reglab/statecodes huggingface dataset:
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 7 - Pharmacies › Section 4115.5.

4115.5. (a) Notwithstanding any other 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 fewer than 120 hours and no more than 140 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 340 hours.
(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 the pharmacy technician trainee’s status as a trainee.
(Amended by Stats. 2019, Ch. 213, Sec. 1. (SB 655) Effective January 1, 2020.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 7 - Pharmacies › Section 4116.

4116. (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.
(Amended by Stats. 1999, Ch. 900, Sec. 4. Effective October 10, 1999.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 7 - Pharmacies › Section 4117.

4117. 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.
(Amended by Stats. 1997, Ch. 549, Sec. 69. Effective January 1, 1998.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 7 - Pharmacies › Section 4118.

4118. (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.
(Amended by Stats. 1997, Ch. 549, Sec. 70. Effective January 1, 1998.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 7 - Pharmacies › Section 4118.5.

4118.5. (a) A pharmacist at a hospital pharmacy shall obtain an accurate medication profile or list for each high-risk patient upon admission of the high-risk patient under the following conditions:
(1) The hospital has more than 100 beds.
(2) The accurate medication profile or list may be acquired by the pharmacist during the hospital pharmacy’s hours of operation.
(b) Notwithstanding any other law, a pharmacy technician or an intern pharmacist may perform the task of obtaining an accurate medication profile or list for a high-risk patient if both of the following conditions are satisfied:
(1) The hospital pharmacy has a quality assurance program to monitor competency.
(2) The hospital has established policies and procedures for training and proctoring pharmacy technicians or intern pharmacists by the hospital pharmacy department and the pharmacy technician or intern pharmacist has completed that training and proctoring.
(c) The hospital shall establish criteria regarding who is a high-risk patient for purposes of this section, and shall determine the timeframe for completion of the medication profile or list, based on the patient populations served by the hospital.
(d) The board may adopt rules and regulations to carry out the purposes and objectives of this section.
(e) This section shall not apply to the State Department of State Hospitals.
(f) Nothing in this section shall be construed to prohibit a healing arts licensee licensed pursuant to this division from obtaining an accurate medication profile or list.
(Added by Stats. 2018, Ch. 697, Sec. 1. (SB 1254) Effective January 1, 2019.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 7 - Pharmacies › Section 4119.

4119. (a) Notwithstanding any other 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 Public Health set forth in Title 22 of the California Code of Regulations and the requirements set forth in Section 1261.5 of the Health and Safety Code. These emergency supplies shall be approved by the facility’s patient care policy committee or 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 48.
(b) Notwithstanding any other 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 (Division 10 (commencing with Section 11000) of the Health and Safety Code).
(Amended by Stats. 2017, Ch. 647, Sec. 2. (SB 443) Effective January 1, 2018.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 7 - Pharmacies › Section 4119.2.

4119.2. (a) Notwithstanding any other law, a pharmacy may furnish epinephrine auto-injectors to a school district, county office of education, or charter school pursuant to Section 49414 of the Education Code if all of the following are met:
(1) The epinephrine auto-injectors are furnished exclusively for use at a school district site, county office of education, or charter school.
(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 the school district, county office of education, or charter school for a period of three years from the date the records were created. The school district, county office of education, or charter school shall be responsible for monitoring the supply of epinephrine auto-injectors and ensuring the destruction of expired epinephrine auto-injectors.
(Amended by Stats. 2014, Ch. 321, Sec. 1. (SB 1266) Effective January 1, 2015.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 7 - Pharmacies › Section 4119.3.

4119.3. (a) Notwithstanding any other law, a pharmacy may dispense epinephrine auto-injectors to a prehospital emergency medical care person or lay rescuer for the purpose of rendering emergency care in accordance with Section 1797.197a of the Health and Safety Code, if both of the following requirements are met:
(1) A physician and surgeon provides a written order that specifies the quantity of epinephrine auto-injectors to be dispensed to a person described in subdivision (b) of Section 1797.197a of the Health and Safety Code. The physician and surgeon may issue the prescription only upon presentation of a current certificate demonstrating that the person is trained and qualified under Section 1797.197a of the Health and Safety Code to administer an epinephrine auto-injector to another person in an emergency situation. The prescription shall specify that the dispensed epinephrine auto-injector is for “First Aid Purposes Only” and that the named recipient is a “Section 1797.197a Responder.” A new prescription shall be written for any additional epinephrine auto-injectors required.
(2) (A) The pharmacy shall label each epinephrine auto-injector dispensed with all of the following:
(i) The name of the person to whom the prescription was issued.
(ii) The designations “Section 1797.197a Responder” and “First Aid Purposes Only.”
(iii) The dosage, use, and expiration date.
(B) Each dispensed prescription shall include the manufacturer’s product information sheet for the epinephrine auto-injector.
(b) The person described in subdivision (b) of Section 1797.197a of the Health and Safety Code receiving epinephrine auto-injectors pursuant to this section shall make and maintain a record for five years reflecting dates of receipt, use, and destruction of each auto-injector dispensed, the name of any person to whom epinephrine was administered using an auto-injector, and the circumstances and manner of destruction of any auto-injectors.
(c) The epinephrine auto-injectors dispensed pursuant to this section may be used only for the purpose, and under the circumstances, described in Section 1797.197a of the Health and Safety Code.
(Added by Stats. 2013, Ch. 725, Sec. 1. (SB 669) Effective January 1, 2014.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 7 - Pharmacies › Section 4119.4.

4119.4. (a) Notwithstanding any other law, a pharmacy may furnish epinephrine auto-injectors to an authorized entity, for the purpose of rendering emergency care in accordance with Section 1797.197a of the Health and Safety Code, if both of the following requirements are met:
(1) The epinephrine auto-injectors are furnished exclusively for use by, or in connection with, an authorized entity.
(2) An authorized health care provider provides a prescription that specifies the quantity of epinephrine auto-injectors to be furnished to an authorized entity described in subdivision (a) of Section 1797.197a of the Health and Safety Code. A new prescription shall be written for any additional epinephrine auto-injectors required for use.
(b) The pharmacy shall label each epinephrine auto-injector dispensed with all of the following:
(1) The name of the person or entity to whom the prescription was issued.
(2) The designations “Section 1797.197a Responder” and “First Aid Purposes Only.”
(3) The dosage, use, and expiration date.
(c) Each dispensed prescription shall include the manufacturer’s product information sheet for the epinephrine auto-injector.
(d) Records regarding the acquisition and disposition of epinephrine auto-injectors furnished pursuant to subdivision (a) shall be maintained by the authorized entity for a period of three years from the date the records were created. The authorized entity shall be responsible for monitoring the supply of epinephrine auto-injectors and ensuring the destruction of expired epinephrine auto-injectors.
(e) The epinephrine auto-injector dispensed pursuant to this section may be used only for the purpose, and under the circumstances, described in Section 1797.197a of the Health and Safety Code.
(f) For purposes of this section, “epinephrine auto-injector” means a disposable delivery device designed for the automatic injection of a premeasured dose of epinephrine into the human body to prevent or treat a life-threatening allergic reaction.
(Added by Stats. 2016, Ch. 374, Sec. 1. (AB 1386) Effective January 1, 2017.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 7 - Pharmacies › Section 4119.5.

4119.5. (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.
(Added by Stats. 1997, Ch. 549, Sec. 72. Effective January 1, 1998.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 7 - Pharmacies › Section 4119.6.

4119.6. An intern pharmacist under the direct supervision and control, as defined in Section 4023.5, of a pharmacist may stock, replenish, and inspect the emergency pharmaceutical supplies container and the emergency medical system supplies of a health care facility licensed under subdivision (a) of Section 1250 of the Health and Safety Code.
(Added by Stats. 2014, Ch. 319, Sec. 2. (SB 1039) Effective January 1, 2015.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 7 - Pharmacies › Section 4119.7.

4119.7. (a) Notwithstanding any other law, a hospital pharmacy serving a health care facility licensed under subdivision (a) of Section 1250 of the Health and Safety Code may furnish a dangerous drug or dangerous device pursuant to preprinted or electronic standing orders, order sets, and protocols established under the policies and procedures of the health care facility, as approved according to the policies of the health care facility’s governing body, if the order is dated, timed, and authenticated in the medical record of the patient to whom the dangerous drug or dangerous device will be provided.
(b) A health care facility shall store and maintain drugs in accordance with national standards regarding the storage area and refrigerator or freezer temperature, and otherwise pursuant to the manufacturer’s guidelines. The health care facility’s policies and procedures shall specify these storage parameters.
(c) An intern pharmacist under the direct supervision and control, as defined in Section 4023.5, of a pharmacist, may inspect the drugs maintained in the health care facility at least once per month. The health care facility shall establish specific written policies and procedures for inspections pursuant to this subdivision.
(d) For purposes of this section, “health care facility” means a health facility licensed under subdivision (a) of Section 1250 of the Health and Safety Code.
(Added by Stats. 2014, Ch. 319, Sec. 3. (SB 1039) Effective January 1, 2015.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 7 - Pharmacies › Section 4119.8.

4119.8. (a) Notwithstanding any other law, a pharmacy may furnish naloxone hydrochloride or another opioid antagonist to a school district, county office of education, or charter school pursuant to Section 49414.3 of the Education Code if all of the following are met:
(1) The naloxone hydrochloride or another opioid antagonist is furnished exclusively for use at a school district schoolsite, county office of education schoolsite, or charter school.
(2) A physician and surgeon provides a written order that specifies the quantity of naloxone hydrochloride or another opioid antagonist to be furnished.
(b) Records regarding the acquisition and disposition of naloxone hydrochloride or another opioid antagonist furnished pursuant to subdivision (a) shall be maintained by the school district, county office of education, or charter school for a period of three years from the date the records were created. The school district, county office of education, or charter school shall be responsible for monitoring the supply of naloxone hydrochloride or another opioid antagonist and ensuring the destruction of expired naloxone hydrochloride or another opioid antagonist.
(Added by Stats. 2016, Ch. 557, Sec. 1. (AB 1748) Effective January 1, 2017.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 7 - Pharmacies › Section 4119.9.

4119.9. Notwithstanding any other law, a pharmacy, wholesaler, or manufacturer may furnish naloxone hydrochloride or other opioid antagonists to a law enforcement agency if both of the following are met:
(a) The naloxone hydrochloride or other opioid antagonist is furnished exclusively for use by employees of the law enforcement agency who have completed training, provided by the law enforcement agency, in administering naloxone hydrochloride or other opioid antagonists.
(b) Records regarding the acquisition and disposition of naloxone hydrochloride or other opioid antagonists furnished pursuant to this section shall be maintained by the law enforcement agency for a period of three years from the date the records were created. The law enforcement agency shall be responsible for monitoring the supply of naloxone hydrochloride or other opioid antagonists and ensuring the destruction of expired naloxone hydrochloride or other opioid antagonists.
(Added by Stats. 2018, Ch. 259, Sec. 1. (AB 2256) Effective January 1, 2019.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 7 - Pharmacies › Section 4120.

4120. (a) A nonresident pharmacy shall not sell or distribute dangerous drugs or dangerous devices in this state through any person or media, other than a wholesaler or third-party logistics provider who has obtained a license pursuant to this chapter or through a selling or distribution outlet that is licensed as a wholesaler or third-party logistics provider 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 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.
(Amended by Stats. 2015, Ch. 303, Sec. 6. (AB 731) Effective January 1, 2016.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 7 - Pharmacies › Section 4121.

4121. (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.
(Repealed and 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 7 - Pharmacies › Section 4122.

4122. (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.
(Amended by Stats. 2007, Ch. 130, Sec. 11. Effective January 1, 2008.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 7 - Pharmacies › Section 4123.

4123. 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.
(Repealed and 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 7 - Pharmacies › Section 4125.

4125. (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.
(Added by Stats. 2000, Ch. 677, Sec. 1. Effective January 1, 2001. Section operative January 1, 2002, by its own provisions.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 7 - Pharmacies › Section 4126.

4126. (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.
(Added by Stats. 2001, Ch. 631, Sec. 2. Effective January 1, 2002.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 7 - Pharmacies › Section 4126.5.

4126.5. (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. During a proclaimed state of emergency, “another pharmacy” as used in this paragraph shall include a mobile pharmacy, as described in subdivision (c) of Section 4062.
(b) Notwithstanding subdivision (a), or any other law, a clinic licensed under Section 4180 may furnish dangerous drugs to any of the following during a proclaimed state of emergency:
(1) Another clinic or wholesaler to alleviate a temporary shortage of a dangerous drug that could result in the denial of health care. A clinic furnishing dangerous drugs pursuant to this paragraph may only furnish a quantity sufficient to alleviate the temporary shortage.
(2) A patient pursuant to a prescription or as otherwise authorized by law.
(3) A health care provider that is not a clinic but that is authorized to purchase dangerous drugs.
(4) To another clinic under common control, including a mobile clinic, as described in subdivision (c) of Section 4062.
(c) Notwithstanding any other law, a violation of this section may subject the person or persons who committed the violation to a fine not to exceed the amount specified in Section 125.9 for each occurrence pursuant to a citation issued by the board.
(d) 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.
(e) For purposes of this section, “common control” means the power to direct or cause the direction of the management and policies of another person whether by ownership, by voting rights, by contract, or by other means.
(Amended by Stats. 2018, Ch. 716, Sec. 4. (AB 2576) Effective January 1, 2019.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 7 - Pharmacies › Section 4126.8.

4126.8. The compounding of drug preparations by a pharmacy for furnishing, distribution, or use in this state shall be consistent with standards established in the pharmacy compounding chapters of the current version of the United States Pharmacopeia-National Formulary, including relevant testing and quality assurance. The board may adopt regulations to impose additional standards for compounding drug preparations.
(Added by Stats. 2019, Ch. 184, Sec. 1. (AB 973) Effective January 1, 2020.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 7 - Pharmacies › Section 4126.9.

4126.9. (a) A pharmacy that issues a recall notice regarding a nonsterile compounded drug product shall, in addition to any other duties, contact the recipient pharmacy, prescriber, or patient of the recalled drug and the board within 12 hours of the recall notice if both of the following apply:
(1) Use of or exposure to the recalled drug may cause serious adverse health consequences or death.
(2) The recalled drug was dispensed, or is intended for use, in this state.
(b) A recall notice issued pursuant to subdivision (a) shall be made as follows:
(1) If the recalled drug was dispensed directly to the patient, the notice shall be made to the patient.
(2) If the recalled drug was dispensed directly to the prescriber, the notice shall be made to the prescriber, who shall ensure the patient is notified.
(3) If the recalled drug was dispensed directly to a pharmacy, the notice shall be made to the pharmacy, which shall notify the prescriber or patient, as appropriate. If the pharmacy notifies the prescriber, the prescriber shall ensure the patient is notified.
(c) A pharmacy that has been advised that a patient has been harmed by using a nonsterile compounded product potentially attributable to the pharmacy shall report the event to MedWatch within 72 hours of the pharmacy being advised.
(Added by Stats. 2016, Ch. 484, Sec. 22. (SB 1193) Effective January 1, 2017.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 7 - Pharmacies › Section 4126.10.

4126.10. (a) A pharmacy located in California may distribute compounded human drug preparations interstate only if all of the following conditions are met:
(1) Between January 1 and March 31 of each year, the pharmacy reports all required data for the previous calendar year into the Information Sharing Network established by the National Association of Boards of Pharmacy in conjunction with the United States Food and Drug Administration (FDA) to implement the Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products.
(2) On an annual basis, in connection with and as a condition of renewal of the pharmacy’s license, the pharmacist-in-charge of the pharmacy certifies that the reporting requirements of paragraph (1) have been satisfied.
(3) The pharmacy reports any adverse drug experience and product quality issue for any compounded product to the board within 12 hours after the pharmacy receives notice of the adverse drug experience or product quality issue.
(b) Information reported by the board to the FDA directly or through the Information Sharing Network established by the National Association of Boards of Pharmacy in conjunction with the FDA to implement the Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products shall not be subject to public disclosure under the California Public Records Act (Division 10 (commencing with Section 7920.000) of Title 1 of the Government Code).
(Amended by Stats. 2022, Ch. 28, Sec. 5. (SB 1380) Effective January 1, 2023.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 7.5 - Sterile Drug Products › Section 4127.

4127. (a) A pharmacy that compounds sterile drug products shall possess a sterile compounding pharmacy license as provided in this article.
(b) The board shall adopt regulations in accordance with the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code) to establish policies, guidelines, and procedures to implement this article.
(c) The board shall review any formal revision to General Chapter 797 of the United States Pharmacopeia and The National Formulary (USP–NF), relating to the compounding of sterile preparations, not later than 90 days after the revision becomes official, to determine whether amendments are necessary for the regulations adopted by the board pursuant to subdivision (b).
(Amended by Stats. 2016, Ch. 484, Sec. 23. (SB 1193) Effective January 1, 2017.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 7.5 - Sterile Drug Products › Section 4127.1.

4127.1. (a) A pharmacy shall not compound sterile drug products unless the pharmacy has obtained a sterile compounding pharmacy license from the board pursuant to this section. The license shall be renewed annually and is not transferable.
(b) A license to compound sterile drug products shall be issued only to a location that is licensed as a pharmacy and shall be issued only to the owner of the pharmacy licensed at that location.
(c) A license to compound sterile drug products shall not be issued or renewed until the location is inspected by the board and found in compliance with this article and regulations adopted by the board.
(d) A license to compound sterile drug products shall not be issued or renewed until the board does all of the following:
(1) Reviews a current copy of the pharmacy’s policies and procedures for sterile compounding.
(2) Reviews the pharmacy’s completed self-assessment form required by Section 1735.2 of Title 16 of the California Code of Regulations.
(3) Is provided with copies of all inspection reports conducted of the pharmacy’s premises, and any reports from a private accrediting agency, conducted in the prior 12 months documenting the pharmacy’s operations.
(4) Receives a list of all sterile medications compounded by the pharmacy since the last license renewal.
(e) A pharmacy licensed pursuant to this section shall do all of the following:
(1) Provide to the board a copy of any disciplinary or other action taken by another state within 10 days of the action.
(2) Notify the board within 10 days of the suspension of any accreditation held by the pharmacy.
(3) Provide to the board, within 12 hours, any recall notice issued by the pharmacy for sterile drug products it has compounded.
(f) Adverse effects reported or potentially attributable to a pharmacy’s sterile drug product shall be reported to the board within 12 hours and immediately reported to the MedWatch program of the federal Food and Drug Administration.
(g) The reconstitution of a sterile powder shall not require a license pursuant to this section if both of the following requirements 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.
(h) This section shall become operative on July 1, 2014.
(Repealed (in Sec. 4) and added by Stats. 2013, Ch. 565, Sec. 5. (SB 294) Effective January 1, 2014. Section operative July 1, 2014, by its own provisions.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 7.5 - Sterile Drug Products › Section 4127.15.

4127.15. Subject to the requirements of this section, the board may issue a license to a hospital satellite compounding pharmacy. The license fee and annual renewal fee shall be in an amount established by the board in subdivision (u) of Section 4400. The license shall not be transferable.
(a) A hospital satellite compounding pharmacy license shall not be issued or renewed until the location is inspected by the board and found to be in compliance with this article and regulations adopted by the board.
(1) A hospital satellite compounding pharmacy shall compound sterile drug products for administration only to registered hospital patients who are on the premises of the same physical plant in which the hospital satellite compounding pharmacy is located.
(2) The services provided shall be directly related to the services or treatment plan administered in the physical plant.
(b) A hospital satellite compounding pharmacy license shall not be issued or renewed until the board does all of the following:
(1) Reviews a current copy of the hospital satellite compounding pharmacy’s policies and procedures for sterile compounding.
(2) Reviews the hospital satellite compounding pharmacy’s completed self-assessment form as described in Section 1735.2 of Title 16 of the California Code of Regulations.
(3) Receives a list of all products compounded by the hospital satellite compounding pharmacy since the last license renewal.
(c) A hospital satellite compounding pharmacy shall do all of the following:
(1) Purchase, procure, or otherwise obtain all components through the license of the hospital pharmacy as defined in subdivision (a) of Section 4029.
(2) Satisfy the ratio of not less than one pharmacist on duty for a total of two pharmacy technicians on duty.
(3) Ensure immediate supervision, as defined in Section 70065 of Title 22 of the California Code of Regulations, by a pharmacist of licensed ancillary staff involved in sterile compounding.
(4) Provide to the board, within 12 hours, any recall notice issued by the hospital satellite compounding pharmacy for sterile drug products it has compounded.
(5) Report to the board, within 12 hours, adverse effects reported or potentially attributable to the sterile drug products compounded by the hospital satellite compounding pharmacy. Unexpected adverse effects shall also be, within 12 hours, reported to the MedWatch program of the federal Food and Drug Administration.
(Added by Stats. 2017, Ch. 623, Sec. 2. (SB 351) Effective January 1, 2018.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 7.5 - Sterile Drug Products › Section 4127.3.

4127.3. (a) Whenever the board has a reasonable belief, based on information obtained during an inspection or investigation by the board, that a pharmacy compounding sterile drug products poses an immediate threat to the public health or safety, the executive officer of the board may issue an order to the pharmacy to immediately cease and desist from compounding sterile drug products. The cease and desist order shall remain in effect for no more than 30 days or the date of a hearing seeking an interim suspension order, whichever is earlier.
(b) Whenever the board issues a cease and desist order pursuant to subdivision (a), the board shall immediately issue the owner a notice setting forth the acts or omissions with which the owner is charged, specifying the pertinent code section or sections.
(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 Section 11425.10 of the Government Code. The hearing shall be held no later than five business days from the date the request of the owner is received by the board. The president shall render a written decision within five business 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. The owner or person in possession or control of the pharmacy may seek review of the decision of the president of the board 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.
(Amended by Stats. 2021, Ch. 629, Sec. 19. (AB 1533) Effective January 1, 2022.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 7.5 - Sterile Drug Products › Section 4127.4.

4127.4. 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.
(Added by Stats. 2001, Ch. 827, Sec. 2. Effective January 1, 2002. Section operative September 5, 2002, pursuant to Section 4127.6.)
2023 California Code › Business and Professions Code - BPC › DIVISION 2 - HEALING ARTS › CHAPTER 9 - Pharmacy › ARTICLE 7.5 - Sterile Drug Products › Section 4127.6.

4127.6. 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.
(Added by Stats. 2001, Ch. 827, Sec. 2. Effective January 1, 2002. Note: The condition in this section for operation of Article 7.5 (comm. with Section 4127), was satisfied on September 5, 2002, when Stats. 2002, Ch. 379, took effect.)