacy. (c) The pharmacy and fixtures and equipment shall be maintained in a clean and orderly c ondition. The pharmacy shall be dry, well - ventilated, free from rodents and insects, and properly lighted. The pharmacy shall be equipped with a sink with hot and cold running water for pharmaceutical purposes. responsible for the security of the (d) Each pharmacist while on duty shall be prescription department, including provisions for effective control against theft or diversion of dangerous drugs and devices, and records for such drugs and devices. Possession of a key to the pharmacy where dangerous d rugs and controlled substances are stored shall be restricted to a pharmacist. (e) The pharmacy owner, the building owner or manager, or a family member of a pharmacist owner (but not more than one of the aforementioned) may that is maintained in a tamper evident container possess a key to the pharmacy for the purpose of 1) delivering the key to a pharmacist or 2) providing access in case of emergency. An emergency would include fire, flood or earthquake. in - charge shall be present in such a way that - The signature of the pharmacist the pharmacist may readily determine whether the key has been removed from the container. (f) The board shall require an applicant for a licensed premise or for renewal of that license to certify that it meets the requirements of this section at the time of licensure or renewal. (g) A pharmacy shall maintain a readily accessible restroom. The restroom shall contain a toilet and washbasin supplied with running water. Authority cited: Sections 4005 and 4116, Business and Profes sions Code. Reference: Sections 4116 and 4117, Business and Professions Code. 1714.1. Pharmacy Operations d uring the Temporary Absence of a Pharmacist. This section is to ensure that pharmacists are able to have duty free breaks and meal periods to whic h they are entitled under Section 512 of the Labor Code and the orders of the Industrial Welfare Commission, without unreasonably impairing the ability of a pharmacy to remain open. (a) In any pharmacy that is staffed by a single pharmacist, the pharmaci st may leave the pharmacy temporarily for breaks and meal periods pursuant to Section 512 of the Labor Code and the orders of the Industrial Welfare Commission without closing the pharmacy and removing ancillary staff from the pharmacy if the pharmacist re asonably believes that the security of the dangerous drugs and devices will be maintained in his or her absence. 250

251 If in the professional judgment of the pharmacist, the pharmacist determines that the pharmacy should close during his or her absence, then the pharmacist shall close the pharmacy and remove all ancillary staff from the pharmacy during his or her absence. (b) During the pharmacist's temporary absence, no prescription medication may be provided to a patient or to a patient's agent unless the pre scription medication is a refill medication that the pharmacist has checked, released for furnishing to the patient and was determined not to require the consultation of a pharmacist. (c) During such times that the pharmacist is temporarily absent from t he pharmacy, the ancillary staff may continue to perform the non discretionary - duties authorized to them by pharmacy law. However, any duty performed by any member of the ancillary staff shall be reviewed by a pharmacist upon his or her return to the pharm acy. (d) During the temporary absence of a pharmacist as authorized by this section, an intern pharmacist may not perform any discretionary duties nor otherwise act as a pharmacist. (e) The temporary absence authorized by this section shall be limited to the minimum period authorized for pharmacists by section 512 of Labor Code or orders of the Industrial Welfare Commission, and any meal shall be limited to 30 minutes. The pharmacist who is on break shall not be required to remain in uring the break period. the pharmacy area d (f) The pharmacy shall have written policies and procedures regarding the operations of the pharmacy during the temporary absence of the pharmacist for breaks and meal periods. The policies and procedures shall include the authori zed duties of ancillary staff, the pharmacist's responsibilities for checking all work performed by ancillary staff and the pharmacist's responsibility for maintaining the security of the pharmacy. The policies and procedures shall be open to inspection by the board or its designee at all times during business hours. (g) For the purposes of this section, ancillary staff includes: an intern licensed personnel as defined in pharmacist, a pharmacy technician, non - Section 1793.3 of Title 16 of the California Code of Regulations and a pharmacy technician trainee as defined in Section 4115.5(a) of the Business and Professions Code. Authority cited: Sections 4005, 4115 and 4116, Business and Professions Code. Reference: Sections 4009, 4115, 4115.5 and 4116, Busi ness and Professions Code; and Sections 512 and 1186, Labor Code. 1714.5. Dangerous Drugs and Devices Exempt from the Provisions of Chapter 9, Division 2 of the Business and Professions Code. As provided in Section 4057 of the Business and Professions C ode, the listing below shall be exempt from the provisions of Chapter 9, Division 2 of the Business and Professions Code where the sale or furnishing is made to a clinic, hospital, institution, or establishment holding a currently valid and unrevoked se or permit under division 2 (commencing with Section 1200) of the licen 251

252 Health and Safety Code, or Chapter 2 (commencing with Section 3300) of Division 3 of, or Part 2 (commencing with Section 6250) of Division 6, of the Welfare and Institutions Code: (a) dan gerous devices, (b) hypodermic needles and syringes, (c) sterilized sutures, (d) parenteral solutions of 50 cubic centimeters or over, (1) sterile water for injection, (2) dextrose solutions of 10% or less, (3) ready - made parenteral nutritional solut ions, (4) pre - diluted ready - to - use electrolyte containing solutions, (5) colloidal and low molecular weight plasma expanders, (6) Mannitol, (7) sodium chloride solutions of 5% or less, (8) alcohol (ethanol) solutions of 10% or less in dextrose infusio ns, (e) sterile water U.S.P., (f) sterile normal saline solution, (g) medicinal gases, (h) inhalation anesthetics, (i) laboratory chemicals, (j) non - controlled topical anesthetics, (k) injectable local anesthetics when in sealed, pre - packaged kits, (l) topical stains and dyes, (m) diagnostic agents and contrast medium for X - ray examination, (n) medicated dressings, (o) irrigation solutions, and (p) ophthalmic irrigation solutions. Authority cited: Section 4005, Business and Professions Code. Re ference: Sections 4005 and 4057, Business and Professions Code. - Assessment of a Pharmacy by the Pharmacist - in - Charge. 1715. Self (a) The pharmacist - in - charge of each pharmacy as defined under section 4029 or section 4037 of the Business and Professions C - ode shall complete a self assessment of the pharmacy's compliance with federal and state pharmacy law. The assessment shall be performed before July 1 of every odd - numbered year. The primary purpose of the self - assessment is to promote compliance through s elf - examination and education. - (b) In addition to the self assessment required in subdivision (a) of this section, the pharmacist - - charge shall complete a self - assessment within 30 in days whenever: (1) A new pharmacy permit has been issued, or (2) There is a change in the pharmacist - in - charge, and he or she becomes the new pharmacist - in - charge of a pharmacy. (3) There is a change in the licensed location of a pharmacy to a new address. (c) The components of this assessment shall be on Form 17M - 13 (Rev ) 1 0 / 14 . Assessment Hospital Outpatient - entitled “Community Pharmacy Self 252

253 - / - Assessment and on Form 17M Pharmacy Self 14 (Rev . 10 ) entitled 14 - Assessment” which are hereby incorporated by “Hospital Pharmacy Self reference to evaluate compliance with federal a nd state laws and regulations. (d) Each self - assessment shall be kept on file in the pharmacy for three years after it is performed. and 4127 s 4005 Authority cited: Section , Business and Professions Code. Reference: Sections 4021, 4022, 4029, 4030, 4037, 4038, 4040, 4050, 4052, 4070, 4081, 4101, 4105, 4113, 4115, 4119, 4127, 4305, 4330, 4332 and 4333, Business and Professions Code , and Sections 1735.2 and 1751. of Title 16 of the California Code of Regulations. . 1715.5. Implementation of Electronic Moni toring of Schedule II Prescriptions. The collection of information authorized by Health and Safety Code section 11165 shall be provided as follows: (a) For each prescription for a Schedule II controlled substance, the dispensing he following information: the full name and address of pharmacy shall provide t the patient; the gender and date of birth of the patient; the DEA (Drug Enforcement Administration) number of the prescriber; the triplicate harmacy license prescription number; the pharmacy prescription number; the p number; the NDC (National Drug Code) number and the quantity of the controlled substance; the ICD - 9 (diagnosis code), if available; the date of issue of the prescription, the date of dispensing of the prescription, and the state medical lic ense number of any prescriber using the DEA number of a government exempt facility. (b) The above information shall be provided in the following format: (1) For each pharmacy with the capacity to do so, by on - line transmission at least every 30 days and no later than the 18th calendar day of the month following the month in which the prescription is dispensed. (2) For each pharmacy which does not have the capacity to transmit the information on line, on a three and one - half inch diskette in a ASCII forma t or - one - half inch nine track magnetic 1600 BPI tape or any other medium approved by the Board of Pharmacy, which diskette, tape or medium shall be mailed or delivered to a location specified by The Board of Pharmacy, at least every 30 days and no later th an the 18th calendar day of the month following the month in which the prescription is dispensed. (3) For each pharmacy without the capacity to comply with either subsection (b)(1) or (2), the original triplicate shall be transmitted to the Department of Justice by the end of the month in which the prescription was filled. For each pharmacy which submits hard copy pursuant to this subdivision and which pharmacy averages more than 25 triplicate prescriptions per month in any six months, the Board of Pharmac y or its designee may thereafter require that pharmacy to comply with subsections (b)(1) and (2). (4) As to a prescription which is partially filled or dispensed, the period for compliance with subsections (1), (2), or (3) shall be measured from the earli er 253

254 of the following dates and times: the prescription is either (1) completely dispensed or (2) can no longer be dispensed. (c) Every pharmacy which has made a submission as required by this section by July 18, 1998, shall receive a reduction of $75 on it s next renewal fee for licensure of the pharmacy by the board. Every pharmacy shall be in compliance with this section and Health and Safety Code section 11165 by September 18, 1998. Authority cited: Sections 4005, Business and Professions Code. Reference : Sections 11164 and 11165, Health and Safety Code. 1715.6. Reporting Drug Loss. The owner shall report to the Board within thirty (30) days of discovery of any loss of the controlled substances, including their amounts and strengths. Authority cited: S ection 4005, Business and Professions Code. Reference: Sections 4081 and 4332, Business and Professions Code. 1715.65. Inventory Reconciliation Report of Controlled Substances (a) Every pharmacy, and every clinic licensed under sections 4180 or 4190 of the Bu siness and Professions Code, shall perform periodic inventory and inventory reconciliation functions to detect and prevent the loss of controlled substances. charge of a pharmacy or consultant pharmacist for a - (b) The pharmacist - in ntory and inventory reconciliation reports taken, clinic shall review all inve and establish and maintain secure methods to prevent losses of controlled drugs. Written policies and procedures shall be developed for performing on. the inventory reconciliation reports required by this secti (c) A pharmacy or clinic shall compile an inventory reconciliation report of all federal Schedule II controlled substances at least every three months. This compilation shall require: A physical count, not an estimate, of all quantities of federal Schedule II (1) controlled substances. The biennial inventory of controlled substances required by federal law may serve as one of the mandated inventories under this section in the year where the federal biennial inventory is performed, provided the biennial inventor y was taken no more than three months from the last inventory required by this section; (2) A review of all acquisitions and dispositions of federal Schedule II controlled substances since the last inventory reconciliation report; (3) A comparison of (1) and (2) t o determine if there are any variances; (4) All records used to compile each inventory reconciliation report shall be maintained in the pharmacy or clinic for at least three years in a readily retrievable form; and (5) Possible causes of overages shall be identif ied in writing and incorporated into the inventory reconciliation report. (d) A pharmacy or clinic shall report in writing identified losses and known causes to the board within 30 days of discovery unless the cause of the loss 254

255 - use in which case the report shall be made within is theft, diversion, or self 14 days of discovery. If the pharmacy or clinic is unable to identify the cause of the loss, further investigation shall be undertaken to identify the cause and actions necessary to prevent additional losses o f controlled substances. (e) The inventory reconciliation report shall be dated and signed by the individual(s) performing the inventory, and countersigned by the pharmacist - in - charge or professional director (if a clinic) and be readily pharmacy or clinic for three years. A countersignature is retrievable in the - in - charge or professional director personally not required if the pharmacist completed the inventory reconciliation report. - in - charge of a pharmacy shall complete an inventory (f) A new pharmacist reconciliation report as identified in subdivision (c) within 30 days of becoming pharmacist in - charge. Whenever possible an outgoing - - in - pharmacist charge should also complete an inventory reconciliation report as required in subdivision (c). (g) For inpat ient hospital pharmacies, a separate quarterly inventory reconciliation report shall be required for federal Schedule II controlled substances stored within the pharmacy and for each pharmacy satellite location. charge of an inpatient - (h) The pharmacist hospital pharmacy or of a - in pharmacy servicing onsite or offsite automated drug delivery systems shall ensure that: (1) All controlled substances added to an automated drug delivery system are accounted for; to authorized facility Access to automated drug delivery systems is limited (2) personnel; (3) An ongoing evaluation of discrepancies or unusual access associated with controlled substances is performed; and (4) Confirmed losses of controlled substances are reported to the board. and Professions Code. Reference: Authority cited: Section 4005, Business Sections 4008, 4037, 4080, 4081, 4101, 4104, 4105, 4105.5, 4110, 4113, 4119.1, 4180, 4181, 4182, 4186, 4190, 4191, 4192, and 4332, Business and Professions Code and 1261.6, Health and Safety Code. 1716. Variation from Pre scriptions. Pharmacists shall not deviate from the requirements of a prescription except upon the prior consent of the prescriber or to select the drug product in accordance with Section 4073 of the Business and Professions Code. Nothing in this regulatio n is intended to prohibit a pharmacist from exercising commonly - accepted pharmaceutical practice in the compounding or dispensing of a prescription. Authority cited: Section 4005, Business and Professions Code. Reference: sions Code. Section 4040, Business and Profes 255

256 1717. Pharmacy Practice. (a) No medication shall be dispensed on prescription except in a new container which conforms with standards established in the official compendia. Notwithstanding the above, a pharmacist may dispense and refill a pre scription for non - liquid oral products in a clean multiple - drug patient medication package (patient med pak), provided: (1) a patient med pak is reused only for the same patient; - month supply is dispensed at one time; and (2) no more than a one (3) each patient med pak bears an auxiliary label which reads, “store in a cool, dry place.” (b) In addition to the requirements of Business and Professions Code Section 4040, the following information shall be maintained for each prescription on file and shall b e readily retrievable: (1) The date dispensed, and the name or initials of the dispensing pharmacist. All prescriptions filled or refilled by an intern pharmacist must also be initialed by the supervising pharmacist before they are dispensed. nd name of the drug or device; or if a generic drug or device is (2) The bra dispensed, the distributor's name which appears on the commercial package label; and (3) If a prescription for a drug or device is refilled, a record of each refill, quantity dispensed, if d ifferent, and the initials or name of the dispensing pharmacist. (4) A new prescription must be created if there is a change in the drug, strength, prescriber or directions for use, unless a complete record of all such changes is otherwise maintained. (c ) Promptly upon receipt of an orally transmitted prescription, the pharmacist shall reduce it to writing, and initial it, and identify it as an orally transmitted prescription. If the prescription is then dispensed by another pharmacist, the dispensing pha rmacist shall also initial the prescription to identify him or herself. All orally transmitted prescriptions shall be received and transcribed by a pharmacist prior to compounding, filling, dispensing, or furnishing. Chart orders as defined in Section 4019 of the Business and Professions Code are not subject to the provisions of this subsection. (d) A pharmacist may furnish a drug or device pursuant to a written or oral order from a prescriber licensed in a State other than California in accordance with Bu siness and Professions Code Section 4005. (e) A pharmacist may transfer a prescription for Schedule III, IV or V controlled substances to another pharmacy for refill purposes in accordance with Title 21, Code of Federal Regulations, 1306.25. Prescriptions for other dangerous drugs which are not controlled substances may also be transferred by direct communication between pharmacists or by the receiving pharmacist's access to prescriptions or electronic files that have been created or verified by a pharmaci st at the transferring pharmacy. The receiving pharmacist shall create a written prescription; identifying it as a transferred prescription; and record the date of transfer and the original prescription number. When a prescription via direct access by the receiving pharmacist, the transfer is accomplished receiving pharmacist shall notify the transferring pharmacy of the transfer. A 256

257 pharmacist at the transferring pharmacy shall then assure that there is a record of the prescription as having been transferre d, and the date of transfer. Each pharmacy shall maintain inventory accountability and pharmacist accountability and dispense in accordance with the provisions of Section 1716. Information maintained by each pharmacy shall at least include: (1) Identifica tion of pharmacist(s) transferring information; (2) Name and identification code or address of the pharmacy from which the prescription was received or to which the prescription was transferred, as appropriate; (3) Original date and last dispensing date; (4) Number of refills and date originally authorized; (5) Number of refills remaining but not dispensed; (6) Number of refills transferred. (f) The pharmacy must have written procedures that identify each individual pharmacist responsible for the fill ing of a prescription and a corresponding entry of information into an automated data processing system, or a manual record system, and the pharmacist shall create in his/her handwriting or through the beginning of the hand - initializing a record of such filling, not later than pharmacy's next operating day. Such record shall be main tained for at least three years. Authority cited: Sections 4005, 4075 and 4114, Business and Professions Code. Reference: Sections 4005, 4019, 4027, 4050, 4051, 4052, 4075, 4114 , 4116, 4117 and 4342, Business and Professions Code. 1717.1. Common Electronic Files. (a) For dangerous drugs other than controlled substances: Two or more pharmacies may establish and use a common electronic file to maintain required dispensing inform ation. Pharmacies using such a common file are not required to transfer prescriptions or information for dispensing purposes between or among pharmacies participating in the same common prescription file. itted by Federal law, two or (b) For controlled substances: To the extent perm more pharmacies may establish and use a common electronic file of prescriptions and dispensing information. (c) All common electronic files must contain complete and accurate records of each prescription and refill dispensed. (d) Common electronic files as authorized by this section shall not permit disclosure of confidential medical information except as authorized by the Confidentiality of Medical Information Act (Civil Code 56 et seq.). on electronic file authorized by this (e) Pharmacies maintaining a comm section shall develop and implement written policies and procedures designed to prevent the unauthorized disclosure of confidential medical information. essions Code. Authority cited: Sections 4005, 4075 and 4114, Business and Prof Reference: Sections 4005, 4019, 4027, 4050, 4051, 4052, 4075, 4114, 4116 and 257

258 4117, Business and Professions Code and Sections 56.10 and 56.11 of the Civil Code. 1717.3. Preprinted Multiple Check o ff Prescription Blanks. (a) No person shall dispense a controlled substance pursuant to a preprinted - off prescription blank. multiple check (b) A person may dispense a dangerous drug, that is not a controlled substance, pursuant to a preprinted multiple checkoff prescription blank and may dispense more than one dangerous drug, that is not a controlled substance, pursuant to such a blank if the prescriber has indicated on the blank the number of dangerous drugs he or she has prescribed. (c) “Preprinted multiple checkoff prescription blank,” as use d in this section means any form listing more than one dangerous drug where the intent is that a mark next to the name of a drug i.e., a “checkoff,” indicates a prescription order for that drug. . Reference: Authority cited: Section 4005, Business and Professions Code Section 4040, Business and Professions Code; and Section 11164, Health and Safety Code. 1717.4. Electronic Transmission of Prescriptions. (a) Except as otherwise prohibited by law, prescriptions may be transmitted by electronic means from t he prescriber to the pharmacy. (b) An electronically transmitted prescription which meets the requirements of this regulation shall be deemed to be a prescription within the meaning of Business and Professions Code section 4040. (c) An electronically t ransmitted prescription order shall include the name and address of the prescriber, a telephone number for oral confirmation, date of transmission and the identity of the recipient, as well as any other information ations. The prescriber's address, license required by federal or state law or regul classification and federal registry number may be omitted if they are on file and readily retrievable in the receiving pharmacy. (d) An “interim storage device” means as electronic file into which a prescription is entered for later retrieval by an authorized individual. Any interim storage device shall, in addition to the above information, record and maintain the date of entry and/or receipt of the prescription order, date of transmission from the interim storag e device and identity of the recipient of such transmission. The interim storage device shall be maintained so as to ensure against unauthorized access and use of prescription information, including dispensing information. ctronic image transmission prescription shall (e) A pharmacy receiving an ele either receive the prescription in hard copy form or have the capacity to retrieve a hard copy facsimile of the prescription from the pharmacy's computer memory. Any hard copy of a prescription shall be maintai ned on paper of permanent quality. 258

259 (f) An electronically transmitted prescription shall be transmitted only to the pharmacy of the patient's choice. This requirement shall not apply to orders for medications to be administered in an acute care hospital. (g) Electronic equipment for transmitting prescriptions (or electronic transmittal technology) shall not be supplied or used so as to violate or circumvent Business and Professions Code section 4000 et seq., Health and Safety Code section 11150 et seq., or any regulations of the board. (h) Any person who transmits, maintains or receives any prescription or prescription refill, orally, in writing or electronically, shall ensure the security, integrity, authenticity, and confidentiality of the prescriptio n and any information contained therein. Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4019, 4040, 4071, 4072 and 4075, Business and Professions Code; and Section 11150, et seq., Health and Safety Code. 1718. Current I nventory Defined. “Current Inventory” as used in Sections 4081 and 4332 of the Business and Professions Code shall be considered to include complete accountability for all dangerous drugs handled by every licensee enumerated in Sections 4081 and controlled substances inventories required by Title 21, CFR, Section 4332. The 1304 shall be available for inspection upon request for at least 3 years after the date of the inventory. Authority cited: Section 4005, Business and Professions Code. Reference: Sectio ns 4080, 4081 and 4332, Business and Professions Code. 1718.1. Manufacturer's Expiration Date. All prescription drugs not bearing a manufacturer's expiration date pursuant to Title 21, Code of Federal Regulations, section 211.137 are deemed to have ed and may not be manufactured, distributed, held for sale, or dispensed expir by any manufacturer, distributor, pharmacist, pharmacy or other persons authorized to dispense such drugs in California. Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4005 and 4342, Business and Professions Code. Article 3. Pharmacist Candidates 1719. Recognized Schools of Pharmacy. As used in this division, “recognized school of pharmacy” means a school of pharmacy accredited, or granted candid ate status, by the Accreditation Council for Pharmacy Education or otherwise recognized by the board. Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4200 of the Business and Professions Code. 259

260 1720. Application for Pharm acist Examination and Licensure. (a) An application for examination shall be submitted on the form provided by the board, and filed with the board at its office in Sacramento. (b) The fee required by subdivision (d) of section 1749 of this Division sha ll be paid for each application for initial examination and for any application to retake the examination described in section 4200.2 of the Business and Professions Code. The fee is nonrefundable. (c) Each applicant shall be solely responsible for apply ing to and complying with the requirements imposed by the administrators of the North American State Pharmacy Jurisprudence - Pharmacist Licensure Examination and the Multi Examination for California for the administration of those examinations. Authority c ited: Section 4005, Business and Professions Code. Reference: Sections 4200 and 4200.2, Business and Professions Code. 1720.1. Graduates of Foreign Pharmacy Schools. Graduates of foreign pharmacy schools who have been certified by the Foreign Pharmacy Gr aduate Equivalency Committee shall be deemed by the board to have satisfied the requirements of paragraphs (3) and (4) of Business and Professions Code Section 4200(a). Candidates who have been certified by the Foreign Pharmacy Graduate Equivalency Committ ee before January 1, 1998, must also provide the board with a score on the Test of Spoken English 30, of least 50. For candidates who took the Tes t of Spoken English before June 1995, a score of at least 220 must be achieved. , Business and Professions Code. Reference: Authority cited: Section 4005 Sections 851 and 4200, Business and Professions Code. 1721. Dishonest Conduct d uring Examination. An applicant for examination as a pharmacist who engages in dishonest conduct during the examination shall not h ave that examination graded, shall not be approved to take the examination for three years from the date of the until eligible to take the incident, and shall surrender his or her intern license examination. The applicant may not be issued a pharmacy techn ician license until the applicant is again eligible to take the examination. Authority cited: Section 4005, Business and Professions Code. Reference: Business and Professions Code. Section s 123, 496 and 4200, 1723.1. Confidentiality of Examination Questi ons Examination questions are confidential. Any applicant for any license issued by the board who removes all or part of any qualifying examination from the examination room or area, or who conveys or exposes all or part of any rson may be disqualified as a candi date qualifying examination to a ny other pe for a license. The applicant shall not be approved to take the examination for three years from the date of the incident and shall surrender his or her intern nation. The applicant may not be license until again eligible to take the exami 260

261 issued a pharmacy technician license until the applicant is again eligible to take the examination. Note: Authority cited: Section 4005, Business and Professions Code. Reference: Sections 123 and 496, business and Professi ons Code. 1724. Passing Grade in Pharmacist Examination. In order to pass the examination, an applicant shall be required to obtain a passing score as determined by a criterion - referenced method of establishing nation. The board may scale the the passing point on each part of the exami passing score to 75 for the purpose of releasing scores to examinees. Authority cited: Section 4005, Business and Professions Code. Reference: Section 4200, Business and Professions Code. 1725. Acceptable Pharmacy Coursewo rk for Examination Candidates with Four Failed Attempts. (a) Coursework that meets the requirements of section 4200.1 of the Business and Professions Code is any pharmacy coursework offered by a recognized school of pharmacy. st be a part of the course of study. (b) A final examination mu (c) When a candidate applies for reexamination after four failed attempts, he or she shall furnish evidence of successful completion of at least 16 semester successful units or the equivalent of pharmacy coursework. Evidence of completion must be posted on a transcript from the pharmacy school sent directly to the board. Authority cited: Section 4005, Business and Professions Code. Reference: Section 4200.1, Business and Professions Code. 1726. Supervision of Intern Pharmacists. (a) The pharmacist supervising an intern pharmacist shall be responsible for all professional activities performed by the intern under his or her supervision. (b) The pharmacist supervising an intern pharmacist shall provide the experience necessary for the intern pharmacist to become proficient in the practice of pharmacy. Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4030, 4114 and 4200, Business and Professions Code. 1727.1 Intern Pharmacist Address. The board shall not make an intern pharmacist’s address publicly available on the “Internet,” as defined by Business and Professions Code section 17538. Note: Authority cited: Section 4005, Business and Professions Code. 100 and 4208, Business and Professions Code. Reference: Section 4005, 4030, 4 261

262 1727.2. Requirements for Pharmacist Intern. Every applicant for a pharmacist intern license shall submit as part of the application process, a sealed, original Self Query Report from the National Practitioner Data Bank - Healthcare Integrity and Protection Data Bank (NPDB - HIPDB), dated no earlier than 60 days before the date an application is submitted to the board. Note: Authority cited: Section 4005, Business and Professions Code. 4208, Business and Professions Code. Reference: Sections 4207 and 1728. Requirements for Examination. (a) Prior to receiving authorization from the board to take the pharmacist licensure examinations required by section 4200 of the Business and ubmit to the board the following: Professions Code, applicants shall s (1) Proof of 1500 hours of pharmacy practice experience that meets the following requirements: (A) A minimum of 900 hours of pharmacy practice experience obtained in a pharmacy. actice experience may be (B) A maximum of 600 hours of pharmacy pr granted at the discretion of the board for other experience substantially related to the practice of pharmacy. (C) Experience in both community pharmacy and institutional pharmacy practice settings. (D) Pharmacy practice experien ce that satisfies the requirements for both introductory and advanced pharmacy practice experiences established by the Accreditation Council for Pharmacy Education. (2) Satisfactory proof that the applicant graduated from a recognized school of pharmacy. (3) Fingerprints to obtain criminal history information from both the Department of Justice and the United States Federal Bureau of Investigation pursuant to Business and Professions Code section 144. (4) A signed copy of the examination security acknowl edgment. (b) Applicants who hold or held a pharmacist license in another state shall provide a current license verification from each state in which the applicant holds or held a pharmacist license prior to being authorized by the boar to take the examin ations. (c) Applicants who graduated from a foreign school of pharmacy shall provide the board with satisfactory proof of certification by the Foreign Pharmacy Graduate Examination Committee prior to being authorized by the board to take the examinations . Authority cited: Sections 851, and 4005, Business and Professions Code. Reference: Sections 144, 851, and 4200, Business and Professions Code. 262

263 Article 3.5. Advanced Practice Pharmacist 1730. Acceptable Certification Programs The board recognizes the pharmacy patient care certification programs that are accredited by the National Commission for Certifying Agencies for purposes of satisfying the requirements in Business and Professions Code section 4210, subdivision (a)(2)(A). Note: Authority cit ed: Sections 4005 and 4210, Business and Professions Code. Reference: Section 4210, Business and Professions Code. 1730.1. Application Requirements for Advanced Practice Pharmacist Licensure , an applicant (a) For purposes of Business and Professions Code section 4210 for advanced practice pharmacist licensure must satisfy two of the following subsections. (1) Demonstrate possession of a current certification as specified in Business and Professions Code section 4210, subdivision (a)(2)(A), by providing either: (A) A copy of the certification award that includes the name of the applicant pharmacist, the area of specialty and date of completion, or (B) A letter from the certification program confirming the award of the name of the applicant pharmacist, the area of certification that includes the specialty and the date of completion. (2) Demonstrate completion of a postgraduate residency earned in the United States through an accredited postgraduate institution as specified in Business Code section 4210, subdivision (a)(2)(B), by providing either: and Professions (A) A copy of the residency certificate awarded by the postgraduate institution that includes the name of the applicant pharmacist, the area of specialty, and dates of participation and comp letion, or signed by the dean or (B) A letter of completion of a postgraduate residency , residency program director of the postgraduate institution and sent directly to the board from the postgraduate institution, that lists the name of the applicant p harmacist, the area of specialty, and the dates of participation and completion. For an applicant who cannot satisfy this documentation requirement, the board may, for good cause shown, grant a waiver for this subsection. earned under a collaborative practice (3) Demonstrate that experience agreement or protocol, as required by Business and Professions Code section 4210, subdivision (a)(2)(C), has been earned within 10 years of the time of application for advanced practice pharmacist licensure. Additional ly, the one year of experience must include no fewer than 1,500 hours of experience providing clinical services to patients. The experience earned under a collaborative practice agreement or protocol must include initiating, adjusting, modifying or discont inuing drug therapy of patients as authorized by law. An applicant shall demonstrate possession of experience by providing both of the following: (A) A written statement from the applicant attesting under penalty of perjury that he or she has: 263

264 (i) Earne d the clinical experience within the required time frame; and (ii) Completed the required number of hours of experience providing clinical services to patients, as specified in subsection (a)(3). (I)The applicant shall provide a copy of the collaborati ve practice agreement or protocol. (II)If a copy of the collaborative practice agreement or protocol is not available, the applicant shall provide a description of the collaborative practice agreement or protocol, including examples of the clinical servi ces the applicant provided to patients. (B) A written statement from the supervising practitioner, program director or health facility administrator attesting under penalty of perjury that the applicant has completed at least 1,500 hours of experience pr oviding clinical services to patients. For an applicant who cannot satisfy this documentation requirement, the board may, for good cause shown, grant a waiver for this subsection. (b) The experience an applicant offers to demonstrate compliance with one o f the three criteria in subsection (a) above may not also be used to satisfy another of the criteria. Note: Authority cited: Sections 4005 and 4210, Business and Professions Code. Reference: Sections 4052.1, 4052.2 and 4210, Business and Professions Code 1730 . Certification Programs .2 (a) For purposes of Business and Professions Code section 4210, subdivision (a)(2)(A), general clinical pharmacy practice is among the relevant areas of practice for which certification may be earned. (b) For a pharmacis t seeking to demonstrate certification in general clinical pharmacy as a criterion for advanced practice pharmacist licensure by the board, the certification may be earned from an organization recognized as a ion Council for Pharmacy continuing education provider by the Accreditat Education or accredited by the National Commission for Certifying Agencies as a certification provider, so long as: (1) The certification program includes specified learning objectives in at least five sequentially - ordered educat ion modules, covering the following topics: performing patient assessments; ordering and interpreting drug therapy - related tests; referring patients to other health care providers; participating in the tions in collaboration evaluation and management of diseases and health condi with other health care providers; and initiating, adjusting, modifying or discontinuing drug therapy; (2) The certification program requires assessment after completion of each of the education modules in an examination format or b y other assessment methodology that confirms the participant’s understanding, knowledge, and application of the specified learning objectives for the module, where any failure to successfully complete the assessment in any module prevents advancement to th e next module; (3) The certification program requires that instruction and assessments in each of the modules are developed and provided by either: (A) An advanced practice pharmacist licensed by the board or 264

265 (B) An expert with experience in the resp ective area(s) of focus specified in subparagraph (1), where “expert” means a person who qualifies to teach at a school of pharmacy recognized by the board. (4) The certification program requires that, upon successful completion of all modules and their respective assessments, each participant shall earn a passing score on a final overall assessment before being awarded certification. The assessment shall be either a final written examination or an objective structured clinical examination developed and a dministered in collaboration with an accredited school of pharmacy recognized by the board; and (5) The certification program require(s) a minimum of ten hours of continuing education on the topics identified in (b)(1) every two years to maintain cation. certifi Authority cited: Section 4005 and 4210, Business and Professions Code. Reference: Sections 4052.6, 4210, and 4233, Business and Professions Code. 1731. Experimental Programs In order to enable any accredited school of pharmacy recognized by t he Board to experiment with new and innovative methods for drug handling, teaching, research, or to develop new and better methods or concepts involving the ethical practice of pharmacy, the Board enacts the following: rovisions of the Pharmacy Rules and (a) The application of particular p Regulations contained in Title 16, California Administrative Code, Chapter 17, may be waived as to an accredited school of pharmacy recognized by the Board if the Dean of said school has filed with the Board an experimen tal plan or program which specifies the particular provisions to be waived, and which has been approved by the Board. (b) Any plan or program approved by the Board shall have: definite time limitations; progress reports which shall be filed as required b y the Board. (c) The Board may rescind approval and terminate said plan or program at its discretion, at any time it may deem the public interest is not fully protected; nor shall any such plan or program be approved by the Board if such proposal might j eopardize public health or welfare or conflict with provisions of Chapter 9, Div. 2, Business and Professions Code. Authority cited: Section 4005, Business and Professions Code. Reference: 5005, 4120, 4161, 4162, 4304 and 4400, Business and Professions Co de Article 4. Continuing Education 1732. Definitions. As used in this article: (a) “Accreditation agency” means an organization which evaluates and accredits providers of continuing education for pharmacists. contact time. (b) “Hour” means at least 50 minutes of 265

266 (c) “Provider” means a person who has been accredited by an approved accreditation agency or accredited by the board to provide a specific continuing education course. Authority cited: Section 4005, Business and Professions Code. Reference : Section 4232, Business and Professions Code. 1732.05. Accreditation Agencies for Continuing Education. (a) The following organizations are approved as accreditation agencies: (1) The Accreditation Council for Pharmacy Education. . (2) The California P harmacists Association (b) Accreditation agencies shall: (1) Evaluate each continuing education provider seeking accreditation in accordance with the provider’s ability to comply with the requirements of section 1732.1 of this Division. (2) Maintain a list of the name and address of person responsible for the provider's continuing education program. The accreditation agency shall require that any change in the responsible person's identity shall be reported to the the effective date of the change. accreditation agency within 15 days of (3) Provide the board with the names, addresses and responsible party of each provider, upon request. (4) Respond to complaints from the board, providers or from pharmacists concerning activities of any of its accredited providers or their coursework. (5) Review at least one course per year offered by each provider accredited by the agency for compliance with the agency's requirements and requirements of the board and, on request, report the findings of such reviews to t he board. (6) Take such action as is necessary to assure that the continuing education coursework offered by its providers meets the continuing education requirements of the board; and (7) Verify the completion of a specific continuing education course b y an individual pharmacist upon request of the board. (c) Substantial failure of an approved accreditation agency to evaluate continuing education providers as set forth in subdivision (b) shall constitute itation agency by the board. cause for revocation of its approval as an accred Authority cited: section 4005, Business and Professions Code. Reference: section 4232, Business and Professions Code. 1732.1. Requirements for Accredited Providers. (a) No person shall provide continuing pharmacy education without being accredited by an approved accreditation agency or having the course accredited by the board pursuant to section 1732.2 of this Division. (b) Providers shall ensure that each continuing education course complies with the requirements of secti on 1732.3 of this Division. (c) Providers shall furnish statements of credit to all participants that complete a continuing education course. The statement of credit shall contain the name of rse, number of the enrollee, name and number of the provider, title of the cou 266

267 completed hours, date of completion, expiration date of the coursework, course number, if applicable and the name of the accrediting agency. (d) Each provider shall notify the accreditation agency at least 15 days in advance of the first ti me each new continuing education course is offered or presented. (e) Providers shall maintain records of completion of their continuing education courses for four years. (f) Providers shall include the following information in promotional materials regar ding continuing education courses: (1) Provider's name. (2) The number of hours awarded for completion of the course. (3) The date when the course’s accreditation expires. (4) The provider number assigned by the accreditation agency. (5) The name of t he provider’s accrediting agency. (6) The learning objectives of the program. (7) The nature of the targeted audiences that may best benefit from participation in the program. (8) The speakers and their credentials. cedures for determining the credit hours (g) Providers shall have written pro awarded for the completion of continuing education courses. Authority cited: Section 4005, Business and Professions Code. Reference: Section 4232, Business and Professions Code. 1732.2. Board Accredited Continuing Education. (a) Individuals may petition the board to allow continuing education credit for specific coursework which is not offered by a provider but meets the standards of Section 1732.3. (b) Notwithstanding subdivision (a) of this section, coursewor k which meets the standard of relevance to pharmacy practice and has been approved for continuing education by the Medical Board of California, the California Board of Podiatric Medicine, the California Board of Registered Nursing or the Dental lifornia shall, upon satisfactory completion, be considered Board of Ca approved continuing education for pharmacists. (c) A pharmacist serving on a designated subcommittee of the board for the purpose of developing the California Practice Standards and Jurisprudence Examination for pharmacists pursuant to section 4200.2 of the Business and Professions Code may annually be awarded up to six (6) hours of continuing education for conducting a review of exam test questions. A subcommittee member shall not receive continu ing education hours pursuant to this subdivision if that subcommittee member requests reimbursement from the board for time spent conducting a review of exam test questions. (d) A pharmacist or pharmacy technician who attends a full day board meeting be awarded six (6) hours of continuing education per renewal period. The may board shall designate on its public agenda which day shall be eligible for continuing education credit. A pharmacist or pharmacy technician requesting o this subdivision must sign in and out on an continuing education pursuant t 267

268 attendance sheet at the board meeting that requires the individual to provide his or her first and last name, license number, time of arrival and time of departure from the meeting. (e) A pharmacist or pharmac y technician who attends a full committee meeting of the board may be awarded two (2) hours of continuing education per renewal period. A pharmacist or pharmacy technician requesting continuing education hours pursuant to this subdivision must sign in and out on an attendance sheet at the committee meeting that requires the individual to provide his or her first and last name, license number, time of arrival and time of departure from the meeting. (f) An individual may be awarded three (3) hours of contin uing education for successfully passing the examination administered by the Commission for Certification in Geriatric Pharmacy. Authority cited: Section 4005, Business and Professions Code. Reference: essions Code. Section 4200.2, 4202, 4231 and 4232, Business and Prof 1732.3. Requirements for Continuing Education Courses. (a) Unless denied by the accreditation agency upon audit, all coursework offered by providers may be used to satisfy the continuing education required by section 1732.5 of this Division . (b) On a random basis or in response to a request by the board, the accreditation agency shall review selected coursework. The material shall be forwarded to a reviewer to judge the quality of the program on the basis of factors established by the accre ditation agency in addition to the requirements of this section. (c) A recognized provider's coursework shall be valid for up to three years following the initial presentation provided that the information is still current. (d) Continuing education cours es shall comply with the following: (1) Courses shall have specific, measurable learning objectives which serve as a basis for an evaluation of the program's effectiveness. (2) Speakers, or those developing the content of the course, shall be competent i n the subject matter and shall be qualified by education, training and/or experience. (3) Courses shall have a syllabus which provides a general outline of the course. The syllabus shall contain at a minimum, the learning objectives for summary containing the main points for each topic. each course and a (4) Courses shall include a mechanism that allows all participants to assess their achievement in accordance with the program's learning objectives. (e) (1) Continuing education courses shall be relevant to the practice of pharmacy as provided in this section and in section 4232 of the Business and Professions Code and related to one or more of the following: (A) The scientific knowledge or technical skills required for the practice of pharmacy. (B) Dir ect and/or indirect patient care. (C) The management and operation of a pharmacy practice. 268

269 (2) Continuing education courses shall not reflect the commercial views of the provider or of any person giving financial assistance to the provider. Authority ci ted: Section 4005 Business and Professions Code. Reference: Section 4232, Business and Professions Code. 1732.4. Provider Audit Requirements. Upon written request from the accreditation agency, relating to an audit of continuing education course, each pr ovider shall submit such materials as are required by the accreditation agency. Authority cited: Section 4005, Business and Professions Code. Reference: Section 4232, Business and Professions Code. 1732.5. Renewal Requirements for Pharmacist. (a) Excep t as provided in section 4234 of the Business and Professions Code and section 1732.6 of this Division, each applicant for renewal of a pharmacist license shall submit proof satisfactory to the board, that the applicant has completed 30 hours of continuing education in the prior 24 months. (b) At least two (2) of the thirty (30) hours required for pharmacist license renewal shall be completed by participation in a Board provided CE course in on or after Law and Ethics. Pharmacists renewing their licenses which expire July 1, 2019, shall be subject to the requirements of this subdivision. c ) All pharmacists shall retain their certificates of completion for four (4) ( years following completion of a continuing education course. Authority cited: Section 400 5, Business and Professions Code. Reference: Sections 4231 and 4232, Business and Professions Code. 1732.6. Exemptions. Pharmacists may seek exemption from the continuing education requirements ing to the board for renewal on the grounds of emergency or hardship by apply in writing, setting forth the reasons why such exemption should be granted. - time enrollment Exemptions may be granted for such reasons as illness or full in a health professional school. Authority cited: Section 4005, Business and Profess ions Code. Reference: Section 4234, Business and Professions Code. 1732.7. Complaint Mechanism. A provider may request reconsideration of any adverse action taken against the provider or its coursework by an accreditation agency. Following such reconside ration, the provider may request review of the accreditation agency's decision by the board. Authority cited: Section 4005, Business and Professions Code. Reference: Section 4232, Business and Professions Code. 269

270 Article 4.5 Compounding 1735. Compounding in Licensed Pharmacies (a) “Compounding” means any of the following activities occurring in a licensed pharmacy, by or under the supervision of a licensed pharmacist, pursuant to a prescription: (1) Altering the dosage form or delivery system of a drug (2) Altering the strength of a drug (3) Combining components or active ingredients (4) Preparing a compounded drug preparation from chemicals or bulk drug substances (b) “Compounding” does not include reconstitution of a drug pursuant to a manufact urer’s direction(s), nor does it include the sole act of tablet splitting or crushing, capsule opening, or the addition of flavoring agent(s) to enhance palatability. (c) The parameters and requirements stated by Article 4.5 (Section 1735 et seq.) apply to all compounding practices. Additional parameters and requirements applicable solely to sterile compounding are stated by Article 7 (Section 1751 et seq.). Authority cited: Sections 4005 and 4127, Business and Professions Code. , 4036, 4037, 4051, 4052, and 4127, Business and Reference: Sections 4005 Professions Code. Compounding Definitions 1735.1. (a) “Ante - area” means an area with ISO Class 8 or better air quality where personnel hand hygiene and garbing procedures, staging of components, and other high - particulate - generating activities are performed, that is adjacent to the area designated for sterile compounding. It is a transition area that begins the systematic reduction of particles, prevents large fluctuations in air temperature in the cleanroom, and maintains air flows from clean to dirty and pressures areas. ISO Class 7 or better air quality is required for ante - areas providing air to a negative pressure room. (b) “Beyond use date” means the date, or date and time, after which administratio n of a compounded drug preparation shall not begin, the preparation shall not be dispensed, and the preparation shall not be stored (other than for quarantine purposes). (c) “Biological Safety Cabinet (BSC)” means a ventilated cabinet for compounding ste rile drug preparations, having an open front with inward airflow for personnel protection, downward HEPA - filtered laminar airflow for product protection, and HEPA - filtered exhausted air for environmental protection. Where hazardous drugs are prepared, the exhaust air from the biological safety cabinet shall be appropriately removed by properly designed external building ventilation. This external venting should be dedicated to one BSC or CACI. 270

271 (d) “Bulk drug substance” means any substance that, when used in the preparation of a compounded drug preparation, processing, or packaging of a drug, is an active ingredient or a finished dosage form of the drug, but the term does not include any intermediate used in the synthesis of such substances. (e) “Cleanroo m or clean area or buffer area” means a room or area with - filtered air that provides ISO Class 7 or better air quality where the HEPA primary engineering control (PEC) is physically located. (1) For nonhazardous compounding a positive pressure differenti al of 0.02 - to 0.05 inch water column relative to all adjacent spaces is required. - (2) For hazardous compounding at least 30 air changes per hour of HEPA - filtered supply air and a negative pressure of between 0.01 to 0.03 inches of water column relative t o all adjacent spaces is required. (f) “Compounding Aseptic Containment Isolator (CACI)” means a unidirectional HEPA - filtered airflow compounding aseptic isolator (CAI) designed to provide worker protection from exposure to undesirable levels of airborne drug throughout the compounding and material transfer processes and to provide an aseptic environment for compounding sterile preparations. Air exchange with the surrounding environment should not occur unless the air is etentive filter (HEPA minimum) system first passed through a microbial r capable of containing airborne concentrations of the physical size and state of the drug being compounded. Where hazardous drugs are prepared, the exhaust y designed air from the isolator shall be appropriately removed by properl external building ventilation. This external venting should be dedicated to one BSC or CACI. Air within the CACI shall not be recirculated nor turbulent. (g) “Compounding Aseptic Isolator (CAI)” means a form of isolator specifically designed fo r non hazardous compounding of pharmaceutical ingredients or preparations while bathed with unidirectional HEPA - filtered air. It is designed to maintain an aseptic compounding environment within the isolator throughout the compounding and material transfer processes. Air exchange into the isolator from the surrounding environment should not occur unless the air has first passed through a microbial retentive filter (HEPA minimum) system capable of containing airborne concentrations of the physical size and s tate of the drug being compounded. Air within the CAI shall not be recirculated nor turbulent. (h) “Controlled cold temperature” means 2 degrees to 8 degrees C (35 degrees to 46 degrees F). 13 (i) “Controlled freezer temperature” means - 25 degrees to - 10 degrees C ( - degrees to 14 degrees F) or at a range otherwise specified by the pharmaceutical manufacturer(s) for that product. (j) “Controlled room temperature” means 20 degrees to 25 degrees C (68 degrees to 77 degrees F). a copy” of a commercially available drug product (k) “Copy or essentially includes all preparations that are comparable in active ingredients to commercially available drug products, except that it does not include any preparations in which there has been a change, made for an ide ntified individual patient, which produces for that patient a clinically significant difference, as determined by a prescribing practitioner, between that 271

272 compounded preparation and the comparable commercially available drug product. (l) “Daily” means oc curring every day the pharmacy is operating, except when daily monitoring of refrigerator and freezer temperature are required, then daily means every 24 hours. (m) “Displacement airflow method” means a concept which utilizes a low high airflow principle to maintain segregation from the pressure differential adjacent ante area by means of specific pressure differentials. This principle of - displacement airflow shall require an air velocity of 40 ft per minute or more, from floor to ceiling and wall to wall , from the clean area across the line of demarcation into the ante - area. The displacement concept may not be used to maintain clean area requirements for sterile compounds which originate from any ingredient that was at any time non - sterile, regardless of intervening sterilization of the ingredient, or for hazardous compounds. (n) “Dosage unit” means a quantity sufficient for one administration to one patient. (o) “Equipment” means items that must be calibrated, maintained or periodically certified. ( p) “First air” means the air exiting the HEPA filter in a unidirectional air stream that is essentially particle free. (q) “Gloved fingertip sampling” means a process whereby compounding personnel lightly press each fingertip and thumb of each hand onto appropriate growth media, which are then incubated at a temperature and for a time period conducive to multiplication of microorganisms, and then examined for growth of microorganisms. - (r) “Hazardous” means all anti tional neoplastic agents identified by the Na Institute for Occupational Safety and Health (NIOSH) as meeting the criteria for a hazardous drug and any other drugs, compounds, or materials identified as - in - hazardous by the pharmacist charge. (s) “Integrity” means retention of potency until th e beyond use date provided on the label, so long as the preparation is stored and handled according to the label directions. (t) “Lot” means one or more compounded drug preparation(s) prepared during one uninterrupted continuous cycle of compounding from one or more common active ingredient(s). fill test” means a test used to measure the efficacy of (u) “Media - compounding personnel in aseptic techniques whereby compounding - based media and then the resulting procedures are mimicked using a growth prepara tion is evaluated for sterility. The media - fill test must mimic the most complex compounding procedures performed by the pharmacy. (v) “Non - sterile - to - sterile batch” means any compounded drug preparation containing two (2) or more dosage units with any i ngredient that was at any time non - sterile, regardless of intervening sterilization of that ingredient. (w) “Parenteral” means a preparation of drugs administered in a manner other than through the digestive tract. It does not include topical, sublingual , rectal or buccal routes of administration. 272

273 (x) “Personal protective equipment” means clothing or devices that protect the employee from exposure to compounding ingredients and/or potential toxins and minimize the contamination of compounded preparation s. These include shoe covers, head and facial hair covers, face masks, gowns, and gloves. (y) “Potency” means active ingredient strength within +/ - 10% (or the range specified in USP37 NF32, 37th Revision, Through 2nd Supplement Effective December 1, 2014 ) of the labeled amount. Sterile injectable products compounded solely from commercially manufactured sterile pharmaceutical products in a health care facility licensed under section 1250 of the Health and Safety Code are exempt from this definition. For t hose exempt, the range shall be calculated and defined in the master formula. (z) “Preparation” means a drug or nutrient compounded in a licensed pharmacy; the preparation may or may not be sterile. (aa) "Prescriber's office" or "prescriber office" mea ns an office or suite of offices in which a prescriber regularly sees patients for outpatient diagnosis and treatment. This definition does not include any hospital, pharmacy, or other facility, whether or not separately licensed, that may be affiliated wi th, adjacent to, or co - owned by, the prescriber’s practice environment. (ab) “Primary Engineering Control (PEC)” means a device that provides an ISO Class 5 or better environment through the use of non - turbulent, filtered first air fo - r compounding sterile preparations. unidirectional HEPA Examples of PEC devices include, but are not limited to, laminar airflow workbenches, biological safety cabinets, sterile compounding automated robots, compounding aseptic isolators, and compounding aseptic containment i solators. (ac) “Process validation” means demonstrating that when a process is repeated within specified limits, the process will consistently produce preparations complying with predetermined requirements. If any aspect of the process is changed, the pr ocess would need to be revalidated. (ad) “Product” means a commercially manufactured drug or nutrient evaluated for safety and efficacy by the FDA. (ae) “Quality” means the absence of harmful levels of contaminants, including filth, putrid, or decompos ed substances, the absence of active ingredients other than those listed on the label, and the absence of inactive ingredients other than those listed on the master formula document. (af) “Segregated sterile compounding area” means a designated space for - to - sterile compounding where a PEC is located within either a sterile demarcated area (at least three foot perimeter) or in a separate room. Such area or room shall not contain and shall be void of activities and materials that are extraneous to sterile c ompounding. The segregated sterile compounding area shall not be in a location that has unsealed windows or doors that connect to the outdoors, in a location with high traffic flow, or in a location that is adjacent to construction sites, warehouses, or fo od preparation. The segregated sterile compounding area shall not have a sink, other than an emergency eye - washing station, located within three feet of a PEC. The segregated sterile compounding e compounded steril area shall be restricted to preparation of sterile - to - preparations. 273

274 (1) The BUD of a sterile drug preparation made in a segregated sterile compounding area is limited to 12 hours or less as defined by section 1751.8(d). (2) When the PEC in the segregated sterile compounding area is a CAI or a CACI and the documentation provided by the manufacturer shows it meets the - (3), the assigned BUD shall comply requirements listed in section 1751.4(f)(1) - b) or (d). with section 1751.8(a (ag) “Strength” means amount of active ingredient per unit of a co mpounded drug preparation Authority cited: Sections 4005 and 4127, Business and Professions Code. 4051, 4052, and 4127, Business and Reference: Sections 4005, 4036, 4037, Professions Code. 1735.2. Compounding Limitations and Requirements ; Self - Assessment (a) Except as specified in (b) and (c), no drug preparation shall be compounded prior to receipt by a pharmacy of a valid prescription for an individual patient where the prescriber has approved use of a compounded drug preparation either orally or in wr iting. Where approval is given orally, that approval shall be noted on the prescription prior to compounding. (b) A pharmacy may prepare and store a limited quantity of a compounded drug preparation in advance of receipt of a patient n where specific prescriptio - and solely in such quantity as is necessary to ensure continuity of care for an identified population of patients of the pharmacy based on a documented history of prescriptions for that patient population. (c) A “reasonable quantity” that may be furnished to a prescriber for office use by the prescriber as authorized by Business and Professions Code section 4052, subdivision (a)(1), means that amount of compounded drug preparation that: (1) Is ordered by the prescriber or the prescriber’s agent using a purchase order or other documentation received by the pharmacy prior to furnishing that lists the number of patients seen or to be seen in the prescriber’s office for whom the drug is needed or anticipated, and the quantity for each patient that is sufficient for office administration; and (2) Is delivered to the prescriber’s office and signed for by the prescriber or the prescriber’s agent; and (3) Is sufficient for administration or application to patients solely in the prescriber's office, or for furnishing of not more than a 120 - hour supply for veterinary medical practices, solely to the prescriber's own veterinary patients seen as part of regular treatment in the prescriber's office, as fairly estimated by the prescriber and documented on th e purchase order or other documentation submitted to the pharmacy prior to furnishing; and (4) That the pharmacist has a credible basis for concluding it is a reasonable quantity for office use considering the intended use of the compounded medication an d the nature of the prescriber’s practice; and (5) With regard to any individual prescriber to whom the pharmacy furnishes, and with regard to all prescribers to whom the pharmacy furnishes, is an mpliance with amount which the pharmacy is capable of compounding in co 274

275 pharmaceutical standards for integrity, potency, quality and strength of the compounded drug preparation; and (6) Does not exceed an amount the pharmacy can reasonably and safely compound. (d) No pharmacy or pharmacist shall compound a dr ug preparation that: (1) Is classified by the FDA as demonstrably difficult to compound; (2) Appears on an FDA list of drugs that have been withdrawn or removed from the market because such drugs or components of such drugs have been found to be unsafe or not effective; or (3) Is a copy or essentially a copy of one or more commercially available drug products, unless that drug product appears on an ASHP (American Society of Health - System Pharmacists) or FDA list of drugs that are in short supply at th e time of compounding and at the time of dispense, and the compounding of that drug preparation is justified by a specific, documented medical need made known to the pharmacist prior to compounding. The pharmacy shall retain a copy of the documentation of the shortage and the specific medical need in the pharmacy records for three years from the date of receipt of the documentation. (e) A drug preparation shall not be compounded until the pharmacy has first prepared a written master formula document that includes at least the following elements: (1) Active ingredients to be used. (2) Equipment to be used. (3) The maximum allowable beyond use date for the preparation, and the rationale or reference source justifying its determination. (4) Inactive i ngredients to be used. (5) Specific and essential compounding steps used to prepare the drug. (6) Quality reviews required at each step in preparation of the drug. (7) Post - compounding process or procedures required, if any. (8) Instructions for st orage and handling of the compounded drug preparation. (f) Where a pharmacy does not routinely compound a particular drug preparation, the master formula record for that preparation may be recorded on the prescription document itself. (g) The pharmacis t performing or supervising compounding is responsible for the integrity, potency, quality, and labeled strength of a compounded drug preparation until the beyond use date indicated on the label, so long as label instructions for storage and handling are f ollowed after the preparation is dispensed. (h) All chemicals, bulk drug substances, drug products, and other components used for drug compounding shall be stored and used according to compendia and other applicable requirements to maintain their integri ty, potency, quality, and labeled strength. (i) Every compounded drug preparation shall be given beyond use date representing the date or date and time beyond which the compounded drug and preparation should not be used, stored, transported or administered, determined based on the professional judgment of the pharmacist performing or supervising the compounding. 275

276 (1) For non - sterile compounded drug preparation(s), the beyond use date shall not exceed any of the following: (A) the shortest expiration da te or beyond use date of any ingredient in the compounded drug preparation, (B) the chemical stability of any one ingredient in the compounded drug preparation; (C) the chemical stability of the combination of all ingredients in the paration, compounded drug pre - aqueous formulations, 180 days or an extended date established (D) for non by the pharmacist’s research, analysis, and documentation, (E) for water - containing oral formulations, 14 days or an extended date established by the pharmacist’s resea rch, analysis, and documentation, and (F) for water - containing topical/dermal and mucosal liquid and semisolid formulations, 30 days or an extended date established by the pharmacist’s research, analysis, and documentation. (G) A pharmacist, using his or her professional judgment may establish an extended date as provided in (D), (E), and (F), if the pharmacist researches by consulting and applying drug specific and general stability documentation and - literature; analyzes such documentation and literatu re as well as the other factors set forth in this subdivision, and maintains documentation of the research, analysis and conclusion. The factors the pharmacist must analyze include: the nature of the drug and its degradation mechanism, (i) age form and its components, (ii) the dos (iii) the potential for microbial proliferation in the preparation, (iv) the container in which it is packaged, (v) the expected storage conditions, and (vi) the intended duration of therapy. Documentation of the pharmacist ’s research and analysis supporting an extension must be maintained in a readily retrievable format as part of the master formula. (2) For sterile compounded drug preparations, the beyond use date shall not exceed any of the following: expiration date or beyond use date of any ingredient in the (A) The shortest sterile compounded drug product preparation, (B) The chemical stability of any one ingredient in the sterile compounded drug preparation, (C) The chemical stability of the combination of all ingredients in the sterile compounded drug preparation, and (D) The beyond use date assigned for sterility in section 1751.8. For sterile compounded drug preparations, e xtension of a beyond use date (3) is only allowable when supported by the following : (A) Method Suitability Test, (B) Container Closure Integrity Test, and (C) Stability Studies (4) In addition to the requirements of paragraph three (3), the drugs or compounded drug preparations tested and studied shall be identical in 276

277 s, specific and essential compounding steps, quality reviews, and ingredient packaging as the finished drug or compounded drug preparation. (5) Shorter dating than set forth in this subsection may be used if it is deemed the responsible pharmacist. appropriate in the professional judgment of (j) The pharmacist performing or supervising compounding is responsible for the proper preparation, labeling, storage, and delivery of the compounded drug preparation. (k) Prior to allowing any drug product preparation to be compounded in a pharmacy, the pharmacist in - charge shall complete a self - assessment for - compounding pharmacies developed by the board (Incorporated by reference is “Community Pharmacy & Hospital Outpatient Pharmacy Compounding Self - Assessment” Form 17M - 39 Rev. 02/12.) as required by Section 1715 of Title 16, Division 17, of the California Code of Regulations. That form contains a first section applicable to all compounding, and a second section applicable to sterile injectable compounding. The first sectio n must be completed by the pharmacist - in - charge before any compounding is performed in the pharmacy. The second section must be completed by the pharmacist - in - charge before any sterile compounding is performed in the pharmacy. The applicable sections of e self - assessment shall subsequently be completed before July 1 of each odd - th numbered year, within 30 days of the start date of a new pharmacist - in - charge or change of location, and within 30 days of the issuance of a new pharmacy license. The primary purpo assessment is to promote compliance - se of the self through self examination and education. - (l) Packages of ingredients, both active and inactive, that lack a supplier’s expiration date are subject to the following limitations: (1) such ingredients cann ot be used for any non - sterile compounded drug preparation more than three (3) years after the date of receipt by the pharmacy. (2) such ingredients cannot be used for any sterile compounded drug preparation more than one (1) year after the date of recei pt by the pharmacy. Authority cited: Sections 4005 and 4127, Business and Professions Code. Reference: Sections 4005, 4036, 4037, 4051, 4052, and 4127, Business and Professions Code. of Compounded Drug Preparations 1735.3. Recordkeeping mpounded drug preparation, pharmacy records shall include: (a) For each co (1) The master formula document. (2) A compounding log consisting of a single document containing all of the following: (A) Name and Strength of the compounded drug preparation. e the drug preparation was compounded. (B) The dat (C) The identity of any pharmacy personnel engaged in compounding the drug preparation. (D) The identity of the pharmacist reviewing the final drug preparation. nding the drug preparation. (E) The quantity of each ingredient used in compou (F) The manufacturer, expiration date and lot number of each component. If the manufacturer name is demonstrably unavailable, the name of the supplier 277

278 for may be substituted. If the manufacturer does not supply an expiration date any component, the records shall include the date of receipt of the component in the pharmacy, and the limitations of section 1735.2, subdivision (l) shall apply. (i) Exempt from the requirements in this paragraph (1735.3(a)(2)(F)) are ations compounded in a single lot for administration within sterile prepar - two (72) hours to a patient in a health care facility licensed under seventy section 1250 of the Health and Safety Code and stored in accordance with standards for “Redispensed CSPs” found in Chap ter 797 of the United States NF32) Through 2nd Supplement Pharmacopeia – National Formulary (USP37 - (37 Revision, Effective December 1, 2014), hereby incorporated by reference. th (G) A pharmacy - assigned unique reference or lot number for the compounded dr ug product preparation. (H) The beyond use date or beyond use date and time of the final compounded drug preparation, expressed in the compounding document in a standard date and time format. ded for (I) The final quantity or amount of drug preparation compoun dispensing. (J) Documentation of quality reviews and required post - compounding process and procedures. (b) Pharmacies shall maintain records of the proper acquisition, storage, and destruction of chemicals, bulk drug substances, drug products, and components used in compounding. (c) Active ingredients shall be obtained from a supplier registered with the Food and Drug Administration (FDA). All other chemicals, bulk drug substances, and drug products used to compound drug preparations shall be registered suppliers. The pharmacy - obtained, whenever possible, from FDA shall acquire and retain certificates of purity or analysis, either written in English or translated into English, for chemicals, bulk drug substances, and unding. Certificates of purity or analysis are not drug products used in compo required for drug products that are approved by the FDA. Any certificates of purity or analysis acquired by the pharmacy shall be matched to the corresponding chemical, bulk drug substance, or drug product s received. (d) Pharmacies shall maintain and retain all records required by this article in the pharmacy in a readily retrievable form for at least three years from the date the record was last in effect. If only recorded and stored electronically, on m agnetic media, or in any other computerized form, the records shall be maintained as specified by Business and Professions Code section 4070 subsection (c). Authority cited: Sections 4005, 4127, and 4169, Business and Professions Code. Reference: Section s 4005, 4036, 4037, 4051, 4052, and 4127, Business and Professions Code. 278

279 1735.4. Labeling of Compounded Drug Preparations (a) Each compounded drug preparation shall be affixed with a container label prior to dispensing that contains at least: e of the compounding pharmacy and dispensing pharmacy (if (1) Nam different); (2) Name (brand or generic) and strength, volume, or weight of each active ingredient. For admixed IV solutions, the intravenous solution utilized shall be included; (3) Instructions for storage, handling, and administration. For admixed IV solutions, the rate of infusion shall be included; (4) The beyond use date for the drug preparation; (5) The date compounded; and (6) The lot number or pharmacy reference number. (b) Any co mpounded drug preparation dispensed to a patient or readied for dispensing to a patient shall also include on the label the information required under Business and Professions Code section 4076 and California Code of Regulations, title 16, section 1707.5. (c) Any compounded drug preparation dispensed to a patient or readied for dispensing to a patient shall also include, on the container label or on a receipt provided to the patient, a statement that the drug has been compounded by the pharmacy. or to dispensing drug preparations compounded into unit (d) Pri dose - containers that are too small or otherwise impractical for full compliance with subdivisions (a), (b), and (c) shall be labeled with at least the name of the compounding pharmacy and dispensing p harmacy, if different, the name(s) of the active ingredient(s), strength, volume or weight of the preparation, pharmacy reference or lot number, and beyond use date, and shall not be subject to minimum font size requirements. Once dispensed, outer packagin g must comply with 1735.4(a) – (c). (e) All hazardous agents shall bear a special label which states “Chemotherapy - Dispose of Properly” or “Hazardous – Dispose of Properly.” Authority cited: Sections 4005 and 4127, Business and Professions Code. Refer ence: Sections 4005, 4036, 4037, 4051, 4052, 4076 and 4127, Business and Professions Code. 1735.5. Compounding Policies and Procedures (a) Any pharmacy engaged in compounding shall maintain written policies and procedures for compounding that establishe s procurement procedures, methodologies for the formulation and compounding of drugs, facilities and equipment cleaning, maintenance, operation, and other standard operating procedures related to compounding. Any material failure to follow the pharmacy’s w ritten policies and procedures shall constitute a basis for disciplinary action. (b) The policies and procedures shall be reviewed and such review shall be in charge. The policies and - - documented on an annual basis by the pharmacist 279

280 dated whenever changes in policies and procedures are procedures shall be up implemented. (c) The policies and procedures shall include at least the following: (1) Procedures for notifying staff assigned to compounding duties of any changes in policies or procedures. written plan for recall of a dispensed compounded drug preparation (2) A where subsequent information demonstrates the potential for adverse effects with continued use. The plan shall ensure that all affected doses can be accounted for during the recall and sha ll provide steps to identify which patients received the affected lot or compounded drug preparation(s). (3) Procedures for maintaining, storing, calibrating, cleaning, and disinfecting as part of equipment used in compounding, and for training on these procedures the staff training and competency evaluation process. (4) Procedures for evaluating, maintaining, certifying, cleaning, and disinfecting the facility (physical plant) used for compounding, and for training on these procedures as part of the st aff training and competency evaluation process. (5) Documentation of the methodology used to validate integrity, potency, quality, and labeled strength of compounded drug preparations. The methodology must be appropriate to compounded drug preparations. (6) Documentation of the methodology and rationale or reference source used to determine appropriate beyond use dates for compounded drug preparations. (7) Dates and signatures reflecting all annual reviews of the policies and charge. - in procedures by the pharmac ist - (8) Dates and signatures accompanying any revisions to the policies and procedures approved by the pharmacist - in - charge. (9) Policies and procedures for storage of compounded drug preparations in the pharmacy and daily documentation of a ll room, refrigerator, and freezer temperatures within the pharmacy. (10) Policies and procedures regarding ensuring appropriate functioning of refrigeration devices, monitoring refrigeration device temperatures, and actions to take regarding any out of range temperature variations within the pharmacy. (11) Policies and procedures for proper garbing when compounding with hazardous products. This shall include when to utilize double shoe covers. Authority cited: Sections 4005 and 4127, Business and Pro fessions Code. Reference: Sections 4005, 4036, 4037, 4051, 4052, 4127, and 4301, Business and Professions Code 1735.6. Compounding Facilities and Equipment (a) Any pharmacy engaged in compounding shall maintain written documentation regarding the facili ties and equipment necessary for safe and accurate compounding of compounded drug preparations. This shall include records of maintenance and cleaning of the facilities and equipment. Where facilities or applicable, this shall also include records of certification(s) of equipment. 280

281 (b) Any equipment used to compound drug preparations shall be stored, used, maintained, and cleaned in accordance with manufacturers' specifications. (c) Any equipment that weighs, measures, or transfers ingredients used to mpound drug preparations for which calibration or adjustment is appropriate co shall be calibrated prior to use, on a schedule and by a method determined by the manufacturer’s specifications, to ensure accuracy. Documentation of each such calibration shall be recorded in a form which is not alterable and these records of calibration shall be maintained and retained in the pharmacy. (d) Any pharmacy engaged in any hazardous drug compounding shall maintain written documentation regarding appropriate cleaning o f facilities and equipment to prevent cross - contamination with non - hazardous drugs. (e) Hazardous drug compounding shall be completed in an externally vented physically separate room with the following requirements: (1) Minimum of 30 air changes per ho ur except that 12 air changes per hour are acceptable for segregated compounding areas with a BSC or CACI when products are assigned a BUD of 12 hrs or less or when non sterile products are compounded; and (2) Maintained at a negative pressure of 0.01 to 0.03 inches of water column relative to all adjacent spaces (rooms, above ceiling, and corridors); and (3) Each PEC in the room shall also be externally vented; and (4) All surfaces within the room shall be smooth, seamless, impervious, and non - sheddi ng. (f) Where compliance with the January 1, 2017 amendments to Article 4.5 or Article 7, requires physical construction or alteration to a facility or physical environment, the board or its designee may grant a waiver of such compliance for a period of time to permit such physical change(s). Application for any waiver shall be made by the licensee in writing, and the request shall identify the provision(s) requiring physical construction or alteration, and the timeline for any such change(s). The board o r its designee may grant the waiver when, in its discretion, good cause is demonstrated for such waiver. Authority cited: Sections 4005 and 4127, Business and Professions Code. Reference: Sections 4005, 4036, 4037, 4051, 4052 and 4127, Business and Profe ssions Code. 1735.7. Training of Compounding Staff (a) A pharmacy engaged in compounding shall maintain documentation demonstrating that personnel involved in compounding have the skills and training required to properly and accurately perform their ass igned responsibilities and documentation demonstrating that all personnel involved in compounding are trained in all aspects of policies and procedures. This training shall include but is not limited to support personnel (e.g. institutional environmental s ervices, housekeeping), maintenance staff, supervising pharmacist and all others whose jobs are related to the compounding process. (b) The pharmacy shall develop and maintain an ongoing competency mpounding, and shall evaluation process for pharmacy personnel involved in co 281

282 maintain documentation of any and all training related to compounding undertaken by pharmacy personnel. (c) Pharmacy personnel assigned to compounding duties shall demonstrate ing prior to knowledge about processes and procedures used in compound compounding any drug preparation. Authority cited: Sections 4005 and 4127, Business and Professions Code. Reference: Sections 4005, 4036, 4037, 4051, 4052 and 4127, Business and Professions Code 1735.8. Compounding Quality Assurance (a) A ny pharmacy engaged in compounding shall maintain, as part of its written policies and procedures, a written quality assurance plan designed to monitor and ensure the integrity, potency, quality, and labeled strength of compounded drug preparations. (b) The quality assurance plan shall include written procedures for verification, monitoring, and review of the adequacy of the compounding processes and shall also include written documentation of review of those processes by qualified pharmacy personnel. c) The quality assurance plan shall include written standards for qualitative ( and quantitative analysis of compounded drug preparations to ensure integrity, potency, quality, and labeled strength, including the frequency of testing. All qualitative and qua ntitative analysis reports for compounded drug preparations shall be retained by the pharmacy and maintained along with the compounding log and master formula document. The quality assurance plan shall include a schedule for routine testing and analysis of specified compounded drug preparations to ensure integrity, potency, quality, and labeled strength, on at least an annual basis. (d) The quality assurance plan shall include a written procedure for scheduled action in the event any compounded drug prepa ration is ever discovered to be outside minimum standards for integrity, potency, quality, or labeled strength. (e) The quality assurance plan shall include a written procedure for responding of range temperature variations within the pharmacy and within patient to out - - care areas of a hospital where furnished drug is returned for redispensing. Authority cited: Sections 4005 and 4127, Business and Professions Code. Reference: Sections 4005, 4036, 4037, 4051, 4052 and 4127, Business and Professions Code. Article 5. Dangerous Drugs 1744. Drug Warnings. Pursuant to Business and Professions Code Section 4074, a pharmacist shall inform the patient or his or her representative of the harmful effects of certain drugs dispensed by prescription. following classes of drugs may impair a person's ability to (a) Because the operate a vehicle or vessel, a pharmacist shall include a written label on the 282

283 drug container indicating that the drug may impair a person’s ability to operate a vehicle or vessel: (1) Muscle re laxants. (2) Antipsychotic drugs with central nervous system depressant effects. (3) Antidepressants with central nervous system depressant effects. (4) Antihistamines, motion sickness agents, antipruritics, antinauseants, anticonvulsants and antihypert ensive agents with central nervous system depressant effects. (5) All Schedule II, III, IV and V agents with central nervous system depressant effects. (6) Anticholinergic agents that may impair vision. professional judgment, (7) Any other drug which, based on the pharmacist’s may impair a patient’s ability to operate a vehicle or vessel. (b) Because the following classes of drugs pose a substantial risk to the person consuming the drug when taken in combination with alcohol, a pharmacist shall include a written label on the drug container to alert the patient about possible potentiating effects: (1) Disulfiram and other drugs (e.g., chlorpropamide, metronidazole) which may cause a disulfiram - like reaction. (2) Mono amine oxidase inhibitors. es. (3) Nitrat (4) Cycloserine. (5) Antidiabetic agents including insulin and sulfonylureas (due to risk of hypoglycemia). (6) Any other drug which, based upon a pharmacist’s professional judgment, may pose a substantial risk to the person consuming the drug when t aken in combination with alcohol. Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4022, 4055 and 4074, Business and Professions Code . 1745. Partial Filling of Schedule II Prescriptions. (a) A prescription for a Schedul e II controlled substance (as defined in Health and Safety Code section 11055) may be partially filled, as defined in paragraph (b), if: (1) The prescription is for an inpatient of a skilled nursing facility as defined 50; or in Health and Safety Code section 12 (2) The prescription is for a terminally ill patient. “Terminally ill” as used herein means a patient for whom a licensed physician and surgeon has made and documented a diagnosis of illness or disease that will result in death. (b) A “partially f illed” prescription is a prescription from which only a portion of the amount for which the prescription is written is filled at any one time; provided that regardless of how many times the prescription is partially filled, the total amount dispensed shall not exceed that written on the face of the prescription. When partially filling a prescription pursuant to subsection (a), all of the (c) following conditions must be met: 283

284 (1) The prescription must be tendered and at least partially filled within 60 day s following the date of issue; (2) The pharmacist records the date and amount of each partial filling in a readily retrievable form and on the original prescription, also recording the initials of the pharmacist dispensing the prescription; (3) No portio n of the prescription is dispensed more than 60 days from the date of issuance of the prescription; and (d) A pharmacist may partially fill a prescription for a controlled substance listed in Schedule II, if the pharmacist is unable to supply the full qua ntity ordered by the prescriber. The pharmacist shall make a notation of the quantity supplied on the face of the written prescription. The remaining portion of the prescription may be filled within 72 hours of the first partial filling. If the remaining p ortion is not filled within the 72 - hour period, the pharmacist shall notify the prescriber. The pharmacist may not supply the drug after 72 hour period has expired without a new prescription. Authority cited: Section 4005, Business and Professions Code. R eference: Section 4301, Business and Professions Code; and Sections 11055, 11153, 11154, 11166, 11200, Health and Safety Code. 1746. Emergency Contraception. (a) A pharmacist furnishing emergency contraception pursuant to Section ness and Professions Code shall follow the protocol 4052.3(a)(2) of the Busi specified in subdivision (b) of this section. (b) Protocol for Pharmacists Furnishing Emergency Contraception (EC). (1) Authority: Section 4052.3(a)(2) of the California Business and Professions Code au thorizes a pharmacist to furnish emergency contraception pursuant to a protocol approved by the California State Board of Pharmacy and the Medical Board of California. Use of the protocol specified in this section satisfies that requirement. (2) Purpose : To provide timely access to emergency contraceptive medication and ensure that the patient receives adequate information to successfully complete therapy. (3) Procedure: When a patient requests emergency contraception, the pharmacist will ask and comm unicate the following: Are you allergic to any medications? Timing is an essential element of the product's effectiveness. EC should be taken as soon as possible after unprotected intercourse. Treatment may be initiated up to five days (120 hours) after unprotected intercourse. EC use will not interfere with an established or implanted pregnancy. If more than 72 hours have elapsed since unprotected intercourse, the use of ella™ (ulipristal) may be more effective than levonorgestrel. For other options fo r EC, consult with your health care provider. Please follow up with your health care provider after the use of EC. 284

285 (4) The pharmacist shall provide a fact sheet and review any questions the patient may have regarding EC. In addition, the pharmacist sh all collect the information required for a patient medication record required by Section 1707.1 of Title 16 of the California Code of Regulations. Fact Sheet: The pharmacist will provide the patient with a copy of the current EC fact sheet approved by the Board of Pharmacy as required by Business and Professions Code Section 4052.3(e). (5) Referrals and Supplies: If emergency contraception services are not immediately available at the pharmacy or the pharmacist declines to furnish pursuant to conscience clause, the pharmacist will refer the patient to another emergency contraception provider. The pharmacist shall comply with all state mandatory reporting laws, including sexual abuse laws. spermicidal condoms - to each (6) The pharmacist may provide up to 12 non Medi Cal and Family PACT client who obtains emergency contraception. - (7) Advanced provision: The pharmacist may dispense emergency contraception medication for a patient in advance of the need for emergency contraception. (8) EC Product Selec tion: The pharmacist will provide emergency contraception medication from the list of products specified in this protocol. This list must be kept current and maintained in the pharmacy. Along with emergency contraception products, the list will include adj unctive medications indicated for nausea and vomiting associated with taking EC containing estrogen. Patients will be provided information concerning dosing and potential adverse effects. (9) Documentation: Each prescription authorized by a pharmacist w ill be documented in a patient medication record as required by law. (10) Training: Prior to furnishing emergency contraception, pharmacists who participate in this protocol must have completed a minimum of one hour of mergency contraception. continuing education specific to e (11) Medications Used for Emergency Contraception Dedicated Approved Products for Emergency Contraception Ethinyl Estradiol Brand Dose per dose (mcg) One Tablet Regimens Plan B™ 1.5mg 1 tablet 0 - Step One levonorgestrel 30mg ™ ella 1 tablet 0 ulipristal 1.5mg 1 tablet 0 Levonorgestrel levonorgestrel Two Tablet Regimens 2 tablets at once Each tablet is mg (1.5mg total dose) 0 Next Choice™ 0.75 or levonorgestrel 285

286 1 tablet (0.75mg) followed by 1 tablet (0.75mg) 12 hours later 2 tablets at once (1.5mg total dose) Each tablet is or 0.75 mg 0 1 tablet (0.75mg) Levonorgestrel followed by levonorgestrel 1 tablet (0.75mg) 12 hours later Oral Contraceptive Pills Ethinyl Tablets per Dose Estradi ol Levonorgestrel doses Brand hours apart*) 12 (two per dose (mcg) per dose (mg)* Alesse 0.50 5 pink tablets 100 5 orange tablets 0.50 Aviane 100 Levlen 4 light - orange tablets 0.60 120 0.50 5 pink tablets Levlite 100 0.60 Levora 4 white tablets 120 Lo/Ovral 4 white tablets 0.50 120 Low - 0.60 4 white tablets 120 Ogestrel 4 light orange tablets Nordette 0.60 - 120 Ogestrel 2 white tablets 0.50 100 Ovral 0.50 2 white tablets 100 - Tri 4 yellow tablets 0.50 100 Levlen 4 yellow tablets Triphasil 0.50 120 Trivora 4 pink tablets 0.50 120 Ovrette 20 yellow tablets 0 0.75 *The progestin in Ovral, Lo/Ovral, and Ovrette is norgestrel, which contains two isomers, only one of which (levonorgestrel) is bioactive; the amount of norgestrel in each dose is twice the amount of levonorgestrel. In a ddition to the products specified in this paragraph, generic equivalent products may be furnished. Estrogen containing regimens are not preferred and should be used only when the other options are not available. 286

287 - nausea Treatment Options for use with Emergency Contraception (12) Anti Timing of Prescription Drugs Dose - Non Administration hour before first 1 mg Meclizine hydrochloride One or two 25 EC dose; Repeat if needed in (Dramamine tablets II, Bonine) 24 hours Diphenhydramine 1 hour before first EC One or two 25 mg hydrochloride dose; repeat as needed tablets capsules or ryl) - every 4 (Benad 6 hours 30 minutes to 1 hour One or two 50 mg Dimenhydrinate before first EC dose; tablets or 4 - 8 (Dramamine) repeat as needed every teaspoons liquid s hour 4 - 6 30 minutes before first Cyclizine hydrochloride EC dose; repeat as One 50 mg tablet (Marezine) - 6 hours needed every 4 4005, Business and Professions Code. Note: Authority cited: Section e. 4052 and 4052.3, Business and Professions Cod Reference: Sections 1746.1 Protocol for Pharmacists Furnishing Self - Administered Hormonal Contraception. (a) A pharmacist furnishing self - administered hormonal contraception pursuant to Section 4052.3 of the Business and Professions Code shall follow the protocol spe cified in subdivision (b) of this section. (b) Protocol for Pharmacists Furnishing Self Administered Hormonal - Contraception (1) Authority: Section 4052.3(a)(1) of the California Business and Professions - admi nistered hormonal Code authorizes a pharmacist to furnish self contraceptives in accordance with a protocol approved by the California State Board of Pharmacy and the Medical Board of California. Use of the protocol in this section satisfies that requirement. o self - administered hormonal (2) Purpose: To provide timely access t contraception medication and to ensure that the patient receives adequate information to successfully comply with therapy. (3) Definition of Self - Administered Hormonal Contraception: Hormonal contraception products with the f ollowing routes of administration are considered self - administered: (A) Oral; (B) Transdermal; 287

288 (C) Vaginal; (D) Depot Injection. (4) Procedure: When a patient requests self administered hormonal - contraception, the pharmacist shall complete the fo llowing steps: (A) Ask the patient to use and complete the self - screening tool; (B) Review the self - screening answers and clarify responses if needed; (C) Measure and record the patient’s seated blood pressure if combined hormonal contraceptives are requested or recommended; (D) Before furnishing self - administered hormonal contraception, the pharmacist shall ensure that the patient is appropriately trained in administration of the requested or recommended contraceptive medication. (E) When a self - administered hormonal contraceptive is furnished, the patient shall be provided with appropriate counseling and information on the product furnished, including: 1. Dosage; 2. Effectiveness; 3. Potential side effects; 4. Safety; 5. The importance of receiving recommended preventative health screenings; 6. That self administered hormonal contraception does not protect against - sexually transmitted infections (STIs). (5) Self Screening Tool: The pharmacist shall provide the patient with a self - - scr eening tool containing the list of questions specified in this protocol. The patient shall complete the self - screening tool, and the pharmacist shall use the answers to screen for all Category 3 and 4 conditions and characteristics for self - administered ho rmonal contraception from the current United States Medical Eligibility Criteria for Contraceptive Use (USMEC) developed by the federal Centers for Disease Control and Prevention (CDC). The patient shall complete the self - screening tool annually, or whenev er the patient indicates a major health change. A copy of the most recently completed self - screening tool shall be securely stored within the originating pharmacy or health care facility for a period of at least three years from the date of dispense. Thi s self screening tool should be made available in alternate languages for - patients whose primary language is not English. (6) Fact Sheets: (A) The pharmacist should provide the patient with a copy of a current, consumer - friendly, comprehensive birth co ntrol guide such as that created by the Food and Drug Administration (FDA). Examples of appropriate guides are available on the Board of Pharmacy’s website. (B) The pharmacist shall provide the patient with the FDA - required patient product information le aflet included in all self - administered hormonal contraception products, as required by Business and Professions Code Section 4052.3(c). The pharmacist shall answer any questions the patient may have administered hormonal contraception. regarding self - 288

289 ( C) The pharmacist should provide the patient with a copy of an administration - specific factsheet. Examples of appropriate factsheets are available on the Board of Pharmacy’s website. (7) Follow - Up Care: Upon furnishing a self - administered hormonal contr aceptive, or if it is determined that use of a self - administered hormonal contraceptive is not recommended, the pharmacist shall refer the patient for appropriate follow up care to the patient’s primary care provider or, if the - ary care provider, to nearby clinics. A patient who patient does not have a prim is determined not to be an appropriate candidate for self - administered hormonal contraception shall be advised of the potential risk and referred to an appropriate health care provider for further evaluat ion. (8) Notifications: The pharmacist shall notify the patient’s primary care provider of any drug(s) or device(s) furnished to the patient, or enter the appropriate information in a patient record system shared with the primary care provider, as permit ted by that primary care provider. If the patient does not have a primary care provider, or is unable to provide contact information for his or her primary care provider, the pharmacist shall provide the patient with a written record of the drug(s) or devi ce(s) furnished and advise the patient to consult an appropriate health care professional of the patient’s choice. (9) Referrals and Supplies: If self administered hormonal contraception - services are not immediately available or the pharmacist declines t o furnish pursuant to a conscience clause, the pharmacist shall refer the patient to another appropriate health care provider. The pharmacist shall comply with all state mandatory reporting laws, including sexual abuse laws. (10) Product Selection: The pharmacist, in consultation with the patient, may select any hormonal contraceptive listed in the current version of the USMEC for individuals identified as Category 1 or 2, based on the information reported in the self - screening tool and the blood pressu re (if recorded by the pharmacist). The USMEC shall be kept current and maintained in the pharmacy or health care facility, and shall be available on the Board of Pharmacy’s website. Generic equivalent products may be furnished. administered hormonal contraceptive furnished (11) Documentation: Each self - by a pharmacist pursuant to this protocol shall be documented in a patient medication record and securely stored within the originating pharmacy or from the date of dispense. health care facility for a period of at least three years A patient medication record shall be maintained in an automated data processing or manual record mode such that the required information under title 16, sections 1717 and 1707.1 of the California Code of Regulations is readily r etrievable during the pharmacy or facility’s normal operating hours. (12) Training: Prior to furnishing self - administered hormonal contraception, pharmacists who participate in this protocol must have completed a minimum of one hour of a board - approved c ontinuing education program specific to self - administered hormonal contraception, application of the USMEC, and other based training - CDC guidance on contraception. An equivalent, curriculum program completed on or after the year 2014 in an accredited Cali fornia school of pharmacy is also sufficient training to participate in this protocol. 289

290 (13) Patient Privacy: All pharmacists furnishing self - administered hormonal contraception in a pharmacy or health care facility shall operate under the ility’s policies and procedures to ensure that patient pharmacy or fac confidentiality and privacy are maintained. - Screening Tool Questions (14) Self SCREENING TOOL - HORMONAL CONTRACEPTION SELF QUESTIONS the f i r s t 1 d ate of y o u r last menst r ual / What w as p e / r io d ? th H v e y ou e v er ta k en bi r a co n t r ol pi lls, or a 2 No Yes bi r th co n t r ol p atch, r i n g , or u s e d a ☐ ☐ ) to q u estion 3 no, I ( f ection? g o j shot/in D i d y ou No v er e x pe r ien c e a b ad r eaction to u s i n g 2b Yes e r th co n t r o ho r monal bi l? ☐ ☐ e y ou c urr e n tly u sing bi Ar th co n t r ol pi lls, 2c No Yes r co n t r ol p atch, r in g , or or a bi r th ☐ ☐ ection? j shot/in H a v e y ou e v er No b een told b y a m e d ical 3 Yes ss i onal not to ta k e ho r mo n e s? r o p e f ☐ ☐ Do y ou sm o k e c i g r ett e s? Yes 4 No a ☐ ☐ Do y 5 t h i nk y ou m i g ht b e p r e g nant no w ? Yes No ou ☐ ☐ Yes No 6 H a v e y ou g i v en bi r th w i thin t h e p ast 6 w e e k s? ☐ ☐ Ar e y ou c urr e n tly b r No f e e d ing an in f a nt 7 Yes east less than 1 month of a g e? w ho i s ☐ ☐ Do y ou ha v e d ia b etes? Yes 8 No ☐ ☐ i 9 Do y ou g et m No gr aine h e a d aches, or h e a d aches Yes that y ou f e el s i ck to ad y o u r stomach, y o u b s o ☐ ☐ il i ty to s e e , it ma k es it ha r d to b e in lose the a b or ht, g li n u m b n e ss? ol it in v v es pe 10 y ou ha v e h i g h b lood p r e ssu r e, h y Do r ten s ion, No Yes i h ch o g r ol? h or leste ☐ ☐ 11 H a v e y ou e v e r had a h e a r t attack or No Yes e, or b een told y ou had any h e a r t st r o k ☐ ☐ isease? d No 12 H a v e y ou e v er had a b l o od clot in y o u r leg or in Yes o r l u u g ? y n ☐ ☐ 290

291 een Yes H a v e y ou e v er b told b y a m e d ical No 13 h e i onal that y ou a r e at a h i g f r i sk of p r o ss ☐ ☐ a b lo od clot i n y o u r leg or i n d e v e lo p ing g n u l our y ? 14 H a v e y ou had b a r iat r ic No urg e r y or stomach Yes s u i on s urg ct ry ? d e r e ☐ ☐ 15 H a v e y ou had r ecent m a j or s urg e r y or a r e y o u No Yes to ha v e s urg e r y in the e x t 4 w e e k s? lanning p n ☐ ☐ 16 Do y ou ha v e o r ha v e y ou e v er had b r east No Yes ? r e canc ☐ ☐ 17 Do y ou ha v e o Yes ha v e y ou e v er had h ep atitis, No r li v er d isease, li v er can c e r , or g all b la dd er ☐ ☐ y y ou h a v e j a u n d i ce ( d e llow s k in or o d isease, s)? e y e or No 18 Do y ou ha v e l u p u s, r he u matoid a r th r iti s , or any Yes s? lood i s o rd e r d b ☐ ☐ s No 19 a Do y o u ta k e m e d ication f or ei z u r e s, Yes u r c u losis ( T B), f un g al be i n f ectio n s, or t ☐ ☐ i mm u n o d e f i c iency v i r us ( H IV ) ? h u man f y e s, list them h e r e: 19b I ha 20 a Do y ou v e any oth e r m e d ical p r o b l e ms o r No Yes lar r e gu ta m e d ication? k e ☐ ☐ f y e 20b list I them h e r e: s, Authority: Sections 4005 and 4052.3, Business and Professions Code. Reference: Sections 733, 4052, 4052.3 and 4103, Business and Professions Code. 1746.2. Protocol for Pharmacists Furnishing Nicotine Replacement Products Operative January 25, 2016 (a) A pharmacist furnishing nicotine replacement products pursuant to Section 4052.9 of the Business and Professions Code shall follow the protocol specified in subdivision (b) of this section. (b) Protocol for Pharmacists Furnishing Nicotine Replace ment Products (1) Authority: section 4052.9(a) of the California Business and Professions Code authorizes a pharmacist to furnish nicotine replacement products approved by the federal Food and Drug Administration for use by prescription only in accordance with a protocol approved by the California State Board of Pharmacy and the Medical Board of California. Use of the protocol in this section satisfies that requirement. 291

292 (2) Purpose: To provide timely access to nicotine replacement products and to ensure tha t the patient receives information to appropriately initiate smoking cessation medication therapy. (3) Explanation of Products Covered: Prescription nicotine replacement products approved by the federal Food and Drug Administration and provided by a pharma cist for smoking cessation are covered under this protocol. Pharmacists may continue to provide over - the - counter smoking cessation products without use of this protocol. (4) Procedure: When a patient requests nicotine replacement therapy or other smoking c essation medication, or when a pharmacist in his or her professional judgment decides to initiate smoking cessation treatment and counseling, the pharmacist shall complete the following steps: (A) Review the patient's current tobacco use and past quit atte mpts. (B) Ask the patient the following screening questions: (i) Are you pregnant or plan to become pregnant? (If yes do not furnish and refer to an appropriate health care provider) (ii) Have you had a heart attack within the last 2 weeks? (If yes, furnis h with caution and refer to an appropriate health care provider) (iii) Do you have any history of heart palpitations, irregular heartbeats, or have you been diagnosed with a serious arrhythmia? (If yes, furnish with th care provider) caution and refer to an appropriate heal (iv) Do you currently experience frequent chest pain or have you been diagnosed with unstable angina? (If yes, furnish with caution and refer to an appropriate health care provider) (v) Do you have any history of allergic rhinitis (e.g., nasal allergies)? (If yes, avoid nasal spray) (vi) Have you been diagnosed with temporal mandibular joint (TMJ) dysfunction? (If yes, avoid nicotine gum) These screening questions shall be made available in alternate languages for patients whose primary la nguage is not English. (C) When a nicotine replacement product is furnished: (i) The pharmacist shall review the instructions for use with every patient using a nicotine replacement product. (ii) Pharmacists should recommend the patient seek additional ass istance for behavior change, including but not limited to the California Smokers' Helpline - 800 (1 based programs (e.g., http://smokefree.gov), apps, - - NO - BUTTS), web and local cessation programs. (D) The pharmacist shall answer any questions the patient may have regarding smoking cessation therapy and/or nicotine replacement products. (5) Product Selection: The pharmacist, in consultation with the patient, may select any nicotine replacement product (alone or in combination) from the list of therapies specifi ed in this protocol in the Table “Nicotine Replacement Therapy Medications for Smoking Cessation.” This list shall be kept current and maintained in the pharmacy or health care facility, and shall be available on ard of Pharmacy's website. the Bo Generic equivalent products may be furnished. 292

293 (6) Notifications: The pharmacist shall notify the patient's primary care provider of any prescription drug(s) and/or device(s) furnished to the patient, or enter the appropriate info rmation in a patient record system shared with the primary care provider, as permitted by that primary care provider. If the patient does not have a primary care provider, or is unable to provide contact information for his or her primary care provider, th e pharmacist shall provide the patient with a written record of the prescription drug(s) and/or device(s) furnished and advise the patient to consult an appropriate health care provider of the patient's choice. product provided for smoking (7) Documentation: Each nicotine replacement cessation and furnished by a pharmacist pursuant to this protocol shall be documented in a patient medication record and securely stored within the originating pharmacy or health care facility for a period of at least three yea rs from the date of dispense. A patient medication record shall be maintained in an automated data processing or manual record mode such that the required information under title 16, sections 1717 and 1707.1 of the California Code of retrievable during the pharmacy or facility's normal Regulations is readily operating hours. (8) Training: Prior to furnishing prescription nicotine replacement products, pharmacists who participate in this protocol must have completed a minimum of two hours of an approved cont inuing education program specific to smoking cessation therapy and nicotine replacement therapy, or an equivalent - based training program completed within the last two years in an curriculum accredited California school of pharmacy. Additionally, pharmacist s who participate in this protocol must complete ongoing continuing education focused on smoking cessation therapy from an approved provider once every two years. (9) Patient Privacy: All pharmacists furnishing nicotine replacement products in a pharmacy o r health care facility shall operate under the pharmacy's or facility's policies and procedures to ensure that patient confidentiality and privacy are maintained. (10) Nicotine Replacement Therapy Medications for Smoking Cessation [See the charts of Nicoti ne Replacement Therapy Medication for Smoking Cessation at http://www.pharmacy.ca.gov/laws_regs/1746_2_ooa.pdf] Note: Authority cited: Sections 4005, 4052(a)(10) and 4052.9, Business and Professions Code. Reference: Sections 4052(a)(10) and 4052.9, Busine ss and Professions Code. 1746.3. Protocol for Pharmacists Furnishing Naloxone Hydrochloride A pharmacist furnishing naloxone hydrochloride pursuant to section 4052.01 of the Business and Professions Code shall satisfy the requirements of this section. (a) As used in this section: - (1) “Opioid” means naturally derived opiates as well as synthetic and semi synthetic opioids. 293

294 (2) “Recipient” means the person to whom naloxone hydrochloride is furnished. (b) Training. Prior to furnishing naloxone hydrochloride, pharmacists who use this protocol must have successfully completed a minimum of one hour of an approved continuing education program specific to the use of naloxone hydrochloride in all routes of administration recognized in subsection (c)(4) of this prot ocol, or an equivalent curriculum - based training program completed in a board recognized school of pharmacy. (c) Protocol for Pharmacists Furnishing Naloxone Hydrochloride. Before providing naloxone hydrochloride, the pharmacist shall: (1) Screen the poten tial recipient by asking the following questions: (A) Whether the potential recipient currently uses or has a history of using illicit or prescription opioids. (If the recipient answers yes, the pharmacist may skip screening question B.); (B) Whether the p otential recipient is in contact with anyone who uses or has a history of using illicit or prescription opioids. (If the recipient answers yes, the pharmacist may continue.); (C) Whether the person to whom the naloxone hydrochloride would be administered h as a known hypersensitivity to naloxone. (If the recipient answers yes, the pharmacist may not provide naloxone. If the recipient responds no, the pharmacist may continue.) The screening questions shall be made available on the Board of Pharmacy’s website in alternate languages for patients whose primary language is not English. (2) Provide the recipient training in opioid overdose prevention, recognition, response, and administration of the antidote naloxone. (3) When naloxone hydrochloride is furnished: (A) The pharmacist shall provide the recipient with appropriate counseling and information on the product furnished, including dosing, effectiveness, adverse effects, storage conditions, shelf --- life, and safety. The recipient is not permitted to waive th e required consultation. (B) The pharmacist shall provide the recipient with any informational resources on hand and/or referrals to appropriate resources if the recipient indicates interest in addiction treatment, recovery services, or medication resources at this time. disposal (C) The pharmacist shall answer any questions the recipient may have regarding naloxone hydrochloride. (4) Product Selection: A pharmacist shall advise the recipient on how to choose the route of administration based on the formul ation available, how well it can likely be administered, the setting, and local context. A pharmacist may supply naloxone hydrochloride as an intramuscular injection, intranasal spray, y auto - injector or in another FDA - approved product form. A pharmacist ma also recommend optional items when appropriate, including alcohol pads, rescue breathing masks, and rubber gloves. 294

295 (5) Labeling: A pharmacist shall label the naloxone hydrochloride consistent with law and regulations. Labels shall include an expiration date for the naloxone hydrochloride furnished. An example of appropriate labeling is available on the Board of Pharmacy’s website. (6) Fact Sheet: The pharmacist shall provide the recipient a copy of the current naloxone fact sheet approved by the Board o f Pharmacy. This fact sheet shall be made available on the Board of Pharmacy’s website in alternate languages for patients whose primary language is not English. (7) Notifications: If the recipient of the naloxone hydrochloride is also the person to whom the naloxone hydrochloride would be administered, then the naloxone recipient is considered a patient for purposes of this protocol and notification may be required under this section. If the patient gives verbal or written consent, then the pharmacist sh all notify the patient’s primary care provider of any drug(s) and/or device(s) furnished, or enter the appropriate information in a patient record system shared with the primary care provider, as permitted by the patient and that primary care provider. If the patient does not have a primary care provider, or chooses not to give notification consent, then the pharmacist shall provide a written record of the drug(s) and/or device(s) furnished and advise the patient to consult an appropriate health care provi der of the patient’s choice. (8) Documentation: Each naloxone hydrochloride product furnished by a pharmacist pursuant to this protocol shall be documented in a medication record for the naloxone recipient, and securely stored within the originating pharm acy or health care facility for a period of at least three years from the date of dispense. The medication record shall be maintained in an automated data or manual record mode such that the required information under title 16, sections the California Code of Regulations is readily retrievable 1707.1 and 1717 of during the pharmacy or facility’s normal operating hours. (9) Privacy: All pharmacists furnishing naloxone hydrochloride in a pharmacy or health care facility shall operate under the pharmacy or fa cility’s policies and procedures to ensure that recipient confidentiality and privacy are maintained. Note: Authority: Section 4052.01, Business and Professions Code. Reference: Section 4052.01, Business and Professions Code. 1746.4 Pharmacists Initiat ing and Administering Vaccines. (a) A pharmacist initiating and/or administering vaccines pursuant to sections 4052 or 4052.8 of the Business and Professions Code shall follow the requirements specified in subdivisions (b) through (f) of this section. (b ) Training: A pharmacist who initiates and/or administers any vaccine shall keep documentation of: (1) Completion of an approved immunization training program, and (2) Basic life support certification. This documentation shall be kept on site and available for inspection. 295

296 (c) Continuing Education: Pharmacists must complete one hour of ongoing continuing education focused on immunizations and vaccines from an approved provider once every two years. (d) Notifications: The pharmacist shall notify the patient’ s primary care provider of any vaccines administered to the patient, or enter the appropriate information in a patient record system shared with the primary care provider, as permitted by the primary care provider. Primary care provider notification must t ake place within 14 days of the administration of any vaccine. If the patient does not have a primary care provider, or is unable to provide contact information for his or her primary care provider, the pharmacist shall advise the patient to consult an app ropriate health care provider of the patient’s choice. If known, notification to the prenatal care provider of immunizations provided to pregnant women must take place within 14 days of the administration of any vaccine. ( e ) Immunization Registry: A pharma cist shall fully report the information described in Section 120440(c) of the Health and Safety Code into one or more state and/or local immunization information systems within 14 days of the administration of any vaccine. The pharmacist shall inform the p atient or the patient’s guardian of immunization record sharing preferences, detailed in Section 120440(e) of the Health and Safety Code. (f) Documentation: For each vaccine administered by a pharmacist, a patient intained in an automated data vaccine administration record shall be ma processing or manual record mode such that the required information under title 25 of the United States Code is readily retrievable during the - 42, section 300aa pharmacy or facility’s normal operating hours. A pharmacist shall provide the patient with a vaccine administration record, which fully documents the vaccines administered by the pharmacist. An example of an appropriate vaccine administration record is available on the Board of Pharmacy’s website. Authority cited: Sec tion 4005, Business and Professions Code. Reference: Sections 4052 and 4052.8, Business and Professions Code, Section 120440, Health and Safety Code, and Sections 300aa – 25, Title 42, United States Code. 1746.5 Pharmacists Furnishing Travel Medications . (a) A pharmacist furnishing prescription medications not requiring a diagnosis that are recommended by the federal Center for Disease Control and Prevention (CDC) for individuals traveling outside the 50 states and the District of section 4052(a)(10)(A)(3) of the Business and Columbia pursuant to Professions Code (hereafter, “travel medications”) shall follow the requirements of this section. (b) For purposes of Business and Professions Code section 4052(a)(10)(A)(3), quiring a diagnosis” means a prescription a prescription medication “not re medication that is either: (1) For treatment of a condition that is recognized as both self - diagnosable and self - treatable by the CDC’s Health Information for International Travel (commonly called the Yellow Book ), or (2) For prophylaxis of a condition. 296

297 (c) Training: A pharmacist who furnishes travel medications shall keep documentation of the following on site and available for inspection by the Board: (1) Completion of an immunization training program that meets the requirements of Business and Professions Code section 4052.8(b)(1), (2) Completion of a travel medicine training program, which must consist of at least 10 hours of training and cover each element of the International Society of Travel Medicin e’s Body of Knowledge for the Practice of Travel Medicine (2012), hereby incorporated by reference, (3) Completion of the CDC Yellow Fever Vaccine Course, and (4) Current basic life support certification. plete two hours of ongoing (d) Continuing Education: Pharmacists must com continuing education focused on travel medicine, separate from continuing education in immunizations and vaccines, from an approved provider once every two years. (e) Prior to furnishing travel medications, a pharmacist shall pe rform a good faith evaluation of the patient, including evaluation of the patient’s travel specific travel criteria. The travel history must include history using destination - all the information necessary for a risk assessment during pre travel - n, as identified in the CDC Yellow Book. An example of an consultatio appropriate and comprehensive travel history is available on the Board’s website. (f) Notifications: The pharmacist shall notify the patient’s primary care ed to the patient within 14 days of the provider of any drugs or devices furnish date of furnishing, or enter the appropriate information in a patient record system shared with the primary care provider, as permitted by the primary care provider. If the patient does not have a primary care provid er, or is unable to provide contact information for his or her primary care provider, the pharmacist shall provide the patient with a written record of the drugs or devices furnished and advise the patient to consult a physician of the patient’s choice. (g) Documentation: For each travel medication furnished by a pharmacist, a patient medication record shall be maintained and securely stored in physical or electronic manner such that the information required under section 300aa 25 of - d States Code is readily retrievable during the pharmacy or title 42 of the Unite facility’s normal operating hours. A pharmacist shall provide the patient with a written document that reflects the clinical assessment and travel medication plan. Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4052 and 4052.8, Business and Professions Code. Article 6. Fees 1749. Fee Schedule. The fees for the issuance and renewal of licenses, certificates, and permits, and ilure to renew in accordance with section the penalties to be assessed for fa 297

298 and Pharmacy Law are hereby fixed 163.5of the Business and Professions Code as follows: (a) The fee for the issuance of a pharmacy license is five hundred twenty ny pharmacy license is six dollars ($520). The fee for the annual renewal of . The penalty for failure to renew is one hundred sixty five dollars ($665) hundred fifty dollars ($150). (b) The fee for the issuance of a temporary license is three hundred twenty - five dollars ($325). (c) The fee for the issuanc e of a pharmacy technician license shall be one hundred and forty dollars ($140) fee for the biennial renewal of a . The pharmacy technician license shall be one hundred and forty dollars ($140) . The e is seventy dollars penalty for failure to renew a pharmacy technician licens ($70) . (d) The fee for application and examination as a pharmacist is two hundred sixty dollars ($260). (e) The fee for regrading an examination is one hundred fifteen dollars ($115). (f) (1) The fee for the issuance of an original p harmacist license is one hundred ninety - five dollars ($195). (2) The fee for application of an advanced practice pharmacist license is three hundred dollars ($300). If granted, there is no fee for the initial license issued, which will expire at the same time the pharmacist’s license expires. The fee for the biennial renewal of a pharmacist's license is three (1) (g) hundred sixty dollars ($360). The penalty fee for failure to renew is one . hundred fifty dollars ($150) (2) The fee for the biennial renewal of an advanced practice pharmacist license is three hundred dollars ($300). The penalty fee for failure to renew is one hundred fifty dollars ($150). The fees in this paragraph are in addition to the fees required to renew the pharmacist’s license as spec ified in paragraph 1. (h) The fee for the issuance or renewal of a wholesaler's license or third - party logistics provider is seven hun dred eighty dollars ($780). The penalty for failure to renew is one hundred fifty dollars ($150). (i) The fee for the is one hundred seventy suance of a hypodermic license is dollars ($170). The fee for the annual renewal of a hypodermic needle license is two hundred dollars ($200). The penalty for failure to renew is one hundred dollars ($100) . (j) The fee for the issuanc e of a license as a designated representative pursuant to Section 4053 of the Business and Professions Code or designated representative - 3PL pursuant to Section 4053.1 is one hundred fifty dollars ($150). The fee for the annual renewal of a license as a de signated representative or designated representative 3PL shall be two hundred and - fifteen dollars ($215). The penalty for failure to renew is one hundred seven dollars and fifty cents ($107.50) . (k) The fee for the application or renewal of a license as a nonresident wholesaler or nonresident third party logistics provider is seven hundred eighty - dollars ($780). The penalty for failure to renew is one hundred fifty dollars ($150). The fee for a temporary license is seven hundred fifteen dollars ($715). 298

299 (l ) The fee for an intern pharmacist license is one hundred sixty - five dollars ($165). The fee for transfer of intern hours or verification of licensure to another state is thirty dollars ($30). (m) The fee for the reissuance of any permit, license, or certi ficate, or renewal thereof, which must be reissued because of change in the information, other than name change, is one hundred dollars ($100). (n) The fee for the reissuance of any license that has been lost or destroyed or reissued due to a name change i s forty - five dollars ($45). (o) The fee for evaluation of continuing education courses for accreditation is forty dollars ($40) for each hour of accreditation requested. (p) The fee for the issuance of a clinic license is five hundred twenty dollars ($520) . The fee for the annual renewal of a clinic license is three hundred twenty - five dollars ($325). The penalty for failure to renew is one hundred fifty dollars ($150). (q) The fee for the issuance of a nongovernmental license to compound sterile drug produ cts is one thousand six hundred forty - five dollars ($1,645). The fee for the annual renewal of a nongovernmental license to compound sterile drug products is one thousand three hundred twenty - five dollars ($1,325). The penalty for failure to renew is one hundred fifty dollars ($150). The fee for a temporary license is five hundred fifty dollars ($550). (r) The fee for the issuance of a nonresident sterile compounding pharmacy is two thousand three hundred eighty dollars ($2,380). The fee for the annual enewal of nonresident sterile compounding pharmacy license is two thousand r two hundred seventy dollars ($2,270). The penalty for failure to renew is one hundred fifty dollars ($150). The fee for a temporary license is five hundred fifty dollars ($550). (s) The fee for the issuance of a license as a designated representative for a - animal drug retailer is one hundred fifty dollars ($150). The fee veterinary food for the annual renewal of a license as a designated representative is two hundred fifteen dolla rs ($215). The penalty for failure to renew is one hundred seven dollars and fifty cents ($107.50). animal drug retailer license is four hundred and (t)The fee for a veterinary food - a nimal thirty - five dollars ($435). The annual renewal fee for a veterinary food - drug retailer is three hundred thirty dollars ($330). The fee for the issuance of a temporary license is two hundred and fifty dollars ($250). The penalty for failure to renew is one hundred fifty dollars ($150). (u) The fee for the issuance of a ret ired pharmacist license shall be forty - five dollars ($45). (v) The fee for the issuance of a centralized hospital packaging pharmacy license is eight hundred twenty dollars ($820). The annual renewal fee for a centralized hospital packaging pharmacy licens e is eight hundred five dollars ($805). The penalty for failure to renew is one hundred fifty dollars ($150). (w) The fee for the issuance of an outsourcing facility license is two thousand two hundred seventy dollars ($2,270). The annual renewal fee for an five dollars ($1,325). - outsourcing facility is one thousand three hundred twenty The penalty for failure to renew is one hundred fifty dollars ($150). The fee for a temporary outsourcing facility license is seven hundred fifteen dollars ($715). 299

300 (x) The fee for the issuance of a nonresident outsourcing facility license is two thousand three hundred eighty dollars ($2,380). The annual renewal fee for a nonresident outsourcing facility is two thousand two hundred seventy dollars failure to renew is one hundred fifty dollars ($150). ($2,270). The penalty for Note: Authority cited: Sections 4005 and 4400, Business and Professions Code. Reference: Sections 163.5, 4005, 4053, 4053.1, 4110, 4112, 4120, 4127.1, 4127.2, 4128.2, 4129.1, 4129.2, 4160, 4161, 418 0, 4190, 4196, 4200, 4202, 4203, 4208, 4210, 4304, 4400, 4401 and 4403, Business and Professions Code. Article 7. Sterile Compounding Assessment 1751. Sterile Compounding ; Compounding Area ; Self - (a) Any pharmacy engaged in compounding sterile drug prepa rations shall conform to the parameters and requirements stated by Article 4.5 (Section 1735 et seq.), applicable to all compounding, and shall also conform to the parameters and requirements stated by this Article 7 (Section 1751 et seq.), applicable sole ly to sterile compounding. (b) Any pharmacy compounding sterile drug preparations shall have a compounding area designated for the preparation of sterile drug preparations that is in a restricted location where traffic has no impact on the performance of the PEC(s). The cleanroom, including the walls, ceilings, and floors, shall be constructed in accordance with Section 1250.4 of Title 24, Part 2, Chapter 12, of the California Code of Regulations. The pharmacy shall be ventilated in a manner in accordance with Section 505.5 of Title 24, Part 4, Chapter 5 of the California Code of Regulations. The environments within the pharmacy shall meet the following standards: (1) Each ISO environment shall be certified at least every six months by a qualified techni cian in accordance with Section 1751.4 . Certification records must be retained in the pharmacy. (2) Items related to the compounding of sterile drug preparations within the compounding area shall be stored in such a way as to maintain the integrity of aseptic environment. an (3) A sink shall be included in accordance with Section 1250.4 of Title 24, Part 2, Chapter 12, of the California Code of Regulations. Sinks and drains shall not be present in any ISO Class 7 or better cleanroom, nor in a segregated sterile compounding area within three feet of an ISO Class 5 or better PEC, rinsing stations. A sink may be located in with the exception of emergency eye - - an ante area. When the PEC in the segregated sterile compounding area is a CAI or CACI and the docum entation provided by the manufacturer shows it meets the requirements listed in 1751.4(f)(1) - (3) the sterile compounding area is exempt from the room requirement listed in 1751(b)(3). f sufficient (4) There shall be a refrigerator and, where appropriate, a freezer, o capacity to meet the storage requirements for all material requiring refrigeration or freezing, and a backup plan to ensure continuity of available compounded drug preparations in the event of a power outage. 300

301 Authority cited: Sections 4005 a nd 4127, Business and Professions Code. Reference: Sections 4005, 4036, 4037, 4051, 4052, and 4127, Business and Professions Code; and Section 18944, Health and Safety Code. 1751.1. Sterile Compounding Recordkeeping Requirements. (a) In addition to the records required by section 1735.3, any pharmacy engaged in any compounding of sterile drug preparations shall maintain the following records, which must be readily retrievable, within the pharmacy: ations of employees (1) Documents evidencing training and competency evalu in sterile drug preparation policies and procedures. (2) Results of hand hygiene and garbing assessments with integrated gloved fingertip testing. (3) Results of assessments of personnel for aseptic techniques including fill tests and gloved fingertip testing performed in association results of m edia - with media - fill tests. (4) Results of viable air and surface sampling. (5) Video of smoke studies in all ISO certified spaces. (6) Documents indicating daily documentation of room, refrigerator, and freezer temperatures appropriate for sterile compounded drug preparations consistent with the temperatures listed in section 1735.1 for: (A) Controlled room temperature. (B) Controlled cold temperature. rature. (C) Controlled freezer tempe (7) Certification(s) of the sterile compounding environment(s). (8) Documents indicating daily documentation of air pressure differentials or air velocity measurements between all adjoining ISO rooms or areas, including those associated with co mpounding aseptic (containment) isolators, and air pressure differentials or air velocity measurements between all rooms or spaces with an immediate entry or opening to ISO rooms or areas. (9) Other facility quality control records specific to the pharma cy’s policies and procedures (e.g., cleaning logs for facilities and equipment). (10) Logs or other documentation of inspections for expired or recalled chemicals, bulk drug substances, drug products, or other ingredients. (11) Preparation records incl uding the master formula document, the preparation compounding log, and records of end - product evaluation testing and results. (b) Pharmacies compounding sterile drug preparations for future use pursuant to section 1735.2 shall, in addition to those reco rds required by section 1735.3, make and keep records indicating the name, lot number, and amount of any drug preparation compounded for future use, the date on which any preparation was provided to a prescriber, and the name, address, license type and num ber of the prescriber. (c) Pharmacies shall maintain and retain all records required by this article in the pharmacy in a readily retrievable form for at least three years from the date on magnetic the record was created. If only recorded and stored electronically, 301

302 media, or in any other computerized form, the records shall be maintained as specified by Business and Professions Code section 4070 subsection (c). Authority cited: Sections 4005 and 4127, Business and Professions Code. Reference: Sections 4 005, 4036, 4037, 4051, 4052, and 4127, Business and Professions Code. Compounding Labeling Requirements. 1751.2. Sterile In addition to the labeling information required under Business and s, title 16, Professions Code section 4076 and California Code of Regulation sections 1707.5 and 1735.4, a pharmacy that compounds sterile drug preparations shall include the following information on the label s for each such preparation: (a) The telephone number of the pharmacy. The telephone number is not n the label for sterile drug preparations administered to inpatients required o within the hospital. (b) Instructions for storage, handling, and administration. (c) All hazardous agents shall bear a special label which states “Chemotherapy Dispose of Properly” o r “Hazardous – - . ” Dispose of Properly Authority cited: Sections 4005 and 4127, Business and Professions Code. Reference: Sections 4005, 4036, 4037, 4051, 4052, 4076 and 4127, Business and Professions Code. Policies and Procedu 1751.3. Sterile res. Compounding (a) Any pharmacy engaged in compounding sterile drug preparations shall maintain written policies and procedures for compounding. Any material failure to follow the pharmacy’s written policies and procedures shall constitute a basis for disciplinary action. In addition to the elements required by section 1735.5, there shall be written policies and procedures regarding the following: (1) Action levels for colony - forming units (CFUs) detected during viable surface sampling, glove fingertip, and viable air sampling and actions to be taken when the levels are exceeded. (2) Airflow considerations and pressure differential monitoring. (3) An environmental sampling plan and procedures specific to viable air, as nonviable particle sampling. surface and gloved fingertip sampling as well (4) Cleaning and maintenance of ISO environments and segregated compounding areas. (5) Compounded sterile drug preparation stability and beyond use dating. ations. (6) Compounding, filling, and labeling of sterile drug prepar (7) Daily and monthly cleaning and disinfection schedule for the controlled areas and any equipment in the controlled area as specified in section 1751.4. (8) Depyrogenation of glassware (if applicable) (9) Facility management including certi fication and maintenance of controlled environments and related equipment. (10) For compounding aseptic isolators and compounding aseptic containment isolators, documentation of the manufacturer’s recommended purge time. 302

303 (11) Hand hygiene and garbing. (12) Labeling of the sterile compounded drug preparations based on the intended route of administration and recommended rate of administration. (13) Methods by which the supervising pharmacist will fulfill his or her responsibility to ensure the qualit y of compounded drug preparations. (14) Orientation, training, and competency evaluation of staff in all aspects of the preparation of sterile drug preparations including didactic training and knowledge/competency assessments that include at minimum: han d hygiene and garbing; decontamination (where applicable); cleaning and disinfection of controlled compounding areas; and proper aseptic technique, demonstrated through the use of a media - fill test performed by applicable personnel; and aseptic area practi ces. (15) Preparing sterile compounded drug preparations from non sterile - components (if applicable). This shall include sterilization method suitability testing for each master formula document. (16) Procedures for handling, compounding and disposal o f hazardous agents. The written policies and procedures shall describe the pharmacy protocols for cleanups and spills in conformity with local health jurisdiction standards. (17) Procedures for handling, compounding and disposal of infectious materials. The written policies and procedures shall describe the pharmacy protocols for cleanups and spills in conformity with local health jurisdiction standards. (18) Proper use of equipment and supplies. (19) Quality assurance program compliant with sections 1711, 1735.8 and 1751.7. (20) Record keeping requirements. (21) Temperature monitoring in compounding and controlled storage areas. (22) The determination and approval by a pharmacist of ingredients and the fore compounding begins. compounding process for each preparation be (23) Use of automated compounding devices (if applicable). (24) Visual inspection and other final quality checks of sterile drug preparations. (b) For lot compounding, the pharmacy shall maintain written policies and procedur es that includes, in addition to the elements required by section 1735.5 and 1751.3(a), written policies and procedures regarding the following: (1) Use of master formula documents and compounding logs. (2) Appropriate documentation. (3) Appropriate sterility and potency testing. to (c) For non - sterile - sterile batch compounding, the pharmacy shall maintain - written policies and procedures for compounding that includes, in addition to the elements required by section 1735.5, 1751.3(a), and 1751.7(e), written policies and procedures regarding the following: (1) Process validation for chosen sterilization methods. product evaluation, quantitative, and qualitative testing. (2) End - (d) Policies and procedures shall be immediately available to all pers onnel involved in compounding activities and to board inspectors. 303

304 (e) All personnel involved must read the policies and procedures before compounding sterile drug preparations. All personnel involved must read all he written policies and procedures. Each additions, revisions, and deletions to t review must be documented by a signature and date. Authority cited: Sections 4005 and 4127, Business and Professions Code. Reference: Sections 4005, 4036, 4037, 4051, 4052, and 4127, Business and Professions Code 1751.4. Facility and Equipment Standards for Sterile Compounding (a) No sterile drug preparation shall be compounded if it is known, or reasonably should be known, that the compounding environment fails to meet criteria specified in the pharmacy’s writ ten policies and procedures for the safe compounding of sterile drug preparations. (b) During the compounding of sterile drug preparations, access to the areas designated for compounding must be limited to those individuals who are properly attired. (c ) All equipment used in the areas designated for compounding must be made of a material that can be easily cleaned and disinfected. (d) Cleaning shall be done using a germicidal detergent and sterile water. The use of a sporicidal agent is required to be used at least monthly. (1) All ISO Class 5 surfaces, work table surfaces, carts, counters, and the cleanroom floor shall be cleaned at least daily. After each cleaning, disinfection using a suitable sterile agent shall occur on all ISO Class 5 surfaces, work table surfaces, carts, and counters. (2) Walls, ceilings, storage shelving, tables, stools, and all other items in the ISO Class 7 or ISO Class 8 environment shall be cleaned at least monthly. (3) Cleaning shall also occur after any unanticipated event that could increase the risk of contamination. (4) All cleaning materials, such as wipers, sponges, and mops, shall be non - shedding and dedicated to use in the cleanroom, or ante - area, and segregated sterile compounding areas and shall not be remo ved from these areas except for disposal. (e) Disinfection, using a suitable sterile agent, shall also occur on all surfaces in the ISO Class 5 PEC frequently, including: (1) At the beginning of each shift; (2) At least every 30 minutes when compound ing involving human staff is occurring or before each lot; (3) After each spill; and (4) When surface contamination is known or suspected. (f) Pharmacies preparing sterile compounded preparations require the use or better air quality. Certification and of a PEC that provides ISO Class 5 air testing of primary and secondary engineering controls shall be performed no less than every six months and whenever the device or area designated for compounding is relocated, altered or a service to the facility i s performed that would impact the device or area. Certification must be completed by a 304

305 qualified technician who is familiar with certification methods and procedures in accordance with CETA Certification Guide for Sterile Compounding Facilities (CAG - 003 - 20 06 - 13, Revised May 20, 2015), which is hereby incorporated by reference. Certification records must be retained for at least 3 years. Unidirectional compounding aseptic isolators or compounding aseptic containment isolators may be used outside of an ISO Cl ass 7 cleanroom if the isolator is certified to meet the following criteria: 12 inches upstream of the - (1) Particle counts sampled approximately 6 critical exposure site shall maintain ISO Class 5 levels during compounding operations. (2) Not more than 3520 particles (0.5 um and larger) per cubic meter shall be counted during material transfer, with the particle counter probe located as near to the transfer door as possible without obstructing transfer. (3) Recovery time to achieve ISO Class 5 air qua lity shall be documented and internal procedures developed to ensure that adequate recovery time is allowed after material transfer before and during compounding operations. Compounding aseptic isolators that do not meet the requirements as outlined in thi s subdivision or are not located within an ISO Class 7 cleanroom may only be used to compound preparations that meet the criteria specified in accordance with subdivision (d) of Section 1751.8 of Title 16, Division 17, . of the California Code of Regulations (g) Pharmacies preparing sterile hazardous agents shall do so in accordance with Section 505.5.1 of Title 24, Chapter 5, of the California Code of Regulations, requiring a negative pressure PEC. Additionally, each PEC used to compound hazardous agents shall be externally vented. The negative pressure PEC must be certified every six months by a qualified technician who is familiar with CETA Certification Guide for Sterile Compounding 003 - - Facilities (CAG 2006 - 13, Revised May 20, 2015), which is hereby in corporated by reference. Any drug preparation that is compounded in a PEC where hazardous drugs are prepared must be labeled as hazardous, regardless of whether the drug ingredients are considered hazardous. is performed in a (1) During the hazardous drug compounding that compounding aseptic containment isolator, full hand hygiene and garbing must occur. Garbing shall include hair cover, facemask, beard cover (if applicable), polypropylene or low shedding gown that closes in the back, shoe covers, and two pairs of sterile ASTM D6978 - 05 standard gloves. (h) If a compounding aseptic isolator is certified by the manufacturer to maintain ISO Class 5 air quality during dynamic operation conditions during compounding as well as during the transfer of ingredien ts into and out of the compounding aseptic isolator, then it may be placed into a non - ISO classified room. Individuals that use compounding aseptic isolators in this manner must ensure appropriate garbing, which consists of donning sterile - hazardous gloves over the isolator gloves immediately before non compounding. These sterile gloves must be changed by each individual whenever continuous compounding is ceased and before compounding starts again. 305

306 (i) Compounding aseptic isolator and compounding aseptic containment isolator used in the compounding of sterile drug preparations shall use non - turbulent unidirectional air flow patterns. A smoke patterned test shall be used to determine air flow patterns. (j) Viable surface sampling shall be done at least ev ery six months for all sterile - to - sterile compounding and quarterly for all non - sterile - to - sterile compounding. Viable air sampling shall be done by volumetric air sampling procedures which test a sufficient volume of air (400 to 1,000 liters) at each tion and shall be done at least once every six months. Viable surface and loca viable air sampling shall be performed by a qualified individual who is familiar with the methods and procedures for surface testing and air rformed under dynamic conditions sampling. Viable air sampling is to be pe that simulate actual production. Viable surface sampling is to be performed under dynamic conditions of actual compounding. When the environmental monitoring action levels are exceeded, the pharmacy shall identify the CFUs at least to the genus level in addition to conducting an investigation pursuant to its policies and procedures. Remediation shall include, at minimum, an immediate investigation of cleaning and compounding operations and facility management. (k) The ster ile compounding area in the pharmacy shall have a comfortable and well - lighted working environment, which includes a room temperature 75 degrees Fahrenheit) or cooler to maintain - 24 degrees Celsius (68 - of 20 comfortable conditions for compounding personnel when attired in the required compounding garb. (l) A licensee may request a waiver of these provisions as provided in section 1735.6(f). Authority Cited: Sections 4005 and 4127, Business and Professions Code. Reference: Sections 4005, 4036, 4037, 4051 , 4052 and 4127, Business and Professions Code; and Section 18944, Health and Safety Code. 1751. 5 . Sterile Compounding Attire. (a) When compounding sterile drug preparations the following standards must be met: (1) Personal protective equipment consist ing of a non - shedding gown, head cover, face mask, facial hair covers (if applicable), and shoe covers must be worn inside the designated area at all times. For hazardous compounding double shoe covers are required. (2) Personal protective equipment must be donned and removed in an ante - area or immediately outside the segregated compounding area. (3) Personnel shall don personal protective equipment in an order that proceeds from those activities considered the dirtiest to those considered the The following order is to be followed unless the pharmacy has a cleanest. procedure in place that documents a method equivalent to or superior to the method described here: The donning of shoe covers or dedicated shoes, head and facial hair covers and face masks sh all be followed by the washing of 306

307 hands and forearms up to the elbows for 30 seconds with soap and water, drying hands, and then the donning of a non - shedding gown. (4) Compounding personnel shall not wear any wrist, hand, finger, or other visible jewelr y, piercing, headphones, earbuds, or personal electronic device. (5) Sterile gloves that have been tested for compatibility with disinfection with isopropyl alcohol are required. Hand cleansing with a persistently active based product followed by the donning of sterile gloves may occur alcohol - within the ante or cleanroom. Gloves are to be routinely disinfected with sterile - entering the PEC and after 70 percent isopropyl alcohol before entering or re - sterile objects. Gloves shall also be routinely inspected for contact with non holes, punctures, or tears and replaced immediately if such are detected. (6) Individuals experiencing exposed rashes, sunburn, weeping sores, conjunctivitis, active respiratory infections or other communicable disease, or those w earing cosmetics, nail polish, or artificial nails shall be excluded from the ISO Class 5 and ISO Class 7 compounding areas until their conditions are remedied. (b) When preparing hazardous agents, appropriate gowns and personal l be worn regardless of the PECs used (e.g., protective equipment shal biological safety cabinet and compounding aseptic containment isolator). Authority cited: Sections 4005 and 4127, Business and Professions Code. Reference: Sections 4005, 4036, 4037, 4051, 4052, and 4127, Busi ness and Professions Code. 1751. Sterile Training of Sterile Compounding Consultation; 6 Staff Compounding (a) Consultation shall be available to the patient and/or primary caregiver concerning proper use, storage, handling, and disposal of sterile drug preparations and related supplies furnished by the pharmacy. (b) The pharmacist - in - charge shall ensure that all pharmacy personnel engaging in compounding sterile drug preparations have training and demonstrated competence in the safe handling and compou nding of sterile drug preparations, including hazardous agents if the pharmacy compounds products with hazardous agents. (c) Records of training and demonstrated competence shall be available for nd the period of each individual and shall be retained for three years beyo employment. charge shall be responsible to ensure the continuing (d) The pharmacist - in - competence of pharmacy personnel engaged in compounding sterile drug preparations. (e) Pharmacies that compound sterile drug preparations must compl y with the following training requirements: (1) The pharmacy must establish and follow a written program of training and performance evaluation designed to ensure that each person working in the designated area has the knowledge and skills necessary to p erform their assigned tasks properly. This program of training and performance evaluation must address at least the following: 307

308 (A) Aseptic technique. (B) Pharmaceutical calculations and terminology. (C) Sterile preparation compounding documentation. (D) Quality assurance procedures. (E) Aseptic preparation procedures. (F) Proper hand hygiene, gowning and gloving technique. (G) General conduct in the controlled area (aseptic area practices). (H) Cleaning, sanitizing, and maintaining of the eq uipment and the controlled area (I) Sterilization techniques for compounding sterile drug preparations from sterile ingredients. one or more non - (J) Container, equipment, and closure system selection. (2) Each person engaged in sterile compounding mu st successfully complete practical skills training in aseptic technique and aseptic area practices using models that are comparable to the most complex manipulations to be performed g and by the individual. Each pharmacist responsible for, or directly supervisin controlling, aseptic techniques or practices, must demonstrate the skills needed to ensure the sterility of compounded drug preparations. Evaluation must include written testing and a written protocol of periodic routine performance checks involving adherence to aseptic area policies and procedures. Each person’s proficiency and continuing training needs must be reassessed at least every 12 months. Results of these assessments must be documented and retained in the pharmacy for three years. Authorit y cited: Sections 4005 and 4127, Business and Professions Code. Reference: Sections 4005, 4036, 4037, 4051, 4052, and 4127, Business and Professions Code. 1751.7. Sterile Compounding Quality Assurance and Process Validation. (a) Any pharmacy engaged in c ompounding sterile drug preparations shall maintain, as part of its written policies and procedures, a written quality assurance plan including, in addition to the elements required by section nitors 1735.8, a documented, ongoing quality assurance program that mo personnel performance, equipment, and facilities. The end product shall be examined on a periodic sampling basis as determined by the pharmacist in - - charge to assure that it meets required specifications. The quality assurance program shall include a t least the following: (1) Procedures for cleaning and sanitization of the sterile preparation area. (2) Actions to be taken in the event of a drug recall. (3) Documentation justifying the chosen beyond use dates for compounded sterile drug preparati ons. (b)(1) The pharmacy and each individual involved in the compounding of sterile drug preparations must successfully demonstrate competency on aseptic technique and aseptic area practices before being allowed to prepare sterile validation process shall be carried out in the same drug preparations. The manner as normal production, except that an appropriate microbiological growth medium is used in place of the actual product used during sterile 308

309 of the types of preparation. The validation process shall be representative manipulations, products and batch sizes the individual is expected to prepare - and include a media fill test. The validation process shall be as complicated as the most complex manipulations performed by staff and contain the same greater amount of volume transferred during the compounding amount or process. The same personnel, procedures, equipment, and materials must be used in the testing. Media used must have demonstrated the ability to support and promote growth. Completed medium sample s must be incubated in a manner consistent with the manufacturer’s recommendations. If microbial growth is detected, then each individual’s sterile preparation process must be evaluated, corrective action taken and documented, and the validation process re peated. (2) Each individual’s competency must be revalidated at least every twelve months for sterile to sterile compounding and at least every six months for individuals compounding sterile preparations from non - sterile ingredients. (3) The pharmacy’s validation process on aseptic technique and aseptic area practices must be revalidated whenever: (A) the quality assurance program yields an unacceptable result, (B) there is any change in the compounding process, the Primary Engineering Control (PEC) , or the compounding environment. For purposes of this subsection, a change includes, but is not limited to, when the PEC is moved, repaired or replaced, when the facility is modified in a manner that affects septic techniques are observed. airflow or traffic patterns, or when improper a (4) The pharmacy must document the validation and revalidation process. (c) All sterile compounding personnel must successfully complete an initial competency evaluation. In addition, immediately following the initial ha nd hygiene and garbing procedure, each individual who may be required to do so in practice must successfully complete a gloved fingertip (all fingers on both hands) sampling procedure (zero colony forming units for both hands) at least three times before i nitially being allowed to compound sterile drug preparations. (d) Re - evaluation of garbing and gloving competency shall occur at least every 12 months for personnel compounding products made from sterile onnel compounding products ingredients and at least every six months for pers from non produced sterile drug preparations - - sterile ingredients. (e)(1) Batch - sterile ingredients, except as provided in compounded from one or more non paragraph (2), shall be subject to documented end product testing for steril ity and pyrogens and shall be quarantined until the end product testing confirms sterility and acceptable levels of pyrogens. Sterility testing shall be USP chapter 71 compliant and pyrogens testing shall confirm acceptable levels of pyrogens per USP chapt er 85 limits, before dispensing. This requirement of end product testing confirming sterility and acceptable levels of pyrogens prior to dispensing shall apply regardless of any sterility or pyrogen testing that may have been conducted on any ingredient or combination of ingredients that were sterile. Exempt from pyrogen testing are topical ophthalmic and - previously non inhalation preparations. 309

310 (2) The following non - sterile - to - sterile batch drug preparations do not require end product testing for sterilit y and pyrogens: (A) Preparations for self - administered ophthalmic drops in a quantity sufficient for administration to a single patient for 30 days or less pursuant to a prescription. - (B) Preparations for self icient for administered inhalation in a quantity suff administration to a single patient for 5 days or less pursuant to a prescription. Authority cited: Sections 4005 and 4127, Business and Professions Code. Reference: Sections 4005, 4036, 4037, 4051, 4052, and 4127, Business and Professions Code . 1751. Beyond Use Dating for Sterile Compounded Drug Preparations 8 . In conformity with and in addition to the requirements and limitations of section 1735.2, subdivision (h), every sterile compounded drug preparation yond use date that does not exceed the shall be given and labeled with a be shortest expiration date or beyond use date of any ingredient in sterile compounded drug preparation, nor the chemical stability of any one ingredient lity of the in the sterile compounded drug preparation, nor the chemical stabi combination of all ingredients in the sterile compounded drug preparation, and that, in the absence of passing a sterility test in accordance with standards for sterility testing found in Chapter 797 of the United States Pharmacopeia – National Formulary (USP37 - NF32) Through 2nd Supplement (37th Revision, Effective December 1, 2014), hereby incorporated by reference, that would justify an extended beyond use date, conforms to the following limitations: (a) The beyond use date shall specify tha t storage and exposure periods cannot exceed 48 hours at controlled room temperature, 14 days at controlled cold temperature, and 45 days in solid frozen state, where the sterile compounded drug preparation is compounded solely with aseptic manipulations a nd all of the following apply: (1) The preparation is compounded entirely within an ISO Class 5 PEC - area or compounded entirely located in an ISO Class 7 cleanroom with an ante within a CAI which meets the requirements in 1751.4(f)(1) (3), using only - ste rile ingredients, products, components, and devices; and (2) The compounding process involves transferring, measuring, and mixing manipulations using not more than three commercially manufactured packages of sterile preparations and not more than two ent ries into any one sterile container or package of sterile preparations or administration containers/devices to prepare the drug preparation; and (3) Compounding manipulations are limited to aseptically opening ampules, penetrating disinfected stoppers on vials with sterile needles and syringes or spiked transfer devices, and transferring sterile liquids in sterile syringes to sterile administration devices, package containers of other sterile preparations, and containers for storage dispensing. beyond use date shall specify that storage and exposure periods cannot (b) The exceed 30 hours at controlled room temperature, 9 days at controlled cold temperature, and 45 days in solid frozen state, where the sterile compounded 310

311 ely with aseptic manipulations and all of drug preparation is compounded sol the following apply: (1) The preparation is compounded entirely within an ISO Class 5 PEC - area or compounded entirely located in an ISO Class 7 cleanroom with an ante 1751.4(f)(1) within a CAI which meets the requirements in (3), using multiple - individual or small doses of sterile preparations combined or pooled to prepare a compounded sterile preparation that will be administered either to multiple patients or to one patient on multiple occasions; and (2) The c ompounding process involves complex aseptic manipulations other than the single volume transfer; and - (3) The compounding process requires unusually long duration such as that required to complete dissolution or homogenous mixing. (c) The beyond use dat e shall specify that storage and exposure periods cannot exceed 24 hours at controlled room temperature, 3 days at controlled cold temperature, and 45 days in solid frozen state, where the sterile compounded drug preparation is compounded solely with asept ic manipulations using non - sterile ingredients, regardless of intervening sterilization of that ingredient and the following applies: (1) The preparation is compounded entirely within an ISO Class 5 PEC ar - located in an ISO Class 7 cleanroom with an ante ea or compounded entirely - (3). within a CAI which meets the requirements in 1751.4(f)(1) (d) The beyond use date shall specify that storage and exposure periods cannot exceed 12 hours where the sterile compounded drug preparation is compounded solely wit h aseptic manipulations and all of the following apply: (1) The preparation was compounded entirely within an ISO Class 5 PEC that is located in a segregated sterile compounding area and restricted to sterile compounding activities, using only sterile in gredients, components, and devices, by personnel properly cleansed and garbed; and (2) The compounding process involves simple transfer of not more than three commercially manufactured packages of sterile nonhazardous preparations or diagnostic radiophar maceutical preparations from the manufacturer’s original containers; and (3) The compounding process involves not more than two entries into any one container or package (e.g., bag, vial) of sterile infusion solution or administration container/device. (e) Where any sterile compounded drug preparation was compounded either outside of an ISO class 5 PEC or under conditions that do not meet all of the requirements for any of subdivisions (a) through (d), the sterile compounded drug preparation shall be la beled “for immediate use only” and administration shall begin no later than one hour following the start of the compounding process. Unless the “immediate use” preparation is immediately and completely administered by the person who prepared it or immediat e and complete administration is witnessed by the preparer, the preparation shall bear a label listing patient identification information, the names and amounts of all ingredients, the name or initials of the person who prepared the compounded - hour beyond use date and time. If aration, and the exact one sterile prep administration has not begun within one hour following the start of the 311

312 compounding process, the compounded sterile preparation shall be promptly, properly, entirely, and safely discarded. This p rovision does not preclude the use of a PEC to compound an “immediate use” preparation. A PEC used solely to compound ‘immediate use’ preparations need not be placed within an ISO - area. Such “immediate use” preparations shal l Class 7 cleanroom, with an ante be compounded only in those limited situations where there is a need for immediate administration of a sterile preparation compounded outside of an ISO class 5 environment and where failure to administer could result in loss of Any such compounding shall be only in such quantity life or intense suffering. as is necessary to meet the immediate need and the circumstance causing the immediate need shall be documented in accordance with policies and procedures. (f) The beyond use date for any compounded all ergen extracts shall be the earliest manufacturer expiration date of the individual allergen extracts. Authority cited: Sections 4005 and 4127, Business and Professions Code. Reference: Sections 4005, 4036, 4037, 4051, 4052, and 4127, Business and Profes sions Code. 1751.9 Single - Dose and Multi - Dose Containers; Limitations on Use (a) Single - dose ampules are for immediate use only, and once opened shall not be stored for any time period. (b) Unless otherwise specified by the manufacturer, any single se container do - of a compounded sterile drug preparation other than an ampule, such as a bag, bottle, syringe or vial, shall be used in its entirety or its remaining contents shall be labeled with a beyond use date and discarded within the following time limi t, depending on the environment: (1) When needle - punctured in an environment with air quality worse than ISO Class 5, within one (1) hour; (2) When needle - punctured in an environment with ISO Class 5 or better air quality, within six (6) hours. A conta iner must remain within the ISO Class 5 or better air quality to be used for the full six hours, unless otherwise specified by the manufacturer. (3) If the puncture time is not noted on the container, the container must immediately be discarded. (c) Un less otherwise specified by the manufacturer, a multi - dose container stored according to the manufacturer’s specifications shall be used in its entirety or its remaining contents shall be labeled with a beyond use date and discarded within twenty eight (28 ) days from initial opening or puncture. Any multi - dose container not stored according to the manufacturer’s specifications shall be discarded immediately upon identification of such storage circumstance. If any open container is not labeled with a beyond use date or the beyond use date is not correct, the container must immediately be discarded. Authority cited: Sections 4005 and 4127, Business and Professions Code. Reference: Sections 4005, 4036, 4037, 4051, 4052, and 4127, Business and Professions Code . 312

313 1751.10 Sterile Compounding Reference Materials. In any pharmacy engaged in compounding sterile injectable drug products, t here shall be current and appropriate reference materials regarding the compounding of sterile injectable products located in or immediately available to the pharmacy. and 4127, Business and Professions Code. Authority cited: Section s 4005 4036, 4037, 4051, 4052, and 4127, Reference: Section 4005, s Business and Professions Code. REFERENCED TITLE 24, PART 2, CHAPTER 12, REGULATIONS 1250.4 Compounding Area for Parenteral Solutions. The pharmacy shall have a designated area for the preparation of sterile products for dispensing which shall: In accordance with Federal Standard 209(b), Clean Room and Work 1. led Environment, as approved by the Station Requirements, Control Commission, Federal Supply Service, General Services Administration meet standards for class 100 HEPA (high efficiency particulate air) filtered air such as laminar air flow hood or clean room. Have non - porous and cleana ble surfaces, walls, floors and floor 2. coverings. 3. The pharmacy shall be arranged in such a manner that the laminar - flow hood is located in an area which is exposed to minimal traffic flow, and is separate from any area used for bulk storage of items not rel ated to the compounding of parenteral solution. There shall be sufficient space, well separated from the laminar - flow hood area, for the storage of bulk materials, equipment and waste materials. A sink with hot and cold running water must be within the par enteral 4. solution compounding area or adjacent to it. 5. Any pharmacy that compounds sterile injectable products from one or more nonsterile ingredients must compound the medication in one of the following environments: thin an ISO class 7 • 5.1 An ISO class laminar airflow hood wi cleanroom. The cleanroom must have a positive air pressure differential relative to adjacent areas. • 5.2 An ISO class 5 cleanroom. • 5.3 A barrier isolator that provides an ISO class 5 environment for compounding. rmacy mechanical standard requirements, : For additional pha Note see Chapter 5, California Mechanical Code. 13 3

314 Pharmacies: Compounding Area for Parenteral Solutions. 505.5 The pharmacy shall have a designated area for the preparation of sterile : products for dispensing which shall 1. Be ventilated in a manner not interfering with laminar air flow. 505.5.1 Pharmacies: Laminar Flow Biological Safety Cabinet. In all pharmacies preparing parenteral cytotoxic agents, all compounding shall be conducted within a certified Class II Type A or Class II Type B vertical laminar air flow hood with bag in - bag out design. The pharmacy must ensure that contaminated air plenums that are under positive air pressure are leak tight. Article 7.5 Furnishing for Home Administration 52 . Furnishi ng to Parenteral Patient at Home. 17 Subject to all provisions of this article, a pharmacist may carry and furnish to a patient at home dangerous drugs, other than controlled substances, and devices for parenteral therapy when the dangerous drug or device is one currently prescribed for the patient. Authority cited: Section 4005, Business and Professions Code. Reference: Section 4005, Business and Professions Code. 3 175 . Furnishing to Home Health Agencies and Licensed Hospices. tions, a licensed pharmacy may furnish to a Subject to the following condi home health agency licensed under provisions of Chapter 8 (commencing with section 1725 of Division 2 of the Health and Safety Code) or to a hospice licensed under provisions of Chapter 8.5 (commencing with secti on 1745 of Division 2 of the Health and Safety Code) dangerous drugs for parenteral therapy other than controlled substances, in a portable container for furnishing to patients at home for emergency treatment or adjustment of parenteral drug home health agency or licensed hospice. therapy by the (a) The pharmacy, having ownership and responsibility for the portable containers, shall ensure that each portable container is: (1) furnished by a registered pharmacist; proof seal must be broken to gain (2) sealed in such a manner that a tamper - access to the drugs; (3) under the effective control of a registered nurse, pharmacist or delivery person at all times when not in the pharmacy; (4) labeled on the outside of the container with a list of the contents; (5) maintained at an appropriate temperature according to United States rd Pharmacopeia Standards (1995, 23 Revision), and protected at all times from extreme temperatures that could damage the contents. (b) The portable container may contain up to: (1) 1 000mL of 0.9% sodium chloride intravenous infusion in containers of a size determined by the pharmacy; (2) 1000mL of 5% dextrose in water injection in containers of a size determined by the pharmacy; 314

315 (3) two vials of urokinase 5000 units; (4) Each of th e following items shall be in sealed, unused containers; the furnishing pharmacy may select any or all of these dangerous drugs in up to five dosage units for inclusion in the sealed, portable container: (A) heparin sodium lock flush 100 units/mL; (B) he parin sodium lock flush 10 units/mL; (C) epinephrine HCl solution 1:1 000; , (D) epinephrine HCl solution 1:10,000; (E) diphenhydramine HCl 50mg/mL; (F) methylprednisolone 125mg/2mL; (G) normal saline, preserved, up to 30 mL vials; (H) naloxone 1mg/mL 2 mL; (I) droperidol 5mg/2mL; (J) prochlorperazine 10mg/2mL; (K) promethazine 25mg/mL; (L) dextrose 25gms/50mL; (M) glucagon 1mg/mL; (N) insulin (human) 100 units/mL; (O) bumetamide 0.5mg/2mL; (P) furosemide 10mg/mL; (Q) EMLA Cream 5 gm tube; Lidocaine 1 percent 30mL vials. (R) (5) The pharmacy shall ensure that the specific dangerous drugs and quantities to be included in the portable container are listed in the home health agenc y's or and procedures. licensed hospice's policies (c) The pharmac y shall not supply a portable container to a home health agency or licensed hospice which does not: (1) implement and maintain policies and procedures for: (A) the storage, temperature stability and transportation of the portable container; (B) the furn ishing of dangerous drugs from the portable container upon the written or oral authorization of a prescriber; and (C) a specific treatment protocol for the administration of each medication contained in the portable container. edures and protocols reviewed and revised (as (2) have the policies, proc needed) annually by a group of professional personnel including a physician and surgeon, a pharmacist and a registered nurse. (d) A copy of these policies, procedures and protocols shall be maintained by the f urnishing pharmacy from each home health agency or licensed hospice for which the pharmacy furnishes portable containers. (e) In cases where a drug has been administered to a patient pursuant to the oral order of a licensed prescriber, the pharmacy shall ensure that the oral order is immediately written down by the registered nurse or pharmacist and communicated by copy or fax within 24 hours to the furnishing pharmacy, with - a copy of the prescriber signed document forwarded to the dispensing in 20 days. pharmacy with 315

316 (f) The pharmacy shall ensure that within seven days (168 hours) after the seal has been broken on the portable container, the home health agency's director of nursing service or a registered nurse employed by the home health agency or license d hospice returns the container to the furnishing pharmacy. The furnishing pharmacy shall then perform an inventory of the drugs used from the container, and if the container will be reused, must restock and reseal the d to the home health agency or licensed container before it is again furnishe hospice. (g) The furnishing pharmacy shall have written policies and procedures for the contents, packaging, inventory monitoring, labeling and storage instructions of the portable container. (h) The furnishing pha rmacy shall ensure that the home health agency or licensed hospice returns the portable containers to the furnishing pharmacy at least every 60 days for verification of product quality, quantity, integrity and expiration dates, or within seven days (168 ho urs) after the seal has been broken. (i) The furnishing pharmacy shall maintain a current inventory and record of all items placed into and furnished from the portable container. Authority cited: Sections 4005 and 4057, Business and Professions Code. Ref erence: Sections 4040, 4057, 4081 and 4332, Business and Professions Code. 175 4 . Obligations of a Pharmacy Furnishing Portable Containers. (a) A licensed pharmacy shall not issue portable containers to any home health agency or licensed hospice unless t he home health agency or licensed hospice complies with provisions of section 175 3 . (b) A licensed pharmacy shall cease to furnish portable containers to a home health agency or licensed hospice if the home health agency or licensed hospice does not comp ly with provisions of section 175 3 . Authority cited: Sections 4005 and 4057, Business and Professions Code. Reference: Sections 4040, 4057, 4081 and 4332, Business and Professions Code. Article 8. Prohibitions and Discipline 1760. Disciplinary Guidelin es. In reaching a decision on a disciplinary action under the Administrative Procedure Act (Government Code section 11400 et seq.) the board shall consider the disciplinary guidelines entitled “Disciplinary Guidelines” (Rev. 2 /20 1 7 ), which are hereby inco rporated by reference. Deviation from these guidelines and orders, including the standard terms of probation, is appropriate where the board, in its sole discretion, determines that the facts of the particular mitigating factors; the age of the case warrant such a deviation -- the presence of case; evidentiary problems. 316

317 Authority cited: Section s 315, 315.2, 315.4 and 4005, Business and Professions Code; and Section 11400.20, Government Code. Reference: Sections 315, 315.2, 315.4, 4300 - 4313 , Business and Prof essions Code; and Sections 11400.20 and 11425.50(e), Government Code. 1761. Erroneous or Uncertain Prescriptions. (a) No pharmacist shall compound or dispense any prescription which contains any significant error, omission, irregularity, uncertainty, am biguity or alteration. Upon receipt of any such prescription, the pharmacist shall contact the prescriber to obtain the information needed to validate the prescription. (b) Even after conferring with the prescriber, a pharmacist shall not compound or dis pense a controlled substance prescription where the pharmacist knows or has objective reason to know that said prescription was not issued for a legitimate medical purpose. Authority cited: Section 4005, Business and Professions Code. Reference: 005, Business and Professions Code; and Section 11153, Health and Section 4 Safety Code. 1762. Unprofessional Conduct Defined. In addition to those acts detailed in Business and Professions Code Section 4301, the following shall also constitute unprofessional condu ct: (a) Including or permitting to be included any of the following provisions in an agreement to settle a civil dispute arising from the licensee's practice, whether the agreement is made before or after the filing of an action: (1) A provision that prohi bits another party to the dispute from contacting, cooperating, or filing a complaint with the board; or, (2) A provision that requires another party to the dispute to attempt to withdraw a complaint the party has filed with the board. (b) Failure or refus al to comply with any court order issued in the enforcement of a subpoena, mandating the release of records to the board. (c) Commission of any act resulting in the requirement that a licensee or applicant registers as a sex offender. The board may revoke the license of any licensee and deny the application of any applicant who is required to register as a sex offender pursuant to Section 290 of the Penal Code or any other equivalent federal, state or territory's law that requires registration as a sex offe nder. Note: Authority: Section 4005, Business and Professions Code. Reference: Sections 726, 4300 and 4301, Business and Professions Code. 1764. Unauthorized Disclosure of Prescriptions. No pharmacist shall exhibit, discuss, or reveal the contents of any prescription, the therapeutic effect thereof, the nature, extent, or degree of illness suffered by any patient or any medical information furnished by the prescriber with any person other than the patient or his or her authorized 317

318 representative, the presc riber or other licensed practitioner then caring for the patient, another licensed pharmacist serving the patient, or a person duly authorized by law to receive such information. Authority cited: Section 4005, Business and Professions Code. Reference: Sec tion 4040 and 4301, Business and Professions Code. 1765. Commissions, Gratuities, and Rebates. An unlawful commission, gratuity or rebate prescribed by this article and Business and Professions Code Section 650 includes the rendering by a armacy of consultant pharmaceutical services such as those pharmacist or ph required pursuant to Title 22, Division 5, Chapters 3 and 4 (skilled nursing facilities and intermediate care facilities) to a licensed health care facility for no cost, nominal cost, or below reas onable cost, if that pharmacist or pharmacy obtains patients, clients or customers and/or their prescription orders from that licensed facility or entity. The determination of the value of consultant pharmaceutical services rendered shall include, but not be limited to, the value of all goods and services furnished by the pharmacist or pharmacy to a licensed health care facility. Authority cited: Section 4005, Business and Professions Code. Reference: Sections 650 and 4301, Business and Professions Code. 1766. False or Misleading Advertising. No pharmacist or permit holder shall violate Section 17500 of the Business and Professions Code. Authority cited: Section 4005, Business and Professions Code. Reference: Sections 651, 4301 and 17500, Business and Prof essions Code. 1768. Denial of Application -- Reapplication. (a) Where the board has denied an application for a license, the earliest date on which the applicant may reapply for a license is one year after the effective date of the denial. tent evidence of rehabilitation presented will be considered upon (b) All compe a reapplication. The board shall use the criteria listed in section 1769 when considering evidence of rehabilitation. : Authority cited: Section 4005, Business and Professions Code. Reference Sections 480, 486 and 489, Business and Professions Code. 1769. Criteria for Rehabilitation. (a) In addition to any other requirements for licensure, when considering the approval of an application, the board or its designee may require an applicant to be examined by one or more physicians and surgeons or psychologists designated by the board if it appears that the applicant may be unable to safely practice due to mental illness or physical illness affecting competency. An applicant's failure to comply w ith the examination requirement shall render his 318

319 or her application incomplete. The board shall pay the full cost of such examination. The board shall seek that the evaluation be conducted within 60 days of the date the applicant is advised that an examina tion is required. The board shall receive the examiner's evaluation within 60 days of the date the examination is completed. The report of the examiner shall be made available to the applicant. If after receiving the report of the evaluation, the board det ermines that the applicant is unable to safely practice, the board may deny the application. (b) When considering the denial of a facility or personal license under Section 480 of the Business and Professions Code, the board, in evaluating the on of the applicant and his present eligibility for licensing or rehabilitati registration, will consider the following criteria: (1) The nature and severity of the act(s) or offense(s) under consideration as grounds for denial. (2) Evidence of any act(s) committed sub sequent to the act(s) or crime(s) under consideration as grounds for denial under Section 480 of the Business and Professions Code. (3) The time that has elapsed since commission of the act(s) or crime(s) referred to in subdivision (1) or (2). (4) Whether the applicant has complied with any terms of parole, probation, restitution or any other sanctions lawfully imposed against the applicant. (5) Evidence, if any, of rehabilitation submitted by the applicant. (c) When considering the suspension or revocation of a facility or a personal license on the ground that the licensee or the registrant has been convicted of a crime, the board, in evaluating the rehabilitation of such person and his present eligibility for a license will consider the following criteria: (1) Nature and severity of the act(s) or offense(s). (2) Total criminal record. (3) The time that has elapsed since commission of the act(s) or offense(s). (4) Whether the licensee has complied with all terms of parole, probation, restitution or any other sanctions lawfully imposed against the licensee. (5) Evidence, if any, of rehabilitation submitted by the licensee. Note: Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4030, 4200 and 4400, Business and Professions Code . 1770. Substantial Relationship Criteria. For the purpose of denial, suspension, or revocation of a personal or facility license pursuant to Division 1.5 (commencing with Section 475) of the Business and Professions Code, a crime or act shall be consider ed substantially related to the qualifications, functions or duties of a licensee or registrant if to a substantial degree it evidences present or potential unfitness of a licensee or registrant to perform the functions authorized by his license or registr ation in a manner consistent with the public health, safety, or welfare. Authority cited: Sections 481, 4005, Business and Professions Code. Reference: Sections 4300, 4309 and 4301, Business and Professions Code. 319

320 1771. Posting of Notice of Suspension. An y holder of a pharmacy permit whose permit is suspended shall post a notice provided by the Board of the Board's suspension order in a location conspicuous to the public. Such notice shall remain posted during the entire period of actual suspension. Failur e to post the notice of suspension as required herein shall be a ground for further disciplinary action. Authority cited: Section 4005, Business and Professions Code. Reference: Section 4005, Business and Professions Code. Suspension. 1772. Disciplinary Condition of Unless otherwise directed by the Board in its sole discretion, any pharmacist who is serving a period of licensure suspension shall not enter any pharmacy prescription area or engage in any pharmacy - related service. 005, Business and Professions Code. Reference: Authority cited: Section 4 Section 4300, Business and Professions Code. 1773. Disciplinary Conditions of Probation of Pharmacist. (a) Unless otherwise directed by the Board in its sole discretion, any pharmacist who is serving a period of probation shall comply with the following conditions: (1) Obey all laws and regulations substantially related to the practice of Pharmacy; 2) Report to the Board or its designee quarterly either in person or in writing ( as directed; the report shall in c lude the name and address of the probationer's employer. If the final probation report is not made as directed, the period of probation shall be extended until such time as the final report is made; (3) Submit to peer review if deemed necessary by the Board; (4) Provide evidence of efforts to maintain skill and knowledge as a pharmacist as directed by the Board; (5) Inform all present and prospective employers of license restrictions and terms of probation. Probationers employed by placement agencies must inform all permittees in whose premises they work of license restrictions and terms of probation. (6) Not supervise any registered interns nor perform any of the duties of a preceptor; (7) The period of probation shall not run during such time that the probationer is engaged in the practice of pharmacy in a jurisdiction other than California. (b) If ordered by the Board in an administrative action or agreed upon in the stipulated settlement of an administrative action, any registered pharmacist who is serving a period of probation shall comply with any or all of the following conditions; (1) Take and pass all or any sections of the pharmacist licensure examination and/or attend continuing education courses in excess of the required number in c areas of practice if directed by the Board; specifi 320

321 (2) Provide evidence of medical or psychiatric care if the need for such care is indicated by the circumstances leading to the violation and is directed by the Board; (3) Allow the Board to obtain samples of blood or urine (at the pharmacist's option) for analysis at the pharmacist's expense, if the need for such a procedure is indicated by the circumstances leading to the violation and is directed by the Board; nly under the supervision of a (4) If and as directed by the Board, practice o pharmacist not on probation to the Board. The supervision directed may be continuous supervision, substantial supervision, partial supervision, or supervision by daily review as deemed necessary by the Board for supervision, partial supervision, or supervision by daily review as deemed necessary by the Board for the protection of the public health and safety. (5) Complete an ethics course that meets the requirements of section 1773.5 (c) When the circumstances of the case so require, the Board may impose conditions of probation in addition to those enumerated herein by the terms of its decision in an administrative case or by stipulation of the parties. Authority cited: Section 4005, Business and Professions Code. Reference: Section 4300, Business and Professions Code. 1773.5 Ethics Course Required as Condition of Probation. When directed by the board, a pharmacist or intern pharmacist may be required to complete an ethics course that meets the requirements of this section as a condition of probation, license reinstatement or as abatement for a citation and fine. Board approval must be obtained prior to the commencement of an ethics course. The board will consider for approval a ) n ethics course that at minimum ( a satisfies the following requirements: ) Duration. The course shall consist of a minimum of 22 hours, of which at (1 least 14 are contact hours and at least 8 additional hours are credited for preparation, evaluation and assessment. (2) Faculty. Every instructor sha ll either possess a valid unrestricted California professional license or otherwise be qualified, by virtue of prior training, education and experience, to teach an ethics or professionalism course at a university or teaching institution. (3) Educational Objectives. There are clearly stated educational objectives that can be realistically accomplished within the framework of the course. (4) Methods of Instruction. The course shall describe the teaching methods for each component of the program, e.g., lect - playing, group ure, seminar, role discussion, video, etc. (5) Content. The course shall contain all of the following components: (A) A background assessment to familiarize the provider and instructors with the factors that led to the prospective candidat e's referral to the class. (B) A baseline assessment of knowledge to determine the participant's practice of knowledge/awareness of ethical and legal issues related to the 321

322 pharmacy in California, including but not limited to those legal and ethical related to the specific case(s) for which the participant has been referred issues to the program. (C) An assessment of the participant's expectations of the program, recognition of need for change, and commitment to change. al related to those areas that were problems (D) Didactic presentation of materi background assessments and for the participants based upon the results of the baseline assessments of knowledge. (E) Experiential exercises that allow the participants to practice concepts and newly developed s kil ls they have learned during the didactic section of the class. (F) A longitudinal follow up component that includes (1) a minimum of two - within one year contacts at spaced intervals (e.g., 6 months and 12 months) participant's probationary after course completion or prior to com pletion of the to assess the participant's status; and period if probation is less than one year, a (2) status report submitted to the division within 10 calendar days after the last contact. (6) Class Size. A class shall not ex ceed a maximum of 12 participants. (7) Evaluation. The course shall include an evaluation method that documents written e.g. written examination or that educational objectives have been met - evaluation and that provides for written follow - up evaluation at the conclusion - of the longitudinal assessment. (8) Records. The course provider shall maintain all records pertaining to the program, including a record of the attendance for each participant, for a minimum of 3 years and shall make those records avai and lable for inspection copying by the board or its designee. (9) Course Completion. The provider shall issue a certificate of completion to a participant who has successfully completed the program. The provider shall that a also notify the board or its designe e in writing of its determination shall fail a participant did not successfully complete the program. The provider demonstrated participant who either was not actively involved in the class or comments, projection behavior indicating a lack of insight (e.g., inappropria te of blame). This notification shall be made within 10 calendar days of that documents supporting the determination and shall be accompanied by all determination. e: Authority cited: Section 4005, Business and Professions Code. Referenc Section 4300, Business and Professions Code. 1774. Disciplinary Conditions of Probation of Permit. (a) Unless otherwise directed by the Board, any pharmacy permit which is on probation to the Board shall be subject to the following conditions: ey all laws and regulations substantially related to the practice of (1) Ob pharmacy; (2) The permit, through its officer, partners or owners, shall report to the Board or its designees quarterly, either in person or in writing as directed; if the 322

323 n report is not made as directed, the period of probation shall be final probatio extended until such time as the final report is made; (3) Cooperate with the Board in its inspectional program; (4) Post or circulate notice of conditions of probation so that they are av ailable to all employees involved in pharmacy operations; (5) Submit the operation of the pharmacy to peer review if deemed necessary by the Board; (6) Provide evidence that owners or officers are knowledgeable in the laws pertaining to pharmacy if deeme d necessary by the Board. (b) When the circumstances of the case so require, the Board may impose conditions of probation in addition to those enumerated herein by the terms of its decision in an administrative case or by stipulation of the parties. Auth ority cited: Section 4005, Business and Professions Code. Reference: Section 4300, Business and Professions Code. Article 9. Citations and Fines 1775. Issuing Citations. (a) The executive officer or his/her designee may issue a citation which may contai n either or both an administrative fine and an order of abatement for: (1) A violation of the Pharmacy Law (Business and Professions Code 4000 et seq.). (2) A violation of a regulation adopted by the board. cal Information Act (Civil Code (3) A violation of the Confidentiality of Medi 56 et seq.). (4) Defaulting on a United States Department of Health and Human Services education loan. (5) A violation of other statutes or regulations for which the board may issue a citation. (b) Each citation shall be in writing and shall describe with particularity the nature and facts of the violation, including a reference to the statute or regulations alleged to have been violated. The citation shall be served upon the individual personally or by certified mail. (c ) A citation must inform the cited person or entity that if he/she or it desires a hearing to contest the finding of a violation, that hearing shall be requested by written notice to the board within 30 days of the issuance of the citation. If a hearing is not requested pursuant to this article, payment of any fine shall not constitute an admission of the violation charged. Authority cited: Sections 125.9, 148, 685 and 4005, Business and Professions Code; and Section 56.36, Civil Code. Reference: Sections 125.9, 148 and 685, Business and Professions Code; and Section 56.36, Civil Code. 1775.1. Amount of Fines. (a) The fine for violating the Pharmacy Law or regulations adopted pursuant siness thereto shall not exceed the amount specified in Section 125.9 of the Bu 323

324 and Professions Code, except for a fine issued pursuant to Section 4067 or Section 4127.4 of the Business and Professions Code. (b) The fine for violating the Confidentiality of Medical Information Act shall not exceed the amount specified in Sectio n 56.36 of the Civil Code. (c) The fine for defaulting on a United States Department of Health and Human Services education loan shall not exceed $2,500. (d) Failure of a person or entity cited to pay a fine within 30 days of the date of assessment, unless the citation is being appealed, may result in disciplinary action by the board. When a citation is not contested and a fine is not paid, the full amount of the fine shall be added to the fee for renewal of the license and the license shall not be renewed without payment of the renewal fee and fine. Authority cited: Sections 125.9, 148, 685 and 4005, Business and Professions Code; and Section 56.36, Civil Code. Reference: Sections 125.9, 148, 685, 4067 and 4127.4, Business and Professions Code; and Section 56.36, Civil Code. 1775.2. Factors Considered. In assessing the amount of an administrative fine, except violations of the Confidentiality of Medical Information Act and when assessing a fine pursuant to Business and Professions Code section 685, the fol lowing factors shall be considered: (a) The gravity of the violation. (b) The good or bad faith of the cited person or entity. (c) The history of previous violations. (d) Evidence that the violation was or was not willful. the cited person or entity has cooperated with the (e) The extent to which board's investigation. (f) The extent to which the cited person or entity has mitigated or attempted to mitigate any damage or injury caused by the violation. (g) Other matters as may be appropriate. (h) The number of violations found in the investigation. Authority cited: Sections 125.9, 148, 685 and 4005, Business and Professions Code; and Section 56.36, Civil Code. Reference: Sections 125.9, 148 and 685, Business and Professions Code; and Section 56.36, Civil Code. 1775.3. Compliance with Orders of Abatement. (a) If a cited person or entity who has been issued an order of abatement is unable to complete the correction within the time set forth in the citation because of conditions beyond his/her or its control after the exercise of reasonable diligence, the person or entity cited may request, from the board, an extension of time in which to complete the correction. Such a request shall be in writing and shall be made within the time set forth for abatement. (b) When an order of abatement is not contested or if the order is appealed and the person or entity cited does not prevail, failure to abate the violation charged ure to within the time specified in the citation shall constitute a violation and fail 324

325 comply with the order of abatement. An order of abatement shall either be personally served or mailed by certified mail. Failure to comply with an order of abatement shall constitute a ground for revocation or suspension of the license, permit, or r egistration. Authority cited: Sections 125.9, 148 and 4005, Business and Professions Code. Reference: Sections 125.9 and 148, Business and Professions Code. 1775.4. Contested Citations. ation by (a) Any person or entity served with a citation may contest the cit appealing to the board in writing within 30 days of the issuance of the citation. Appeals shall be conducted pursuant to the adjudication provisions of the Administrative Procedure Act. (Government Code Section 11500 et seq.) (b) In addition to r equesting a hearing, as provided for in subdivision (a), the person or entity cited may, within 14 calendar days after service of a citation, submit a written request for an informal office conference. The person or entity cited may contest any or all aspe cts of the citation. The informal office conference will be conducted by the executive officer or his/her designee within 30 calendars days of receiving the request. (c) The executive officer or his/her designee shall hold an informal office conference up on request as provided for in subdivision (b) with the person or entity cited and their legal counsel or authorized representative if they desire representation at the informal office conference. At the conclusion of the informal office conference, the exe cutive officer or his/her designee may affirm, modify or dismiss the citation, including any administrative fine levied or order of abatement issued. The executive officer or his/her designee shall state in writing the reasons for their action and serve or send by certified mail, a copy of their findings and decision to the person or entity cited within 14 calendar days from the date of the informal office conference. This decision uding shall be deemed to be a final order with regard to the citation issued, incl the administrative fine levied and/or an order of abatement. (d) The person or entity cited does not waive their request for a hearing to contest a citation by requesting an informal office conference after which the citation is affirmed by the exec utive officer or his/her designee. If the citation is dismissed after the informal office conference, the request for a hearing on the matter of the citation shall be deemed to be withdrawn. If the citation, including any administrative fine levied or orde r of abatement, is modified, the citation originally issued shall be considered withdrawn and a new citation issued. If a hearing is requested for the subsequent citation, it shall be requested within 30 days of the issuance of the subsequent citation. thority cited: Sections 125.9, 148 and 4005, Business and Professions Code. Au Reference: Sections 125.9 and 148, Business and Professions Code. 325

326 - Back Services Article 9.1. Prescription Drug Take - 1776. Prescription Drug Take Back Services: Authorization Pha rmacies, hospitals/clinics with onsite pharmacies, distributors and reverse distributors licensed by the board may offer, under the requirements in this - article, specified prescription drug take back services through collection receptacles and/or mail back envelopes or packages to provide options for the public to discard unwanted, unused or outdated prescription drugs. Each entity must comply with regulations of the federal Drug Enforcement Administration (DEA) and this article. Only California - licensed p harmacies, hospitals/clinics with onsite pharmacies, and drug distributors (licensed wholesalers and third party logistics providers) - who are registered with the DEA as collectors and licensed in good standing with the board may host a pharmaceutical take - back receptacle as authorized under this article. Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4005, 4026.5, and 4301, Business and Professions Code and Section 1317.40, Title 21 Code of Federal Regulations. 1776.1 . Pharmacies (a) Pharmacies may provide take back services to the public. Retail - pharmacies and hospital/clinics with onsite pharmacies may maintain collection - back services as receptacles in their facilities. Pharmacies may offer drug take specified in s ection 1776.4 in skilled nursing facilities licensed under Health and Safety Code section 1250(c). (b) There are multiple federal, state and local requirements governing the collection and destruction of dangerous drugs. Pharmacies are expected to know a nd adhere to these requirements when operating a prescription drug take - back program. (c) For purposes of this article, prescription drugs means dangerous drugs as defined by Business and Professions Code section 4022, which includes controlled substance s. Controlled substances may be commingled in collection receptacles or mail back envelopes or packages with other dangerous drugs. (d) Once drugs are deposited into a collection receptacle or mail back o be removed, counted, envelopes or packages by a consumer, they are not t sorted or otherwise individually handled. (e) The collection receptacle shall contain signage that includes: (1) The name and phone number of the responsible pharmacy; (2) Medical sharps and needles (e.g., insulin syringes) sha ll not be deposited; and (3) Consumers may deposit prescription drugs including Schedule II - V controlled substances. - back (f) Prescription drugs that are eligible for collection as part of drug take services maintained by pharmacies are only those pres cription drugs that have been dispensed by any pharmacy or practitioner to a consumer. Dangerous drugs that have not been dispensed to consumers for use (such as outdated drug 326

327 stock in a pharmacy, drug samples provided to a medical practitioner or medical waste) may not be collected as part of a pharmacy’s drug take - back service. (g) As part of its drug take - back services, a pharmacy shall not: (1) Review, accept, count, sort, or otherwise individually handle any prescription drugs from consumers. (2) Accept or possess prescription drugs from skilled nursing facilities, residential care homes, health care practitioners or any other entity. (3) Dispose of quarantined, recalled or outdated prescription drugs from pharmacy stock. e registered with the federal DEA as a collector for (h) A pharmacy must b purposes of maintaining a prescription drug take - back collection receptacle. Such pharmacies cannot employ anyone convicted of a felony related to controlled substances, or anyone who has had a DEA permi t denied, surrendered or revoked. (i) Any pharmacy that maintains a drug take - back collection receptacle as authorized in this article shall notify the board in writing within 30 days of establishing the collection program. Additionally: y that ceases to maintain a drug take (1) Any pharmac - back collection receptacle shall notify the board in writing within 30 days. (2) Any pharmacy maintaining a collection receptacle shall disclose to the ewal of the board that it provides such services annually at the time of ren pharmacy license, and shall identify all locations where its collection receptacles are located. (3) Any tampering with a collection receptacle or theft of deposited drugs shall be reported to the board in writing within 14 days. (4) Any ta mpering, damage or theft of a removed liner shall be reported to the board in writing within 14 days. (j) If the pharmacy ceases to maintain a registered collection receptacle, the pharmacy must notify the DEA within 30 days. (k) A pharmacy shall not p rovide take - back services to consumers if, in the professional judgment of the pharmacist - in - charge, the pharmacy cannot comply with the provisions of this article or the DEA rules. - back services to consumers if the (l) A pharmacy shall not provide take pharmacy or the pharmacist in - charge is on probation with the board, and, if - the pharmacy had previously provided take - back services, the pharmacist - in - charge shall notify the board and the DEA as required in subsections (i) and (j), above. ed: Section 4005, Business and Professions Code. Authority cit Reference: Section 4005 and 4022, Business and Professions Code and Sections 1301.71, 1317.30, 1317.40, Title 21 Code of Federal Regulations. 1776.2. Pharmacies Offering Mail Back Envelope or Package Servi ces back services may do so by - (a) Pharmacies that provide prescription drug take providing preaddressed mailing envelopes or packages to allow a consumer to return prescription drugs to an authorized DEA destruction location. 327

328 (b) All envelopes and pack ages must be preaddressed to a location registered with the DEA as a collector. The pharmacy is responsible for ensuring that all preaddressed envelopes and packages it makes available to the public are preaddressed for delivery to facilities that comply w ith this section. (c) The preaddressed envelopes and packages must be water and spill proof, tamper evident, tear resistant and sealable. The exterior shall be nondescript and not include markings that indicate the envelope or package contains prescripti on drugs. Postage shall be prepaid on each envelope or package. (d) The preaddressed envelope and package shall contain a unique identification number for each envelope and package, and instructions for users that indicate the process to mail back drugs. (e) A pharmacy shall not accept any mail back packages or envelopes that contain drugs unless they are registered as a collector and have an onsite method of destruction that complies with the DEA requirements. Instead, consumers shall be directed to ma il the envelopes or packages. Authority cited: Section 4005, Business and Professions Code. Reference: Section 4005, Business and Professions Code and Section 1317.70, Title 21 Code of Federal Regulations. 1776.3. Collection Receptacles in Pharmacies (a) A pharmacy may maintain a collection receptacle for the public to deposit their unwanted prescription drugs for destruction. The pharmacy is responsible for the management and maintenance of the receptacle. The receptacle shall be ucted, with a permanent outer container and a removable substantially constr inner liner. The collection receptacle shall be locked at all times to prevent access to the inner liner. (b) A pharmacy maintaining a collection receptacle must securely fasten the permanent structure so it cannot be removed. The receptacle receptacle to a shall be installed in an inside location. Except as provided in subsection (c), the receptacle is visible to pharmacy or DEA registrant employees, but not located in or near emergency areas, nor b ehind the pharmacy’s counter. (c) In hospitals/clinics with a pharmacy on the premises, the collection receptacle must be located in an area that is regularly monitored by pharmacy or DEA registrant employees and not in the proximity of any emergency or urgent care areas. When no pharmacy or DEA registrant employees are present, the collection receptacle shall be locked so that drugs may not be deposited into the collection receptacle. (d) The receptacle shall include a small opening that allows deposit of drugs into the inside of the receptacle directly into the inner liner, but does not allow for an individual to reach into the receptacle’s contents. During hours when the pharmacy is closed, the collection receptacle shall not be accessible to the publ ic for deposit of drugs. The pharmacy shall lock the deposit opening on the collection receptacle. (e) A pharmacy shall direct consumers to directly deposit drugs into the collection receptacle. A pharmacy shall not accept, count, sort or otherwise e prescription drugs from consumers. handl 328

329 (f) A liner as used in this article shall be made of material that is certified by the manufacturer to meet the American Society for Testing Materials (ASTM) D1709 standard test for impact resistance of 165 grams (dro p dart test), and the ASTM D1922 standards for tear resistance of 480 grams in both parallel and perpendicular planes. (1) The liner shall be waterproof, tamper evident and tear resistant. (2) The liner shall be opaque to prevent viewing or removal of any contents once the liner has been removed from a collection receptacle. The liner shall be clearly marked to display the maximum contents (for example, in gallons). The liner shall bear a permanent, unique identification number established by the - entered onto the liner by the liner’s manufacturer or pharma cy or pre distributor. (g) The liner shall be removable as specified in this section. The receptacle shall allow the public to deposit prescription drugs into the receptacle for containment into the i nner liner, without permitting access to or removal of prescription drugs already deposited into the collection receptacle and liner. Once a prescription drug or any other item is placed in the collection receptacle, the prescription drug or item cannot be removed, counted, sorted or otherwise individually handled. (h) If the liner is not already itself rigid or already inside of a rigid container when it is removed from the collection receptacle, the liner must be immediately, without interruption, place d in a rigid container for storage, handling and transport. A rigid container may be disposable, reusable, or - fitting recyclable. Rigid containers shall be leak resistant, have sealable tight covers, and be kept clean and in good repair. y be removed from a locked collection receptacle only by or (i) The liner ma under the supervision of two employees of the pharmacy. Upon removal, the liner shall be immediately, without interruption, sealed and the pharmacy employees shall record, in a log, their particip ation in the removal of each liner from a collection receptacle. Liners and their rigid containers shall not be - rayed, analyzed or penetrated at any time by the pharmacy or opened, x pharmacy personnel. (j) Liners and their rigid containers that have bee n filled and removed from a collection receptacle must be stored in a secured, locked location in the pharmacy no longer than 14 days. (k) The pharmacy shall make and keep the records specified in 1776.6. liners and their contents are (l) The pharmacy shall ensure the sealed inner shipped to a reverse distributor's registered location by common or contract carrier (such as UPS, FEDEX or USPS) or by licensed reverse distributor pick - up at the licensed pharmacy's premises. hall contain signage that includes: (m)The collection receptacle s (1) The name and phone number of the responsible pharmacy; (2) Medical sharps and needles (e.g., insulin syringes) shall not be deposited; and - (3) Consumers may deposit prescription drugs including Schedule II V trolled substances. con 329

330 Authority cited: Section 4005, Business and Professions Code. Reference: Section 4005, Business and Professions Code and Sections 1304.22, 1317.05, 1317.60, and 1317.75, Title 21 Code of Federal Regulations. 1776.4. Drug Take - Back S ervices in Skilled Nursing Facilities A pharmacy may offer drug take - back services in skilled nursing facilities licensed under Health and Safety Code section 1250(c) as authorized by this article. (a) Skilled nursing facility employees or person lawfull y entitled to dispose of the resident decedent’s property may dispose of unwanted or unused prescription drugs by using mail back envelopes or packages. The pharmacy shall require skilled nursing facility employees to keep records noting the specific quant ity of each prescription drug mailed back, the unique identification number of the mail back package and the preaddressed location to which the mail back envelope is sent. (b) Only pharmacies and hospitals/clinics with onsite pharmacies may establish col lection receptacles in skilled nursing facilities for the collection and ultimate disposal of unwanted prescription drugs. A pharmacy and hospital/clinic with an onsite pharmacy maintaining a collection receptacle in a skilled nursing facility shall: Be registered and maintain registration with the DEA as a collector. (1) (2) Notify the board in writing within 30 days of establishing a collection receptacle. (3) Notify the board in writing within 30 days when they cease to maintain the collection rece ptacle. (4) Notify the board in writing within 14 days of any tampering of the collection receptacle or theft of deposited drugs. (5) Notify the board in writing within 14 days of any tampering, damage or theft of a removed liner. (6) List all collec tion receptacles it maintains annually at the time of renewal of the pharmacy license. (d) Within three business days after the permanent discontinuation of use of a medication by a prescriber, as a result of the resident’s transfer to another facility or as a result of death, the skilled nursing facility may place the patient’s unneeded prescription drugs into a collection receptacle. Records of such deposit shall be made in the patient’s records, with the name and signature of the employee discarding the drugs. (e) A collection receptacle must be located in a secured area regularly monitored by skilled nursing facility employees. (f) The collection receptacle shall be securely fastened to a permanent structure so that it cannot be removed. The collect ion receptacle shall have a small opening that allows deposit of drugs into the inside of the collection receptacle and directly into the inner liner, but does not allow for an individual to reach into the receptacle’s contents. be securely locked and substantially constructed, with (g) The receptacle shall a permanent outer container and a removable inner liner. 330

331 (1) The liner shall comply with provisions in this article. The receptacle shall allow deposit of prescription drugs into the receptacle for co ntainment into the inner liner, without permitting access to or removal of prescription drugs already deposited into the collection receptacle and liner. Once a prescription drug or any other item is placed in the collection receptacle, the prescription dr ug or item cannot be removed, sorted, counted, or otherwise individually handled. (2) If the liner is not already itself rigid or already inside of a rigid container when it is removed from the collection receptacle, the liner must be immediately placed in a rigid container for storage, handling and transport. A rigid container may be disposable, reusable, or recyclable. Rigid containers shall be leak resistant, have sealable tight - fitting covers, and be kept clean and in good repair. d in this article shall be made of material that is certified by (h) A liner as use the manufacturer to meet American Society for Testing Materials (ASTM) D1709 standard test for impact resistance of 165 grams (drop dart test), and the ASTM D1922 standards for tear resistanc e of 480 grams in both parallel and perpendicular planes. (1) The liner shall be waterproof, tamper evident and tear resistant. (2) The liner shall be opaque to prevent viewing and discourage removal of any contents once the liner has been removed from a collection receptacle. The liner shall be clearly marked to display the maximum contents (for example, in gallons). The liner shall bear a permanent, unique identification number. (i) The collection receptacle shall contain signage that includes: ) The name and phone number of the responsible pharmacy; (1 (2) Medical sharps and needles (e.g., insulin syringes) shall not be deposited; and (3) Consumers may deposit prescription drugs including Schedule II - V controlled substances. (j) Once deposite d, the prescription drugs shall not be counted, sorted or otherwise individually handled. (k) The installation, removal, transfer and storage of inner liners shall be performed only by: visory (1) One employee of the authorized collector pharmacy and one super level employee of the long - term care facility (e.g., a charge nurse or supervisor) designated by the authorized collector, or (2) By or under the supervision of two employees of the authorized collector pharmacy. placed in a container may be stored at the (l) Sealed inner liners that are skilled nursing facility for up to three business days in a securely locked, substantially constructed cabinet or a securely locked room with controlled access until transfer to a reverse distributor for destruct ion. (m) Liners still housed in a rigid container may be delivered to a reverse distributor for destruction by common or contract carrier or by reverse distributor pickup at the skilled nursing facility. (n) A pharmacy maintaining a collection receptac le in a skilled nursing facility shall make and keep the records as specified in 1776.6. 331

332 Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4005, Business and Professions Code and Sections 1304.22, 1317.05, 1317.40, 1317.6 0, 1317.75, 1317.80, and 1317.95, Title 21 Code of Federal Regulations Reverse Distributors 1776.5. (a) A licensed reverse distributor (either a reverse wholesaler or a reverse third - party logistics provider) registered with the DEA may accept the sealed inner liners of collection receptacles at the reverse distributor’s registered - - up, or by reverse distributor pick location by common or contract carrier pick up at the collector’s authorized collection location. Once received, the reverse l establish records required by this section. distributor shal (b) A licensed reverse distributor may not open, survey, or otherwise analyze the contents of inner liners. All liners shall be destroyed by an appropriately licensed and registered DEA reverse distributor in a manner that makes the drugs irretrievable. (c) If a reverse distributor picks up the sealed inner liners from the collector’s authorized location, at least two employees of the reverse distributor shall be present. If the sealed inner liners are deliv ered to the reverse distributor via common or contract carrier, at least one employee of the reverse distributor shall accept the receipt of the inner liners at the reverse distributor’s registered location. (d) A reverse distributor shall not employ as an agent or employee anyone who has access to or influence over controlled substances, any person who has been convicted of any felony offense related to controlled substances or who at any time had a DEA registration revoked or suspended, or has surrender ed a DEA registration for cause. 332

333 (e) For each sealed liner or mail back envelopes or packages received pursuant to federal Title 21 CFR section 1317.55, the reverse distributor shall maintain records of the number of sealed inner liners or mail back envel opes or packages, including the: (1) Date of acquisition; (2) Number and the size (e.g., five 10 - gallon liners, etc.); (3) Unique Identification number of each liner or envelope/package; (4) The method of delivery to the reverse distributor, the signat ure of the individuals delivering the liners to the reverse distributor, and the reverse distributor’s employees who received the sealed liner; (5) The date, place and method of destruction; (6) Number of packages and inner liners received; (7) Number o f packages and inner liners destroyed; (8) The name and signature of the two employees of the registrant that witnessed the destruction. (e) For liners only, the information specified in subsection (e)(1) - (8) above shall be created at the time of receipt and at the time of destruction. Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4005, Business and Professions Code and Section 1301.71, 1304.21, 1304.22, 1317.15, 1317.55, and 1317.95, Title 21 Code of Federal Regulat ions. 1776.6. Record Keeping Requirements for Board Licensees Providing - Drug Take Back Services Each entity authorized by this article to collect unwanted prescription drugs from consumers shall maintain the records required by this article for three year s. (a) For pharmacies maintaining collection receptacles, the pharmacy shall make and keep the following records for each liner: (1) Date each unused liner is acquired, its unique identification number and size (e.g., 5 gallon, 10 gallon). The pharmacy shall assign the unique identification number if the liner does not already contain one. (2) Date each liner is installed in a collection receptacle, the address of the location where each liner is installed, the unique identification number and size (e .g., 5 gallon, 10 gallon), the registration number of the collector pharmacy, and the names and signatures of the two employees that witnessed each installation. (3) Date each inner liner is removed and sealed, the address of the location from which each inner liner is removed, the unique identification number and size (e.g., 5 gallon, 10 gallon) of each inner liner removed, the registration number of the collector pharmacy, and the names and signatures of the two employees that witnessed the removal and sealing. (4) Date each sealed inner liner is transferred to storage, the unique identification number and size (e.g., 5 gallon, 10 gallon) of each inner liner stored, and the names and signatures of the two employees that transferred each ner to storage. sealed inner li 333

334 (5) Date each sealed inner liner is transferred for destruction, the address and registration number of the reverse distributor or distributor to whom each sealed inner liner was transferred, the unique Identification number and the size (e.g., 5 gallon, 10 gallon) of each liner transferred, and the names and signatures of the two employees who transferred each sealed inner liner to the reverse distributor or distributor, or the common carrier who delivered it, the company used, and any re lated paperwork (invoice, bill of lading). Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4005, Business and Professions Code and Section 1304.22, Title 21 Code of Federal Regulations Article 10. Wholesalers 1780. Min imum Standards for Wholesalers. The following minimum standards shall apply to all wholesale establishments for which permits have been issued by the Board: (a) A wholesaler shall store dangerous drugs in a secured and lockable area. (b) All wholesaler pre mises, fixtures and equipment therein shall be maintained in a clean and orderly condition. Wholesale premises shall be well ventilated, free from rodents and insects, and adequately lighted. Plumbing oring shall be shall be in good repair. Temperature and humidity monit conducted to assure compliance with the United States Pharmacopeia Standards (1990, 22nd Revision). (c) Entry into areas where prescription drugs are held shall be limited to authorized personnel. (1) All facilities shall be equipped with an alarm system to detect entry after hours. (2) All facilities shall be equipped with a security system that will provide suitable protection against theft and diversion. When appropriate, the security system shall provide protection against theft or divers ion that is facilitated or hidden by tampering with computers or electronic records. (3) The outside perimeter of the wholesaler premises shall be well - lighted. (d) All materials must be examined upon receipt or before shipment. (1) Upon receipt, each outs ide shipping container shall be visually examined for identity and to prevent the acceptance of contaminated prescription drugs or prescription drugs that are otherwise unfit for distribution. This examination shall be adequate to reveal container damage t hat would suggest possible contamination or other damage to the contents. (2) Each outgoing shipment shall be carefully inspected for identity of the prescription drug products and to ensure that there is no delivery of prescription drugs that have been da maged in storage or held under improper conditions. (e) The following procedures must be followed for handling returned, damaged and outdated prescription drugs. (1) Prescription drugs that are outdated, damaged, deteriorated, misbranded ll be placed in a quarantine area and physically separated or adulterated sha from other drugs until they are destroyed or returned to their supplier. 334

335 (2) Any prescription drugs whose immediate or sealed outer or sealed secondary containers have been opened or used shall be identified as such, and shall be placed in a quarantine area and physically separated from other prescription drugs until they are either destroyed or returned to the supplier. (3) If the conditions under which a prescription drug has been returned cast do ubt on the drug's safety, identity, strength, quality or purity, the drug shall be destroyed or returned to the supplier unless testing or other investigation proves that the drug meets appropriate United States Pharmacopeia Standards (1990, 22nd Revision) . (f) Policies and procedures must be written and made available upon request by the board. (1) Wholesale drug distributors shall establish, maintain, and adhere to written policies and procedures, which shall be followed for the receipt, security, storage , inventory and distribution of prescription drugs, including policies and procedures for identifying, recording, and reporting losses or thefts, for correcting all errors and inaccuracies in inventories, and for age. maintaining records to document proper stor (2) The records required by paragraph (1) shall be in accordance with Title 21, Code of Federal Regulations, Section 205.50(g). These records shall be maintained for three years after disposition of the drugs. (3) Wholesale drug distributors shall est ablish and maintain lists of officers, directors, managers and other persons in charge of wholesale drug distribution, storage and handling, including a description of their duties and a summary of their qualifications. equate training and experience to assure (4) Each wholesaler shall provide ad compliance with licensing requirements by all personnel. (g) The board shall require an applicant for a licensed premise or for renewal e time of that license to certify that it meets the requirements of this section at th of licensure or renewal. Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4043, 4051, 4053, 4054, 4059, 4120, 4160, 4161 and 4304, Business and Professions Code. - Animal Drug Retailers. 1780.1. Minimum Standards for Veterinary Food In addition to the minimum standards required of wholesalers by section 1780, the following standards shall apply to veterinary food - animal drug retailers. (a) Drugs dispensed by a veterinary food - animal drug retailer pursuant to a veterin arian's prescription to a veterinarian's client are for use on food - producing animals. (b) Repackaged within the meaning of Business and Professions Code section 4041 means that a veterinary food - animal drug retailer may break down case lots of dangerous d rugs as described in 4022(a), legend drugs or extra label use drugs, so long as the seals on the individual containers are not broken. - Veterinary food animal drug retailers shall not open a container and count out , legend or extra label use drug. or measure out any quantity of a dangerous 335

336 (c) Dangerous drugs, legend drugs or extra label use drugs returned to a veterinary food - animal drug retailer from a client shall be treated as damaged or outdated prescription drugs and stored in the quarantine area speci fied in section 1780(e)(1). Returned drugs may not be returned to stock, or dispensed, distributed or resold. (d) A pharmacist or person issued a permit under Business and Professions Code section 4053 (hereafter called a vet retailer designated representa tive) may dispense drugs for use on food - producing animals on the basis of a written, electronically transmitted or oral order received from a licensed veterinarian. Only a pharmacist or the vet retailer designated representative animal drug from the may receive an oral order for a veterinary food - veterinarian. A written copy of the oral prescription shall be sent or electronically transmitted to the prescribing veterinarian within 72 hours. (e) When a vet retailer designated representative dispenses a pres cription for controlled substances, the labels of the containers shall be countersigned by the prescribing veterinarian before being provided to the client. (f) Whenever a vet retailer designated representative dispenses to the same ame production class of food - client for use on the s animals, dangerous drugs, legend drugs or extra label use drugs prescribed by multiple veterinarians, the vet retailer designated representative shall contact the prescribing veterinarians for authorization before dispensing an y drugs. (g) Refilling a veterinarian's prescription animal drug retailer may refill a prescription only if the (1) A veterinary food - initial prescription is issued indicating that a specific number of refills are the initial prescription, no refills may authorized. If no refills are indicated on be dispensed. Instead, a new prescription is needed from the veterinarian. (2) A veterinary food - animal drug retailer may not refill a veterinarian's prescription order six months after the issuance date of the ini tial order. Records of any refills shall be retained by the veterinary food - animal drug retailer for three years. (h) Labels affixed to a veterinary food - animal drug dispensed pursuant to Business and Professions Code section 4041 shall contain the: (1) Ac tive ingredients or the generic names(s) of the drug (2) Manufacturer of the drug (3) Strength of the drug dispensed (4) Quantity of the drug dispensed (5) Name of the client (6) Species of food - producing animals for which the drug is prescribed (7) Condit ion for which the drug is prescribed (8) Directions for use (9) Withdrawal time (10) Cautionary statements, if any (11) Name of the veterinarian prescriber (12) Date dispensed - animal drug retailer (13) Name and address of the veterinary food (14) Prescript ion number or another means of identifying the prescription, and if an order is filled in multiple containers, a sequential numbering system to 336

337 provide a means to identify multiple units if shipped to the same client from the same prescription (container 1 of 6, container 2 of 6, etc.) (15) Manufacturer's expiration date (i) A record of shipment or an expanded invoice shall be included in the client's shipment, and shall include the names of the drugs, quantity shipped, manufacturer's name and lot number, d ate of shipment and the name of the pharmacist or vet retailer designated representative who is responsible for the distribution. Copies of the records shall be distributed to the prescribing animal drug ret ailer for three veterinarian and retained by the veterinary food - years. (j) If a retailer is unable at any one time to fill the full quantity of drugs prescribed, the retailer may partially ship a portion so long as the full quantity is shipped within 30 days. When partially filling a veterinarian's pres cription, a pharmacist or vet retailer designated representative must note on the written prescription for each date the drugs are shipped: the quantity shipped, the date shipped, and number of containers shipped, and if multiple containers are dispensed a t one time, each container must be sequentially numbered (e.g., 1 of 6 containers),. If a retailer is unable to dispense the full quantity prescribed within 30 days, a new veterinarian's prescription is required to dispense the remainder of the drugs origi nally prescribed. (k) Upon delivery of the drugs, the supplier or his or her agent shall obtain the signature of the client or the client's agent on the invoice with notations of any discrepancies, corrections or damage. (l) If a person, on the basis of wh ose qualifications a certificate of exemption has been granted under Business and Professions Code Section 4053 (the vet - retailer designated representative), leaves the employ of a veterinary food animal drug retailer, the retailer shall immediately return the certificate of exemption to the board. (m) Training of Vet Retailer Designated representative: (1) A course of training that meets the requirements of section 4053(b)(4) shall include at least 240 hours of theoretical and practical instruction, provid ed that at least 40 hours are theoretical instruction stressing: (A) Knowledge and understanding of the importance and obligations relative animals and residue hazards to consumers. to drug use on food - aw regarding (B) Knowledge and understanding of state and federal l dispensing of drugs, including those prescribed by a veterinarian. (C) Knowledge and understanding of prescription terminology, abbreviations, dosages and format, particularly for drugs prescribed by a veterinarian. (D) Understanding of cautio nary statements and withdrawal times. (E) Knowledge and understanding of information contained in package inserts. (2) As an alternative to the training program specified in paragraph (1), other training programs that satisfy the training requirements of 4 053 include fulfillment of one of the following: (A) Possessing a registration as a registered veterinary technician with the California Veterinary Medical Board. 337

338 (B) Being eligible to take the State Board of Pharmacy's pharmacist licensure exam or the Vet erinary Medical Board's veterinarian licensure examination. (C) Having worked at least 1,500 hours within the last three years at a veterinary food - animal drug retailer's premises working under the direct supervision of a vet retailer designated representa tive. The specific knowledge, skills and abilities listed in sections 1780.1(m)(1)(A - E) shall be learned as part of the 1500 hours of work experience. A vet retailer designated representative who vouches for the qualifying experience earned by an applicant for registration must do so under penalty of perjury. Authority cited: Sections 4005 and 4197, Business and Professions Code. Reference: Sections 4040, 4041, 4053, 4059, 4063, 4070, 4081, 4196, 4197, 4198 and 4199, Business and Professions Code. 1781. E xemption Certificate. A registered pharmacist, or an designated representative certified in accordance with Section 4053 or 4054 of the Business and Professions Code shall be present and in control of a manufacturer's or wholesaler's licensed ng the conduct of business. premises duri Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4053 or 4054, Business and Professions Code. 1782. Reporting Sales of Drugs Subject to Abuse. All manufacturers and wholesalers shall report to the Board or its designee, up to twelve (12) times a year, all sales of dangerous drugs subject to abuse as designated by the Board for reporting, in excess of amounts to be determined by the Board from time to time. Reports shall be made within thirty (30 ) days of the request in the form specified by the Board. Authority cited: Section 4005, Business and Professions Code; and Section 26692, Health and Safety Code. Reference: Sections 4081 and 4332, Business and Professions Code; and Section 26692, Health and Safety Code. 1783. Manufacturer or Wholesaler Furnishing Drugs and Devices. (a) A manufacturer or wholesaler shall furnish dangerous drugs or devices only to an authorized person; prior to furnishing dangerous drugs and devices to a person not known t o the furnisher, the manufacturer or wholesaler shall contact the board or, if the person is licensed or registered by another government entity, that entity, to confirm the recipient is an authorized person. the board has issued a (b) “Authorized person” means a person to whom permit which enables the permit holder to purchase dangerous drugs or devices for use within the scope of its permit. “Authorized person” also means any person in this state or in another jurisdiction within the United States to the extent such furnishing is authorized by the law of this state, any applicable federal law, and the law of the jurisdiction in which that person is located. The manufacturer or wholesaler furnishing to such person shall, prior to furnishing 338

339 the dangerous dr ugs and devices, establish the intended recipient is legally authorized to receive the dangerous drugs or devices. (c) Dangerous drugs or devices furnished by a manufacturer or wholesaler shall be delivered only to the premises listed on the permit; provid ed that a manufacturer or wholesaler may furnish drugs to an authorized person or an agent of that person at the premises of the manufacturer or wholesaler if (1) the identity and authorization of the recipient is properly established and (2) this method o f receipt is employed only to meet the immediate needs of a particular patient of the authorized person. Dangerous drugs or devices may be furnished to a hospital pharmacy receiving area provided that a pharmacist or authorized t the time of delivery, a receipt showing the type receiving personnel signs, a and quantity of the dangerous drugs or devices so received. Any discrepancy between the receipt and the type and quantity of dangerous drugs and devices g manufacturer or wholesaler actually received shall be reported to the deliverin by the next business day after the delivery to the pharmacy receiving area. (d) A manufacturer or wholesaler shall not accept payment for or allow the use of an entity's credit to establish an account for the purchase of danger ous drugs or devices from any person other than: (1) the owner(s) of record, chief executive officer, or chief financial officer listed on the permit for the authorized person; and (2) on an account bearing the name of the permittee. (e) All records of dan gerous drugs or devices furnished by a manufacturer or wholesaler to an authorized person shall be preserved by the authorized person for at least three years from the date of making and shall, at all times during business hours, be open to inspection by a uthorized officers of the law at the licensed premises. The manufacturer or wholesaler shall also maintain all records of dangerous drugs or devices furnished pursuant to this section for at during business least three years from the date of making and shall, at all times hours, keep them open to inspection by authorized officers of the law at the premises from which the dangerous drugs or devices were furnished. Authority cited: Section 4005, Business and Professions Code. Reference: 4059.5, 4080, 4081, 4120, 4160, 4161, 4163 and 4304, Sections 4043, 4059, Business and Professions Code; and Section 11209, Health and Safety Code. - 1784. Self Assessment of a Wholesaler by the Designated Representative - in - Charge. each wholesaler as defined (a) The designated representative - in - charge of under section 4160 of the Business and Professions Code shall complete a self - assessment of the wholesaler’s compliance with federal and state pharmacy law. The assessment shall be performed before July 1 of every odd - numbered - y ear. The primary purpose of the self assessment is to promote compliance examination and education. through self - (b) In addition to the self - assessment required in subdivision (a) of this - lf section, the designated representative - in - charge shall complete a se assessment within 30 days whenever: (1) A new wholesaler permit is issued, or 339

340 (2) There is a change in the designated representative - in - charge. The new in designated representative - charge of a wholesaler is responsible for - compliance with this subdivisi on. (3) There is a change in the licensed location of a wholesaler to a new address. 6 (R 2 ev. (c) The components of this assessment shall be on Form 17M - / 14 ) entitled “Wholesaler Dangerous Drugs & Dangerous Devices Self - 10 orated by reference to evaluate compliance Assessment ” which is hereby incorp with federal and state laws and regulations. (d) Each self - assessment shall be kept on file in the licensed wholesale premises for three years after it is completed. (e) The wholesaler is jointly responsible with the designated representative - charge for compliance with this section. in - Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4022.5, 201, 4301 and 4 305.5, 4043, 4053, 4059, 4120, 4160, 4161, 4 Business and Professions Code. A rticle 10.1 Home Dialysis Drugs and Devices 1787. Authorization to Distribute Dialysis Drugs and Devices. (a) Only the following dangerous drugs and devices may be distributed directly to home dialysis patients in case or full shelf package lots: (1) Dia lysate (2) Heparin 1000u/cc (3) Sterile Sodium Chloride 0.9% for injection (4) Needles (5) Syringes (6) Dialyzers, delivery systems and their accessory equipment necessary for chronic hemodialysis. ributed on the (b) The drugs and devices specified in 1787(a) may be dist basis of a written or oral order received from a licensed prescriber. The prescriber or his or her authorized employee may transmit oral orders directly to a pharmacist or designated representative. (c) Orders are refillable during a six - mon th interval as ordered by the prescriber. Records of such refills shall be retained by the supplier for three years. Authority cited: Sections 4005 and 4059, Business and Professions Code. Reference: Sections 4059, 4081 and 4332, Business and Profession C ode. 340

341 1790. Assembling and Packaging. A record of shipment or expanded invoice shall be included in the patient's shipment, and shall include the name(s) of the drugs or devices, quantities, manufacturer's name and lot number, date of shipment, and the nam e of the pharmacist or designated representative who supervised and was responsible for the distribution. Copies of the record shall also be distributed to the prescribing physician and retained by the supplier for three years. Authority cited: Sections 4 005 and 4059, Business and Profession Code. Reference: Sections 4059, 4081 and 4332, Business and Professions Code. 1791. Labeling. In addition to the manufacturer's label, each case or full shelf package furnished to a home hemodialysis patient shall ha ve affixed in a conspicuous place the name of that patient. In addition the shipment must include the following information: the patient's name and address, the name, strength, dosage size and quantity of the dangerous drugs or devices contained therein, t he name of the prescriber, the name and address of the supplier, the date of assembly, and appropriate directions for use. Authority cited: Sections 4005 and 4059, Business and Professions Code. sions Code. Reference: Sections 4059, 4081 and 4332, Business and Profes 1792. Receipt for Shipment. Upon delivery of such drugs and devices, the supplier or his or her agent shall obtain the signature of the patient or his or her agent on the invoice with notations of any discrepancies, corrections or damage. Aut hority cited: Sections 4005 and 4059, Business and Professions Code. Reference: Sections 4059, 4081 and 4332, Business and Professions Code. Article 11. Ancillary Personnel 1793. Definitions . t “Pharmacy technician” means an individual who, under the direc supervision and control of a pharmacist, performs packaging, manipulative, repetitive, or other nondiscretionary tasks related to the processing of a prescription in a pharmacy, but who does not perform duties restricted to a 3.1. pharmacist under section 179 Authority cited: Sections 4005, 4007, 4038, 4115 and 4202, Business and Professions Code. Reference: Sections 4005, 4007, 4038, 4115 and 4202, Business and Professions Code. 1793.1. Duties of a Pharmacist. acting under the supervision of a Only a pharmacist, or an intern pharmacist pharmacist, may: 341

342 (a) Receive a new prescription order orally from a prescriber or other person authorized by law. (b) Consult with a patient or his or her agent regarding a prescription, either prior to or after dispensing , or regarding any medical information contained in a patient medication record system or patient chart. (c) Identify, evaluate and interpret a prescription. (d) Interpret the clinical data in a patient medication record system or patient chart. (e) Consul t with any prescriber, nurse or other health care professional or authorized agent thereof. (f) Supervise the packaging of drugs and check the packaging procedure and product upon completion. (g) Perform all functions which require professional judgment. Authority cited: Sections 4005, 4007, 4038, 4115 and 4202, Business and Professions Code. Reference: Sections 4005, 4007, 4038, 4115 and 4202, Business and Professions Code. 1793.2. Duties of a Pharmacy Technician. “Nondiscretionary tasks” as used in Bus iness and Professions Code section 4115, include: (a) removing the drug or drugs from stock; (b) counting, pouring, or mixing pharmaceuticals; (c) placing the product into a container; (d) affixing the label or labels to the container; packaging. (e) packaging and re Authority cited: Sections 4005, 4007, 4038, 4115 and 4202, Business and Professions Code. Reference: Sections 4005, 4007, 4038, 4115 and 4202, Business and Professions Code. - Licensed Pharmacy Personnel. 1793.3. Other Non loying a pharmacy technician to perform the tasks (a) In addition to emp specified in section 1793.2, a pharmacy may employ a non - licensed person to type a prescription label or otherwise enter prescription information into a computer record system, but the responsibility for th e accuracy of the prescription information and the prescription as dispensed lies with the registered pharmacist who initials the prescription or prescription record. At the direction of the registered pharmacist, a non - licensed person may also request and receive refill authorization. (b) A pharmacist may supervise the number of non - licensed personnel performing the duties specified in subdivision (a) that the pharmacist determines, in the exercise of his or her professional judgment, does not interfere wi th the effective performance of the pharmacist's responsibilities under the Pharmacy Law. (c) A pharmacist who, exercising his or her professional judgment pursuant to subdivision (b), refuses to supervise the number of non licensed personnel - 342

343 scheduled by the pharmacy, shall notify the pharmacist - in - charge in writing of his or her determination, specifying the circumstances of concern with respect to the pharmacy or the non - licensed personnel that have led to the determination, within a reasonable period, b ut not to exceed 24 hours, after the posting of the relevant schedule. (d) No entity employing a pharmacist may discharge, discipline, or otherwise discriminate against any pharmacist in the terms and conditions of employment for exercising or attempting t o exercise in good faith the right established pursuant to this section. Authority cited: Sections 4005 and 4007, Business and Professions Code. Reference: Sections 4005 and 4007, Business and Professions Code. 1793.5. Pharmacy Technician Application. Operative 1/1/2016 The “Pharmacy Technician Application” (Form 17A - 5 (Rev. 10/15)), incorporated by reference herein, required by this section is available from the Board of Pharmacy upon request. hall include: (a) Each application for a pharmacy technician license s (1) Information sufficient to identify the applicant. (2) A description of the applicant's qualifications and supporting documentation for those qualifications. (3) A criminal background check that will require submission of fingerprints in a manner specified by the board and the fee authorized in Penal Code section 11105(e). (4) A sealed, original Self - Query from the National Practitioner Data Bank (NPDB) dated no earlier than 60 days of the date an application is submitted to the board. (b) The applicant shall sign the application under penalty of perjury and shall submit it to the Board of Pharmacy. (c) The board shall notify the applicant within 30 days if an application is deficient; and what is needed to correct the deficiency. Once the a pplication is complete, and upon completion of any investigation conducted pursuant to section 4207 of the Business and Professions Code, the board will notify the applicant within 60 days of a license decision. (d) Before expiration of a pharmacy technici an license, a pharmacy technician must renew that license by payment of the fee specified in subdivision (r) of section 4400 of the Business and Professions Code. Note: Authority cited: Sections 163.5, 4005, 4007, 4038, 4115, 4202, 4207 and 4400, Business and Professions Code. Reference: Sections 163.5, 4005, 4007, 4038, 4115, 4202, 4207, 4402 and 4400, Business and Professions Code; and Section 11105, Penal Code. 1793.6. Training Courses Specified by the Board. A course of training that meets the require ments of Business and Professions Code section 4202 (a)(2) is: 343

344 (a) Any pharmacy technician training program accredited by the American Society of Health -- System Pharmacists, (b) Any pharmacy technician training program provided by a branch of the rmed services for which the applicant possesses a certificate of federal a completion, or (c) Any other course that provides a training period of at least 240 hours of instruction covering at least the following: (1) Knowledge and understanding of different pharmacy practice settings. (2) Knowledge and understanding of the duties and responsibilities of a pharmacy technician in relationship to other pharmacy personnel and knowledge of standards and ethics, laws and regulations governing the practice of pharmacy. (3) Knowledge and ability to identify and employ pharmaceutical and medical terms, abbreviations and symbols commonly used in prescribing, dispensing and record keeping of medications. (4) Knowledge of and the ability to carry out calculations required for com mon dosage determination, employing both the metric and apothecary systems. (5) Knowledge and understanding of the identification of drugs, drug dosages, routes of administration, dosage forms and storage requirements. (6) Knowledge of and ability to perfo keeping - rm the manipulative and record functions involved in and related to dispensing prescriptions. (7) Knowledge of and ability to perform procedures and techniques relating to manufacturing, packaging, and labeling of drug products. ections 4005, 4007, 4038, 4115 and 4202, Business and Authority cited: S Professions Code. Reference: Sections 4005, 4007, 4038, 4115 and 4202, Business and Professions Code. 1793.7. Requirements for Pharmacies Employing Pharmacy Technicians. d in section 1793.8, any function performed (a) Except as otherwise provide by a pharmacy technician in connection with the dispensing of a prescription, including repackaging from bulk and storage of pharmaceuticals, must be the preparation verified and documented in writing by a pharmacist. Except for of prescriptions for an inpatient of a hospital and for an inmate of a correctional facility, the pharmacist shall indicate verification of the prescription by ent. initialing the prescription label before the medication is provided to the pati (b) Pharmacy technicians must work under the direct supervision of a pharmacist and in such a relationship that the supervising pharmacist is fully aware of all activities involved in the preparation and dispensing of medications, including the mainte nance of appropriate records. (c) A pharmacy technician must wear identification clearly identifying him or her as a pharmacy technician. (d) Any pharmacy employing or using a pharmacy technician shall develop a cedures adequate to ensure job description and written policies and pro compliance with the provisions of Article 11 of this Chapter, and shall 344

345 maintain, for at least three years from the time of making, records adequate to establish compliance with these sections and written policies and procedures. (e) A pharmacist shall be responsible for all activities of pharmacy technicians to ensure that all such activities are performed completely, safely and without risk of harm to patients. (f) For the preparation of a prescription for an inpatient of a lice nsed health facility and for a patient of a licensed home health agency, the ratio shall not be less than one pharmacist on duty for a total of two pharmacy technicians on duty. Pursuant to Business and Professions Code section 4115(g)(1), this ratio not apply to the preparation of a prescription for an inmate of a shall correctional facility of the Department of the Youth Authority or the Department of Corrections, or for a person receiving treatment in a facility operated by the State Department of Mental Health, the State Department of Developmental Services, or the Department of Veterans Affairs. Authority cited: Sections 4005, 4007, 4038, 4115 and 4202, Business and Professions Code. Reference: Sections 4005, 4007, 4038, 4115 and 4202, Business and Pro fessions Code. 1793.8 Technicians in Hospitals with Clinical Pharmacy Programs. (a) A general acute care hospital, as defined in Health and Safety Code 1250 (a), that has an ongoing clinical pharmacy program may allow pharmacy technicians to check the wor k of other pharmacy technicians in connection with the filling of floor and ward stock and unit dose distribution systems for patients admitted to the hospital whose orders have previously been reviewed and approved by a licensed pharmacist. Only inpatient hospital pharmacies as defined in 4029(a) that maintain a clinical pharmacy services program as described in 4052.1 may have a technician checking technician program as described. The pharmacy shall have on file a description of the clinical pharmacy prog ram prior to initiating a technician checking technician program. (1) This section shall only apply to acute care inpatient hospital pharmacy settings. (2) Hospital pharmacies that have a technician checking technician program he inpatient care setting to provide clinical shall deploy pharmacists to t services. (b) Compounded or repackaged products must have been previously checked by a pharmacist and then may be used by the technician to fill unit dose distribution systems, and floor and ward stock. (c) To ensure quality patient care and reduce medication errors, programs that use pharmacy technicians to check the work of other pharmacy technicians pursuant to this section must include the following components: (1) The overall operation of the program shall be the responsibility of the charge. pharmacist - in - (2) The program shall be under the direct supervision of a pharmacist and the parameters for the direct supervision shall be specified in the facility’s policies and procedures 345

346 who performs the checking function has (3) The pharmacy technician received specialized and advanced training as prescribed in the policies and procedures of the facility. (4) To ensure quality there shall be ongoing evaluation of programs that use pharmacy technicians to check the w ork of other pharmacy technicians. Authority cited: Section 4005 and 4115, Business and Professions Code. Reference: Section 4005, 4052.1 and 4115 Business and Professions Code. 346

347 HEALTH & SAFETY CODE DIVISION 2. LICENSING PROVISIONS Section 1211 nics Sharing Office Space Cli Emergency Supplies; Doses Stored in Emergency Supplies 1261.5 Container Automated Drug Delivery Systems 1261.6 DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT CHAPTER 1. GENERAL PROVISIONS AND DEFINITIONS Section 11000 Desig nation 11001. Definitions Govern Construction 11002. Administer Defined Agent Defined 11003. 11004. Attorney General Defined 11005. Board of Pharmacy Defined 11006.5 Concentrated Cannabis Defined 11007. Controlled Substance Defined 11008. Customs B roker Defined 11009. Deliver or Delivery Defined Dispense Defined 11010. 11011. Dispenser Defined Distribute Defined 11012. 11013. Distributor Defined 11014. Drug Defined 11014.5. Drug Paraphernalia Defined 11015. Federal Bureau Defined 11016. Fur nish Defined 11017. Manufacturer Defined Marijuana Defined 11018. 11019. Narcotic Drug Defined Opiate Defined 11020. 11021. Opium Poppy Defined 11022. Person Defined 11023. Pharmacy Defined 11024. Physician, Dentist, Podiatrist, Pharmacist , and Vete rinarian Defined 11025. Poppy Straw Defined 11026. Practitioner Defined Prescription Defined 11027. 347

348 Section 11029. Production Defined 11029.5 Security Printer Defined Ultimate User Defined 11030. Wholesaler Defined 11031. 11032. References to Narcot ics, Restricted Dangerous Drugs, Marijuana as Schedule I, II, III and IV Controlled Substances Isomer Defined 11033. CHAPTER 2. STANDARDS AND SCHEDULES Section 11053. Substances Included by Whatever Name Used 11054. Schedule I Controlled Substances 11055 Schedule II Controlled Substances 11056 Schedule III Controlled Substances 11057 Schedule IV Controlled Substances Schedule V Controlled Substances 11058. CHAPTER 3. REGULATION AND CONTROL Article 1. Reporting Section 11100. Report of Certa in Chemical: Chemicals Included; Exclusions; Penalties Drug Cleanup Fine 11100.05. 11100.1. Report of Chemicals Received from Outside State; Penalties 11101. Reporting Form Contents 11102. Adoption of Necessary Regulations 11103. Report of Theft, Loss, or Shipping Discrepancy Providing Chemical for Illicit Manufacturing; Evasion of 11104. Reporting Requirements; Penalties 11104.5. Illegal Possession of Certain Glassware or Lab Apparatus 11105. False Statement in Report 11106. Permit for Providing Chem icals; Process; Discipline; Renewal and Fees 11106.5. Order Suspending or Imposing Permit Restrictions 11106.7. System for DOJ Citations to Permittees; Order of Abatement or Order to Pay Fine; System Requirements 11107. Sale of Laboratory Items: Required Procedures and Records; Penalties for Violation Requirements When Selling Specified Chemicals; Violation 11107.1. as Misdemeanor 348

349 Section 11110 Sale of Dextromethorphan Prohibited to Those Under 18 ithout Prescription Years of Age w Use of Cash Regist er with Age - Verification Feature for OTC 11111 Sale of Dextromethorphan CHAPTER 4. PRESCRIPTIONS Article 1. Requirements of Prescriptions Section Persons Authorized to Write or Issue a Prescription 11150. 11150.6. Methaqualone as Schedule I Controlled S ubstance 11151. Limitation on Filling Prescriptions From Medical Students Nonconforming Prescriptions Prohibited 11152. 11153. Responsibility for Legitimacy of Prescription; Corresponding Responsibility of Pharmacist; Knowing Violation 11153.5. Wholesale r or Manufacturer Furnishing Controlled Substance Other Than for Legitimate Medical Purpose; Knowing Violation; Factors in Assessing Legitimacy Prescription, etc. Must Be for Treatment; Knowing 11154. Solicitation of Unlawful Prescription, etc. 11155. ibition on Physician Prescribing, etc., Where Controlled Proh Substance Privileges Surrendered Prescribing, etc. Controlled Substances to Addict Only as 11156. Authorized 11157. No False or Fictitious Prescriptions 11158. III, IV, or V Prescription Required for Schedule II, Controlled Substance; Exception for Limited Dispensing, Administration 11158.1. Prescribing Controlled Substance Containing an Opioid to a Minor 11159. Chart Order Exemption for Patient in County or Licensed Hospital; Maintaining Record for Seven Years 11159.1. Chart Order Exemption for Clinic Patient; Maintaining Record for Seven Years 11159.2. Exception to Controlled Substance Prescription Requirement; Terminally Ill Patient 11161. Controlled Substance Prescription Blanks; Issuance by Depa rtment; Unlawful Possession; Restriction in Criminal Proceeding 11161.5. Prescription Forms for Controlled Substance Prescriptions; Requirements 11161.7. Prescriber Authority to Prescribe Restricted; Information to Board; Board Notification to Security Pri nters Prescription Forms for Controlled Substances; Requirements 11162.1. 349

350 Section 11162.5. Counterfeiting or Possession of Counterfeit Controlled Substance Prescription Blank; Penalty Controlled Substance Prescription Form; Counterfeiting, 11162.6. Posses sion of, Attempt to Obtain or Obtain Under False Pretenses; Penalty Prescribing, Filling, Compounding or Dispensing 11164. Prescription for Controlled Substance; Requirements Prescription Issued in Another State for 11164.1. Controlled Substance o Patient in Another State; Dispensing by Delivery t California Pharmacy 11164.5. Electronic Prescriptions or Orders to Pharmacies and Hospitals 11165. Controlled Substance Utilization Review and Evaluation System: Establishment; Operation; Funding; Reporting to Depa rtment of Justice History of Controlled Substances Dispensed to an 11165.1. Individual /PDMP 11165.2 CURES Violation: Citations; Request for Hearing; Fines 11165.3 Report Theft/Loss of Security Forms CURES: Prescribers’ Duty Required to Consul t CURES 11165.4 11165.5. CURES Funding; Definitions 11165.6 Prescriber Access for List of Prescriber’s Patients 11166. Time Limit for Filling Schedule II Prescription; Knowingly Filling Mutilated, Forged, or Altered Prescription Prohibited Emergency Disp ensing of Controlled Substance: 11167. Circumstances and Requirements 11167.5. Oral or Electronic Prescriptions for Schedule II Controlled Substance for Specified Inpatients, Residents, and Home Hospice Patients; Requirements Prohibition on Prescribing, e tc. Controlled Substance for Self 11170. Prescribing, etc. Controlled Substance Only as Authorized 11171. 11172. Antedating or Postdating Prescription Prohibited 11173. Fraud, Deceit, Misrepresentation or False Statement; False Representation; False Label . Prohibition on Providing False Name or Address in 11174 Connection with Prescription, etc. 11175. Prohibition on Obtaining or Possessing Nonconforming Prescription; Prohibition on Obtaining Controlled Substance by Nonconforming Prescription 11179. Retention o f Controlled Substance Prescription 11180. Prohibition of Controlled Substance Obtained or Possessed by Nonconforming Prescription 350

351 Article 2. Prescriber’s Record Section 11190. Prescriber’s Record for Schedule II, III or IV Controlled Substances; Pr escription Requirements 11191. Retention Period; Violation 11192. Prima Facie Evidence of Violation of Section 11190 Article 3. Copies of Prescriptions Section 11195. Providing Receipt for Prescription Removed by Peace Officer, Board Inspector, etc . Article 4. Refilling Prescriptions Section 11200. Restrictions on Dispensing or Refilling; Refill of Schedule II Prescription Prohibited 11201. Emergency Refill of Schedule III, IV, or V Prescription; Circumstances; Requirements Article 5. Pharmaci sts’ Records Section 11205 Maintenance and Retention of Records in Separate File Required Information on Prescription 11206. Only Pharmacist or Intern Authorized to Fill Prescription 11207. 11208. Prima Facie Evidence of Violation of Controlled Subst ance Act 11209. Delivery and Receiving Requirements for Schedule II, III, and IV Substances; Violation CHAPTER 5. USE OF CONTROLLED SUBSTANCES Article 1. Lawful Medical Use Other Than Treatment of Addicts Section 11210. Issuing Prescription: By Whom ; For What Purpose; Quantity to Be Prescribed 11211. Purchases of Controlled Substances by Hospital Without a Pharmacist for Emergencies; Conditions on Providing to Patients 11212. Obtaining and Using Controlled Substance for Research, Instruction, or Anal ysis; Conditions Research Approval by Research Advisory Panel 11213. 351

352 Ar ticle 2. Treatment of Addicts f or Addiction Section 11215. Administration of Narcotics By or Under Direction of Physician, etc.; Who Physician May Direct to Administer 11217. Autho rized Place of Treatment arcotic Administration in Off ice or Medical Facility of Non - N 11217.5. Drugs 11218. Limitation on Narcotics in First 15 Days of Treatment 11219. Limitation on Narcotics after First 15 Days of Treatment Required Discontinuan 11220. ce of Controlled Substances, Except Methadone or LAAM, After 30 Days 11222. Persons in Custody: Treatment for Withdrawal Symptoms; Continued Participation in Narcotic Treatment Programs Article 3. Veterinarians Section , etc. Controlled Substance for Prohibition on Prescribing 11240. Human Being 11241. Prescription Contents Article 4. Sale Without Prescription Section 11250. Authorized Retail Sale by Pharmacists to Physicians, etc.; Required Order Form 11251. Authorized Wholesale Sale by Pharmacist s 11252. Preservation of Federally Required Forms Duration of Retention 11253. Actions Constituting Sale 11255. 11256. State Required Report of Order by or Sale to Out - of - Wholesaler or Manufacturer 11364 Possession of Illegal Drug Paraphernalia 11364.1 Unlawful Possession of Drug Paraphernalia in Effect until January 1, 2015 Unless Another Law is Enacted Before That Date 352

353 CHAPTER 13.5. DISEASE PREVENTION DEMONSTRATION PROJECT Section 121281 Board Web Site: Testing for HIV and Viral Hepatitis; D isposal of Sharps Waste; How to Access Drug Treatment 121285 The Disease Prevention Demonstration Project; Furnishing or Sale of Nonprescription Hypodermic Needles or Syringes CHAPTER 18. CLEAN NEEDLE AND SYRINGE EXCHANGE PROGRAM Section 121349 Legisla tive Findings and Declaration 121349.1 Needle and Syringe Exchange Project; Requirements 121349.2 Local, Health and Law Enforcement Comment Biennually; Public Input 121349.2 Local, Health and Law Enforcement Comment Annually; Public Input 121349.3 Bienni al Report of Health Officer of Participating Jurisdiction 121349.3 Annual Report of Health Officer of Participating Jurisdiction 124960 Treatment of Severe Chronic Intractable Pain 124961 Pain Patient’s Bill of Rights DIVISION 106. Part 5. HEREDITARY DI SEASES/CONGENITAL DEFECTS CHAPTER 2. GENETIC DISEASE SERVICES Article 5. Standards of Service Home For Providers of Blood Clotting Products for Use Act Section Standards of Service for Providers of Blood Clotting Products 125286.10 for Home Use Act 1252 86.15 Legislative Declarations 125186.20 Definitions 125286.26 Requirements for Providers of Blood Clotting Products for Home Use 125286.30 Administration and Enforcement Exemptions 126286.35 353

354 DIVISION 114. PRESCRIPTION DRUG DISCOUNT PROHIBITION Section Prescription Drug Discount Prohibition 13 2000. Food and Drug – Administration’s “Approved Drug Products with Therapeutic Equivalence Evaluations” 132002. Prescription Drug Discount Prohibition – Active Ingredients Available at Regulated by Food and Drug Administration, Lower Cost and Otherwise Not Contraindicated 132004. Prescription Drug Discount Prohibition – Exceptions 132006. Prescription Drug Discount Prohibition – Exception if Product is Free for Patient and Insurer, Health Care Service Plan or Othe r Health Coverage 132008. Pharmacist’s Ability to Substitute Prescription Drug; Assistance by Independent Charity Patient Assistance Program; Assistance by Pharmaceutical Manufacturer DIVISION 116. SURPLUS MEDICATION COLLECTION AND DISTRIBUTION 12. HEALTH FACILITIES CHAPTER Section 150200 Legislative Intent to Establish Voluntary Drug Repository and Distribution Program 150201 Medication or Medications Defined 150202 Skilled Nursing Facilities May Donate Unused Medications 150203 Drug Wholesalers a nd Manufacturers May Donate Unused Medications Section 150204 County May Establish Repository and Distribution Program for Dispensing Donated Drugs 150205 Liability 150206 No Immunity for Noncompliance or Negligence 150207 Disciplinary Actions SAFETY CODE HEALTH & Division 2. Licensing Provisions 1211.Clinics Sharing Office Space (a) Notwithstanding any other law, a clinic licensed pursuant to Section 1204 may operate in shared clinic space with a clinic exempt from licensure pursuant to subdivision (b) of Section 1206 under the following conditions: 354

355 (1) Each clinic uses signage that clearly identifies which clinic is operating during the hours of operation. (2) The licensed clinic reports the operating hours of both clinics. (3) Each clinic maint ains separate medical records. (4) Each clinic maintains separate drug storage. (5) Both clinics are licensed by the California State Board of Pharmacy pursuant to Section 4180.5 of the Business and Professions Code. pect the shared space at any time (b) The department may enter and ins pursuant to Section 1227 of the Health and Safety Code, including accessing records. The exempt clinic shall allow the department to access and inspect its records. (c) The licensed clinic shall be responsible for any sta tutory or regulatory violations occurring on the premises. (d) Notwithstanding the rulemaking provisions of the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code), the depar tment may implement, interpret, or make specific this section by means of all - facility letters, or similar instructions, without taking regulatory action. (e) This section shall become inoperative on January 1, 2021, and as of that date is repealed. . Emergency Supplies; Doses Stored in Emergency Supplies .5 1261 Container (a) The number of oral dosage form or suppository form drugs provided by a pharmacy to a health facility licensed pursuant to subdivision (c) or (d), or both (c) and (d), of Section 12 50 for storage in a secured emergency supplies container, pursuant to Section 4119 of the Business and Professions Code, shall be limited to 48. The State Department of Public Health may limit the number of doses of each drug available to not more than 16 doses of any separate drug dosage form in each emergency supply. (b) Not more than four of the 48 oral form or suppository form drugs secured for storage in the emergency supplies container shall be psychotherapeutic grant a program flexibility request to the drugs, except that the department may facility to increase the number of psychotherapeutic drugs in the emergency supplies container to not more than 10 if the facility can demonstrate the necessity for an increased number of drugs based on the needs of the patient population at the facility. In addition, the four oral form or suppository form psychotherapeutic drug limit shall not apply to a special treatment program service unit distinct part, as defined in Section 1276.9. The department shall limit the number of doses of psychotherapeutic drugs available to not more than four doses in each emergency supply. Nothing in this section shall alter or diminish informed consent requirements, including, but not limited to, the requirements of Section 1418.9 . (c) Any limitations established pursuant to subdivisions (a) and (b) on the number and quantity of oral dosage or suppository form drugs provided by a pharmacy to a health facility licensed pursuant to subdivision (c), (d), or both ion 1250 for storage in a secured emergency supplies (c) and (d), of Sect 355

356 container shall not apply to an automated drug delivery system, as defined in Section 1261.6, when a pharmacist controls access to the drugs. Automated Drug Delivery Systems 1261.6 (a) (1) For purpose s of this section and Section 1261.5, an "automated drug delivery system" means a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, d drug delivery system shall dispensing, or distribution of drugs. An automate collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability. (2) For purposes of this section, "facility" means a h ealth facility licensed of Section 1250 that has an automated pursuant to subdivision (c), (d), or (k) drug delivery system provided by a pharmacy. (3) For purposes of this section, "pharmacy services" means the provision of both routine and emergency dru gs and biologicals to meet the needs of the patient, as prescribed by a physician. (b) Transaction information shall be made readily available in a written format for review and inspection by individuals authorized by law. These records shall be maintaine d in the facility for a minimum of three years. (c) Individualized and specific access to automated drug delivery systems shall be limited to facility and contract personnel authorized by law to administer drugs. (d) (1) The facility and the pharmacy sha ll develop and implement written policies and procedures to ensure safety , accuracy, accountability, security, patient confidentiality, and maintenance of the quality, potency, and purity of stored drugs. Policies and procedures shall define access to the automated drug delivery system and limits to access to equipment and drugs. (2) All policies and procedures shall be maintained at the pharmacy operating the automated drug delivery system and the location where the automated drug delivery system is being used. (e) When used as an emergency pharmaceutical supplies container, drugs removed from the automated drug delivery system shall be limited to the following: (1) A new drug order given by a prescriber for a patient of the facility for administration p rior to the next scheduled delivery from the pharmacy, or 72 hours, whichever is less. The drugs shall be retrieved only upon authorization by a pharmacist and after the pharmacist has reviewed the prescriber's order contraindications and adverse drug and the patient's profile for potential reactions. (2) Drugs that a prescriber has ordered for a patient on an as - needed basis, if the utilization and retrieval of those drugs are subject to ongoing review by a pharmacist. are policy committee or pharmaceutical (3) Drugs designed by the patient c service committee of the facility as emergency drugs or acute onset drugs. These drugs may be retrieved from an automated drug delivery system pursuant to the order of a prescriber for emergency or immediate administr ation to a 356

357 patient of the facility. Within 48 hours after retrieval under this paragraph, the case shall be reviewed by a pharmacist. (f) When used to provide pharmacy services pursuant to Section 4119.1 of the Code , the automated drug delivery system shall be Business and Professions subject to all of the following requirements: (1) Drugs removed from the automated drug delivery system for administration to a patient shall be in properly labeled units of administration containers or packages. macist shall review and approve all orders prior to a drug being (2) A phar removed from the automated drug delivery system for administration to a patient. The pharmacist shall review the prescriber's order and the patient's profile for potential contraindications a nd adverse drug reactions. (3) The pharmacy providing services to the facility pursuant to Section 4119.1 of the Business and Professions Code shall control access to the drugs stored in the automated drug delivery system. (4) Access to the automated dru g delivery system shall be controlled and tracked using an identification or password system or biosensor. (5) The automated drug delivery system shall make a complete and accurate m and all record of all transactions that will include all users accessing the syste drugs added to, or removed from, the system. (6) After the pharmacist reviews the prescriber's order, access by licensed personnel to the automated drug delivery system shall be limited only to drugs ordered by the prescriber and reviewed by the pharmacist and that are specific to the patient. When the prescriber' s order requires a dosage variation of the same drug, licensed personnel shall have access to the drug ordered for that scheduled time of administration. (7) (A) Systems that allow lic ensed personnel to have access to multiple drugs and are not patient specific in their design, shall be allowed under this subdivision if those systems have electronic and mechanical safeguards in place specific to that patient. Each to ensure that the drugs delivered to the patient are facility using such an automated drug system shall notify the department in writing prior to the utilization of the system. The notification submitted to the mited to, department pursuant to this paragraph shall include, but is not li information regarding system design, personnel with system access, and policies and procedures covering staff training, storage, and security, and the facility's administration of these types of systems. hese facilities, the department shall (B) As part of its routine oversight of t review a facility's medication training, storage, and security, and its administration procedures related to its use of an automated drug delivery system to ensure that adequate staff training and safeguards are in pla ce to make sure that the drugs delivered are appropriate for the patient. If the department determines that a facility is not in compliance with this section, the department may revoke its authorization to use automated drug delivery systems granted under subparagraph (A). (C) This paragraph shall remain in effect only until January 1, 2012, unless a later enacted statute is enacted on or before January 1, 2012, deletes or extends that date. 357

358 (g) The stocking of an automated drug delivery system shall be performed by a pharmacist. If the automated drug delivery system utilizes removable pockets, cards, drawers, or similar technology, the stocking system may be done outside of the facility and be delivered to the facility if all of the following conditions are met: (1) The task of placing drugs into the removable pockets, cards, or drawers is performed by a pharmacist or by an intern pharmacist or a pharmacy technician working under the direct supervision of a pharmacist. (2) The removable pockets, cards, or drawers are transported between the pharmacy and the facility in a secure tamper - evident container. (3) The facility, in conjunction with the pharmacy, has developed policies and procedures to ensure that the pockets, cards, or drawers are properly pla ced into the automated drug delivery system. (h) Review of the drugs contained within, and the operation and maintenance of, the automated drug delivery system shall be done in accordance with law and shall be the responsibility of the pharmacy. The revi ew shall be conducted on a monthly basis by a pharmacist and shall include a physical inspection of the drugs in the automated drug delivery system, an inspection of the automated drug delivery system machine for cleanliness, and a review of all transactio n records in order to verify the security and accountability of the system. (i) Drugs dispensed from an automated drug delivery system that meets the requirements of this section shall not be subject to the labeling requirements of or Section 111480 of this Code siness and Professions Section 4076 of the Bu if the drugs to be placed into the automated drug delivery system are in code unit dose packaging or unit of use and if the information required by Section and 4076 of the Business and Professions Code Section 111480 of this code is readily available at the time of drug administration. For purposes of this section, unit dose packaging includes blister pack cards. (j) This section shall become inoperative on July 1, 2019, and, as of January 1, pealed. 2020, is re DIVISION 10. UNIFORM CONTROLLED SUBSTANCE ACT CHAPTER 1. GENERAL PROVISIONS AND DEFINITIONS 11000. Designation This division shall be known as the "California Uniform Controlled Substances Act." 11001. Definitions Govern Construction Unless the context otherwise requires, the definitions in this chapter govern the construction of this division. 358

359 11002. Administer Defined "Administer" means the direct application of a controlled substance, whether by injection, inhalation, ingestion , or any other means, to the body of a patient for his immediate needs or to the body of a research subject by any of the following: (a) A practitioner or, in his presence, by his authorized agent. (b) The patient or research subject at the direction a nd in the presence of the practitioner. 11003. Agent Defined "Agent" means an authorized person who acts on behalf of or at the direction of a manufacturer, distributor, or dispenser. It does not include a common or contract carrier, public warehousema n, or employee of the carrier or warehouseman. 11004. Attorney General Defined "Attorney General" means the Attorney General of the State of California. 11005. Board of Pharmacy Defined "Board of Pharmacy" means the California State Board of Pharma cy. 11006.5. Concentrated Cannabis Defined "Concentrated cannabis" means the separated resin, whether crude or purified, obtained from marijuana. 11007. Controlled Substance Defined "Controlled substance," unless otherwise specified, means a drug, substance, or immediate precursor which is listed in any schedule in Section 11054, 11055, 11056, 11057, or 11058. 11008. Customs Broker Defined "Customs broker" means a person in this state who is authorized to act as a : broker for any of the following (a) A person in this state who is licensed to sell, distribute, or otherwise possess any controlled substance. (b) A person in any other state who ships any controlled substance into this state. (c) A person in this state or any other state who shi ps or transfers any controlled substance through this state. 11009. Deliver or Delivery Defined "Deliver" or "delivery" means the actual, constructive, or attempted transfer an from one person to another of a controlled substance, whether or not there is agency relationship. 359

360 11010. Dispense Defined "Dispense" means to deliver a controlled substance to an ultimate user or research subject by or pursuant to the lawful order of a practitioner, including the prescribing, furnishing, packaging, labelin g, or compounding necessary to prepare the substance for that delivery. 11011. Dispenser Defined "Dispenser" means a practitioner who dispenses. 11012. Distribute Defined "Distribute" means to deliver other than by administering or dispensing a con trolled substance. 11013. Distributor Defined "Distributor" means a person who distributes. The term distributor also includes warehousemen handling or storing controlled substances and customs brokers. 11014. Drug Defined "Drug" means (a) substanc es recognized as drugs in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; (b) substances intended for use in the diagnosis, cure, mitigatio n, treatment, or prevention of disease in man or animals; (c) substances (other than food) intended to affect the structure or any function of the body of man or animals; and (d) substances ision (a), (b), intended for use as a component of any article specified in subdiv or (c) of this section. It does not include devices or their components, parts, or accessories. 11014.5. Drug Paraphernalia Defined (a) "Drug paraphernalia" means all equipment, products and materials of any kind which are designed for u se or marketed for use, in planting, propagating, cultivating, growing, harvesting, manufacturing, compounding, converting, producing, processing, preparing, testing, analyzing, packaging, repackaging, storing, containing, concealing, injecting, ingesting, inhaling, or otherwise introducing into the human body a controlled substance in violation of this division. It includes, but is not limited to: (1) Kits designed for use or marketed for use in planting, propagating, cultivating, growing, or harvesting o f any species of plant which is a controlled substance or from which a controlled substance can be derived. (2) Kits designed for use or marketed for use in manufacturing, compounding, converting, producing, processing, or preparing controlled substances. (3) Isomerization devices designed for use or marketed for use in increasing the potency of any species of plant which is a controlled substance. (4) Testing equipment designed for use or marketed for use in identifying, or fectiveness, or purity of controlled substances. in analyzing the strength, ef 360

361 (5) Scales and balances designed for use or marketed for use in weighing or measuring controlled substances. (6) Containers and other objects designed for use or marketed for use in storing or concealing c ontrolled substances. (7) Hypodermic syringes, needles, and other objects designed for use or marketed for use in parenterally injecting controlled substances into the human body. (8) Objects designed for use or marketed for use in ingesting, inhaling, o r otherwise introducing marijuana, cocaine, hashish, or hashish oil into the human body, such as: (A) Carburetion tubes and devices. (B) Smoking and carburetion masks. (C) Roach clips, meaning objects used to hold burning material, such as a marijuana c igarette, that has become too small or too short to be held in the hand. (D) Miniature cocaine spoons, and cocaine vials. (E) Chamber pipes. (F) Carburetor pipes. (G) Electric pipes. (H) Air - driven pipes. (I) Chillums. (J) Bongs. (K) Ice pipes or c hillers. (b) For the purposes of this section, the phrase "marketed for use" means advertising, distributing, offering for sale, displaying for sale, or selling in a manner which promotes the use of equipment, products, or materials with controlled subst ances. (c) In determining whether an object is drug paraphernalia, a court or other authority may consider, in addition to all other logically relevant factors, the following: (1) Statements by an owner or by anyone in control of the object concerning ts use. i (2) Instructions, oral or written, provided with the object concerning its use for ingesting, inhaling, or otherwise introducing a controlled substance into the human body. (3) Descriptive materials accompanying the object which explain or depict its use. (4) National and local advertising concerning its use. (5) The manner in which the object is displayed for sale. (6) Whether the owner, or anyone in control of the object, is a legitimate supplier of like or related items to the community, suc h as a licensed distributor or dealer of tobacco products. (7) Expert testimony concerning its use. (d) If any provision of this section or the application thereof to any person or he invalidity circumstance is held invalid, it is the intent of the Legislature that t shall not affect other provisions or applications of the section which can be 361

362 given effect without the invalid provision or application and to this end the provisions of this section are severable. 11015. Federal Bureau Defined ureau" means the Drug Enforcement Administration of the United "Federal b States Department of Justice, or its successor agency. 11016. Furnish Defined "Furnish" has the same meaning as provided in Section 4048.5 of the Business and Professions Code. 11017. Man ufacturer Defined "Manufacturer" has the same meaning as provided in Section 4034 of the Business and Professions Code. 11018. Marijuana Defined "Marijuana" means all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; t he resin extracted from any part of the plant; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds or resin. It does not include the mature stalks of the plant, fiber produced from the stalks, oil or cake made from the seeds of the plant, any other compound, manufacture, salt, derivative, mixture, or preparation of the mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of the plant which is incapable of germination . (Added by Stats. 1972, Ch. Superseded on operative date of amendment by Stats. 1407. Ch. 398.) 2013, 11018. Marijuana Defined “Marijuana” means all parts of the plant Cannabis sativa L., whether growing or not; the seeds of that plant; the resin extr acted from any part of the plant; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds or resin. It does not include industrial hemp, as defined in Section 11018.5, except where the plant is cultivated or proce ssed for purposes not expressly allowed for by Division 24 (commencing with Section 81000) of the Food and Agricultural Code. 2014. (Amended by Stats. 2013, Ch. 398, Sec. 5. Effective January 1, Conditionally Ch. as prescribed by Sec. 8 of operative 398.) 11018.5. Industrial Hemp Defined “Industrial hemp” means a crop that is limited to nonpsychoactive types of the plant Cannabis sativa L. and the seed produced therefrom, having no more than three - tenths of 1 percent tetrahydrocannabinol (THC) contained in the dried flowering tops, and that is cultivated and processed exclusively for the purpose of producing the mature stalks of the plant, fiber produced from the stalks, oil or cake made from the seeds of the plant, or any other compound, manufacture, t, derivative, mixture, or preparation of the mature stalks, except the resin or sal flowering tops extracted therefrom, fiber, oil, or cake, or the sterilized seed, or any component of the seed, of the plant that is incapable of germination. 362

363 Sec. by Stats. 2013, Ch. 398, (Added 6. Effective January 1, 2014. Conditionally prescribed operative as 398.) by Sec. 8 of Ch. 11019. Narcotic Drug Defined "Narcotic drug" means any of the following, whether produced directly or indirectly by extraction from substanc es of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis: (a) Opium and opiate, and any salt, compound, derivative, or preparation of opium or opiate. (b) Any salt, compound, isom er, or derivative, whether natural or synthetic, of the substances referred to in subdivision (a), but not including the isoquinoline alkaloids of opium. (c) Opium poppy and poppy straw. (d) Coca leaves and any salt, compound, derivative, or preparatio n of coca leaves, but not including decocainized coca leaves or extractions of coca leaves which do not contain cocaine or ecgonine. (e) Cocaine, whether natural or synthetic, or any salt, isomer, derivative, or preparation thereof. (f) Ecgonine, wheth er natural or synthetic, or any salt, isomer, derivative, or preparation thereof. (g) Acetylfentanyl, the thiophene analog thereof, derivatives of either, and any salt, compound, isomer, or preparation of acetylfentanyl or the thiophene analog thereof. 11020. Opiate Defined "Opiate" means any substance having an addiction - forming or addiction - sustaining liability similar to morphine or being capable of conversion into a - sustaining liability. It does not - drug having addiction forming or addiction de, unless specifically designated as controlled under Chapter 2 inclu (commencing with Section 11053) of this division, the dextrorotatory isomer of methoxy 3 - - n - methylmorphinan and its salts (dextromethorphan). It does include its racemic and levorotatory forms . 11021. Opium Poppy Defined "Opium poppy" means the plant of the species Papaver somniferum L., except its seeds. 11022. Person Defined "Person" means individual, corporation, government or governmental subdivision or agency, business trust, estat e, trust, partnership, limited liability company, or association, or any other legal entity. 363

364 11023. Pharmacy Defined "Pharmacy" has the same meaning as provided in Section 4035 of the Business and Professions Code. atrist, Pharmacist , and Veterinarian 11024. Physician, Dentist, Podi Defined "Physician," "dentist," "podiatrist," "pharmacist," "veterinarian," and "optometrist" means persons who are licensed to practice their respective professions in this state. 11025. Poppy Straw Defined "Popp y straw" means all parts, except the seeds, of the opium poppy, after mowing. 11026. Practitioner Defined "Practitioner" means any of the following: (a) A physician, dentist, veterinarian, podiatrist, or pharmacist acting within the scope of a projec t authorized under Article 1 (commencing with Section 128125) of Chapter 3 of Part 3 of Division 107, a registered nurse acting within the scope of a project authorized under Article 1 (commencing with Section , a certified nurse 128125) of Chapter 3 of Part 3 of Division 107 midwife - acting within the scope of Section 2746.51 of the Business and Professions Code, a nurse practitioner acting within the scope of Section 2836.1 of the Business and Professions Code, or a physician assistant acting within the sco pe of a project authorized under Article 1 (commencing with Section 128125) of Chapter 3 of Part 3 of Division 107 or Section 3502.1 of the Business and Professions Code, or an optometrist acting within the scope of Section 3041 of the Business and Profess ions Code. (b) A pharmacy, hospital, or other institution licensed, registered, or otherwise permitted to distribute, dispense, conduct research with respect to, or to administer, a controlled substance in the course of professional practice or research in this state. (c) A scientific investigator, or other person licensed, registered, or otherwise permitted, to distribute, dispense, conduct research with respect to, or administer, a controlled substance in the course of professional practice or researc h in this state. 11027. Prescription Defined (a) "Prescription" means an oral order or electronic transmission prescription for a controlled substance given individually for the person(s) for whom prescribed, directly from the prescriber to the furnish er or indirectly by means of a written order of the prescriber. (b) "Electronic transmission prescription" includes both image and data prescriptions. "Electronic image transmission prescription" is any prescription order for which a facsimile of the ord er is received by a pharmacy from a licensed prescriber. "Electronic data transmission prescription" is any 364

365 prescription order, other than an electronic image transmission prescription, which is electronically transmitted from a licensed prescriber to a ph armacy. 11029. Production Defined "Production" includes the manufacture, planting, cultivation, growing, or harvesting of a controlled substance. 11029.5. Security Printer Defined stance "Security printer" means a person approved to produce controlled sub prescription forms pursuant to Section 11161.5. 11030. Ultimate User Defined "Ultimate user" means a person who lawfully possesses a controlled substance for his own use or for the use of a member of his household or for administering to an anim al owned by him or by a member of his household. 11031. Wholesaler Defined "Wholesaler" has the same meaning as provided in Section 4038 of the Business and Professions Code. 11032. References to Narcotics, Restricted Dangerous Drugs, Marijuana as Sc hedule I, II, III and IV Controlled Substances Whenever reference is made to the term "narcotics" in any provision of law outside of this division, unless otherwise expressly provided, it shall be construed to mean controlled substances classified in Sch edules I and II, as defined in this division. Whenever reference is made to "restricted dangerous drugs" outside of this division, unless otherwise expressly provided, it shall be construed to mean controlled substances classified in Schedules III and IV. Whenever reference is made to the term "marijuana" in any provision of law outside of this division, unless otherwise expressly provided, it shall be construed to mean marijuana as defined in this division. 11033. Isomer Defined As used in this divisio n, except as otherwise defined, the term "isomer" includes optical and geometrical (diastereomeric) isomers. CHAPTER 2. STANDARDS AND SCHEDULES 11053. Substances Included by Whatever Name Used The controlled substances listed or to be listed in the schedules in this chapter are included by whatever official, common, usual, chemical, or trade name designated. 11054. Schedule I Controlled Substances (a) The controlled substances listed in this section are included in Schedule I. 365

366 (b) Opiates. Unles s specifically excepted or unless listed in another schedule, any of the following opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of those isomers, esters, ethers, and salts is possi ble within the specific chemical designation: (1) Acetylmethadol. (2) Allylprodine. (3) Alphacetylmethadol (except levoalphacetylmethadol, also known as levo - - alpha acetylmethadol, levomethadyl acetate, or LAAM). (4) Alphameprodine. (5) Alphamethadol . (6) Benzethidine. (7) Betacetylmethadol. (8) Betameprodine. (9) Betamethadol. (10) Betaprodine. (11) Clonitazene. (12) Dextromoramide. (13) Diampromide. (14) Diethylthiambutene. (15) Difenoxin. (16) Dimenoxadol. (17) Dimepheptanol. (18) Dimethylthiambutene. (19) Dioxaphetyl butyrate. (20) Dipipanone. (21) Ethylmethylthiambutene. (22) Etonitazene. (23) Etoxeridine. (24) Furethidine. (25) Hydroxypethidine. (26) Ketobemidone. (27) Levomoramide. (28) Levophenacylmorphan. (29) Morph eridine. (30) Noracymethadol. (31) Norlevorphanol. (32) Normethadone. (33) Norpipanone. (34) Phenadoxone. (35) Phenampromide. (36) Phenomorphan. (37) Phenoperidine. (38) Piritramide. (39) Proheptazine. (40) Properidine. (41) Propiram. emoramide. (42) Rac 366

367 (43) Tilidine. (44) Trimeperidine. (45) Any substance which contains any quantity of acetylfentanyl (N - - (1 - - piperidinyl) acetanilide) or a derivative thereof. phenethyl 4 (46) Any substance which contains any quantity of the thiophene analog o f - - - (2 - (2 - thienyl)ethyl) acetylfentanyl (N 4 - piperidinyl) acetanilide) or a (1 deri