BUSINESS AND PROFESSIONS CODE
2010 LAWBOOK FOR
PHARMACY
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 California 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
BUSINESS & PROFESSIONS CODE
CHAPTER 9, DIVISION 2
Article 1. Administration
Section
4000. Chapter
Title
4001. Board of Pharmacy; Appointment; Terms
4001.1. Purpose of the Board
4001.5. Pharmacist Shortage; Recommendations to Alleviate
4002. Officers
4003. Executive Officer; Records; Revenue
4004. Teaching by Board Members
4005. Adoption of Rules and Regulations
4006. Regulations Restricting Furnishing of Particular Drug
4007. Limitations of Rules
4008. Inspectors; Authority as Public Officers
4009 Board Rules; Exemption From Coverage Under Industrial Welfare Commission Rules
4010. Immunity
of
Officers
4011. Administration and Enforcement of Uniform Controlled Substances Act
4012 Board to Provide Copy of Laws or Regulations
4013
Board-Licensed Facilities to Join E-Mail Notification List
Article 2. Definitions
4015. Definitions
to
Govern Construction
4016. Administer
4017. Authorized Officers of the Law
4018. Board
4019. Chart
Order
4021. Controlled
Substance
4022. Dangerous Drug - Dangerous Device Defined
4022.5. Designated Representative; Designated Representative-in-Charge
4023. Device
4023.5. Direct Supervision and Control
4024. Dispense
4025. Drug
4025.1. Non-Prescription Drug
4026. Furnish
4026.5 Good Standing
4027. Skilled Nursing Facility - Intermediate Care Facility - Other Health Care Facilities
4028. Licensed
Hospital
4029. Hospital
Pharmacy
4030. Intern
Pharmacist
4031. Laboratory
4032. License
4033. Manufacturer
Section
4034. Pedigree
4034.1. Enactment of Federal Pedigree Legislation
4035. Person
4036. Pharmacist
4036.5 Pharmacist-in-Charge
4037. Pharmacy
4038. Pharmacy
Technician
4039. Physician;
Other
Practitioners Defined
4040. Prescription; Content Requirements
4040.5. Reverse Distributor
4041. Veterinary Food-Animal Drug Retailer
4042. Veterinary Food-Animal Drugs
4043. Wholesaler
4044. Repackager
4045. Third-Party Logistics Provider or Reverse Third-Party Logistics Provider
Article 3. Scope of Practice and Exemptions
4050. Legislative
Declaration
4051. Conduct Limited to Pharmacist; Conduct Authorized by Pharmacist
4052. Furnishing to Prescriber; Permitted Pharmacist Procedures by Pharmacist
4052.1. Permitted Pharmacist Procedures in Licensed Health Care Facility
4052.2. Permitted Pharmacist Procedures in Health Care Facility, Home Health Agency or Clinic
with Physician Oversight
4052.3. Emergency Contraception Drug Therapy; Requirements and Limitations
4052.4. Skin Puncture by Pharmacist
4052.5. Pharmacist May Select Different Form of Medication with Same Active Chemical
Ingredient; Exceptions
4052.7. Repackage Previously Dispensed Drug; Requirements
4053. Designated Representative to Supervise Wholesaler or Veterinary Food-Animal Drug
Retailer
4054. Supply by Manufacturer, etc. of Certain Dialysis Drugs and Devices
4055. Sale of Devices to Licensed Clinics, etc.
4056. Purchase of Drugs at Wholesale - Hospital Containing 100 Beds or Less
4057. Exceptions to Application of this Chapter
4058. Display of Original License
4059. Furnishing Dangerous Drugs or Devices Prohibited Without Prescription: Exceptions
4059.5. Who May Order Dangerous Drugs or Devices: Exceptions; Compliance with Laws of
All Involved Jurisdictions
4060. Controlled Substance - Prescription Required; Exceptions
4061. Distribution of Drug as Sample; Written Request Required
4062. Furnishing Dangerous Drugs During Emergency
4063. Refill of Prescription for Dangerous Drug or Device Requires Prescriber Authorization
4064. Emergency Refill of Prescription without Prescriber Authorization
4065. Injection Card System; Requirements for Administration
4066. Furnishing Dangerous Drugs to Master or First Officer of Vessel
4067. Internet; Dispensing Dangerous Drugs or Devices without Prescription
Section
4068. Dispense Dangerous Drugs or Controlled Substances to Emergency Room Patient;
Requirements
Article 4. Requirements for Prescriptions
4070. Reduction of Oral or Electronic Prescription to Writing
4071. Prescriber May Authorize Agent to Transmit Prescription; Schedule II Excluded
4071.1. Electronic Prescription Entry Into Pharmacy or Hospital Computer
4072. Oral or Electronic Transmission of Prescription - Health Care Facility
4073. Substitution of Generic Drug - Requirements and Exceptions
4074. Drug Risk: Informing Patient; Providing Consultation for Discharge Medications
4075. Proof of Identity Required - Oral or Electronic Prescription
4076. Prescription Container - Requirements for Labeling
4076.5 Standardized, Patient-Centered Prescription Labels; Requirements
4077. Dispensing Dangerous Drug in Incorrectly Labeled Container
4078. False or Misleading Label on Prescription
Article 5. Authority of Inspectors
4080. Stock of Dangerous Drugs and Devices Kept Open for Inspection
4081. Records of Dangerous Drugs and Devices Kept Open for Inspection; Maintenance of
Records, Current Inventory
4082. Names of Owners, Managers and Employees Open for Inspection
4083. Orders of Correction
4084. Adulterated, Misbranded or Counterfeit Dangerous Drug or Device
4085. Unlawful to Remove, Sell, Dispose of Embargoed Dangerous Drug or Dangerous Device
4086. Adulterated, Misbranded, or Counterfeit Dangerous Drug or Dangerous Device; Court
Proceedings
Article 6. General Requirements
4100. Change of Address or Name - Notification to Board
4101. Pharmacist-in-Charge, Designated Representative-in-Charge: Termination of
Employment; Notification to Board
4103. Blood Pressure - Taking by Pharmacist
4104. Licensed Employee, Theft or Impairment: Pharmacy Procedures
4105. Retaining Records of Dangerous Drugs and Devices on Licensed Premises; Temporary
Removal; Waivers; Access to Electronically Maintained Records
4106. License Verification Using Board Web Site
4107. One Site License per Premises; Exception
Article 7. Pharmacies
4110. Licensed Required; Temporary Permit Upon Transfer of Ownership; Temporary Use of
Mobile Pharmacy
Section
4111. Restrictions on Prescriber Ownership
4112. Nonresident Pharmacy: Registration; Provision of Information to Board; Maintaining
Records; Patient Consultation
4113. Pharmacist in Charge: Notification to Board; Responsibilities
4114. Intern Pharmacist: Activities Permitted
4115. Pharmacy Technician: Activities Permitted; Required Supervision; Activities Limited to
Pharmacist; Registration; Requirements for Registration; Ratios
4115.5 Pharmacy Technician Trainee; Placement; Supervision; Requirements
4116. Security of Dangerous Drugs and Devices in Pharmacy: Pharmacist Responsibility for
Individuals on Premises; Regulations
4117. Admission to Area Where Narcotics are Stored, etc. - Who May Enter
4118. Waiving of Minimum Requirements by Board
4119. Furnish Prescription Drug to Licensed Health Care Facility – Secured Emergency
Supplies
4119.1 Pharmacy May Provide Services to Health Facility
4119.2. Furnish Epinephrine Auto-Injectors to School; Requirements
4119.5. Transfer or Repackaging Dangerous Drugs by Pharmacy
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 Drug 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 Board; 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; Return of Drugs not Dispensed; Wholesale License Not
Permitted or Required
4126.5 Furnishing Dangerous Drug by Pharmacy
Article 7.5. Injectable Sterile Drug Products
4127. Board Shall Adopt Regulations Establishing Standards
4127.1. License to Compound Injectable Sterile Drug Products Required
4127.2. Nonresident Pharmacy – License to Compound and Ship Injectable Drug Products into
California Required
4127.3. Cease and Desist Order; Hearing
4127.4. Fine for Violation
4127.5. Fee
4127.6. Article Operative upon Allocation of Positions
4127.7. Compounding Sterile Injectable from Nonsterile Ingredients; Requirements
4127.8. Temporary License to Compound Injectable Sterile Drug Products for Change of
Ownership
Article 9. Hypodermic Needles and Syringes
Section
4140. Unlawful Possession
4141. Furnishing without License
4142. Prescription Required
4143. Exemption: Sale to Other Entity, Physician, etc.
4144. Industrial Use Exception
4145. Exception: Furnishing for Administration of Insulin, Adrenaline, or Specified Animal
Uses; Conditions
4146 Needle/Syringe Return in Sharps Container
4147. Disposal of Needle or Syringe
4148. Confiscation if Found Outside Licensed Premises
4149. Sale by Nonresident Distributor; License Required
Article 10. Pharmacy Corporations
4150. Definitions
4151. Licensure Requirements
4152. Corporate Name Requirements
4153. Shareholder Income While Disqualified
4154. Regulations Authorized
4155. Corporate Form Not Required
4156. Unprofessional Conduct by Corporation
Article 11. Wholesalers and Manufacturers
4160. Wholesaler: License Required
4161. Nonresident Wholesaler Requirements
4162. Wholesaler License Surety Bond Requirements
4162.5 Issuance or Renewal of Nonresident Wholesaler License; Surety Bond
4163. Unauthorized Furnishing by Manufacturer or Wholesaler
4163.1 Legislative Intent on Pedigree Requirements
4163.1. Drop Shipment by Manufacturer
4163.2. Pedigree; Grandfathering
4163.3. Pedigree Inference Standards
4163.4. Holding Legal Title on Pedigree Required Effective Date
4163.5 Pedigree Requirement Implementation Date
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
4166. Shipping of Dangerous Drugs or Devices - Wholesaler or Distributor Liable for Security
and Integrity Until Delivery
4167. Wholesaler: Bar on Obtaining Dangerous Drugs or Devices It Cannot Maintain on
Licensed Premises
4168. Board License Required for Local Business License
4169. Prohibited
Acts
Article 12. Prescriber Dispensing
Section
4170. Dispensing by Prescriber: Requirements and Restrictions; Enforcement
4170.5 Veterinarian in Teaching Hospital May Dispense and Administer Dangerous Drugs and
Devices; Requirements
4171. Exceptions to Section 4170: Samples; Clinics; Veterinarians; Narcotic Treatment
Programs; Certain Cancer Medications
4172. Storage Requirements
4173. Dispensing by Registered Nurses
4174. Dispensing by Pharmacist upon Order of Nurse Practitioner
4175. Processing of Complaints
Article 13. Nonprofit or Free Clinics
4180. Purchase of Drugs at Wholesale Only with License: Eligible Clinics
4181. License Requirements; Policies and Procedures; Who May Dispense
4182. Duties of Professional 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
Article 14. Surgical Clinics
4190. Purchase of Drugs at Wholesale: Permitted Uses of Drugs; Required Records and
Policies; License Required
4191. Compliance with Department of Health Services Requirements; Who May Dispense
Drugs
4192. Duties of Professional Director; Providing Information to Board
4193. Clinic Not Eligible for Professional Dispensing Fee; Ban on Offering Drugs for Sale
4194. Dispensing of Schedule II Substance by Clinic Prohibited; Physician May Dispense;
Administration Authorized in Clinic
4195. Inspection Authorized
Article 15. Veterinary Food-Animal Drug Retailers
4196. License Required: Temporary License on Transfer of Ownership; Board Approval of
Designated Representative-in-Charge
4197. Minimum Standards: Security; Sanitation; Board Regulations; Waivers
4198. Written Policies and Procedures Required: Contents; Training of Personnel; Quality
Assurance; Consulting Pharmacist
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 Examination: Additional Education Requirement
4200.2. California Practice Standards and Jurisprudence Examination for Pharmacist; Required
Inclusions
4200.3. Examination Process to be Reviewed Regularly; Required Standards
4200.4. Retaking National Examination after Failure; Waiting Period
4200.5. Retired Licensee: Eligibility; Bar on Practice; Requirement for Restoration to Active
Status
4201. Application Form: Required Information; Authority Granted by License; Reporting
Changes in Beneficial Ownership
4202. Pharmacy Technician: License Requirements for Education, Experience; Board
Regulations; Criminal Background Check; Discipline
4203. Non-Profit Clinic License Application: Form; Investigation
4204. Surgical Clinic Application: Form; Investigation
4205. Sale or Dispensing of Hypodermic Syringes and Needles: When Separate License
Required; Form and Content of Application; Renewability; Discipline
4207. Investigation by Board
4208. Intern Pharmacist License
4209. Intern Pharmacist; Minimum Hours of Practice to Apply for Pharmacist Exam
Article 17. Continuing Education
4231. Requirements for Renewal of Pharmacist License: Clock Hours; Exemption for New
Licensee
4232. Content of Courses
4234. Exceptions: Emergencies; Hardship
Article 18. Poisons
4240. California Hazardous Substances Act; Application of Act
Article 19. Disciplinary Proceedings
4300. Revocation and Suspension: Authority; Conditions; Issuance of Probationary License;
Application of Administrative Procedure Act; Judicial Review
4301. Obtaining License by Fraud or Misrepresentation; Unprofessional Conduct
4301.5 Pharmacist License; Out-of-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
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
Section
4305.5. Disciplinary Grounds: Failure of Wholesaler or Veterinary Food-Animal Drug Retailer to
Notify Board of Termination of Designated Representative-in-Charge; Continuing to
Operate Without a Designated Representative-in-Charge
4306. Violation of Professional Corporation Act as Unprofessional Conduct
4306.5. Acts or Omissions by Pharmacist: Unprofessional Conduct
4306.6 Mitigating Factors for Pharmacist-in-Charge Reporting Violations 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
4309. Petition for Reinstatement, etc. of Disciplined License: Time for 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: Petition 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: Notice; 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
Article 20. Prohibitions and Offenses
4320. Penalties for Violation of Pharmacy Law: Actions Authorized; Who May File Actions
4321. Penalties: Misdemeanors; Infractions
4322. Misdemeanor or Infraction: False Representations to Secure License for Self or Others;
False Representation of Licensure; Penalties
4323. Misdemeanor: False Representation of Self as Physician, Agent of Physician, etc. to
Obtain Drug
4324. Felony or Misdemeanor: Forgery of Prescription; Possession of Drugs Obtained Through
Forged Prescription
4325. Misdemeanor: Manufacture, Possession, etc. of False Prescription Blank
4326. Misdemeanor: Obtaining Needle or Syringe by Fraud, etc.; Unlawful Use of Needle or
Syringe Obtained from Another
4327. Misdemeanor: Sale, Dispensing, or Compounding While under the Influence of Drugs or
Alcoholic Beverages
4328. Misdemeanor: Permitting Compounding, Dispensing, or Furnishing by Non-Pharmacist
4329. Misdemeanor: Non-Pharmacist Acting as Manager; Compounding, Dispensing or
Furnishing Drugs
4330. Misdemeanor: Non-Pharmacist Owner Failing to Place Pharmacist in Charge; Dispensing
or Compounding Except by Pharmacist; Interfering with Pharmacist in Charge
4331. Misdemeanor: Medical Device Retailer, 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
4332. Misdemeanor: Failure or Refusal to Maintain or Produce Required Drug or Device
Records; Willful Production of False Records
Section
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
as Misdemeanor
4335. Knowingly Failing to Arrange for 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
4337. Distribution of Fines Collected
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
4341. Advertisement of Prescription Drugs or Devices
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 Certain Signs Unless Licensed Pharmacy Within
Article 21. Pharmacists Recovery Program
4360. Impaired Pharmacists: Legislative Intent
4361. Definitions
4362. Function of Program: Board Referrals; Voluntary, Confidential Participation
4364. Criteria for Participation to Be Established by Board
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
Non-compliance; Report to Board of Termination When Public Safety Threatened;
Authority to Discipline
4371. Review of Activities of Program
4372. Confidential Records; Exception for Disciplinary Proceeding
4373. Immunity from Civil Liability
Article 22. Unfair Trade Practices
4380. Resale of Preferentially Priced Drugs: Prohibition; Exceptions
4381. Violation of Article as Unfair Competition; Private Actions Authorized; Triple Damages
and Attorneys’ Fees; Proof Required
4382. Board May Audit Sales to Walk-in Customers
Article 23. Revenue and Renewal
4400. Fees
4401. Pharmacist: Biennial Renewal
4402. Cancellation: of Pharmacist After Non-renewal for Three Years; All Other Licenses After
60 Days
Section
4403. Reissuance without Payment of 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
4409. Pharmacist Scholarship Program, Donations
Article 24. Prescription Rates for Medicare Beneficiaries
4425. Pharmacy Participation in Medi-Cal Program; Conditions; Department of Health Services
Utilization Review and Monitoring
4426. Department of Health Services to Study Reimbursement Rates
Other Important Sections of the Business & Professions Code
125.3. Recovery of Investigation and Enforcement Costs: Procedures; Proof; Enforcement
125.9. Citation and Fine
148.
Unlicensed Activity
460
Licensed Department of Consumer Affair Businesses
480
Denial of Licenses
650.
Rebates or discounts for Referral Prohibited
650.1. Lease Prohibition - Hospitals or Prescribers
651.
Professional Advertising Requirements
652.
Violation as Unprofessional Conduct
652.5. Violation as Misdemeanor
733.
Dispensing Prescription Drugs and Devices
17500. False or Misleading Statements, Generally
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; Appointment; 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 competent 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, and a
long-term health care or skilled nursing facility. The pharmacist 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 California
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 shall 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 member 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 provided in Section 103.
(f) In accordance with Sections 101.1 and 473.1, this section shall remain in effect only until
January 1, 2013, and as of that date is repealed, unless a later enacted statute, that is enacted
before January 1, 2013, deletes or extends that date. The repeal of this section renders the board
subject to the review required by Division 1.2 (commencing with Section 473).
4001.1. Protection of the Public is Board’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.
4001.5. Pharmacist Shortage ; Recommendations to Alleviate
The Joint Committee on Boards, Commissions, and Consumer Protection shall review the state's
shortage of pharmacists and make recommendations on a course of action to alleviate the
shortage, including, but not limited to, a review of the current California pharmacist licensure
examination.
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 the 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
(a) The board may appoint a person exempt 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 also be entitled to travel and other
expenses necessary in the performance of his 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 of Consumer Affairs, 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) In accordance with Sections 101.1 and 473.1, this section shall remain in effect only until
January 1, 2013, and as of that date is repealed, unless a later enacted statute, that is enacted
before January 1, 2013, deletes or extends that date.
4004. Teaching by Board Members
No member of the board shall teach pharmacy 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.
4005. Adoption of Rules and Regulations
(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 therein shall be the right to adopt rules
and regulations as follows: for the proper and more effective enforcement and administration of
this chapter; pertaining to the practice of pharmacy; relating to the sanitation of persons and
establishments licensed under this chapter; pertaining to establishments 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 mechanical 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 emergency 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 California 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
regulations 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 dangerous 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 Section 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 reasonably
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 inspectors of pharmacy. The
inspectors, whether the inspectors are employed by the board or the department's Division of
Investigation, 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 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 in 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 provision 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 to believe that
the person to be arrested has violated any provision that is 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 subdivision 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 5C (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 part 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 aggressor or lose his or her right to self-defense by the use of reasonable force 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 drug
delivery system operated pursuant to Section 4119 or 4119.1.
4009. Board Rules; Exemption From Coverage Under Industrial Welfare Commission
Rules
The 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 chapter in performance
of their official duties, and any person working under their immediate direction, supervision, or
instruction are immune from prosecution under this chapter.
4011. Administration and Enforcement of Uniform Controlled Substances Act
The board shall administer 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 to Join E-Mail Notification List
(a) Any facility licensed by the 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 e-mail address with the board’s e-mail
notification list within 30 days of a change in the facility’s e-mail address.
(c) This section shall become operative on July 1, 2010.
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 patient or
research subject by injection, inhalation, ingestion, or other means.
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 Department of Health Services, and
investigators of the department's Division of Investigation or peace officers engaged in official
investigations.
4018. Board
"Board" means the California State Board 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 order of a practitioner authorized
by law to prescribe drugs, shall be 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 furnished 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 the 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.
4022. Dangerous Drug – Dangerous Device Defined
"Dangerous drug" or "dangerous device" means any drug or device unsafe for self-use in
humans or animals, and includes the following:
(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.
4022.5. Designated Representative; Designated Representative-in-Charge
(a) "Designated representative" means an individual to whom a license has been granted
pursuant to Section 4053. A pharmacist fulfilling the duties of Section 4053 shall not be required
to obtain a license as a designated representative.
(b) "Designated representative-in-charge" means a designated representative or a pharmacist
proposed by a wholesaler or veterinary food-animal drug retailer and approved by the board as
the supervisor or manager responsible for ensuring the wholesaler’s or veterinary food-animal
drug retailer’s compliance with all state and federal laws and regulations pertaining to practice in
the applicable license category.
4023. Device
"Device" means any instrument, apparatus, machine, implant, in vitro reagent, or contrivance,
including its components, parts, products, or the byproducts 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
For the purposes of this chapter, "direct supervision and control" means that a 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 subdivision (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 upon an order to furnish drugs or transmit a prescription
from a certified nurse-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 devices directly to a patient
by a physician, dentist, optometrist, podiatrist, or veterinarian, or by a certified nurse-midwife,
nurse practitioner, naturopathic doctor, or physician assistant acting within the scope of his or her
practice.
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 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.
4027. Skilled Nursing Facility – Intermediate Care Facility – Other Health 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 with 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 (commencing 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 the Health and Safety Code, that is
owned or operated 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 "licensed 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 a health facility
licensed pursuant to Article 1 (commencing with Section 1250) 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 Division 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
organized 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 regulations issued by the State Department of Health Services as a general or
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 Pharmacy
(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 illnesses 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.
(b) A hospital pharmacy also includes a pharmacy that may be located outside of the hospital, in
another physical plant that is regulated under a hospital's consolidated license issued pursuant to
Section 1250.8 of the Health and Safety Code. As a condition of licensure by the board, the
pharmacy in another physical plant shall provide pharmaceutical services only to registered
hospital patients who are on the premises of the same physical plant in which the pharmacy is
located. The pharmacy services provided shall be directly related to the services or treatment
plan administered in the physical plant. Nothing in this paragraph shall be construed to restrict or
expand the services that a hospital pharmacy may provide.
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 not 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.
4033. Manufacturer
(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 consumer.
(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 drug to the patient or patients named in the
prescription, provided that neither 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" shall 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 (NDA), 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 whom 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 label
distributor, whether the establishment is a member of the manufacturer's affiliated group
(regardless of whether the member takes title to the drug) or is a contract distributor site.
4034. Pedigree
(a) "Pedigree" means a record, in electronic form, containing information regarding each
transaction resulting in a change of ownership of a given dangerous drug, from sale by a
manufacturer, through acquisition and sale by one or more wholesalers, manufacturers,
repackagers, or pharmacies, until final sale to a pharmacy or other person furnishing,
administering, or dispensing the dangerous drug. The pedigree shall be created and maintained in
an interoperable electronic system, ensuring compatibility throughout all stages of distribution.
(b) A pedigree shall include all of the following information:
(1) The source of the dangerous drug, including the name, the federal manufacturer's
registration number or a state license number as determined by the board, and principal address of
the source.
(2) The trade or generic name of the dangerous drug, the quantity of the dangerous drug, its
dosage form and strength, the date of the transaction, the sales invoice number or, if not
immediately available, a customer-specific shipping reference number linked to the sales invoice
number, the container size, the number of containers, the expiration dates, and the lot numbers.
(3) The business name, address, and the federal manufacturer's registration number or a state
license number as determined by the board, of each owner of the dangerous drug, and the
dangerous drug shipping information, including the name and address of each person certifying
delivery or receipt of the dangerous drug.
(4) A certification under penalty of perjury from a responsible party of the source of the
dangerous drug that the information contained in the pedigree is true and accurate.
(5) The unique identification number described in subdivision (i).
(c) A single pedigree shall include every change of ownership of a given dangerous drug from
its initial manufacture through to its final transaction to a pharmacy or other person for
furnishing, administering, or dispensing the drug, regardless of repackaging or assignment of
another National Drug Code (NDC) Directory number. Dangerous drugs that are repackaged shall
be serialized by the repackager and a pedigree shall be provided that references the pedigree of
the original package or packages provided by the manufacturer.
(d) A pedigree shall track each dangerous drug at the smallest package or immediate container
distributed by the manufacturer, received and distributed by the wholesaler or repackager, and
received by the pharmacy or another person furnishing, administering, or dispensing the
dangerous drug. For purposes of this section, the "smallest package or immediate container" of a
dangerous drug shall include any dangerous drug package or container made available to a
repackager, wholesaler, pharmacy, or other entity for repackaging or redistribution, as well as the
smallest unit made by the manufacturer for sale to the pharmacy or other person furnishing,
administering, or dispensing the drug.
(e) Any return of a dangerous drug to a wholesaler or manufacturer shall be documented on the
same pedigree as the transaction that resulted in the receipt of the drug by the party returning it.
(f) If a licensed health care service plan, hospital organization, and one or more physician
organizations have exclusive contractual relationships to provide health care services, drugs
distributed between these persons shall be deemed not to have changed ownership.
(g) The following transactions are exempt from the pedigree requirement created by this section:
(1) An intracompany sale or transfer of a dangerous drug. For purposes of this section,
"intracompany sale or transfer" means any transaction for any valid business purpose between a
division, subsidiary, parent, or affiliated or related company under the common ownership and
control of the same corporate or legal entity.
(2) Dangerous drugs received by the state or a local government entity from a department or
agency of the federal government or an agent of the federal government specifically authorized to
deliver dangerous drugs to the state or local government entity.
(3) The provision of samples of dangerous drugs by a manufacturer's employee to an
authorized prescriber, provided the samples are dispensed to a patient of the prescriber without
charge.
(4) (A) A sale, trade, or transfer of a radioactive drug, as defined in Section 1708.3 of Title 16
of the California Code of Regulations, between any two entities licensed by the Radiologic
Health Branch of the State Department of Public Health, the federal Nuclear Regulatory
Commission, or an Agreement state.
(B) The exemption in this paragraph shall remain in effect unless the board, no earlier than
the date that is two years after the compliance date for manufacturers set forth in subdivision (k)
of Section 4034 or Section 4163.5, determines after consultation with the Radiologic Health
Branch of the State Department of Public Health that the risk of counterfeiting or diversion of a
radioactive drug is sufficient to require a pedigree. Two years following the date of any such
determination, this paragraph shall become inoperative.
(5) The sale, trade, or transfer of a dangerous drug that is labeled by the manufacturer as "for
veterinary use only."
(6) The sale, trade, or transfer of compressed medical gas. For purposes of this section,
"compressed medical gas" means any substance in its gaseous or cryogenic liquid form that meets
medical purity standards and has application in a medical or homecare environment, including,
but not limited to, oxygen and nitrous oxide.
(7) The sale, trade, or transfer of solutions. For purposes of this section, "solutions" means any
of the following:
(A) Those intravenous products that, by their formulation, are intended for the replenishment
of fluids and electrolytes, such as sodium, chloride, and potassium, calories, such as dextrose and
amino acids, or both.
(B) Those intravenous products used to maintain the equilibrium of water and minerals in
the body, such as dialysis solutions.
(C) Products that are intended for irrigation or reconstitution, as well as sterile water,
whether intended for those purposes or for injection.
(8) Dangerous drugs that are placed in a sealed package with a medical device or medical
supplies at the point of first shipment into commerce by the manufacturer and the package
remains sealed until the drug and device are used, provided that the package is only used for
surgical purposes.
(9) A product that meets either of the following criteria:
(A) A product comprised of two or more regulated components, such as a drug/device,
biologic/device, or drug/device/biologic, that are physically, chemically, or otherwise combined
or mixed and produced as a single entity.
(B) Two or more separate products packaged together in a single package or as a unit and
comprised of drug and device products or device and biological products.
(h) If a manufacturer, wholesaler, or pharmacy has reasonable cause to believe that a dangerous
drug in, or having been in, its possession is counterfeit or the subject of a fraudulent transaction,
the manufacturer, wholesaler, or pharmacy shall notify the board within 72 hours of obtaining
that knowledge. This subdivision shall apply to any dangerous drug that has been sold or
distributed in or through this state.
(i) "Interoperable electronic system" as used in this chapter means an electronic track and trace
system for dangerous drugs that uses a unique identification number, established at the point of
manufacture and supplemented by a linked unique identification number in the event that drug is
repackaged, contained within a standardized nonproprietary data format and architecture, that is
uniformly used by manufacturers, wholesalers, repackagers, and pharmacies for the pedigree of a
dangerous drug. No particular data carrier or other technology is mandated to accomplish the
attachment of the unique identification number described in this subdivision.
(j) The application of the pedigree requirement shall be subject to review during the board's
evaluation pursuant to Section 473.4.
(k) This section shall become operative on January 1, 2015.
4034.1. Enactment of Federal Pedigree Legislation
(a) (1) Upon the effective date of federal legislation or adoption of a federal regulation
addressing pedigree or serialization measures for dangerous drugs, Sections 4034, 4163, 4163.1,
4163.2, 4163.4, and 4163.5 shall become inoperative.
(2) Within 90 days of the enactment of federal legislation or adoption of a regulation
addressing pedigree or serialization measures for dangerous drugs, the board shall publish a
notice that Sections 4034, 4163, 4163.1, 4163.2, 4163.4, and 4163.5 are inoperative.
(3) Within 90 days of the enactment of federal legislation or adoption of a regulation that is
inconsistent with any provision of California law governing the application of any pedigree or
serialization requirement or standard, the board shall adopt emergency regulations necessary to
reflect the inoperation of state law.
(b) (1) If the Food and Drug Administration (FDA) enacts any rule, standard, or takes any other
action that is inconsistent with any provision of California law governing application of a
pedigree to a dangerous drug, that provision of California law shall be inoperative.
(2) Within 90 days of the FDA enacting any rule, standard, or taking any other action that is
inconsistent with any provision of California law governing application of a pedigree to a
dangerous drug, the board shall publish a notice that the provision is inoperative.
(3) Within 90 days of the FDA enacting any rule, standard, or taking any other action that is
inconsistent with any provision of California law governing application of a pedigree to a
dangerous drug, the board shall adopt emergency regulations necessary to reflect the inoperation
of state law.
(c) If the board fails to recognize the inoperation within 90 days pursuant to this section, nothing
in this section shall preclude a party from filing an action in state or federal court for declaratory
or injunctive relief as an alternative to filing a petition with the board.
4035. Person
“Person" includes firm, association, partnership, corporation, limited liability company, state
governmental agency, 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
unexpired 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.
4036.5. Pharmacist-in-Charge
“Pharmacist-in-charge” means a pharmacist 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
(a) "Pharmacy" means an area, place, or premises licensed by the board in which the profession
of pharmacy is practiced and where prescriptions are compounded. "Pharmacy" includes, but is
not limited to, any area, place, or premises described in a license issued by the board wherein
controlled substances, dangerous drugs, or dangerous devices are stored, possessed, prepared,
manufactured, derived, compounded, or repackaged, and from which 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
Health Services where floor supplies, ward supplies, operating room supplies, or emergency room
supplies of dangerous drugs or dangerous 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
(a) "Pharmacy technician" means an individual who assists a pharmacist in a 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 California 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," "optometrists," "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 professions 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 of 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
(a) "Prescription" means an oral, written, or electronic transmission order that is both of the
following:
(1) Given individually for the person or persons for whom ordered that includes all of the
following:
(A) The name or names and address of the patient or patients.
(B) The name and quantity of the drug or device prescribed and the directions for use.
(C) The date of issue.
(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 registry
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.
(F) If in writing, signed by the prescriber issuing the order, or the certified nurse-midwife,
nurse practitioner, physician assistant, or naturopathic doctor 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 either subparagraph (D) of paragraph (4) of, or clause (iv) of subparagraph (A)
of paragraph (5) of, subdivision (a) of Section 4052.
(2) Issued by a physician, dentist, optometrist, podiatrist, veterinarian, or naturopathic
doctor pursuant to Section 3640.7 or, if a drug order is issued pursuant to Section 2746.51,
2836.1, 3502.1, or 3460.5, by a certified nurse-midwife, nurse practitioner, physician assistant, or
naturopathic doctor licensed in this state, or pursuant to either subparagraph (D) of paragraph (4)
of, or clause (iv) of subparagraph (A) of paragraph (5) of, subdivision (a) of Section 4052 by a
pharmacist licensed in this state.
(b) Notwithstanding subdivision (a), a written order of the prescriber 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 (3) of
subdivision (b) of Section 11164 of the Health and Safety Code, the name and quantity of the
drug 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 required by subdivision (a) is readily
retrievable in the pharmacy. In the event 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 image 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.
(d) The use of commonly used abbreviations shall not invalidate an otherwise 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 prescribe a device.
4040.5. Reverse Distributor
"Reverse distributor" means every person who acts as an agent for pharmacies, drug
wholesalers, manufacturers, and other entities by receiving, inventorying, and managing the
disposition of outdated or nonsalable dangerous drugs.
4041. Veterinary Food-Animal Drug Retailer
"Veterinary food-animal drug retailer" is an area, place, or premises, other 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 licensed veterinarian. "Veterinary food-animal retailer" includes, but is not
limited to, any area, place, or premises described in a permit issued by the board wherein
veterinary food-animal drugs, as defined in Section 4042, are stored, possessed, or repackaged,
and from which veterinary drugs are furnished, sold, or dispensed at retail pursuant to a
prescription from a licensed veterinarian.
4042. Veterinary Food-Animal Drugs
"Veterinary food-animal drugs" as used in this chapter shall include the following:
(a) Any drug to be used in food-producing animals bearing the 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 require a veterinary prescription.
4043. Wholesaler
(a) "Wholesaler" means and includes a person who acts as a wholesale merchant, broker, jobber,
customs broker, reverse distributor, agent, or a nonresident wholesaler, who sells for resale, or
negotiates for distribution, or takes 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.
(b) This section shall become operative January 1, 2006.
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 packages finished drugs from
bulk or that repackages dangerous drugs into different containers, excluding shipping containers.
4045. Third-Party Logistics Provider or Reverse Third-Party Logistics Provider
"Third-party logistics provider" or "reverse third-party logistic provider" means an entity licensed
as a wholesaler that contracts with a dangerous drug manufacturer to provide or coordinate
warehousing, distribution, or other similar services on behalf of a manufacturer, but for which
there is no change of ownership in the dangerous drugs. For purposes of Sections 4034, 4163,
4163.1, 4163.2, 4163.3, 4163.4, and 4163.5, a third-party logistics provider shall not be
responsible for generating or updating pedigree documentation, but shall maintain copies of the
pedigree. To be exempt from documentation for pedigrees, a reverse third-party logistic provider
may only accept decommissioned drugs from pharmacies or wholesalers.
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 by means of appropriate drug use, drug-
related therapy, and communication for clinical and consultative purposes. Pharmacy practice is
continually evolving to include more sophisticated and comprehensive patient care activities.
4051. Conduct Limited to Pharmacist; Conduct Authorized by Pharmacist
(a) Except as otherwise provided in this chapter, it is unlawful for any person to manufacture,
compound, furnish, sell, or dispense any dangerous drug or dangerous device, or to dispense or
compound any prescription pursuant to 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 of a prescription,
pursuant to Section 4052.1, 4052.2, or 4052.3, and otherwise provide clinical advice or
information or patient consultation if all of the following conditions are met:
(1) The clinical advice or information or patient consultation is 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.
(3) Access to the information described in paragraph (2) is secure from unauthorized access
and use.
4052. Furnishing to Prescriber; Permitted Procedures by Pharmacist
(a) Notwithstanding any other provision of law, a pharmacist may:
(1) Furnish a reasonable quantity of compounded drug product to a prescriber for office use by
the prescriber.
(2) Transmit a valid prescription to another pharmacist.
(3) Administer, orally or topically, drugs and biologicals pursuant to a prescriber's order.
(4) Perform procedures or functions in a licensed health care facility as authorized by Section
4052.1.
(5) Perform procedures or functions as part of the care provided by a health care facility, a
licensed home health agency, a licensed clinic in which there is a physician oversight, a provider
who contracts with a licensed health care service plan with regard to the care or services provided
to the enrollees of that health care service plan, or a physician, as authorized by Section 4052.2.
(6) Manufacture, measure, fit to the patient, or sell and repair dangerous devices or furnish
instructions to the patient or the patient's representative concerning the use of those devices.
(7) Provide consultation to patients and professional information, including clinical or
pharmacological information, advice, or consultation to other health care professionals.
(8) Furnish emergency contraception drug therapy as authorized by Section 4052.3.
(9) Administer immunizations pursuant to a protocol with a prescriber.
(b) A pharmacist who is authorized to issue an order to initiate or adjust a controlled substance
therapy pursuant to this section shall personally register with the federal Drug Enforcement
Administration.
(c) Nothing in this section shall affect the requirements of existing law relating to maintaining
the confidentiality of medical records.
(d) Nothing in this section shall affect the requirements of existing law relating to the licensing
of a health care facility.
4052.1. Permitted Pharmacist Procedures in Licensed Health Care Facility
(a) Notwithstanding 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 laboratory 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 with 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 procedures of the licensed health
care facility.
4052.2. Permitted Pharmacist Procedures in Health Care Facility; Home Health Agency
or Clinic with Physician Oversight
(a) Notwithstanding any other provision of law, a pharmacist may perform the following
procedures or functions as part of the care provided by a health care facility, a licensed home
health agency, a licensed clinic in which there is a physician oversight, a provider who contracts
with a licensed health care service plan with regard 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 care 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 laboratory 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 written order or
authorization made by the individual patient's treating prescriber, and in accordance with the
policies, procedures, or protocols of the health care facility, home health agency, licensed 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 policies, 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 function 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 the 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 physician.
(4) Except for procedures or functions provided by a health care facility, a licensed clinic in
which there is physician oversight, or a provider who contracts with a licensed health care plan
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 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
(a) Notwithstanding any other provision of law, a pharmacist may furnish emergency
contraception drug therapy in accordance with either of the following:
(1) Standardized procedures or protocols developed by the pharmacist and an authorized
prescriber who is acting within his or her scope of practice.
(2) Standardized procedures or protocols developed and approved by both the board and the
Medical Board of California in consultation with the American College of Obstetricians and
Gynecologists, the California Pharmacist Association, and other appropriate entities. Both the
board and the Medical Board of California shall have authority to ensure compliance with this
clause, and both boards are specifically charged with the enforcement of this provision with
respect to their respective licensees. Nothing in this clause shall be construed to expand the
authority of a pharmacist to prescribe any prescription medication.
(b) Prior to performing a procedure authorized under this paragraph, a pharmacist shall complete
a training program on emergency contraception that consists of at least one hour of approved
continuing education on emergency contraception drug therapy.
(c) A pharmacist, pharmacist's employer, or pharmacist's agent may not directly charge a patient
a separate consultation fee for emergency contraception drug therapy services initiated pursuant
to this paragraph, but may charge an administrative fee not to exceed ten dollars ($10) above the
retail cost of the drug. Upon an oral, telephonic, electronic, or written request from a patient or
customer, a pharmacist or pharmacist's employee shall disclose the total retail price that a
consumer would pay for emergency contraception drug therapy. As used in this subparagraph,
total retail price includes providing the consumer with specific information regarding the price of
the emergency contraception drugs and the price of the administrative fee charged. This limitation
is not intended to interfere with other contractually agreed-upon terms between a pharmacist, a
pharmacist's employer, or a pharmacist's agent, and a health care service plan or insurer. Patients
who are insured or covered and receive a pharmacy benefit that covers the cost of emergency
contraception shall not be required to pay an administrative fee. These patients shall be required
to pay copayments pursuant to the terms and conditions of their coverage. The provisions of this
subparagraph shall cease to be operative for dedicated emergency contraception drugs when these
drugs are reclassified as over-the-counter products by the federal Food and Drug Administration.
(d) A pharmacist may not require a patient to provide individually identifiable medical
information that is not specified in Section 1707.1 of Title 16 of the California Code of
Regulations before initiating emergency contraception drug therapy pursuant to this section.
(e) For each emergency contraception drug therapy initiated pursuant to this section, the
pharmacist shall provide the recipient of the emergency contraception drugs with a standardized
factsheet that includes, but is not limited to, the indications for use of the drug, the appropriate
method for using the drug, the need for medical followup, and other appropriate information. The
board shall develop this form in consultation with the State Department of Health Services, the
American College of Obstetricians and Gynecologists, the California Pharmacists Association,
and other health care organizations. The provisions of this section do not preclude 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. 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 the 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. 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 be in violation of Section 2052.
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 form 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 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 prescriber from checking a box on 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. 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.
(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.
(e) When a substitution is made pursuant to this section, the use of the 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.
4052.7. Repackage Previously Dispensed Drug; Requirements
(a) A pharmacy may, at a patient's request, repackage a drug previously dispensed to the patient
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 pharmacy 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.
4053. Designated Representative to Supervise Wholesaler or Veterinary 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 representative shall protect the public health and safety in the handling,
storage, and shipment of dangerous drugs and dangerous devices in the wholesaler or veterinary
food-animal drug retailer.
(b) An individual may apply for a designated 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
equivalent.
(2) He or she shall have a minimum of one year of paid work experience, in the past three
years, related to the distribution or dispensing of dangerous drugs or dangerous devices or meet
all of the prerequisites to take the examination required for licensure as a pharmacist by the
board.
(3) He or she shall complete a training program approved by the board that, at a minimum,
addresses each of the following subjects:
(A) Knowledge and understanding of California law and federal law relating to the
distribution of dangerous drugs and dangerous devices.
(B) Knowledge and understanding of California law and federal law relating to the
distribution of controlled substances.
(C) Knowledge and understanding of quality control systems.
(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 terminology, 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 applicant
provides proof of completion of the required training to the board.
(c) The veterinary food-animal drug retailer or wholesaler shall not operate without a pharmacist
or a designated representative on its premises.
(d) Only a pharmacist or a designated representative shall prepare 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).
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.
4055. Sale of Devices to Licensed Clinics, etc.
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 (commencing with Section 4180) of this
chapter, or to skilled nursing facilities 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 100 Beds or Less
(a) Notwithstanding any provision of this chapter, a licensed hospital that contains 100 beds or
fewer, and that does not employ a full-time pharmacist, 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 as 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 under this section shall be made on a form furnished by the
board. Upon the filing of the application and payment of the fee prescribed in subdivision (a) of
Section 4400, the executive officer of the board shall issue a license authorizing the hospital to
which 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 transferable.
(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, the name of its chief medical officer, and the name of its
administrator.
(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 himself 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 reasonably
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 services or within a
30-mile radius from the hospital pharmaceutical services by 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 4076.
(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 this 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 pursuant 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 Sections 4006, 4240, and 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 or distributor'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 made 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.
(c) This 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, when it purchases, stores, furnishes, or transports
specific dangerous drugs and 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
devices 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 or distributor's container and labeled in accordance with applicable
federal and 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
controlled substances. The dangerous drugs and dangerous devices shall be used for training
purposes only, and not for the cure, mitigation, or treatment of disease in humans. Recognized
schools of nursing for purposes of this subdivision are those schools recognized as training
facilities by the California Board of Registered Nursing.
4058. Display of Original License
Every person holding a license issued under this chapter to operate a premises shall display the
original license and current renewal license upon the licensed 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, veterinarian, 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 the buyer, the drug or device, and its quantity. This section does not apply to 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, the 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 patients 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 adopted 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 devices 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 drugs or devices pursuant to subdivision (c) shall
have completed a full course of home training given by a dialysis center licensed by the State
Department of Health Services. The physician prescribing the dialysis products shall submit proof
satisfactory to the 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 address of the buyer, and name and
quantity of the drug shall be maintained. This subdivision shall not be construed to authorize the
furnishing of a controlled substance.
(f) A pharmacist may furnish electroneuromyographic needle electrodes or hypodermic needles
used for the purpose of placing wire electrodes for kinesiological electromyographic testing to
physical therapists who are certified by the Physical Therapy Examining Committee of California
to perform tissue penetration in accordance with Section 2620.5.
(g) Nothing in this section 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.
(h) A veterinary food-animal drug retailer shall dispense, furnish, transfer, or 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 shall be delivered to the licensed premises
and signed for and received by a pharmacist. Where a licensee is permitted to operate through a
designated representative, the designated representative 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
manufacturer, 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 provision of 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 scope 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 drug 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 the 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 which
the dangerous drugs or dangerous devices are to be delivered shall include, but not be limited to,
determining that the recipient of the dangerous 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 pharmacist-in-charge has
access to the secure storage facility after dangerous drugs or dangerous devices have been
delivered.
(3) The secure storage facility has a means of indicating whether it has been 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) The 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.
The pharmacy shall be responsible for the dangerous drugs and dangerous devices delivered to
the secure storage facility. The pharmacy shall also be responsible for obtaining and maintaining
records relating to the delivery of dangerous drugs and dangerous devices to a secure storage
facility.
4060. Controlled Substance – Prescription Required; Exceptions
No person shall possess any controlled substance, except that furnished to a person upon the
prescription of a physician, dentist, podiatrist, optometrist, veterinarian, or naturopathic doctor
pursuant to Section 3640.7, or furnished pursuant to a drug order issued by a certified nurse-
midwife pursuant to Section 2746.51, a nurse practitioner pursuant to Section 2836.1, a physician
assistant pursuant to Section 3502.1, a naturopathic doctor pursuant to Section 3640.5, or a
pharmacist pursuant to either Section 4052.1 or 4052.2. This section shall not apply to the
possession of any controlled substance by a manufacturer, wholesaler, pharmacy, pharmacist,
physician, podiatrist, dentist, optometrist, veterinarian, naturopathic doctor, certified nurse-
midwife, nurse practitioner, or physician assistant, when in stock in containers correctly labeled
with the name and address of the supplier or producer. Nothing in this section authorizes a
certified nurse-midwife, a nurse practitioner, a physician assistant, or a naturopathic doctor, to
order his or her own stock of dangerous drugs and devices.
4061. Distribution of a Drug as Sample; Written Request Required
(a) No manufacturer's sales representative shall distribute any dangerous drug or dangerous
device as a complimentary sample without the written request of a physician, dentist, podiatrist,
optometrist, veterinarian, or naturopathic doctor 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
described in Section 2836.1, or protocol, a physician assistant who functions 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
receipt 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 physician. 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 defined 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, the name of the certified nurse-
midwife, nurse practitioner, physician assistant, 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 records 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.
4062. Furnishing Dangerous Drugs During Emergency; Mobile Pharmacy
(a) Notwithstanding Section 4059 or any other provision of law, a pharmacist may, in good
faith, furnish a dangerous drug or dangerous device in reasonable 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, strength, and quantity of the drug or device furnished shall be
maintained. The pharmacist shall communicate this information to the patient's attending
physician as soon as possible. Notwithstanding Section 4060 or any other provision of law, a
person may possess a dangerous drug or dangerous device furnished without prescription
pursuant to this section.
(b) During a declared federal, state, or local emergency, the board may waive application of any
provisions of this chapter or the regulations adopted pursuant 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 in impacted areas in order to ensure the continuity of patient
care, if all of the following conditions are met:
(1) The mobile pharmacy shares common ownership with at least one currently licensed
pharmacy in good standing.
(2) The mobile pharmacy retains records of dispensing, as required by subdivision (a).
(3) A licensed pharmacist is on the premises and the mobile pharmacy is under the control
and management of a pharmacist while the drugs are being dispensed.
(4) Reasonable security measures are taken to safeguard the drug supply maintained in the
mobile pharmacy.
(5) The mobile pharmacy is located within the declared emergency area or affected areas.
(6) The mobile pharmacy ceases the provision of services within 48 hours following the
termination of the declared emergency.
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 Authorization
(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 prescription 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.
(c) The pharmacist shall inform the prescriber within a reasonable period of time of any refills
dispensed pursuant to this section.
(d) Prior to refilling a prescription pursuant to this section, the pharmacist shall make every
reasonable effort to contact the prescriber. The pharmacist 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.
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 injections 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 (commencing 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 an injection card system for
controlled substances.
(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 one 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.
(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
presence 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, provide
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 vessel'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 furnished 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 undertaking 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 without 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 issued pursuant to a good faith prior examination of
a human or animal for 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 has 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 may 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 Board, upon
notification by the Attorney General or the board of a final 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 Section 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.
(e) Nothing in this section shall be construed to permit the unlicensed practice 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 the requirements for
a physician and surgeon in Section 2242 and the 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 Room Patient;
Requirements
(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 pharmacist 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 information 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
the patient.
(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 accessible, 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 drugs dispensed.
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 subdivision (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 classification, 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 required to reduce
that prescription to writing or to hard copy form if, for three 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 copy report that includes for each date of dispensing of a dangerous
drug or 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 the 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 the
Health and Safety Code.
(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 required 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 her
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 approving the correction.
(d) Nothing in this section shall impair the requirement to have an electronically transmitted
prescription transmitted only to the pharmacy of the patient's choice or to have a written
prescription. This requirement shall not apply to orders 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 behalf 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 the name of the authorized agent of the prescriber who
transmits the order. This section shall not apply to orders for Schedule II controlled substances.
4071.1. Electronic Prescription Entry Into Pharmacy or Hospital Computer
(a) A prescriber, a prescriber's authorized agent, or a pharmacist 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 permission of the pharmacy or
hospital. For purposes of this section, a "prescriber's authorized agent" is a person licensed or
registered under Division 2 (commencing with Section 500). 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 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 Electronic 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 administrative 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 authorized 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 the Department of
Health Services in regulating drug order processing requirements for licensed health care
facilities as set forth in Title 22 of the California Code of Regulations as they may be amended
from time to time.
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 ingredients.
(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 prescriber 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 prescription 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, except as
provided in subdivision (b). The person 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 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 product selected costs the patient
less than the prescribed drug product. Cost, as 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 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.
(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 prescriber orders otherwise.
4074. Drug Risk: Informing 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 the drug poses substantial risk to the person consuming the drug
when taken in combination with alcohol or if the drug may impair a person's ability to drive a
motor vehicle, whichever is applicable, and provided the drug is determined by the board
pursuant to subdivision (b) to be a drug or drug type for which this warning shall be given.
(b) The board may by regulation require additional information or labeling.
(c) This section shall not apply to drugs furnished to patients in conjunction with treatment or
emergency services provided in health facilities or, except as provided in subdivision (d), to drugs
furnished to patients pursuant to subdivision (a) of Section 4056.
(d) A health facility shall establish and implement a written policy to ensure that each patient
shall receive information regarding each medication given at the time of discharge and each
medication given pursuant to subdivision (a) of Section 4056. This information shall include the
use and storage of each medication, the precautions and relevant warnings, and the importance of
compliance with directions. This 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
collaboration with a physician, a pharmacist, and a registered nurse. The written policy shall be
approved by the medical staff. Nothing in this subdivision or any other provision of law shall be
construed to require that only a pharmacist provide this consultation.
4075. Proof of Identity Required – Oral or Electronic Prescription
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 procedures 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) A pharmacist shall not dispense any prescription except in a container that meets the
requirements of state and federal law and is correctly labeled with all of the following:
(1) Except where the prescriber or the certified nurse-midwife who functions 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 Section 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 either
subparagraph (D) of paragraph (4) of, or clause (iv) of subparagraph (A) of paragraph (5) of,
subdivision (a) of Section 4052 orders otherwise, either the manufacturer's trade name of the drug
or the generic 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.
(2) The directions for the use of the drug.
(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 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 Section 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 either subparagraph (D) of paragraph (4) of, or clause (iv) of subparagraph (A) of
paragraph (5) of, subdivision (a) of Section 4052.
(5) The date of issue.
(6) The name and address of the pharmacy, and prescription 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 condition or purpose for which the drug was prescribed if the condition or purpose is
indicated on the prescription.
(11) (A) Commencing January 1, 2006, the physical description of the dispensed medication,
including its color, shape, and any identification code that appears on the tablets or capsules,
except as follows:
(i) Prescriptions dispensed by a veterinarian.
(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.
(iii) Dispensed medications for which no physical description exists in any commercially
available database.
(B) This paragraph applies to outpatient pharmacies only.
(C) The information required by this paragraph may be printed on an auxiliary 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 other
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 pharmacist 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 functions 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 Section 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 either subparagraph (D) of paragraph (4) of, or clause (iv) of subparagraph (A) of
paragraph (5) of, subdivision (a) of Section 4052.
(d) If a pharmacist dispenses a prescription drug for use in a facility licensed pursuant to Section
1250 of the Health and Safety Code, it is not necessary to include the information required in
paragraph (11) of subdivision (a) when the prescription drug is administered to a patient by a
person licensed under the Medical Practice Act (Chapter 5 (commencing with Section 2000)), the
Nursing Practice Act (Chapter 6 (commencing with Section 2700)), or the Vocational Nursing
Practice Act (Chapter 6.5 (commencing with Section 2840)), who is acting within his or her
scope of practice.
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) (1) On or before January 1, 2010, the board shall report to the Legislature on its progress
under this section as of the time of the report.
(2) On or before January 1, 2013, the board shall report to the Legislature the status of
implementation of the prescription drug label requirements adopted pursuant to this section.
4077. Dispensing Dangerous Drug in Incorrectly 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, podiatrists, 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.
(c) Devices that bear the legend "Caution: federal law restricts this device to 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 dimethyl 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) The label of any retail package of DMSO shall include appropriate 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 prescription, 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 program approved by
the federal Food and Drug Administration or a legitimate 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 proper
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 manner in which the information on the
prescription label varies from the 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.
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 a customs broker
or carrier shall be, at all times during business hours, open to inspection by authorized officers of
the law.
4081. Records of Dangerous Drugs and Devices Kept Open for Inspection; Maintenance of
Records, Current Inventory
(a) All records of manufacture and of sale, acquisition, 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 date of making. A
current inventory shall be kept by every manufacturer, wholesaler, pharmacy, veterinary food-
animal drug retailer, physician, dentist, podiatrist, veterinarian, laboratory, 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, or veterinary food-animal drug
retailer shall be jointly responsible, with the pharmacist-in-charge or designated representative-in-
charge, for maintaining the records and inventory described in this section.
(c) The pharmacist-in-charge or designated 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 pharmacist-in-charge or designated representative-in-charge had no knowledge, or in
which he or she did not knowingly participate.
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 names of the owner or owners, manager or managers, and
employees together 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 executive officer to
contest the order of correction.
(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 executive officer
declarations and documents pertinent to the subject matter of 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 (Chapter 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 officer, 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 serve or send by certified mail to the licensee'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 prejudicial 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
section, 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 and 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:
(1) Issue a citation pursuant to Section 125.9, 148, or 4067 or pursuant to 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 (commencing 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 pursuant 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 finds, 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 board inspector shall remove the tag or other
marking.
(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 defined in Article 2
(commencing with Section 111250) of Chapter 6 of Part 5 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.
4085. Unlawful to Remove, Sell, or Dispose of Embargoed Dangerous Drugs or Dangerous
Devices
(a) It is unlawful for any person 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 commence 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 adulterated 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 board 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.
(c) A superior court of this state may condemn any dangerous drug or 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 authorized representative. If the board cannot ascertain ownership of the
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
4100. Change of Address or Name – Notification to Board
(a) 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 pharmacist, technician, or designated
representative shall notify the executive officer of the board of the change of address or change of
name.
(b) This section shall become operative on January 1, 2006.
4101. Pharmacist-in-Charge, Designated Representative-in-Charge: Termination of
Employment; Notification to Board
(a) A pharmacist may take charge of and act as the pharmacist-in-charge of a pharmacy upon
application by the pharmacy and approval by the board. Any pharmacist-in-charge who ceases to
act as the pharmacist-in-charge of the pharmacy shall notify the board in writing within 30 days
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 drug-animal retailer upon application
by the wholesaler or veterinary food-animal drug retailer and approval by the board. Any
designated representative-in-charge who ceases to act as the designated representative-in-charge
at that entity shall notify the board in writing within 30 days of the date of that change 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. Enforcement 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 shall 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 extent it affects his or her ability to practice the profession
or occupation 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 chemical, mental,
or physical impairment, as well as theft, diversion, or self-use of dangerous drugs, among
licensed individuals employed by or with the pharmacy.
(c) Every pharmacy shall report to the board, within 30 days of the receipt or development 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 self-use of
dangerous drugs by a licensed individual.
(5) Any termination based on chemical, mental, or physical impairment of a licensed individual
to the extent it affects his or her ability to practice.
(6) Any termination of a licensed individual based on theft, diversion, or self-use of dangerous
drugs.
(d) 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 report. 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 retrievable form.
(b) The licensee may remove the original records or documentation from the licensed premises
on a temporary basis for license-related purposes. However, a duplicate set of those records or
other documentation shall be retained on the licensed premises.
(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 that the pharmacist-in-
charge, the pharmacist on duty if the pharmacist-in-charge is not on duty, or, in the case of a
veterinary food-animal drug retailer or wholesaler, the designated representative on duty, shall, at
all times during which the licensed premises are open for business, be able to produce a hard copy
and electronic copy of all records of acquisition or disposition or other drug or dispensing-related
records maintained electronically.
(e) (1) Notwithstanding subdivisions (a), (b), and (c), the board, may upon 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 shall not affect the board's authority under
this section or any other provision of this chapter.
(f) This section shall become operative on January 1, 2006.
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.
4107. One Site License per Premises; Exception
The board may not issue more than one site license to a single premises except to issue a
veterinary food-animal drug retailer license to a wholesaler or to issue a license to compound
sterile injectable drugs to a pharmacy. For the purposes of this subdivision, "premises" means a
location with its own address and an independent means of ingress and egress.
4110. License Required; Temporary Permit Upon Transfer of Ownership; Mobile
Pharmacy Requirements
(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 pharmacy owned or operated by a
specific person. A separate license shall be required for each of the premises of any person
operating a pharmacy in more than one location. The license shall be renewed annually. The
board may, by regulation, determine the circumstances under which a license may be transferred.
(b) The board may, at its discretion, issue a temporary permit, when the ownership of a
pharmacy is transferred from one person to another, upon the conditions and for any periods of
time as the board determines to be in the public interest. A temporary permit fee shall be required
in an amount established by the board as specified in subdivision (a) of Section 4400. When
needed to protect public safety, a temporary permit 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 temporary permit was issued by 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, return
receipt requested, at the permitholder's address of record with the board, whichever comes first.
Neither for purposes of retaining a temporary permit nor for purposes of any disciplinary or
license denial proceeding before the board shall the temporary permitholder be deemed to have a
vested property right or 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-charge 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) Except as otherwise provided in subdivision (b), (d), or (e), the board shall not issue or renew
a license to conduct a pharmacy to any of the following:
(1) A person or persons authorized to prescribe or write a prescription, as specified in Section
4040, in the State of California.
(2) A person or persons with whom a person or persons specified in paragraph (1) shares a
community or other financial interest in the permit sought.
(3) Any corporation that is controlled by, or in which 10 percent or more of the stock is owned
by a person or persons prohibited from pharmacy ownership by paragraph (1) or (2).
(b) Subdivision (a) shall not preclude the issuance of a permit for an inpatient hospital pharmacy
to the owner of the hospital in which it is located.
(c) The board may require any information the board deems is reasonably necessary for the
enforcement of this section.
(d) Subdivision (a) shall not preclude the issuance of a new or renewal license for a pharmacy to
be owned or owned and operated by a person licensed on or before August 1, 1981, under the
Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2 (commencing with Section
1340) of Division 2 of the Health and Safety Code) and qualified on 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 (2) of
subdivision (a).
(e) Subdivision (a) shall not preclude the issuance of a new or renewal license for a pharmacy to
be owned or owned and operated by a pharmacist authorized to issue a drug order pursuant to
either Section 4052.1 or 4052.2.
4112. Nonresident Pharmacy: Registration; Provision of Information to Board;
Maintaining Records; Patient Consultation
(a) Any pharmacy located outside 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 has 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 titles 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 of 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 requests 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 unexpired 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 report resulting from an inspection conducted by the regulatory or licensing agency of
the state in which it is located.
(e) All nonresident pharmacies shall maintain records of controlled substances, dangerous drugs,
or dangerous devices dispensed to patients in this 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 operation, but not less
than six days per week, and for a minimum of 40 hours 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 label affixed to each container of drugs dispensed to patients in this state.
(g) The board shall adopt regulations that apply the same requirements or standards for oral
consultation to a nonresident pharmacy that operates 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 the patient. The
regulations adopted pursuant to this subdivision shall not result in any unnecessary delay in
patients receiving their medication.
(h) The registration fee shall be the fee specified in subdivision (a) of Section 4400.
(i) The registration 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.
(j) Nothing in this section shall be construed to authorize the dispensing of contact lenses by
nonresident pharmacists except as provided by Section 4124.
4113. Pharmacist-in-Charge: Notification to Board; Responsibilities
(a) Every pharmacy shall designate a pharmacist-in-charge and, within 30 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.
(b) The proposed pharmacist-in-charge shall be subject to approval by the board. The board
shall not issue or renew a pharmacy license without identification of an approved pharmacist-in-
charge for the pharmacy.
(c) The pharmacist-in-charge shall be responsible for a pharmacy's compliance with all state and
federal laws and regulations pertaining to the practice of pharmacy.
(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 as the pharmacist-in-charge, and shall
on the same form propose another pharmacist to take over as the pharmacist-in-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 within 30 days a
permanent replacement pharmacist-in-charge to propose to the 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 pharmacy 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
interim pharmacist-in-charge in the daily management of the pharmacy, and with documentation
of the pharmacy’s good faith efforts prior to naming the interim pharmacist-in-charge to obtain a
permanent pharmacist-in-charge. By 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 serve as the permanent pharmacist-in-charge. The proposed permanent 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.
4114. Intern Pharmacist: Activities Permitted
(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 intern pharmacists at any one time.
4115. Pharmacy Technician: Activities Permitted; Required Supervision; Activities
Limited to Pharmacist; Registration; Requirements for Registration; Ratio
(a) A pharmacy technician may perform packaging, manipulative, repetitive, or other
nondiscretionary tasks, only while assisting, and while under the direct supervision and control of
a pharmacist.
(b) This section does not authorize the performance of any tasks specified in 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 pharmacist. Any pharmacy that
employs a pharmacy technician shall do so in conformity 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.
(f) (1) A pharmacy with only one pharmacist shall have no more than one pharmacy technician
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 clerical 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
correctional facility of the Department of the Youth Authority or the Department of Corrections,
and 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.
(2) The board may adopt regulations establishing the ratio of pharmacy 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 patient 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 pharmacy technicians for
each additional pharmacist, except that this ratio shall 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 pharmacist 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 assigned 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, within 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 exercising 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
pharmacist, remain in the pharmacy but may only perform nondiscretionary 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 construed to authorize 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.
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 technician.
(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 externship 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 procedures 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 subdivision (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 vocational
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 period 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 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.
(d) An externship in which a pharmacy technician trainee may participate as 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 pharmacy. 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 in subdivision (a)
shall wear identification that indicates his or her trainee 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, possessed, prepared, manufactured, derived, compounded, dispensed, or
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, maintenance, 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 conditions 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
pharmacist'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 registered 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, maintenance, or similar functions relating to the 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, dangerous drugs, or dangerous devices are
stored, possessed, prepared, 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, consistent with good
patient care, can be provided by the licensure of a 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 care, 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 waiver 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 cases under treatment in the hospital.
4119. Furnish Prescription Drug to Licensed Health Care Facility – Secured Emergency
Supplies
(a) Notwithstanding any other provision of law, a pharmacy 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 Health Services 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
pharmaceutical 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 24.
(b) Notwithstanding any other provision of law, a pharmacy may furnish a dangerous drug 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 procedures 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 services 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 dangerous 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.
The furnishing of controlled substances to an approved emergency medical services provider
shall be in accordance with the California Uniform Controlled Substances Act.
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, through 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 of dangerous
drugs and dangerous devices stored in the automated drug 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 pharmacy 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) Nothing in this section shall be construed to revise or limit the use of automated 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 Safety Code.
4119.2. Furnish Epinephrine Auto-Injectors to School; Requirements
(a) Notwithstanding any other provision of law, a pharmacy may furnish epinephrine auto-
injectors to a school district or county office of education pursuant to Section 49414 of the
Education Code if all of the following are met:
(1) The epinephrine auto-injectors are furnished exclusively for use at a school district site or
county office of education.
(2) A physician and surgeon provides a written order that specifies the quantity of epinephrine
auto-injectors to be furnished.
(b) Records regarding the acquisition and disposition of epinephrine auto-injectors furnished
pursuant to subdivision (a) shall be maintained by both the school district or county office of
education for a period of three years from the date the records were created. The school district
or county office of education shall be responsible for monitoring the supply of auto-injectors and
assuring the destruction of expired auto-injectors.
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.
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 who has obtained a license
pursuant to this chapter or through a selling or distribution outlet that is licensed as a wholesaler
pursuant to this chapter without registering as a nonresident pharmacy.
(b) Applications for a nonresident pharmacy registration shall be made on a 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 nonresident pharmacy.
(d) The Legislature, by enacting this section, does not intend a license issued to any nonresident
pharmacy pursuant to this section to serve as any evidence that the nonresident pharmacy is doing
business within this state.
4121. Advertisement 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 are consistent with good medical
practice 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 medical staff and personnel.
4122. Required Notice of Availability of Prescription Price Information, General Product
Availability, Pharmacy Services; Providing Price Information; Limitations on Price
Information Requests
(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
services 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 contains 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 request 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 information 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 period 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 pharmacy shall be required to respond to more than three requests as described in this
subdivision from any one person or entity in a six-month period.
(d) This section shall not apply to a pharmacy that is located in a licensed hospital and that is
accessible only to hospital medical staff and personnel.
(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.
4124. 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. 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 lenses 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 date 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 are 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 shall direct the
patient to confer with his or her eyecare practitioner in the event 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 patient whenever contact lenses
are supplied:
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.
(f) Any pharmacy and pharmacist dispensing replacement contact lenses shall 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 the 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 application 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. The 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 as defined in
subdivision (a) of Section 4112. A nonresident pharmacy may dispense contact lenses only as
provided in this section.
4125. Pharmacy Quality Assurance Program Required; Records Considered Peer Review
Documents
(a) Every pharmacy shall establish a quality assurance program that 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 prescription medications so that the pharmacy may take appropriate
action to 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 the 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 shall 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 Pharmacy 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 services 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.
(b) Drugs purchased pursuant to Section 256b of Title 42 of the United States 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 for 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,
but is not limited to, the termination or expiration of the contract between the pharmacy and the
covered entity, the closure of a pharmacy, disciplinary action against the pharmacy, or closure of
the covered entity.
(d) A licensee that participates in a contract to dispense preferentially priced drugs pursuant to
this section shall 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 Section 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
could 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.
(5) A patient or to another pharmacy pursuant to a prescription or as otherwise 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.
(b) Notwithstanding any other provision of 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.
(c) Amounts due from any person under this section on or after January 1, 2005, shall be offset
as 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) For purposes of this section, "common control" means the power to direct or cause the
direction of the management and policies of another person whether by ownership, by voting
rights, by contract, or by other means.
Article 7.5 Injectable Sterile Drug Products
4127. Board Shall Adopt Regulations Establishing Standards
The board shall adopt regulations establishing standards for compounding injectable sterile drug
products in a pharmacy.
4127.1. License to Compound Injectable Sterile Drug Products Required
(a) A pharmacy shall not compound injectable sterile drug products in this state unless the
pharmacy has obtained a license from the board pursuant to this section. The license shall be
renewed annually and is not transferable.
(b) A license to compound injectable sterile drug products may only be issued for a location that
is licensed as a pharmacy. Furthermore, the license to compound injectable sterile drug products
may only be issued to the owner of the pharmacy license at that location. A license to compound
injectable sterile drug products may not be issued until the location is inspected by the board and
found in compliance with this article and regulations adopted by the board.
(c) A license to compound injectable sterile drug products may not be renewed until the location
has been inspected by the board and found to be in compliance with this article and regulations
adopted by the board.
(d) Pharmacies operated by entities that are licensed by either the board or the State Department
of Health Services and that have current accreditation from the Joint Commission on
Accreditation of Healthcare Organizations, or other private accreditation agencies approved by
the board, are exempt from the requirement to obtain a license pursuant to this section.
(e) The reconstitution of a sterile powder shall not require a license pursuant to this section if
both of the following are met:
(1) The sterile powder was obtained from a manufacturer.
(2) The drug is reconstituted for administration to patients by a health care professional
licensed to administer drugs by injection pursuant to this division.
(f) This section shall become effective on the earlier of July 1, 2003, or the effective date of
regulations adopted by the board pursuant to Section 4127.
4127.2. Nonresident Pharmacy – License to Compound and Ship Injectable Drug Products
into California Required
(a) A nonresident pharmacy may not compound injectable sterile drug products for shipment
into the State of California without a license issued by the board pursuant to this section. The
license shall be renewed annually and shall not be transferable.
(b) A license to compound injectable sterile drug products may only be issued for a location that
is licensed as a nonresident pharmacy. Furthermore, the license to compound injectable sterile
drug products may only be issued to the owner of the nonresident pharmacy license at that
location. A license to compound injectable sterile drug products may not be issued or renewed
until the board receives the following from the nonresident pharmacy:
(1) A copy of an inspection report issued by the pharmacy's licensing agency, or a report from
a private accrediting agency approved by the board, in the prior 12 months documenting the
pharmacy's compliance with board regulations regarding the compounding of injectable sterile
drug products.
(2) A copy of the nonresident pharmacy's proposed policies and procedures for sterile
compounding.
(c) Nonresident pharmacies operated by entities that are licensed as a hospital, home health
agency, or a skilled nursing facility and have current accreditation from the Joint Commission on
Accreditation of Healthcare Organizations, or other private accreditation agencies approved by
the board, are exempt from the requirement to obtain a license pursuant to this section.
(d) This section shall become effective on the earlier of July 1, 2003, or the effective date of
regulations adopted by the board pursuant to Section 4127.
4127.3. Cease and Desist Order; Hearing
(a) Whenever the board has a reasonable belief, based on information obtained during an
inspection or investigation by the board, that a pharmacy compounding injectable 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
injectable 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.
(c) The order shall provide 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. 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 desist 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 committed 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.
4127.5. Fee
This section is repealed.
4127.6. Article Operative Upon Allocation of Positions
This article shall become operative upon the allocation of positions to the board for the
implementation of the provisions of this article in the annual Budget Act.
4127.7. Compounding Sterile Injectables from Nonsterile Ingredients; Requirements
On and after July 1, 2005, a pharmacy shall compound sterile injectable products from one or
more nonsterile ingredients in one of the following environments:
(a) An ISO class 5 laminar airflow hood within an ISO class cleanroom. The cleanroom must
have a positive air pressure differential relative to adjacent areas.
(b) An ISO class 5 cleanroom.
(c) A barrier isolator that provides an ISO class 5 environment for compounding.
4127.8. Temporary License to Compound Injectables
The board may, at its discretion, issue a temporary license to compound injectable sterile drug
products, when the ownership of a pharmacy that is licensed to compound injectable sterile drug
products is transferred from one person to another, 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
in an amount established by the board as specified in subdivision (u) 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 board 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 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.
Article 9. Hypodermic Needles and Syringes
4140. Unlawful Possession
No person shall possess or have under his or her control any hypodermic needle or syringe
except when acquired in accordance with this article.
4141. Furnishing without License
No person shall furnish hypodermic needles or syringes, by sale or otherwise, 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 shall be sold at
retail except upon the prescription of a physician, dentist, veterinarian, podiatrist, or naturopathic
doctor pursuant to Section 3640.7.
4143. Exemption: Sale to Other Entity, Physician, etc.
This article shall not apply to the sale of hypodermic syringes and needles at wholesale by
pharmacies, 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. Industrial Use: Exception
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 or 4146.
4145. Exception: Furnishing for Administration of Insulin, Adrenaline, or Specified
Animal Uses; Conditions
(a) Notwithstanding any other provision of law, a pharmacist or physician may, without a
prescription or a permit, furnish hypodermic needles and 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 one of the following requirements is met:
(1) The person is known to the furnisher and the furnisher has previously been provided a
prescription or other proof of a legitimate medical need requiring a hypodermic needle or syringe
to administer a medicine or treatment.
(2) Pursuant to authorization by a county, with respect to all of the territory within the county,
or a city, with respect to the territory within the city, for the period commencing January 1, 2005,
and ending December 31, 2010, a pharmacist may furnish or sell 10 or fewer hypodermic needles
or syringes at any one time to a person 18 years of age or older if the pharmacist works for a
pharmacy that is registered for the Disease Prevention Demonstration Project pursuant to Chapter
13.5 (commencing with Section 121285) of Part 4 of Division 105 of the Health and Safety Code
and the pharmacy complies with the provisions of that chapter.
(b) Notwithstanding any other provision of law, a pharmacist, veterinarian, or person licensed
pursuant to Section 4141 may, without a prescription or license, furnish hypodermic needles and
syringes for use on animals, 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.
4146. Needle/Syringe Return in Sharps Container
A pharmacy may accept 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.
(b) Any hypodermic needle or syringe that is to be disposed of, shall be 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
playground, 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 dollars ($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 sharps
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.
4148. Confiscation if Found Outside Licensed Premises
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, or 4145.
4149. Sale by Nonresident Distributor; License Required
(a) A nonresident distributor shall not sell or distribute hypodermic needles or syringes in this
state without obtaining a license from the board pursuant to Section 4141.
(b) Notwithstanding subdivision (a), no license shall be required if the nonresident distributor
sells or distributes solely through a person who is licensed as a wholesaler pursuant to Section
4160.
(c) The Legislature, by enacting this section, does not intend a license issued to any nonresident
distributor pursuant to this article to serve as evidence that 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 professional
services, as defined in Section 13401 of the Corporations Code, so 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 to in the
Moscone-Knox Professional Corporation Act is the Board of 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 defined in Section 13401 of the
Corporations Code.
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 abbreviations 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 13401 of the Corporations Code, shall
not in any manner accrue to the benefit 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 deceased 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 of a pharmacy
permit pursuant to Section 4110 to be a pharmacy corporation.
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 and Manufacturers
4160. Wholesaler: License Required
(a) A person may not act as a wholesaler of any dangerous drug or dangerous device unless he
or she has obtained a license from the board.
(b) Upon approval by the board and the payment of the required fee, the board shall issue a
license to the applicant.
(c) A separate license shall be required for each place of business owned or operated by a
wholesaler. Each license shall be renewed annually and shall not be transferable.
(d) Every wholesaler shall be supervised or managed by a designated representative-in-charge.
The designated representative 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 each
renewal, each wholesaler shall, on a form designed by the board, provide 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 the board. The board shall not issue or renew a wholesaler license
without identification of an approved designated representative-in-charge for the wholesaler.
(e) Every wholesaler shall notify the board in writing, on a form designed by the board, within
30 days of the date when a designated representative-in-charge ceases to act as the designated
representative-in-charge, and shall on the same form propose another designated representative or
pharmacist to take over as the designated representative-in-charge. The proposed replacement
designated representative-in-charge shall be subject to approval by the board. If disapproved, the
wholesaler shall propose another replacement within 15 days of the date of disapproval, and shall
continue to name proposed replacements until a designated representative-in-charge is approved
by the board.
(f) 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 manufacture is exempt from this section and Section 4161.
(g) 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 shall be required in
an amount established by the 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 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 certified mail, return receipt requested, at the licenseholder's
address of record 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.
4161. Nonresident Wholesaler; Requirements
(a) A person located outside this state that (1) ships, sells, mails, or delivers dangerous drugs or
dangerous devices into this state or (2) sells, brokers, or distributes dangerous drugs or devices
within this state shall be considered a nonresident wholesaler.
(b) A nonresident wholesaler shall be licensed by the board prior to shipping, selling, mailing, or
delivering dangerous drugs or dangerous devices to a site located in this state or selling,
brokering, or distributing dangerous drugs or devices within this state.
(c) A separate license shall be required for each place of business owned or operated by a
nonresident wholesaler from or through which dangerous drugs or dangerous devices are shipped,
sold, mailed, or delivered to a site located in this state or sold, brokered, or distributed within this
state. A license shall be renewed annually and shall not be transferable.
(d) The following information shall be reported, in writing, to the board at the time of initial
application for licensure by a nonresident wholesaler, on renewal of a nonresident wholesaler
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.
(3) Its general partners, as specified by the board, if any.
(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
change of ownership, office, corporate officer, or partner.
(f) A nonresident wholesaler shall comply with all directions and requests 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.
(g) A nonresident wholesaler shall maintain records of dangerous drugs and dangerous devices
sold, traded, or transferred to persons in this state or within this state, so that the records are in a
readily retrievable form.
(h) A nonresident wholesaler shall at all times maintain a valid, unexpired license, permit, or
registration to conduct the business of the wholesaler in compliance with the laws of the state in
which it is a resident. An application for a nonresident wholesaler license in this state shall
include a license verification from the licensing authority in the applicant's state of residence.
(i) The board may not issue or renew a nonresident wholesaler license until the nonresident
wholesaler identifies a designated representative-in-charge and notifies the board in writing of the
identity and license number of the designated representative-in-charge.
(j) The designated representative-in-charge shall be responsible for the nonresident wholesaler's
compliance with state and federal laws governing wholesalers. A nonresident wholesaler shall
identify and notify the board of a new designated representative-in-charge within 30 days of the
date that the prior designated representative-in-charge ceases to be the designated representative-
in-charge.
(k) 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 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 injectable sterile drug products. 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 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 certified mail, return receipt requested, at the licenseholder's address of record 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.
4162. Wholesaler License Surety Bond Requirements
(a) (1) An applicant, that is not a government owned and operated wholesaler, for the issuance
or renewal of a wholesaler license shall submit a surety bond of one hundred thousand dollars
($100,000) 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 imposed by the board and any cost recovery ordered pursuant to Section
125.3.
(2) For purposes of paragraph (1), the board may accept a surety bond less than one hundred
thousand dollars ($100,000) if the annual gross receipts of the previous tax year for the
wholesaler is ten million dollars ($10,000,000) or less, in which case the surety bond shall be
twenty-five thousand dollars ($25,000).
(3) A person to whom an approved new drug application has been issued by the United 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, shall not be required to post a surety bond as provided in paragraph (1).
(4) For licensees subject to paragraph (2) or (3), 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
federal 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 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.
4162.5. Issuance or Renewal of Nonresident Wholesaler License; Surety Bond [Repeals 1-1-
2015]
(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) For purposes of paragraph (1), the board may accept a surety bond less than one hundred
thousand dollars ($100,000) if the annual gross receipts of the previous tax year for the
nonresident wholesaler is ten million dollars ($10,000,000) or less in which the surety bond shall
be twenty-five thousand dollars ($25,000).
(3) For applicants who satisfy paragraph (2), the board may require a bond up to one hundred
thousand dollars ($100,000) for any nonresident wholesaler who has been disciplined by any state
or federal agency or has been issued an administrative fine pursuant to this chapter.
(4) A person to whom an approved new drug application or a biologics license application has
been issued by the United States Food and Drug Administration who engages in the wholesale
distribution of only the dangerous drug specified in the new drug application or biologics license
application, and is licensed or applies for licensure as a nonresident wholesaler, shall not be
required to post a surety bond as provided in this section.
(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) A manufacturer, wholesaler, repackager, or pharmacy may not furnish 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. When the person acquiring the
dangerous 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.
(c) Except as otherwise provided in Section 4163.5, commencing on July 1, 2016, a wholesaler
or repackager may not sell, trade, or transfer a dangerous drug at wholesale without providing a
pedigree.
(d) Except as otherwise provided in Section 4163.5, commencing on July 1, 2016, a wholesaler
or repackager may not acquire a dangerous drug without receiving a pedigree.
(e) Except as otherwise provided in Section 4163.5, commencing on July 1, 2017, a pharmacy
may not sell, trade, or transfer a dangerous drug at wholesale without providing a pedigree.
(f) Except as otherwise provided in Section 4163.5, commencing on July 1, 2017, a pharmacy
may not acquire a dangerous drug without receiving a pedigree.
(g) Except as otherwise provided in Section 4163.5, commencing on July 1, 2017, a pharmacy
warehouse may not acquire a dangerous drug without receiving a pedigree. For purposes of this
section and Section 4034, a "pharmacy warehouse" means a physical location licensed as a
wholesaler for prescription drugs that acts as a central warehouse and performs intracompany
sales or transfers of those drugs to a group of pharmacies under common ownership and control.
4163.1. Legislative Intent on Pedigree Requirements [A Second Like-Numbered Section
Follows]
It is the intent of the Legislature that commencing on January 1, 2007, and continuing through the
full implementation of the pedigree requirements specified by Section 4163, manufacturers and
wholesalers shall use best efforts to provide in the most readily accessible form possible,
information regarding the manufacturer's specific relationships in the distribution of dangerous
drugs with wholesalers.
4163.1. Drop Shipment by Manufacturer
(a) For purposes of Sections 4034 and 4163, "drop shipment" means a sale of a dangerous drug
by the manufacturer of the dangerous drug whereby all of the following occur:
(1) The pharmacy, or other person authorized by law to dispense or administer the drug,
receives delivery of the dangerous drug directly from the manufacturer.
(2) The wholesale distributor takes ownership of, but not physical possession of, the dangerous
drug.
(3) The wholesale distributor invoices the pharmacy or other person authorized by law to
dispense or administer the drug in place of the manufacturer.
(b) The board may develop regulations to establish an alternative process to convey the pedigree
information required in Section 4034 for dangerous drugs that are sold by drop shipment.
4163.2. Pedigree; Grandfathering
(a) (1) A manufacturer, wholesaler, or pharmacy lawfully possessing or owning dangerous drugs
manufactured or distributed prior to the operative date of the pedigree requirements, specified in
Sections 4034 and 4163, may designate these dangerous drugs as not subject to the pedigree
requirements by preparing a written declaration made under penalty of perjury that lists those
dangerous drugs.
(2) The written declaration shall include the National Drug Code Directory lot number for each
dangerous drug designated. The written declaration shall be submitted to and received by the
board no later than 30 days after the operative date of the pedigree requirements. The entity or
person submitting the written declaration shall also retain for a period of three years and make
available for inspection by the board a copy of each written declaration submitted.
(3) The board may, by regulation, further specify the requirements and procedures for the
creation and submission of these written declarations. Information contained in these declarations
shall be considered trade secrets and kept confidential by the board.
(b) Any dangerous drugs designated on a written declaration timely created and submitted to the
board may be purchased, sold, acquired, returned, or otherwise transferred without meeting the
pedigree requirements, if the transfer complies with the other requirements of this chapter.
4163.3. Pedigree Inference Standards
(a) It is the intent of the Legislature that participants in the distribution chain for dangerous
drugs, including manufacturers, wholesalers, or pharmacies furnishing, administering, or
dispensing dangerous drugs, distribute and receive electronic pedigrees, and verify and validate
the delivery and receipt of dangerous drugs against those pedigrees at the unit level, in a manner
that maintains the integrity of the pedigree system without an unacceptable increase in the risk of
diversion or counterfeiting.
(b) To meet this goal, and to facilitate efficiency and safety in the distribution chain, the board
shall, by regulation, define the circumstances under which participants in the distribution chain
may infer the contents of a case, pallet, or other aggregate of individual units, packages, or
containers of dangerous drugs, from a unique identifier associated with the case, pallet, or other
aggregate, without opening each case, pallet, or other aggregate or otherwise individually
validating each unit.
(c) Manufacturers, wholesalers, and pharmacies opting to employ the use of inference as
authorized by the board to comply with the pedigree requirements shall document their processes
and procedures in their standard operating procedures (SOPs) and shall make those SOPs
available for board review.
(d) SOPs regarding inference shall include a process for statistically sampling the accuracy of
information sent with inbound product.
(e) Liability associated with accuracy of product information and pedigree using inference shall
be specified in the board's regulations.
4163.4. Holding Legal Title on Pedigree Requirement Effective Date
(a) All units of dangerous drug in the possession of a wholesaler or pharmacy, for which the
manufacturer does not hold legal title on the effective date of the pedigree requirement set forth in
Section 4163.5, shall not be subject to the pedigree requirements set forth in Sections 4034 and
4163. However, if any units of those drugs are subsequently returned to the manufacturer, they
shall be subject to the pedigree requirements if the manufacturer distributes those units in
California.
(b) All units of dangerous drug manufactured in California but distributed outside the state for
dispensing outside the state shall not be subject to the pedigree requirements set forth in Sections
4034 and 4163 at either the time of initial distribution or in the event that any of those units are
subsequently returned to the manufacturer.
4163.5. Pedigree Requirement Implementation Date
(a) The Legislature hereby finds and declares that:
(1) The electronic pedigree system required by Sections 4034 and 4163 will provide
tremendous benefits to the public and to all participants in the distribution chain. Those benefits
should be made available as quickly as possible through the full cooperation of prescription drug
supply chain participants. To this end, all drug manufacturers and repackagers are strongly
encouraged to serialize drug products and initiate electronic pedigrees as soon as possible, and all
participants in the supply chain are encouraged to immediately ready themselves to receive and
pass electronic pedigrees.
(2) At the same time, it is recognized that the process of implementing serialized electronic
pedigree for all prescription drugs in the entire chain of distribution is a complicated
technological and logistical undertaking for manufacturers, wholesalers, repackagers, pharmacies,
and other supply chain participants. The Legislature seeks to ensure continued availability of
prescription drugs in California while participants implement these requirements.
(b) Before January 1, 2015, each manufacturer of a dangerous drug distributed in California
shall designate those dangerous drugs representing a minimum of 50 percent of its drugs, generic
or single source, distributed in California, for which it is listed as the manufacturer by the federal
Food and Drug Administration, which shall be the subject of its initial phase of compliance with
the January 1, 2015, deadline of the state's serialized electronic pedigree requirements set forth in
Sections 4034 and 4163. Each manufacturer shall notify the Board of Pharmacy of the drugs so
designated and the measure or measures used in designating its drugs to be serialized, and shall
include in the notification the technology to be used to meet the serialized electronic pedigree
requirements. The notification process for these specific actions may be specified by the board.
(c) Before January 1, 2016, each manufacturer of a dangerous drug distributed in California
shall designate the final 50 percent of its drugs, generic or single source, distributed in California
for which it is listed as the manufacturer by the federal Food and Drug Administration that are
subject to the state's serialized electronic pedigree requirements set forth in Sections 4034 and
4163, which shall comply with the state's serialized electronic pedigree requirement by January 1,
2016. Each manufacturer shall notify the Board of Pharmacy of the drugs so designated and the
measure or measures used in designating its drugs to be serialized, and shall include in the
notification the technology to be used to meet the serialized electronic pedigree requirements. The
notification process for these specific actions may be specified by the board.
(d) For purposes of designating drugs to be serialized as required by subdivisions (b) and (c),
manufacturers shall select from any of the following measures:
(1) Unit volume.
(2) Product package (SKU) type.
(3) Drug product family.
(e) Drugs not subject to compliance with the pedigree requirements set forth in Sections 4034
and 4163 under this section shall not be subject to the provisions of subdivisions (c), (d), (e), and
(f) of Section 4163.
4164. Reports Required
(a) A wholesaler licensed by the board that distributes controlled substances, dangerous drugs,
or dangerous devices within or into this state shall report to the board all sales of dangerous drugs
and controlled 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 dispense
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 customer, 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. Each wholesaler shall have the tracking system required by
this subdivision in place no later than January 1, 2006.
(c) Upon written, oral, or electronic request by the board, a wholesaler shall furnish data tracked
pursuant to subdivision (b) to the board in written, hardcopy, or electronic form. The board shall
specify the dangerous drugs, the customers, or both the dangerous drugs and customers for which
data are to be 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 drugs at prices below the market wholesale price for those drugs.
(e) This section shall become operative on January 1, 2006.
4165. Sale or Transfer of Dangerous Drug or Device Into State: Furnishing Records to
Authorized Officer on Demand; Citation for Non-Compliance
A wholesaler licensed by the board who sells 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 records or other documentation of that sale or transfer.
4166. Shipping of Dangerous Drugs or Devices – Wholesaler or Distributor Liable for
Security and Integrity Until Delivery
(a) Any wholesaler that uses the services of any carrier, including, but not limited to, the United
States Postal Service or any common carrier, shall be liable for the security and integrity of any
dangerous drugs or dangerous devices through that carrier until the drugs or devices are delivered
to the transferee at its board-licensed premises.
(b) Nothing in this section is intended to affect the liability of a wholesaler or other distributor
for dangerous drugs or dangerous devices after their delivery to the transferee.
4167. Wholesaler: Bar on Obtaining Dangerous Drugs or Devices it Cannot Maintain on
Licensed Premises
A wholesaler shall not obtain, by purchase or otherwise, any dangerous drugs or dangerous
devices that it cannot maintain, in a secure manner, on the premises licensed by the board.
4168. Board License Required for Local Business License
A county or municipality may not issue a business license for any establishment that requires a
wholesaler license unless the establishment possesses a current wholesaler license issued by the
board. For purposes of this section, an "establishment" is the licensee's physical location in
California.
4169. Prohibited Acts
(a) A person or entity may not do any of the following:
(1) Purchase, trade, sell, or transfer dangerous drugs or dangerous devices at wholesale with a
person or entity that is not licensed with the board as a wholesaler or pharmacy.
(2) Purchase, trade, sell, or transfer dangerous drugs that the person knew or 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 person knew or reasonably should
have known were misbranded, as defined in Section 111335 of the Health and Safety Code.
(4) Purchase, trade, sell, or transfer dangerous drugs or dangerous devices after the beyond use
date on the label.
(5) Fail to maintain records of the acquisition or disposition of dangerous drugs or dangerous
devices for at least three years.
(b) Notwithstanding any other provision of law, a violation of this section or of subdivision (c)
or (d) of Section 4163 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.
(c) Amounts due from any person under this section shall be offset as 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 Health Services.
(e) This section shall become operative on January 1, 2008.
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
place 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 dangerous 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 dangerous 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 chapter, and all of the packaging
requirements of good pharmaceutical practice, 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.
(8) 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 described in Section 2836.1, or protocol, a physician assistant who functions pursuant
to Section 3502.1, or a 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 Bureau of Naturopathic
Medicine, the Dental Board of California, the Osteopathic Medical Board of 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 boards are specifically charged with the enforcement of this chapter with
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 medicine, a license
to practice dentistry, a license to practice veterinary medicine, or a certificate to practice podiatry,
and who is duly registered by the Medical Board of California, the State Board of Optometry, the
Bureau of Naturopathic Medicine, the Dental Board of California, the Veterinary Medical Board,
or the Board of Osteopathic Examiners of this state.
4170.5. Veterinarian in Teaching Hospital May Dispense and Administer Dangerous Drugs
and Devices; Requirements
(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 hospital 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,
recordkeeping, packaging, labeling, and dispensing occur in a manner that is consistent with the
promotion and protection of the health and safety of the public.
(c) The veterinary teaching hospital's pharmacist-in-charge shall develop policies, procedures,
and guidelines that recognize the unique relationship 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 administering drugs
pursuant to this section.
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 samples by a
prescriber, if the prescriber dispenses the samples to the patient in 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.
(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 the Health and Safety Code, or to a prescriber
dispensing parenteral 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 drugs to be dispensed
in an area that is secure. The Medical Board of 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 pursuant to Section 2725.1.
4174. Dispensing by Pharmacist Upon Order of Nurse Practitioner
Notwithstanding any other provision of law, a pharmacist may dispense drugs or devices upon
the drug order of a nurse practitioner functioning pursuant to Section 2836.1 or a certified nurse-
midwife functioning pursuant to Section 2746.51, a 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 4052.1, 4052.2, or 4052.3.
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 Osteopathic Medical Board of California,
the Board of Registered Nursing, the Bureau of Naturopathic Medicine, or the Physician
Assistant Committee, all complaints 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 injury 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 Board of California, the State Board of Optometry, the Osteopathic
Medical Board of California, the Bureau of Naturopathic Medicine, the Board of Registered
Nursing, the Veterinary Medical Board, or the Physician Assistant Committee as a case of
greatest potential harm to a patient.
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 following 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 paragraph (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 recognized 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 open 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 of 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, administered,
and dispensed, and the records shall be available and maintained 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 separate 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.
4181. License 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 Department of Health Services
relating to the drug distribution service to ensure 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 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 consulting pharmacist, the professional director, and the clinic administrator.
(b) The dispensing of drugs 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 Required
(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 professional director's responsibilities, a consulting
pharmacist shall be retained to approve the policies and procedures in conjunction with the
professional 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 agreement of all the parties approving the policies and
procedures.
(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 years 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 podiatrist acting in his or her capacity as a
director in a clinic where only dental 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 Dispensing 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 Welfare and Institutions Code).
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 II drug to the extent permitted by law.
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 Systems
(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 written 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 drug 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 drug reactions. Drugs removed from the automated drug
delivery system shall be provided to the patient by a health professional licensed pursuant to this
division.
(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 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 transaction records in order to verify the security and
accountability of the system.
(e) The automated drug delivery system used at the clinic shall provide for 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.
(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 of drugs into and out
of the system for security, accuracy, and accountability.
Article 14. Surgical Clinics
4190. Purchase of Drugs at Wholesale: Permitted Uses of Drugs; Required Records and
Policies; License Required
(a) Notwithstanding any provision of this chapter, a surgical clinic, as defined in paragraph (1)
of subdivision (b) of Section 1204 of the Health and Safety Code may purchase drugs at
wholesale for administration or dispensing, under the direction of a physician, to patients
registered for care at the clinic, as provided in subdivision (b). 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.
(b) The drug distribution service of a surgical clinic shall be limited to the use of drugs for
administration to the patients of the surgical 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, inhalation, ingestion, or any other means, to the body
of a patient for his or her immediate needs.
(c) No surgical clinic shall operate without a license issued by the board nor shall it be entitled
to the benefits of this section until it has obtained a license from the board. A separate 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.
(d) 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.
4191. Compliance With Department of Health Services Requirements; Who 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 Health Services 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 consulting 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 lawfully authorized to dispense
drugs, and only in compliance with all 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 show evidence that
the professional director is responsible for the safe, orderly, 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 conjunction with the professional 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 agreement of all the parties approving the policies and procedures.
(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 years 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 podiatrist acting in his or her capacity as a
director in a clinic where only dental 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.
4193. Clinic Not Eligible for Professional Dispensing Fee; Ban on Offering Drugs for Sale
No clinic holding a license 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 Welfare and Institutions Code). No clinic holding a
license pursuant to this article shall offer drugs for sale or shall charge or bill for professional
services for the dispensing or administering of drugs.
4194. Dispensing of Schedule II Substance by Clinic Prohibited; Physician May Dispense;
Administration Authorized 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 Safety Code and all other provisions of law, nor does it
prevent the lawful administration of Schedule II drugs on the premises of the clinic.
4195. Inspection Authorized
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 and all other provisions of the law.
Article 15. Veterinary Food-Animal Drug Retailers
4196. License Required: Temporary Licenses; Persons Authorized in Storage Area; Other
Requirements; Board Approval of Designated Representative-in-Charge
(a) No person shall conduct a veterinary food-animal drug retailer in the State of California
unless he or she has obtained a license from the board. A license shall be required for each
veterinary food-animal drug retailer owned or 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 one 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 representative, an
authorized officer of the law, or a person authorized to 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 designated
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 veterinary food-animal drug retailer.
(d) Every veterinary food-animal drug retailer shall be supervised or managed by a designated
representative-in-charge. The designated representative-in-charge shall be responsible for the
veterinary food-animal drug retailer's compliance with state and federal laws governing
veterinary food-animal drug retailers. As part of its initial application for a license, and for each
renewal, each veterinary food-animal drug retailer shall, on a form designed by the board, provide
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 the board. The board shall not issue or
renew a veterinary food-animal drug retailer license without identification of an approved
designated representative-in-charge for the veterinary food-animal drug retailer.
(e) Every veterinary food-animal drug retailer shall notify the board in 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 or pharmacist to take over as the
designated representative-in-charge. The proposed replacement designated representative-in-
charge shall be subject to approval by the board. If disapproved, the veterinary food-animal drug
retailer shall propose another replacement within 15 days of the date of disapproval, and shall
continue to name proposed replacements until a designated representative-in-charge is approved
by the board.
(f) For purposes of this section, designated representative-in-charge means a person granted a
designated representative license pursuant to Section 4053, or a registered pharmacist, who is the
supervisor or manager of the facility.
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 equipment 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.
(c) When, in the opinion of the board, a high standard of patient safety 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 retailer, the board may waive any licensing requirements.
4198. Written Policies and Procedures Required: Contents; Training of Personnel; Quality
Assurance; Consulting Pharmacist
(a) Each veterinary food-animal drug retailer shall have written policies and procedures related
to the handling and dispensing of veterinary food-animal 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 for
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 not limited to:
(1) Monitoring personnel performance.
(2) Storage, maintenance, and dispensing of veterinary food-animal drugs.
(d) The records and documents specified in subdivisions (a) and (b) shall be maintained for three
years from the date of making. 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 operations of the
veterinary food-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 revise the policies and procedures of
the veterinary food-animal drug retailer, and assure compliance with California and 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 or not the
veterinary food-animal drug retailer is operating in compliance with 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
(a) Any veterinary food-animal drug dispensed pursuant to a prescription from a licensed
veterinarian for food producing animals from a veterinary 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 following
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-educated
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 semester 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.
(5) Has completed 1,500 hours of pharmacy practice experience or the equivalent in
accordance with Section 4209.
(6) Has passed a written and practical examination given by the board prior to December 31,
2003, or 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 licensure 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.
4200.1. Multiple Failures of License Examination; Additional Education Requirements
[Repeals 1-1-2010]
(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 Pharmacists 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 she successfully completes, at minimum, 16
additional semester units of 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 California Practice
Standards and Jurisprudence Examination for Pharmacists.
(f) From January 1, 2004, to July 1, 2008, inclusive, the board shall collect data on the
applicants who are admitted to, and take, the licensure examinations required by Section 4200.
The board shall report to the Joint Committee on Boards, Commissions, and Consumer Protection
before September 1, 2008, regarding the impact on those applicants of the examination
limitations imposed by this section. The report shall include, but not be limited to, the following
information:
(1) The number of applicants taking the examination and the number who fail the examination
for the fourth time.
(2) The number of applicants who, after failing the examination for the fourth time, complete a
pharmacy studies program in California or another state to satisfy the requirements of this section
and who apply to take the licensure examination required by Section 4200.
(3) To the extent possible, the school from which the applicant graduated and the school's
location and the pass/fail rates on the examination for each school.
(g) This section shall remain in effect only until January 1, 2010, and as of that date is repealed,
unless a later enacted statute, that is enacted before January 1, 2010, deletes or extends that date.
4200.2. California Practice Standards and Jurisprudence Examination for Pharmacists;
Required Inclusions
When developing the California Practice Standards and Jurisprudence Examination 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 California, including, but
not limited to, the provision of pharmacist care and the application of clinical knowledge to
typical pharmacy practice situations that are not evaluated by the North American Pharmacy
Licensure Examination.
4200.3. Examination Process to be Reviewed Regularly; Required 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 Testing and the Federal Uniform Guidelines for Employee
Selection Procedures. The board shall work with the Office of Professional Examination Services
of the department or with an equivalent organization who shall certify at minimum once every
five years that 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.
(e) The board shall annually publish the pass and fail rates for the pharmacist's 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 Joint 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 examination. 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 Failure; Waiting Period
An applicant who fails the national examination may not retake the examination for at least 90
days or for a period established by regulations adopted by the board in consultation with the
Office of Professional Examination Services of the department.
4200.5. Retired Licensee: Eligibility; Bar on Practice; Requirement for Restoration 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 whose license has been revoked.
(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 pharmacist holding a retired license shall
be permitted to use the titles "retired 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 active 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, or veterinary food-animal drug retailer,
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 other than
a natural person, the application shall state the information as to each person beneficially
interested therein.
(b) As used in this section, and 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 no natural person shall 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) In any case where the applicant is a partnership or other unincorporated association, is a
limited liability company, or is a corporation, and where 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 not been
convicted of a felony and has not violated any of the provisions of this 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 comply 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, or veterinary food-animal drug retailer, the executive
officer of the board shall issue a license to conduct a pharmacy, wholesaler, or veterinary food-
animal drug retailer, if all of the provisions of this chapter have been complied with.
(f) Notwithstanding any other provision of law, the pharmacy license shall authorize the holder
to conduct a pharmacy. The license shall be renewed annually and shall not be transferable.
(g) Notwithstanding any other provision of law, the wholesale license shall authorize the holder
to wholesale dangerous drugs and dangerous devices. The license shall be renewed annually and
shall not be transferable.
(h) Notwithstanding any other provision of law, the veterinary food-animal drug retailer license
shall authorize the holder thereof to conduct a veterinary food-animal drug retailer and to sell and
dispense veterinary food-animal drugs as defined in Section 4042.
(i) For licenses referred to in subdivisions (f), (g), and (h), any change in the proposed beneficial
ownership interest shall be reported to the board within 30 days thereafter upon a form to be
furnished by the board.
(j) This section shall become operative on July 1, 2001.
4202. Pharmacy Technician: License Requirements for Education, 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 equivalent, 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 the Pharmacy Technician Certification Board.
(b) The board shall adopt regulations pursuant 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 to 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 denial 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.
(e) Once licensed as a pharmacist, the pharmacy technician registration is no longer valid and
the pharmacy technician license shall be returned to the board within 15 days.
4203. Non-Profit Clinic License Application: Form; Investigation
(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 with 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 applicant 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 this 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 payment of the renewal fee prescribed in subdivision (s) of Section 4400 and 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 this 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 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, recordkeeping, 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 fee 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 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 relating 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.
(c) If the board determines that the applicant and the premises for which 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 which it is issued to purchase drugs at wholesale pursuant to
Section 4190. The 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.
(b) The board may, in its discretion, issue a license to any person authorizing 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 information 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 syringes 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.
4207. Investigation 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 this 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
those 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 necessary in carrying out this section in any application or
related form devised by the board shall not be required to be adopted by regulation pursuant to
the Administrative Procedures Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of
Division 3 of Title 2 of the Government 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
paragraphs (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 pharmacist 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 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) An intern pharmacist shall complete 1,500 hours of pharmacy practice before applying
for the pharmacist licensure examination.
(2) This pharmacy practice shall comply with the Standards of Curriculum established by the
Accreditation Council for Pharmacy Education or with regulations adopted by the board.
(b) An intern pharmacist shall submit proof of his or her experience on board-approved
affidavits, or another form specified by the board, which shall be certified under penalty of
perjury by a pharmacist under whose supervision such experience was obtained or by the
pharmacist-in-charge at the pharmacy while the pharmacist intern obtained the experience.
(c) An applicant for the examination who has been licensed as a pharmacist in any state for at
least one year, as certified by the licensing agency of that state, may submit this certification to
satisfy the required 1,500 hours of intern experience. 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.
Article 17. Continuing Education
4231. Requirements for Renewal of Pharmacist License: Clock 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 during 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 pharmacist 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 licensee 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 subdivision
(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 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, seminars, lectures,
conferences, workshops, extension studies, correspondence courses, and other similar methods of
conveying continuing professional pharmacy education.
(b) The subject matter shall be pertinent to the socioeconomic and legal aspects of health care,
the properties and actions of drugs and dosage forms and 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 pharmacy.
4234. Exceptions: Emergencies; Hardship
The board may, in accordance with the intent of this article, make exceptions from the
requirements of this article in emergency or hardship cases.
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 the 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
hazardous 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 board may by regulation make the category
more specific.
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 deem 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 all 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 psychiatric 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) Compliance 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
satisfactory 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.
4301. Obtaining License by Fraud or Misrepresentation; Unprofessional Conduct
The board shall take action against any holder of a license who is guilty of unprofessional
conduct or whose license has been procured by fraud or misrepresentation or issued by mistake.
Unprofessional conduct shall include, but is not limited to, any of the following:
(a) Gross immorality.
(b) Incompetence.
(c) Gross negligence.
(d) The clearly excessive furnishing of controlled substances in violation 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 determining 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 and 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 a licensee or otherwise, and
whether the act is a felony or misdemeanor or not.
(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 controlled 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 that 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 away, or
administering, or offering to sell, furnish, give away, or administer, 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 use, consumption,
or self-administration of any dangerous drug or alcoholic 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 controlled 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 circumstances surrounding the commission of the crime, in order to fix the degree of
discipline or, in the case of a conviction not involving controlled substances or dangerous drugs,
to determine if the conviction is of an offense substantially related to the qualifications, 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 person 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 with Section
801) of Title 21 of the United States Code regulating controlled 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. The record of the compromise is conclusive evidence of
unprofessional conduct.
(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.
(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 of 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 license.
(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 licensee 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.
(s) The clearly excessive furnishing of dangerous drugs by a wholesaler to a 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
primarily or solely dispenses prescription drugs to patients of long-term care facilities, the
previous ordering pattern of the pharmacy, and the general patient population to whom the
pharmacy distributes the dangerous drugs. That a wholesaler has established, and employs, a
tracking system that complies with 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 the Civil Code. For purposes of this section,
“long-term care facility” shall have the same meaning given the term in Section 1418 of the
Health and Safety Code.
4301.5. Pharmacist License; Out-of-State 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 revoked, 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 by the board sitting with an
administrative law judge, at the board's discretion. 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, or committee of the board by the pharmacist that
the out-of-state action is not a 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.
(e) If a summary suspension has been issued pursuant to this section, the 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 of a corporation where conditions exist in
relation to any person holding 10 percent or more of the corporate stock of the corporation, or
where conditions exist in relation to any officer or director of the corporation that would
constitute grounds for disciplinary action against a licensee.
4303. Nonresident Pharmacy: Grounds for Discipline
(a) The board may report any violation by a nonresident pharmacy of the laws and regulations 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 deny, revoke, or suspend a nonresident pharmacy registration, issue a citation
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 grounds upon which such action might be taken against a resident pharmacy, provided that
the grounds for the action are also grounds for action in the state in which the nonresident
pharmacy is permanently located.
4304. Nonresident Wholesaler; Authority to Discipline
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 Safety Code.
4305. Disciplinary Grounds: Failure of Pharmacy or Pharmacist to Notify Board of
Termination of Pharmacist-in-Charge; Continuing to Operate Without Pharmacist
(a) Failure by any pharmacist to notify the board in writing that he or she has ceased to act as the
pharmacist-in-charge of a pharmacy, or by any pharmacy to notify the board in writing that a
pharmacist-in-charge is no longer acting in that capacity, within the 30-day period specified in
Sections 4101 and 4113 shall constitute grounds for disciplinary action.
(b) Operation of a pharmacy for more than 30 days without supervision or management by a
pharmacist-in-charge shall constitute grounds for disciplinary action.
(c) Any person who has obtained a license to conduct a pharmacy, who willfully fails to timely
notify the board that the pharmacist-in-charge of the pharmacy has ceased to act in that capacity,
and who continues to permit the compounding or dispensing of prescriptions, or the furnishing of
drugs or poisons, in his or her pharmacy, except by a pharmacist subject to the supervision and
management of a responsible pharmacist-in-charge, shall be subject to summary suspension or
revocation of his or her license to conduct a pharmacy.
4305.5. Disciplinary Grounds: Failure of Wholesaler or Veterinary Food-Animal Drug
Retailer to Notify Board of Termination of Designated Representative-in-Charge;
Continuing to Operate Without Designated Representative-in-Charge
(a) A person who has obtained a license to conduct a wholesaler or veterinary food-animal drug
retailer shall notify the board within 30 days of the termination of employment of the designated
representative-in-charge. Failure to notify the board within the 30-day period shall constitute
grounds for disciplinary action.
(b) A person who has obtained a license to conduct a wholesaler or veterinary food-animal drug
retailer, who willfully fails to notify the board of the termination of employment of the designated
representative-in-charge, and who continues to operate the licensee in the absence of the
designated representative-in-charge for that location, shall be subject to summary suspension or
revocation of his or her license to conduct a wholesaler or veterinary food-animal drug retailer.
(c) A designated representative-in-charge of a wholesaler or veterinary food-animal drug
retailer, who terminates his or her employment at the licensee, shall notify the board within 30
days of the termination of employment. Failure to notify the board within the 30-day period shall
constitute grounds for disciplinary action.
(d) This section shall become operative on January 1, 2006.
4306. Violation of Professional Corporation Act as Unprofessional Conduct
It shall constitute unprofessional 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 provision or term of this article, the Moscone-Knox
Professional Corporation 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 pharmacy or the ownership, management, administration, or operation of
a 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 dispensing 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 appropriate patient,
prescription, and other records pertaining to the performance of any pharmacy function.
(d) Acts or omissions that involve, in whole or in part, the failure to fully maintain and retain
appropriate patient-specific information pertaining to the performance of any pharmacy function.
4306.6. Mitigating Factors for Pharmacist-in-Charge Reporting Violations of Others
If the board disciplines a pharmacist-in-charge for the violation of a state or federal law or
regulation committed by another person and the pharmacist-in-charge reported to the board that
violation or suspected violation, the board 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 that
violated any state or federal law or regulation pertaining to the practice of pharmacy.
(b) The pharmacist-in-charge did not permit, encourage, approve of, either tacitly or implicitly
or through willful ignorance, any conduct committed by another person that violated state or
federal law or regulation pertaining to the practice of pharmacy.
(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 regulation pertaining to the
practice of pharmacy as soon as reasonably possible 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, or partner of any
partnership, corporation, firm, or association whose application for a license has been denied or
revoked, is under suspension or has been placed on probation, and while acting as the manager,
administrator, owner, member, officer, director, associate, or partner 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, or partner of a licensee as follows:
(1) Where a probationary license is issued or where 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.
(b) "Manager, administrator, owner, member, officer, director, associate, or partner," as used in
this section and Section 4308, may refer to a pharmacist or to any other person who serves in that
capacity in 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 to 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 1 of
Division 3 of the Government Code. The authority to proceed as provided by this subdivision
shall be in addition to the board's authority to proceed under Section 4339 or any other provision
of law.
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, or partner of a licensee as provided by Section 4307, the board shall,
in each case where it has that information, notify in writing each licensee for whom the person is
a manager, administrator, owner, member, officer, director, associate, or partner of the
prohibition. The board shall send the notification to the licensee's address 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 revoked 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 effective 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 condition, 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 recommendations 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 the board may assign the
petition to an administrative law judge. Where the 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 Government
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.
(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 Government Code finds necessary.
(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 sentence 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 probation pending against the person. The board may 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 otherwise 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. Notice of Denial of Application: Petition for Licensure; Application 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, the applicant may present his or her
written petition for a license to the board. 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.
4311. 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 person 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 automatically
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 summarily 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:
(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 affirmed 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 right 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.
(5) The hearing shall be before an administrative law judge, a committee of 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 review by the board, at its discretion. The hearing shall
be limited to (A) 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 chapter; provided that if an accusation under Chapter 5 (commencing with 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 case.
(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) Upon 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 penalty heard as provided in
paragraph (2) of subdivision (d).
(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
accusation 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 Division 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 the 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 under Chapter 5
(commencing with 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 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 appears 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 Section 1203.4 of the Penal Code allowing the person to withdraw his or
her 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.
(2) The issue of penalty shall be heard by an administrative law judge sitting 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
of 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 to have the issue of penalty decided before
those time periods have elapsed. 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
substantially related to the qualifications, functions, or duties of the licensee. If 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 prohibit 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
any 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 Section 11500) of Part 1 of Division 3 of Title 2 of the Government
Code. A 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 shall 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 Section 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 postconviction 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 United States. A conviction includes a plea or
verdict of guilty or a conviction 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 officer of the board.
4312. Voiding License of Entity Remaining Closed: Notice; Disposition of Stock;
Distribution of Proceeds Where Board Sells Stock
(a) The board may cancel the license of a wholesaler, pharmacy, or veterinary food-animal drug
retailer if the licensed premises remain closed, as defined in subdivision (e), other than by order
of the board. For good cause shown, the board may cancel a license after a shorter period of
closure. To cancel 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.
(b) In the event that the license of a wholesaler, pharmacy, or veterinary food-animal drug
retailer is cancelled pursuant to subdivision (a) or revoked pursuant to Article 19 (commencing
with Section 4300), or a wholesaler, pharmacy, or veterinary food-animal drug retailer notifies
the board 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 controlled substances or
dangerous devices to another licensee authorized to possess the dangerous drugs and controlled
substances or dangerous devices. The licensee transferring the dangerous drugs and controlled
substances or dangerous devices shall immediately confirm in writing to the board that the
transfer has taken place.
(c) If a wholesaler, pharmacy, or veterinary food-animal drug retailer fails to comply with
subdivision (b), the board may seek and obtain an order from the superior court in the county in
which the wholesaler, pharmacy, or veterinary food-animal drug retailer is located, authorizing
the board to enter the wholesaler, pharmacy, or veterinary food-animal drug retailer and inventory
and store, transfer, sell, or arrange for the sale of, all dangerous drugs and controlled substances
and dangerous devices found in the wholesaler, pharmacy, or veterinary food-animal drug
retailer.
(d) In the event that the board sells or arranges for the sale of any dangerous drugs, controlled
substances, or dangerous devices pursuant to subdivision (c), the board 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 devices. 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 personal
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,
postage 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.
(e) For the 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 issue 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 (commencing with Section 150200) of the Health and Safety
Code, in 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 citation 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 violation. 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 abatement shall be in addition to those required for
license renewal.
(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 pursuant 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 adopted 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.
(b) 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.
(c) The letter of admonishment shall inform the licensee that within 30 days of service of the
order of admonishment the licensee 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 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 legal
counsel or authorized representative of the licensee may accompany the licensee to the office
conference.
(B) Prior to or at the office conference, the licensee may submit to the executive officer
declarations and documents pertinent to the subject matter of the letter of admonishment.
(C) The office conference is intended to be an informal proceeding and shall not be subject
to the provisions of the Administrative Procedure Act (Chapter 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 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 send by certified mail to the licensee's
address of record with the board a written decision. This decision shall be deemed the final
administrative decision concerning the letter of admonishment.
(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 prejudicial abuse of discretion in the issuance
of the letter of admonishment.
(2) Comply with the letter of admonishment and submit a written 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.
(d) The letter of admonishment 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 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.
(f) Nothing in this section shall in any way limit the board's authority or 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 Article 19 (commencing with Section 4300).
Article 20. Prohibitions and Offenses
4320. Penalties for Violation of Pharmacy Law: Actions Authorized; Who May File Actions
(a) The penalties prescribed in this chapter 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 this 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.
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 fine 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.
(b) In all other instances, any person who violates any of the provisions of this 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).
4322. Misdemeanor or Infraction: False Representations 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 representations, 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 herself to be a
physician or other person who can lawfully prescribe the drug, or 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 county jail for not
more than one year.
4324. Felony or Misdemeanor: Forgery of Prescription; Possession of Drugs Obtained
Through Forged Prescription
(a) Every person who signs the name of another, or of a fictitious person, or falsely makes,
alters, forges, utters, publishes, passes, or attempts to pass, as genuine, any prescription for any
drugs is guilty of forgery and upon conviction thereof shall be punished by imprisonment in the
state prison, or by imprisonment in the 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 in the state prison, or by imprisonment 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 dispense, administer, or 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 the person's profession, shall knowingly and willfully manufacture, copy,
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, veterinarian, 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 of 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 causes, 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 thousand
dollars ($1,000), or by imprisonment in a county jail not exceeding one year, or both a fine and
imprisonment.
4327. Misdemeanor: Sale, Dispensing, or Compounding While Under the Influence of
Drugs or Alcoholic Beverages
Any person who, while on duty, sells, dispenses or compounds any drug while 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 provided 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.
4329. Misdemeanor: Non-Pharmacist Acting as Manager, Compounding, 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 chapter, is guilty of a misdemeanor.
4330. Misdemeanor: Non-Pharmacist Owner Failing to Place Pharmacist in Charge,
Dispensing or Compounding Except by Pharmacist, Interfering with Pharmacist-in-Charge
(a) Any person who has obtained a license to conduct a pharmacy, who fails to 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
his or her pharmacy, except by a pharmacist, or as otherwise provided in this chapter, is guilty of
a misdemeanor.
(b) Any pharmacy owner who commits any act that would subvert or tend to subvert the efforts
of the pharmacist-in-charge to comply with the laws 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
(a) A person who is neither a pharmacist nor a designated representative and who takes charge
of a wholesaler or veterinary food-animal drug retailer or who dispenses a prescription or
furnishes dangerous devices except as otherwise provided in this chapter is guilty of a
misdemeanor.
(b) A person who has obtained a license to conduct a veterinary food-animal drug retailer and
who fails to place in charge of that veterinary food-animal drug 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.
(c) A person who has obtained a license to conduct a wholesaler and who 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 dangerous drugs or dangerous devices,
except by a pharmacist or designated representative, or as otherwise provided in this chapter, is
guilty of a misdemeanor.
(d) This section shall become operative on January 1, 2006.
4332. Misdemeanor: Failure or Refusal to Maintain or Produce Required Drug or Device
Records; Willful Production of False Reports
Any person who fails, neglects, or refuses to maintain the records 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 of Prescriptions, Other
Records as Misdemeanor
(a) All prescriptions filled by a pharmacy and all other records required by 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, these 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).
(c) (1) Notwithstanding subdivisions (a) and (b), the board may, upon written 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 licensed 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 any other provision of this chapter.
4335. Knowingly Failing to Arrange for Disposition of Stock of Closed or 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, 4077, 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. Distribution 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 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 with Section 1463.23 of the Penal Code. The court shall,
however, take into 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 Law; 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 requirements 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 damage or loss. The
action shall be brought in the name of the people of the 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 the 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 administrative, civil, or criminal action.
4340. Unlawful Advertising by Nonresident Pharmacy Not Registered with Board
It is unlawful for any nonresident pharmacy that is not registered pursuant to Section 4112 or for
any person who is a resident of this state to advertise the 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.
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 and 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 4336 and 4321.
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 connection with it a
sign bearing the word or words "Pharmacist," "Pharmacy," "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
prescription sign (Rx) or similar design, unless there is upon or within the 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 pharmacists 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
pharmacists 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 recovery 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 pharmacists 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.
(2) The pharmacist or intern pharmacist voluntarily elects to enter the pharmacists recovery
program.
(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 into the pharmacists recovery program or on information
obtained from the 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 information 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
(a) The board shall establish criteria for the participation of pharmacists and 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
The functions of the contractor administering the pharmacists recovery program shall include,
but not be limited to, the following:
(a) To evaluate those pharmacists and intern pharmacists who request participation in the
program.
(b) To develop a treatment contract with each participant in the pharmacists 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;
Termination for Non-Compliance; Report to Board of Termination When Public Safety
Threatened; 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 pharmacists recovery
program may result in the termination of the 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 preclude 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 pharmacists
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 to established guidelines and to
develop treatment contracts and evaluate 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 pharmacist 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 records 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 pharmacist 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 pursuant 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).
(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 purchases 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; Private 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 enforceable 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 this 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 her
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 this section. In
any action under this article in which judgment is entered 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 may, in its discretion,
include any other restraint it deems expedient in order to 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.
4382. Board May Audit Sales to Walk-In Customers
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 health care service plan, those audits
may be undertaken solely by the Department of Managed Health Care pursuant to its authority to
audit those plans.
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:
(a) The fee for a nongovernmental pharmacy license shall be four hundred dollars ($400) and
may be increased to five hundred twenty dollars ($520). 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).
(b) The fee for a nongovernmental pharmacy license annual renewal shall be two hundred fifty
dollars ($250) and may be increased to three hundred twenty-five dollars ($325).
(c) The fee for the pharmacist application and examination shall be two hundred dollars ($200)
and may be increased to two hundred sixty dollars ($260).
(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 refunded.
(e) The fee for a pharmacist license and biennial renewal shall be one hundred fifty dollars
($150) and may be increased to one hundred ninety-five dollars ($195).
(f) The fee for a nongovernmental wholesaler license and annual renewal shall be six hundred
dollars ($600) and may be increased to seven hundred eighty dollars ($780). The application fee
for any additional location after licensure of the first 20 locations shall be two hundred twenty-
five dollars ($225) and may be increased to three hundred dollars ($300). A temporary license fee
shall be five hundred fifty dollars ($550) and may be increased to seven hundred fifteen dollars
($715).
(g) The fee for a hypodermic license and renewal shall be one hundred twenty-five dollars
($125) and may be increased to one hundred sixty-five dollars ($165).
(h) (1) The fee for application, investigation, and issuance of license as a designated
representative pursuant to Section 4053 shall be two hundred fifty-five dollars ($255) and may be
increased to three hundred thirty dollars ($330).
(2) The fee for the annual renewal of a license as a designated representative shall be one
hundred fifty dollars ($150) and may be increased to one hundred ninety-five dollars ($195).
(i) (1) The fee for the application, investigation, and issuance of a license as a designated
representative for a veterinary food-animal drug retailer pursuant to Section 4053 shall be two
hundred fifty-five dollars ($255) and may be increased to three hundred thirty dollars ($330).
(2) The fee for the annual renewal of a license as a designated representative for a veterinary
food-animal drug retailer shall be one hundred fifty dollars ($150) and may be increase to one
hundred ninety-five dollars ($195).
(j) (1) The application fee for a nonresident wholesaler’s license issued pursuant to Section 4161
shall be six hundred dollars ($600) and may be increased to seven hundred eighty dollars ($780).
(2) For nonresident wholesalers who have 21 or more facilities operating nationwide the
application fees for the first 20 locations shall be six hundred dollars ($600) and may be increased
to seven hundred eighty dollars ($780). The application fee for any additional location after
licensure of the first 20 locations shall be two hundred twenty-five dollars ($225) and may be
increased to three hundred dollars ($300). A temporary license fee shall be five hundred fifty
dollars ($550) and may be increased to seven hundred fifteen dollars ($715).
(3) The annual renewal fee for a nonresident wholesaler's license issued pursuant to Section
4161 shall be six hundred dollars ($600) and may be increased to seven hundred eighty dollars
($780).
(k) The fee for evaluation of continuing education courses for accreditation 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 license shall be ninety dollars ($90) and may be increased to
one hundred fifteen dollars ($115). 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.
(n) The fee for the reissuance of any license, or renewal thereof, that has been 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).
(p) It is the intent of the Legislature that, in setting fees pursuant to this 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 four hundred dollars
($400) and may be increased to five hundred twenty dollars ($520) for each license. The annual
fee for renewal of the license shall be two hundred fifty dollars ($250) and may be increased to
three hundred twenty-five dollars ($325) for each license.
(r) The fee for the issuance of a pharmacy technician license shall be eighty dollars ($80) and
may be increased to one hundred five dollars ($105). The fee for renewal of a pharmacy
technician license shall be one hundred dollars ($100) and may be increased to one hundred thirty
dollars ($130).
(s) The fee for a veterinary food-animal drug retailer license shall be four hundred five dollars
($405) and may be increased to four hundred twenty-five dollars ($425). The annual renewal fee
for a veterinary food-animal drug retailer license shall be two hundred fifty dollars ($250) and
may be increased to three hundred twenty-five dollars ($325).
(t) The fee for issuance of a retired license pursuant to Section 4200.5 shall be thirty-five dollars
($35) and may be increased to forty-five dollars ($45).
(u) The fee for issuance or renewal of a nongovernmental license to compound sterile drug
products shall be six hundred dollars ($600) and may be increased to seven hundred eighty
dollars ($780). The fee for a temporary license shall be five hundred fifty dollars ($550) and may
be increased to seven hundred fifteen dollars ($715).
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 board,
within the limits prescribed by this chapter. In return for the payment of the renewal fee, a
certificate of renewal shall be issued.
4402. Cancellation: Of Pharmacist After Non-Renewal for Three Years; All Other Licenses
After 60 Days
(a) Any pharmacist 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 pursuant 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.
(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.
(d) This section shall not affect the authority of the board to proceed with any 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 expiration. 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 required 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 person 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 the license has not been lost or destroyed, upon the surrender of the old license.
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 State Controller and at the same time the
entire amount shall be paid into the State Treasury and shall be credited to the Pharmacy Board
Contingent Fund which is hereby created. This contingent fund shall be for the use of the board
and out of it and not otherwise shall be paid all expenses of the board.
4407. Compensation 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 the 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 of
Division 107 of the Health and Safety Code. The contribution submitted 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. Prescription Rates for Medicare Beneficiaries
4425. Pharmacy Participation in Medi-Cal Program; Conditions; Department of Health
Services Utilization Review and Monitoring
(a) As a condition for the participation of a pharmacy in the Medi-Cal program pursuant 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 Services to cover electronic transmission charges. However, Medicare beneficiaries shall
not be allowed to use the Medi-Cal reimbursement rate for over-the-counter medications or
compounded prescriptions.
(b) The State Department of Health Services shall provide a mechanism to calculate and
transmit the price to the pharmacy, but shall not apply the Medi-Cal drug utilization review
process for purposes of this section.
(c) The State Department of Health Services shall monitor pharmacy participation with the
requirements of subdivision (a).
(d) The State Department of Health Services shall conduct an outreach program to inform
Medicare beneficiaries of their right to participate in the program described in subdivision (a),
including, but not limited to, the following:
(1) Including on its Internet Web site the Medi-Cal reimbursement rate for, at 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 department's telephone number, e-mail address, and Internet Web site address 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 the 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.
4426. Department of Health Services to Study Reimbursement Rates
The State Department of Health Services shall conduct a study of the adequacy of Medi-Cal
pharmacy reimbursement rates including the cost of providing prescription drugs and services.
OTHER IMPORTANT SECTIONS OF THE BUSINESS & PROFESSIONS CODE
125.3. Recovery of Investigation and Enforcement Costs: Procedures; Proof; Enforcement
(a) Except as otherwise provided by law, in any order issued in resolution of a disciplinary
proceeding before any board within the department or before the Osteopathic Medical Board,
upon request of the entity bringing the proceeding, the administrative law judge may direct a
licentiate 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 partnership, 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 actual costs are
not available, signed by the entity bringing the proceeding or its 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 limited 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 administrative 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 costs 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 repayment in any appropriate court. This
right of enforcement shall be in 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 payment.
(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 agreement with the board to reimburse the board within
that one-year period for 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 shall 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, investigation and prosecution costs for a
disciplinary proceeding against the licentiate. The board shall ensure that this subdivision is
revenue neutral with 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 initial 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 Section 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 appropriate, 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 assessing a fine, the board, bureau, or commission shall give due consideration 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 commission within 30 days of the date of issuance of the
citation or assessment. 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 pursuant to
Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 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 fine.
(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.
(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) Administrative fines collected pursuant to this section shall be deposited in the special fund
of the particular board, bureau, or commission.
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 establish, 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 citation system authorized by this section shall meet the requirements of 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 establishment of an administrative citation system
for unlicensed activity does not preclude the use of other enforcement statutes for unlicensed
activities at the discretion of the board, bureau, or commission.
460. Licensed Department of Consumer Affairs Businesses
(a) No city or county shall prohibit a person or group of persons, authorized by one of the
agencies in the Department of Consumer Affairs by a license, certificate, or other such means to
engage in a particular business, from engaging in that business, occupation, or profession or any
portion thereof.
(b) No city, county, or city and county shall prohibit a healing arts professional licensed with the
state under Division 2 (commencing with Section 500) from engaging in any act or performing
any procedure that falls within the professionally recognized scope of practice of that licensee.
(1) 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 procedure that falls within the professionally
recognized scope of practice of a healing arts professional licensed under Division 2
(commencing with Section 500).
(2) This subdivision shall not be construed to prevent a city, county, or city and county from
adopting or enforcing any local ordinance governing zoning, business licensing, or reasonable
health and safety requirements for establishments of businesses of a healing arts professional
licensed under Division 2 (commencing with Section 500).
(c) Nothing in this section shall prohibit any city, county, or city and county 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.
480. Denial of Licenses
(a) A board may deny a license regulated by this code on the grounds that the 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
granting probation is made suspending the imposition of sentence, irrespective of a subsequent
order under the provisions of Section 1203.4 of the Penal Code.
(2) Done any act involving dishonesty, fraud, or deceit with the intent to substantially benefit
himself or herself or another, or substantially injure 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 deny 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.
(b) Notwithstanding any other provision of this code, no person shall be 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 that 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) A board may deny a license regulated by this code on the ground that the applicant
knowingly made a false statement of fact required to be revealed in the application for the license.
650. Rebates or Discounts for Referral Prohibited
(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 Initiative Act of any rebate, refund, commission, preference,
patronage 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, proprietary 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 of 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 value of any premises or equipment leased or provided by the recipient to the 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
availability, 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 Section 1400) of Division 2 of the
Health and Safety Code and in Sections 654.1 and 654.2 of this code, it shall not be unlawful for
any person licensed under this division to refer a person to any laboratory, pharmacy, clinic
(including entities exempt 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 licensee'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 Division 2 of the
Health and Safety Code and in Sections 654.1 and 654.2 of this code, it shall not be unlawful to
provide nonmonetary remuneration, in the form of hardware, software, or information technology
and training services, as described in subsections (x) and (y) of Section 1001.952 of Title 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 psychiatric 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) 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 imprisonment in the state prison,
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 in the state prison or by
imprisonment in the state prison 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 person or
corporation prohibited from pharmacy permit ownership by 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) the 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
compliance 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 or 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 amounts not in excess of the prevailing charges in similar hospitals in the 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 enforcement 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 responsibility of both lessee
and lessor, and shall be grounds for disciplinary action or other sanctions against both.
651. Professional Advertising Requirements
(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 professional 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, television, 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 includes a statement
or claim that does any of the following:
(1) Contains a misrepresentation of fact.
(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,
including 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 photograph 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 paragraph, a model is anyone other than an actual patient,
who has undergone 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, or 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
comparable 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.
(4) Relates to fees, other than a standard consultation fee or a range of fees for 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 substantiated 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
because 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 refers 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 comparison. 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 price for each product or service shall be clearly
identifiable. The price advertised for products shall include charges for any related professional
services, including dispensing and fitting services, unless the advertisement specifically and
clearly indicates otherwise.
(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 list, medical directory listing, or a
similar professional notice or device if it 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 defense 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.
(3) A statement of office hours regularly maintained by the practitioner.
(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 practitioner 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 recognition 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 advertise 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 organization shall condition
membership or credentialing of its members upon all of the following:
(I) Successful completion of a formal, full-time advanced education program that is
affiliated with or sponsored by a university based dental school and is beyond the dental degree at
a graduate or postgraduate level.
(II) Prior didactic training and clinical experience in the specific area of dentistry that is
greater than that of other dentists.
(III) Successful completion of oral and written examinations based on psychometric
principles.
(iii) Notwithstanding the requirements of clauses (i) and (ii), a dentist who lacks
membership in or certification, diplomate status, other similar credentials, or completed advanced
training approved as bona fide either by an American 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 from 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 Section 2000) by
the Medical Board of California may include a statement that 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 not 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 licensing 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 use the term "board certified" in reference to that certification, unless the
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 name of the certifying
board is also used and given comparable prominence 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.
For purposes of the term "board certified," as used in this subparagraph, the terms "board" and
"association" mean an organization that is an American Board of Medical Specialties member
board, an organization with equivalent requirements approved by a physician and surgeon's
licensing board, or an organization with an Accreditation 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 each 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 operative 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 podiatric 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, including,
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,
(ii) is a board or association with equivalent requirements approved by the 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
the 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 who 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.
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 California Board of Podiatric Medicine, for certifying doctors of podiatric medicine that is
based on the applicant's education, training, 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
requirements 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 Treasury in the Podiatry Fund, pursuant to Section
2499. 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 postgraduate 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 practitioner, 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 accepts 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 name, color,
size, or type of commodities advertised.
(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), or (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 Government 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 determining 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, the manner in which defined services may
be advertised, and 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 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 violation of this section and seek
other appropriate relief to enforce this section. Notwithstanding any other provision of law, the
costs of enforcing this section to the respective licensing boards or committees may be awarded
against any licensee found to be in violation of any provision of this section. This shall not
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, and
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 violation 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 this 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 provided 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
exceeding two thousand five hundred dollars ($2,500), or by both the imprisonment and fine.
733. Dispensing Prescription Drugs and Devices
(a) No licentiate shall obstruct a patient in obtaining a prescription drug or device that has been
legally prescribed or ordered for that patient. A violation 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 provision of 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 judgment, 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) Immediately 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.
(B) Promptly transfer the prescription to another pharmacy known to stock the prescription
drug or device that is near enough to the site from which the 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 to 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 access 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 subdivision (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) The provisions of this section shall apply to the drug therapy described in Section 4052.3.
(e) This section imposes no duty on a licentiate to dispense a drug or device pursuant to a
prescription or order without payment for the drug or device, including payment directly by the
patient or through a third-party payer 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 that describes
patients' rights relative to the requirements of this section.
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 public 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 disseminated from this state
before the public in any state, in any newspaper or 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, professional
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 reasonable care should be known, to be untrue or misleading, or for any person,
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 to sell that personal property or those
services, professional or otherwise, so 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 five hundred
dollars ($2,500), or by both that imprisonment and fine.
CALIFORNIA CODE OF REGULATIONS
DIVISION 17, TITLE 16
Article 1. General Provisions
Section
1703. Delegation of Certain Functions
1704. Change of Address
1705. Notification of Bankruptcy, Receivership or Liquidation
1706. Words of Similar Import
1706.1. Permit Processing Times
1706.2. Abandonment of Application Files
1706.5. Experimental Programs
Article 2. Pharmacies
1707. Waiver Requirements for Off-Site Storage of Records
1707.1. Duty to Maintain Medication Profiles (Patient Medication Records)
1707.2. Notice to Consumers and Duty to Consult
1707.3. Duty to Review Drug Therapy and Patient Medication Record Prior to Delivery
1707.4. Procedures for Refill Pharmacies
1708.2. Discontinuance of Business
1708.3. Radioactive Drugs
1708.4. Pharmacist Handling Radioactive Drugs
1708.5. Pharmacy Furnishing Radioactive Drugs
1709. Names of Owners and Pharmacist in Charge
1709.1. Designation of Pharmacist in Charge
1710. Hospital Pharmacy
1711. Quality Assurance Programs
1712. Use of Pharmacist Identifiers
1713. Receipt and Delivery of Prescriptions and Prescription Medications Must be to or from
Licensed Pharmacy
1714. Operational Standards and Security
1714.1. Pharmacy Operations During 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
1715.6. Reporting Drug Loss
1716. Variation from Prescriptions
1717. Pharmacy Practice
1717.1. Common Electronic Files
1717.3. Preprinted, Multiple Check off Prescription Blanks
1717.4. Electronic Transmission of Prescriptions
1718. Current Inventory Defined
1718.1 Manufacturer’s Expiration Date
Article 3. Pharmacist Candidates
Section
1719. Recognized Schools of Pharmacy
1720. Application for Pharmacist Examination and Licensure
1720.1. Graduates of Foreign Pharmacy Schools
1721. Dishonest Conduct During Examination
1723.1. Confidentiality of Examination Questions
1724. Passing Grade in Pharmacist Examination
1725. Acceptable Pharmacy Coursework for Examination Candidates with Four Failed
Attempts
1726. Supervision of Intern Pharmacists
1728. Requirements for Examination
Article 4. Continuing Education
1732. Definitions
1732.05.Accreditation Agencies for Continuing Education
1732.1. Requirements for Accredited Providers
1732.2. Board Accredited Continuing Education
1732.3. Requirements 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
1735. Compounding in Licensed Pharmacies
1735.1. Compounding Definitions
1735.2. Compounding Limitations and Requirements
1735.3. Records of Compounded Drug Products
1735.4. Labeling of Compounded Drug Products
1735.5. Compounding Policies and Procedures
1735.6. Compounding Facilities and Equipment
1735.7. Training of Compounding Staff
1735.8. Compounding Quality Assurance
Article 5. Dangerous Drugs
1744. Drug Warnings
1745. Partial Filling of Schedule II Prescriptions
1746. Emergency Contraception
Article 6. Fees
Section
1749. Fee Schedule
Article 7. Sterile Injectable Compounding
1751. Sterile Injectable; Compounding Area
1751.1. Sterile Injectable Recordkeeping Requirements
1751.2. Sterile Injectable Labeling Requirements
1751.3 Sterile Injectable Policies and Procedures
1751.4 Facility and Equipment Standards for Sterile Injectable Compounding
1751.5. Sterile Injectable Compounding Attire
1751.6. Training of Sterile Injectable Compounding Staff, Patient, and Caregiver
1751.7. Sterile Injectable Compounding Quality Assurance and Process Validation
1751.8. Sterile Injectable Compounding Reference Materials
1751.10. Furnishing to Parenteral Patient at Home
1751.11. Furnishing to Home Health Agencies and Licensed Hospices
1751.12 Obligations of a Pharmacy Furnishing Portable Containers
Referenced Title 24 Regulations
Article 8. Rules of Professional Conduct
1760. Disciplinary Guidelines
1761. Erroneous or Uncertain Prescriptions
1764. Unauthorized Disclosure of Prescriptions
1765. Commissions, Gratuities, and Rebates
1766. False or Misleading Advertising
1768. Denial of Application - Reapplication
1769. Criteria for Rehabilitation
1770. Substantial Relationship Criteria
1771. Posting of Notice of Suspension
1772. Disciplinary Condition of Suspension
1773. Disciplinary Conditions of Probation of Pharmacist
1773.5 Ethics Course Required as Condition of Probation
1774. Disciplinary Conditions of Probation of Permit
Article 9. Citations and Fines
1775. Issuing Citations
1775.1 Amount of Fines
1775.2. Factors Considered
1775.3. Compliance with Orders of Abatement
1775.4. Contested Citations
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 or Wholesaler Furnishing Drugs or Devices
1784. Self-Assessment of a Wholesaler by the Designated Representative-in-Charge
Article 10.1. Home Dialysis Drugs and Devices
1787. Authorization to Distribute Hemodialysis Drugs and Devices
1790. Assembling and Packaging
1791. Labeling
1792. Receipt for Shipment
Article 11. Ancillary Personnel
1793. Definitions
1793.1. Duties of a Pharmacist
1793.2. Duties of a Pharmacy Technician
1793.3. Other Non-Licensed Pharmacy Personnel
1793.5. Pharmacy Technician Application
1793.6. Training Courses Specified by the Board
1793.7. Requirements for Pharmacies Employing Pharmacy Technicians
1793.8. Technicians in Hospitals with Clinical Pharmacy Programs
CALIFORNIA CODE OF REGULATIONS
DIVISION 17, TITLE 16
Article 1. General Provisions
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 for hearing and perform other functions necessary to the business-like
dispatch 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 mailing 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 are hereby delegated to and conferred upon the executive officer,
or, in his or her absence from the office of the board, the acting executive officer.
Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4003 and
4311, Business and Professions Code.
1704. Change of Address
Each person holding a certificate, license, permit, registration or exemption to 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 Board 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.
1705. Notification of 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 who files a petition in
bankruptcy, or who has a receiver appointed, or who 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 writing 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;
(d) Location of records of manufacture, sale, purchase, and disposition of dangerous drugs and
devices.
Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4005, 4024,
4080, 4081 and 4332, Business and Professions Code.
1706 Words of Similar Import
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: Section 4005, Business and Professions Code. Reference: Section 4005.
1706.1 Permit Processing Times
"Permit" as defined by the Permit Reform Act of 1981 means any license, certificate, registration,
permit or any other form of authorization required by a state agency to 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 Maximum Time in
Maximum Time in
Actual License or
type
Days for Notification
Days after Filing a
Processing Time in
That an Application
Complete Application
Days
Incomplete or
in Which the Board
Based on Two-Year
Deficient; and What is Will Notify Applicant
Compilation
Needed to Correct the
of Decision
Deficiency
Min Med
Max
Pharmacist License
30
30
67 167
2,192
Foreign Graduate
30
30
154 549
Application
1,047
Intern Permit
30
60
1 4
83
Pharmacy Permit
30
60
6 72
305
Clinic Permit
30
60
20 96
325
Non-Resident
30
60
12* 56*
Pharmacy Permit
122*
Exemption Certificate
30
60
20 85
185
Hypodermic
30
60
7 87
Distributor’s Permit
258
Wholesale Drug
30
60
13 88
Permit
605
Medical Device
30 60
Retailer Permit
Medical Device
30 60
Retailer Warehouse
Permit
Out-of-State
30
60
1 21
Distributor Permit
265
*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, clinic, veterinary food-animal drug
retailer, or to furnish hypodermic 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 application
and meet all of the requirements in effect at the time of 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 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.
(c) An applicant who fails to pay the fee for licensure as a pharmacist required 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 abandoned the application and must file a new application and
be in 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 year 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.
Authority 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.
1706.5 Experimental Programs
In order to enable any accredited school of pharmacy recognized by the 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:
(a) The application of particular provisions of the Pharmacy Rules and 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
experimental 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 by 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 jeopardize 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 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 shall be granted
to any entity licensed by the board for off-site storage of the records described in subdivisions (a),
(b) and (c) of Section 4105 of the Business and Professions Code unless the applicant has, within
the preceding five years, failed to produce records pursuant to Section 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.
(d) A licensee whose 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 subdivision (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 the board may store
the records described in subdivisions (a), (b) and (c) of 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:
(1) The records are readily accessible to the pharmacist-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 so that the confidentiality
of any patient-related information is maintained.
Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4081, 4105
and 4333, Business and Professions Code.
1707.1. Duty to Maintain Medication Profiles (Patient Medication 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 medications 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 patient'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 any 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 nonprescription medications and
relevant devices, or medical conditions which are communicated by the patient or the patient's
agent.
(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 year 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 Notice to Consumers and Duty to Consult.
(a) A pharmacist shall 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 obligation 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 dispensed 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.
(2) When the patient or agent is not present (including but not limited to a 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:
(1) directions for use and storage and the importance of compliance with 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 warranted 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 for use and storage;
(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 adverse 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 such
consultation.
(f) In every pharmacy subject to the provisions of Business and Professions Code Section 4122,
there shall be prominently posted in a place conspicuous to and readable by prescription drug
consumers the following notice:
“NOTICE TO CONSUMERS”
At your request, this pharmacy will provide its current retail price of any prescription without
obligation. You may request price information in person or by telephone.
Ask your pharmacist if a lower-cost generic drug is available to fill your prescription.
Prescription prices for the same drug vary from pharmacy to pharmacy. One reason for
differences in price is differences in services provided.
Before taking any prescription medicine, talk to your pharmacist; be sure you know:
What is the name of the medicine and what does it do?
How and when do I take it – and for how long? What if I miss a dose?
What are the possible side effects and what should I do if they occur?
Will the new medicine work safely with other medicines and herbal supplements I am taking?
What foods, drinks or activities should I avoid while taking this medicine?
Ask your pharmacist if you have additional questions.
(g) In addition to the “NOTICE TO CONSUMERS” referred to in subdivision (f), every
pharmacy subject to the provisions of Business and Professions Code §4122 shall prominently
post in a place conspicuous to and readable by prescription drug consumers the following notice:
Know your rights under California law concerning medicine and devices prescribed to you.
You have the right to receive medicine and devices legally prescribed to you, unless:
1. The medicine or device is not in stock in the pharmacy,
2. The pharmacist, based upon his or her professional judgment determines providing the
item:
is against the law,
could cause a harmful drug interaction, or
could have a harmful effect on your health
This pharmacist may decline to fill your prescription for ethical, moral or religious reasons,
but the pharmacy is required to help you get the prescription filled at this or another nearby
pharmacy timely.
The pharmacy may decline to provide the medicine or device if it is not covered by your
insurance or if you are unable to pay for the item or any copayment you owe.
If the pharmacy is unable to fill your prescription, you are entitled to have the prescription
returned to you or transferred to another nearby pharmacy. Ask about our procedure to help
you get an item that we don’t have in stock.
Any questions? Ask the pharmacist!
Authority cited: Sections 4005 and 4122, Business and Professions Code. Reference: Sections
733, 4005 and 4122, Business and Professions Code.
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.
Authority 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 for 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) The 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 prescription and/or the
name and address of the pharmacy which receives 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 patient 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 prescription; and
(C) the name of the pharmacy that received the refill request.
(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 ensuring 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 construed 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: Sections 4063, 4076,
4081 and 4333, Business & Professions 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 bankruptcy
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 11205, Health and Safety Code.
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
exhibits 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 generators which
are intended to be used in the preparation of any such substance but does not include drugs such
as carbon-containing compounds, potassium-containing compounds or potassium-containing salts
which contain trace quantities of naturally occurring radionuclides.
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 preparation, 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
Board. Education and experience in non-approved programs may be granted 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, Business 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
issued 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 Section 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 personnel 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 Code. Reference:
Sections 4005, 4008 and 4008.2, Business and Professions Code.
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 annual renewal form, report the name of the
pharmacist-in-charge, the names of 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 for a change of
ownership: any transfer of a beneficial interest in a business 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 more of the beneficial interest in that license.
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 Code
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.
(b) The pharmacy owner shall vest the pharmacist-in-charge with adequate 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 pharmacies. If a
pharmacist serves as pharmacist-in- charge at two pharmacies, those 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 concurrently serving
as the designated representative-in-charge for a wholesaler or a veterinary food-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 representative of the
board with documentation of the involvement of a pharmacist-in-charge designated pursuant to
this subdivision with the pharmacy and efforts to obtain and designate a permanent pharmacist-
in-charge.
(f) A pharmacist may refuse to act as a pharmacist-in-charge at a second pharmacy if the
pharmacist determines, in the exercise of his or her 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 refuses 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 discharge, 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.
Authority cited: Section 4005, Business and Professions Code. Reference: 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 the 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.
(5) Both pharmacies shall maintain complete and accurate records of each 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 pharmacies.
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 quality 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.
(b) For purposes of this section, “medication error” means any variation from 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 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 that 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
resulted 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 as 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 the 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 review, 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 board as a mitigating
factor in the investigation and evaluation of a medication error.
(h) Nothing in this section shall be construed to prevent a pharmacy from contracting or
otherwise arranging for the provision of personnel or other resources, by a third party or
administrative offices, with such skill or expertise 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, Business 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 in 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 system pursuant to
subdivision (a) of this section shall be immediately retrievable in the pharmacy.
Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4005 and
4115, Business and Professions Code.
1713. Receipt and Delivery of Prescriptions and Prescription Medications Must be to or
from 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,
picked 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 her 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.
(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 patient requires counseling as set
forth in section 1707.2(a)(2).
(5) The pharmacy provides an immediate consultation with a pharmacist, either in-person or
via telephone, upon the request of a patient.
(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
occurred 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 dangerous drugs within
the device.
(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 that 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 maintenance 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 the device, and ensuring that patient
use of the device does not interfere with 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
section 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. Reference:
Sections 4005, 4052, 4116 and 4117 Business and Professions Code.
1714. Operational Standards and Security.
(a) All pharmacies (except hospital inpatient pharmacies as defined by Business and Professions
Code section 4029 which solely or predominantly 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
condition. 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.
(d) Each pharmacist while on duty shall be responsible for the security of the 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 drugs 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 possess a key to the pharmacy that is
maintained in a tamper evident container 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. The signature of the pharmacist-in-charge shall be present in such a way that 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 Professions Code. Reference: Sections
4116 and 4117, Business and Professions Code.
1714.1. Pharmacy Operations During the Temporary Absence of a Pharmacist.
This section is to ensure that pharmacists are able to have duty free breaks and meal periods to
which 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 pharmacist 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 reasonably believes that the security of the
dangerous drugs and devices will be maintained in his or her absence.
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 prescription 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 the 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 pharmacy.
(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 the pharmacy area during the break period.
(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 authorized 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 pharmacist, a pharmacy
technician, non-licensed personnel as defined in 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, Business 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 Code, 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 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:
(a) dangerous 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 solutions,
(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 infusions,
(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. Reference: Sections 4005 and
4057, Business and Professions Code.
1715. Self-Assessment of a Pharmacy by the Pharmacist-in-Charge.
(a) The pharmacist-in-charge of each pharmacy as defined under section 4029 or section 4037 of
the Business and Professions Code 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 self-examination and education.
(b) In addition to the self-assessment required in subdivision (a) of this section, the pharmacist-
in-charge shall complete a self-assessment within 30 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.
(c) The components of this assessment shall be on Form 17M-13 (Rev 10/08) entitled
“Community Pharmacy & Hospital Outpatient Pharmacy Self-Assessment (or Form 17M-14 (Rev
10/08) entitled “Hospital Pharmacy Self-Assessment” which are hereby incorporated by reference
to evaluate compliance with federal and state laws and regulations.
(d) Each self-assessment shall be kept on file in the pharmacy for three years after it is
performed.
Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4021, 4022,
4029, 4030, 4037, 4038, 4040, 4050, 4052, 4070, 4081, 4101, 4105, 4113, 4115, 4119, 4305,
4330, 4332 and 4333, Business and Professions Code.
1715.5. Implementation of Electronic Monitoring 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 pharmacy shall
provide the following information: the full name and address of the patient; the gender and date
of birth of the patient; the DEA (Drug Enforcement Administration) number of the prescriber; the
triplicate prescription number; the pharmacy prescription number; the pharmacy license 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 license 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 format 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 than 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
Pharmacy 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 earlier 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 its 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: Section 4005, Business and Professions Code. Reference: Sections 4081 and
4332, Business and Professions Code.
1716. Variation from Prescriptions.
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 regulation 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: Section 4040, Business
and Professions Code.
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 prescription 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;
(2) no more than a one-month supply is dispensed at one time; and
(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 be 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.
(2) The brand name of the drug or device; or if a generic drug or device is 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
different, 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 pharmacist 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 Business 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 pharmacist 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 transfer is accomplished via direct access by the receiving pharmacist, the
receiving pharmacist shall notify the transferring pharmacy of the transfer. A pharmacist at the
transferring pharmacy shall then assure that there is a record of the prescription as having been
transferred, 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) Identification 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 filling of a prescription and a corresponding entry of information into an 
