reglab/statecodes huggingface dataset:
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 11 - Wholesalers, Third-Party Logistics Providers, and Manufacturers › Section 4162.

4162. (a) (1) An applicant for the issuance or renewal of a wholesaler license, which is not government owned and operated, 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) An applicant for the issuance or renewal of a third-party logistics provider license, which is not government owned and operated, shall submit a surety bond of ninety thousand dollars ($90,000) or other equivalent means of security acceptable to the board payable to the Pharmacy Board Contingent Fund. The purpose of the surety bond is to secure payment of any administrative fine imposed by the board and any cost recovery ordered pursuant to Section 125.3.
(3) For purposes of paragraphs (1) and (2), the board may accept a surety bond less than the amount required under paragraph (1) or (2) if the annual gross receipts of the previous tax year for the wholesaler or third-party logistics provider is ten million dollars ($10,000,000) or less, in which case the surety bond shall be twenty-five thousand dollars ($25,000).
(4) A person to whom an approved new drug application has been issued by the 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 or third-party logistics provider, shall not be required to post a surety bond as provided in paragraph (1) or (2).
(5) For licensees subject to paragraph (3) or (4), the board may require a bond up to one hundred thousand dollars ($100,000) for any licensee who has been disciplined by any state or 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.
(Amended by Stats. 2014, Ch. 507, Sec. 20. (AB 2605) Effective January 1, 2015.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 11 - Wholesalers, Third-Party Logistics Providers, and Manufacturers › Section 4162.5.

4162.5. (a) (1) An applicant for the issuance or renewal of a nonresident wholesaler license shall submit a surety bond of one hundred thousand dollars ($100,000), or other equivalent means of security acceptable to the board, such as an irrevocable letter of credit, or a deposit in a trust account or financial institution, payable to the Pharmacy Board Contingent Fund. The purpose of the surety bond is to secure payment of any administrative fine imposed by the board and any cost recovery ordered pursuant to Section 125.3.
(2) An applicant for the issuance or renewal of a nonresident third-party logistics provider license shall submit a surety bond of ninety thousand dollars ($90,000), or other equivalent means of 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.
(3) For purposes of paragraphs (1) and (2), the board may accept a surety bond less than the amount required under paragraph (1) or (2) if the annual gross receipts of the previous tax year for the nonresident wholesaler or the nonresident third-party logistics provider is ten million dollars ($10,000,000) or less, in which case the surety bond shall be twenty-five thousand dollars ($25,000).
(4) For applicants who satisfy paragraph (3), the board may require a bond up to one hundred thousand dollars ($100,000) for any nonresident wholesaler or nonresident third-party logistics provider who has been disciplined by any state or federal agency or has been issued an administrative fine pursuant to this chapter.
(5) 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 or a nonresident third-party logistics provider, 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.
(Amended by Stats. 2014, Ch. 507, Sec. 21. (AB 2605) Effective January 1, 2015.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 11 - Wholesalers, Third-Party Logistics Providers, and Manufacturers › Section 4163.

4163. (a) A manufacturer, wholesaler, repackager, or pharmacy shall not furnish a dangerous drug or dangerous device to an unauthorized person.
(b) Except as provided in subdivision (c), dangerous drugs or dangerous devices shall be acquired from a person authorized by law to possess or furnish dangerous drugs or dangerous devices. If the person acquiring the 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) Upon approval of the board, a reverse distributor licensed as a wholesaler may acquire a dangerous drug or dangerous device from an unlicensed source that was previously licensed with the board for the sole purpose of destruction of the dangerous drug or dangerous device.
(Amended by Stats. 2019, Ch. 213, Sec. 2. (SB 655) Effective January 1, 2020.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 11 - Wholesalers, Third-Party Logistics Providers, and Manufacturers › Section 4164.

4164. (a) A wholesaler or third-party logistics provider licensed by the board that distributes controlled substances, dangerous drugs, or dangerous devices within or into this state shall report to the board all distributions 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.
(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.
(Amended by Stats. 2014, Ch. 507, Sec. 22. (AB 2605) Effective January 1, 2015.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 11 - Wholesalers, Third-Party Logistics Providers, and Manufacturers › Section 4165.

4165. A wholesaler or third-party logistics provider 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.
(Amended by Stats. 2014, Ch. 507, Sec. 23. (AB 2605) Effective January 1, 2015.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 11 - Wholesalers, Third-Party Logistics Providers, and Manufacturers › Section 4166.

4166. (a) A wholesaler that uses the services of a third-party logistics provider or carrier, including, but not limited to, the United States Postal Service or a common carrier, shall be liable for the security and integrity of any dangerous drugs or dangerous devices through that provider or carrier until the drugs or devices are delivered to the transferee at its board-licensed premises.
(b) A third-party logistics provider that uses the services of a carrier, including, but not limited to, the United States Postal Service or a common carrier, shall have in place and comply with written policies and procedures that provide for both of the following:
(1) Verification that the third-party logistics provider, or the owner of the dangerous drugs or dangerous devices stored at the third-party logistics provider, has imposed obligations on the carrier that provide for the security and integrity of any dangerous drugs or dangerous devices transported by the carrier until the drugs or devices are delivered to the transferee at its premises.
(2) Confirmation, prior to shipping a dangerous drug or dangerous device, that the intended recipient is legally authorized to receive the dangerous drug or dangerous device.
(c) Nothing in this section is intended to affect the liability of a wholesaler, third-party logistics provider, or other distributor for dangerous drugs or dangerous devices after their delivery to the transferee.
(Amended by Stats. 2014, Ch. 507, Sec. 24. (AB 2605) Effective January 1, 2015.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 11 - Wholesalers, Third-Party Logistics Providers, and Manufacturers › Section 4167.

4167. A wholesaler or third-party logistics provider shall not obtain, by purchase or otherwise, any dangerous drugs or dangerous devices that it cannot maintain, in a secure manner, at the place of business licensed by the board.
(Amended by Stats. 2014, Ch. 507, Sec. 25. (AB 2605) Effective January 1, 2015.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 11 - Wholesalers, Third-Party Logistics Providers, and Manufacturers › Section 4168.

4168. A county or municipality shall not issue a business license for any establishment that requires a wholesaler or third-party logistics provider license unless the establishment possesses a current wholesaler or third-party logistics provider license issued by the board. For purposes of this section, an “establishment” is the licensee’s physical location in California.
(Amended by Stats. 2014, Ch. 507, Sec. 26. (AB 2605) Effective January 1, 2015.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 11 - Wholesalers, Third-Party Logistics Providers, and Manufacturers › Section 4169.

4169. (a) A person or entity shall not do any of the following:
(1) Purchase, trade, sell, warehouse, distribute, or transfer dangerous drugs or dangerous devices at wholesale with a person or entity that is not licensed with the board as a wholesaler, third-party logistics provider, or pharmacy.
(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 law, a violation of this section may subject the person or entity that has committed the violation to a fine not to exceed the amount specified in Section 125.9 for each occurrence, pursuant to a citation issued by the board.
(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 Public Health.
(Amended by Stats. 2014, Ch. 507, Sec. 27. (AB 2605) Effective January 1, 2015.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 11 - Wholesalers, Third-Party Logistics Providers, and Manufacturers › Section 4169.1.

4169.1. A wholesaler, upon discovery, shall notify the board in writing of any suspicious orders of controlled substances placed by a California-licensed pharmacy or wholesaler by providing the board a copy of the information that the wholesaler provides to the United States Drug Enforcement Administration. Suspicious orders include, but are not limited to, orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.
(Added by Stats. 2017, Ch. 548, Sec. 8. (AB 401) Effective January 1, 2018.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 12 - Prescriber Dispensing › Section 4170.5.

4170.5. (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.
(Added by Stats. 2004, Ch. 695, Sec. 37. Effective January 1, 2005.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 12 - Prescriber Dispensing › Section 4171.

4171. (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.
(Amended by Stats. 2003, Ch. 250, Sec. 4. Effective January 1, 2004.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 12 - Prescriber Dispensing › Section 4172.

4172. 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.
(Added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 12 - Prescriber Dispensing › Section 4173.

4173. This chapter does not prevent the dispensing of drugs or devices by registered nurses functioning pursuant to Section 2725.1.
(Added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 12 - Prescriber Dispensing › Section 4174.

4174. Notwithstanding any other law, a pharmacist may dispense drugs or devices upon the drug order of a nurse practitioner practicing pursuant to Section 2836.1, 2837.103, or 2837.104, 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, 4052.3, or 4052.6.
(Amended by Stats. 2022, Ch. 413, Sec. 27. (AB 2684) Effective January 1, 2023.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 12 - Prescriber Dispensing › Section 4175.

4175. (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 California State Board of Optometry, the California Board of Podiatric Medicine, the Osteopathic Medical Board of California, the Board of Registered Nursing, the Bureau of Naturopathic Medicine, or the Physician Assistant Board, 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 California State Board of Optometry, the California Board of Podiatric Medicine, the Osteopathic Medical Board of California, the Bureau of Naturopathic Medicine, the Board of Registered Nursing, the Veterinary Medical Board, or the Physician Assistant Committee as a case of greatest potential harm to a patient.
(Amended by Stats. 2022, Ch. 511, Sec. 24. (SB 1495) Effective January 1, 2023.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 13 - Nonprofit or Free Clinics › Section 4180.

4180. (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 the number of 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.
(c) The board shall synchronize license renewal dates and aggregate fees for multiple clinics under common nonprofit ownership at the request of the parent organization.
(Amended by Stats. 2019, Ch. 323, Sec. 1. (AB 1723) Effective January 1, 2020.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 13 - Nonprofit or Free Clinics › Section 4181.

4181. (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 Public Health 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.
(Amended by Stats. 2010, Ch. 653, Sec. 30. (SB 1489) Effective January 1, 2011.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 13 - Nonprofit or Free Clinics › Section 4182.

4182. (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.
(Amended by Stats. 2006, Ch. 659, Sec. 13. Effective January 1, 2007.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 13 - Nonprofit or Free Clinics › Section 4183.

4183. 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).
(Added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 13 - Nonprofit or Free Clinics › Section 4184.

4184. 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.
(Added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 13 - Nonprofit or Free Clinics › Section 4185.

4185. 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.
(Added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 13 - Nonprofit or Free Clinics › Section 4186.

4186. (a) Automated drug delivery systems, as defined in Section 4017.3, 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 and with Section 1707.5 of Title 16 of the California Code of Regulations.
(h) This section shall become operative on July 1, 2019.
(Repealed and added by Stats. 2018, Ch. 666, Sec. 7. (SB 1447) Effective January 1, 2019. Section operative July 1, 2019, by its own provisions.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 13.5 - Correctional Clinics › Section 4187.

4187. For purposes of this article the following terms shall have the following meanings:
(a) “Correctional clinic” means a primary care clinic, as referred to in subdivision (b) of Section 1206 of the Health and Safety Code, conducted, maintained, or operated by the state to provide health care to eligible patients of the Department of Corrections and Rehabilitation.
(b) “Chief executive officer” means the highest ranking health care administrator at a correctional institution.
(c) “Chief medical executive” means a physician and surgeon acting in the capacity of medical director within the correctional institution.
(d) “Chief nurse executive” means the highest ranking nurse within the correctional institution.
(e) “Licensed correctional clinic” means a correctional clinic that is licensed pursuant to this article.
(f) “Supervising dentist” means the highest ranking dentist within the correctional institution.
(Added by Stats. 2018, Ch. 36, Sec. 6. (AB 1812) Effective June 27, 2018.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 13.5 - Correctional Clinics › Section 4187.1.

4187.1. (a) Notwithstanding any other provision of this chapter, a correctional clinic licensed by the board under this article may obtain drugs from a licensed correctional pharmacy, the Department of Corrections and Rehabilitation’s Central Fill Pharmacy, or from another correctional clinic licensed by the board under this article within the same institution for the administration or dispensing of drugs or devices to patients eligible for care at the correctional facility if under either:
(1) The direction of a physician and surgeon, dentist, or other person lawfully authorized to prescribe.
(2) An approved protocol as identified within the statewide Inmate Medical Services Policies and Procedures.
(b) The dispensing or administering of drugs in a correctional clinic may be performed pursuant to a chart order, as defined in Section 4019, a valid prescription consistent with this chapter, or pursuant to an approved protocol as identified within the statewide Inmate Medical Services Policies and Procedures. The dispensing of drugs in a correctional clinic shall only be performed by a physician and surgeon, a dentist, a pharmacist, or other person lawfully authorized to dispense drugs. Medications dispensed to patients that are to be kept on the patient’s person for use shall meet the labeling requirements of Section 4076 and all recordkeeping requirements of this chapter.
(c) A correctional clinic shall keep records of the kind and amounts of drugs acquired, administered, transferred, and dispensed. The records shall be available and maintained for a minimum of three years for inspection by all properly authorized personnel.
(d) (1) A correctional clinic shall not be entitled to the benefits of this section until it has obtained a license from the board.
(2) A separate license shall be required for each correctional clinic location and shall not be transferrable.
(3) A correctional clinic’s location and address shall be identified by correctional institution and building within that correctional institution.
(4) A clinic shall notify the board in advance of any change in the clinic’s address on a form furnished by the board.
(Amended by Stats. 2019, Ch. 497, Sec. 6. (AB 991) Effective January 1, 2020.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 13.5 - Correctional Clinics › Section 4187.2.

4187.2. (a) The policies and procedures to implement the laws and regulations of this article within a correctional clinic shall be developed and approved by the statewide Correctional Pharmacy and Therapeutics Committee referenced in Section 5024.2 of the Penal Code. Prior to the issuance of a correctional clinic license by the board, an acknowledgment shall be signed by the correctional facility pharmacist-in-charge servicing that institution, the pharmacist-in-charge for the Department of Corrections and Rehabilitation’s Central Fill Pharmacy, and the correctional clinic’s chief medical executive, supervising dentist, chief nurse executive, and chief executive officer.
(b) (1) The chief executive officer shall be responsible for the safe, orderly, and lawful provision of pharmacy services. The pharmacist-in-charge of servicing the correctional facility shall implement the policies and procedures developed and approved by the statewide Correctional Pharmacy and Therapeutics Committee referenced in Section 5024.2 of the Penal Code and the California Correctional Health Care Services Health Care Department Operations Manual in conjunction with the chief executive officer, the chief medical executive, the supervising dentist, and the chief nurse executive.
(2) A licensed correctional clinic shall notify the board within 30 days of any change in the chief executive officer on a form furnished by the board.
(c) A correctional clinic shall be inspected at least quarterly by a pharmacist of the correctional pharmacy assigned to service that facility.
(Amended by Stats. 2020, Ch. 29, Sec. 2. (SB 118) Effective August 6, 2020.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 13.5 - Correctional Clinics › Section 4187.3.

4187.3. A Schedule II, III, IV, or V controlled substance may be administered by health care staff of the licensed correctional clinic lawfully authorized to administer pursuant to a chart order, as defined in Section 4019, a valid prescription consistent with this chapter, or pursuant to an approved protocol as identified within the statewide Inmate Medical Services Policies and Procedures.
(Added by Stats. 2018, Ch. 36, Sec. 6. (AB 1812) Effective June 27, 2018.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 13.5 - Correctional Clinics › Section 4187.4.

4187.4. The board shall have the authority to inspect a correctional clinic at any time in order to determine whether a correctional clinic is, or is not, operating in compliance with this article.
(Added by Stats. 2018, Ch. 36, Sec. 6. (AB 1812) Effective June 27, 2018.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 14 - Clinics › Section 4190.

4190. (a) For the purposes of this article, “clinic” means a surgical clinic licensed pursuant to paragraph (1) of subdivision (b) of Section 1204 of the Health and Safety Code, an outpatient setting accredited by an accreditation agency, as defined in Section 1248 of the Health and Safety Code, or an ambulatory surgical center certified to participate in the Medicare Program under Title XVIII of the federal Social Security Act (42 U.S.C. Sec. 1395 et seq.).
(b) A clinic licensed by the board may purchase drugs at wholesale for administration or dispensing, under the direction of a physician and surgeon, to patients registered for care at the clinic, as provided in subdivision (c). A separate license shall be required for each clinic location. A clinic licensed by the board shall notify the board of any change in the clinic’s address on a form furnished by the board. The clinic shall keep records of the kind and amounts of drugs purchased, administered, and dispensed, and the records shall be available and maintained for a minimum of three years for inspection by all properly authorized personnel.
(c) The drug distribution service of a clinic shall be limited to the use of drugs for administration to the patients of the clinic and to the dispensing of drugs for the control of pain and nausea for patients of the clinic. Drugs shall not be dispensed in an amount greater than that required to meet the patient’s needs for 72 hours. Drugs for administration shall be those drugs directly applied, whether by injection, inhalation, ingestion, or any other means, to the body of a patient for his or her immediate needs.
(d) No clinic shall be entitled to the benefits of this section until it has obtained a license from the board.
(e) If a clinic is licensed by the board, any proposed change in ownership or beneficial interest in the licensee shall be reported to the board, on a form to be furnished by the board, at least 30 days prior to the execution of any agreement to purchase, sell, exchange, gift or otherwise transfer any ownership or beneficial interest or prior to any transfer of ownership or beneficial interest, whichever occurs earlier.
(f) Nothing in this section shall limit the ability of a physician and surgeon to prescribe, dispense, administer, or furnish drugs at a clinic as provided in Sections 2241.5, 2242, and 4170.
(Amended by Stats. 2012, Ch. 454, Sec. 3. (SB 1095) Effective January 1, 2013.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 14 - Clinics › Section 4191.

4191. (a) Prior to the issuance of a clinic license authorized under this article, the clinic shall comply with all applicable laws and regulations of the State Department of Public Health and the board relating to drug distribution to ensure that inventories, security procedures, training, protocol development, recordkeeping, packaging, labeling, dispensing, and patient consultation are carried out in a manner that is consistent with the promotion and protection of the health and safety of the public. The policies and procedures to implement the laws and regulations shall be developed and approved by the 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.
(Amended by Stats. 2010, Ch. 653, Sec. 31. (SB 1489) Effective January 1, 2011.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 14 - Clinics › Section 4192.

4192. (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. Before July 1 of every odd-numbered year, the consulting pharmacist shall complete a Surgical Clinic Self-Assessment Form as determined by the board as a means to promote compliance through self-examination and education. The self-assessment shall assess the clinic’s compliance with current laws and regulations and include information on compounding practices as specified on the most recent version of the Surgical Clinic Self-Assessment Form approved by the board and posted on its internet website. The professional director of the clinic and consulting pharmacist shall certify on the final page of the Surgical Clinic Self-Assessment Form that they have read, reviewed, and completed self-assessment to the best of their professional ability and acknowledge that failure to correct any deficiency identified could result in action by the board. The completed form shall be signed under penalty of perjury, kept on file in the clinic for three years, and made available to the board or its designee, upon request.
(c) For the purposes of this article, “professional director” means a physician and surgeon acting in their capacity as medical director or a dentist or podiatrist acting in their 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.
(Amended by Stats. 2023, Ch. 470, Sec. 5. (AB 1286) Effective January 1, 2024.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 14 - Clinics › Section 4193.

4193. 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.
(Added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 14 - Clinics › Section 4194.

4194. 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.
(Added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 14 - Clinics › Section 4195.

4195. The board shall have the authority to inspect a clinic that is licensed pursuant to this article at any time in order to determine whether the clinic is, or is not, operating in compliance with this article and all other provisions of the law.
(Amended by Stats. 2012, Ch. 454, Sec. 4. (SB 1095) Effective January 1, 2013.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 15 - Veterinary Food-Animal Drug Retailers › Section 4197.

4197. (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.
(Amended by Stats. 1997, Ch. 549, Sec. 104. Effective January 1, 1998.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 15 - Veterinary Food-Animal Drug Retailers › Section 4198.

4198. (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.
(Added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 15 - Veterinary Food-Animal Drug Retailers › Section 4199.

4199. (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, 4076.6, 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.
(Amended by Stats. 2015, Ch. 784, Sec. 3. (AB 1073) Effective January 1, 2016.)