text:
(a) A pharmacy located in the state may provide pharmacy services to the patients of a “covered entity,” as defined in Section 256b of Title 42 of the United States Code, through the use of an automated patient dispensing system located on the premises of the covered entity or on the premises of medical professional practices under contract to provide medical services to covered entity patients, which need not be the same location as the pharmacy, if all of the following conditions are met:

(1) The pharmacy obtains a license from the board to operate the automated patient dispensing system at the covered entity or affiliated site. As part of the application, the pharmacy shall provide the address at which the automated patient dispensing system shall be placed and identify the covered entity. A separate license shall be required for each location and shall be renewed annually concurrent with the pharmacy license.

(2) The pharmacy providing the pharmacy services to the patients of the covered entity, including, unless otherwise prohibited by any other law, patients enrolled in the Medi-Cal program, shall be under contract with that covered entity as described in Section 4126 to provide those pharmacy services through the use of the automated patient dispensing system.

(3) Drugs stored in an automated patient dispensing system shall be part of the inventory of the pharmacy providing pharmacy services to the patients of the covered entity and drugs dispensed from the automated patient dispensing system shall be considered to have been dispensed by that pharmacy.

(4) The pharmacy shall maintain records of the acquisition and disposition of dangerous drugs stored in the automated patient dispensing system separate from other pharmacy records.

(5) The pharmacy shall be solely responsible for the security, operation, and maintenance of the automated patient dispensing system.

(6) The pharmacy shall provide training regarding the operation and use of the automated patient dispensing system to both pharmacy and covered entity personnel using the system.

(7) The operation of the automated patient dispensing system shall be under the supervision of a licensed pharmacist acting on behalf of the pharmacy providing services to the patients of the covered entity. The pharmacist need not be physically present at the site of the automated patient dispensing system and may supervise the system electronically.

(8) Notwithstanding Section 4107, the board may issue a license for the operation of an automated patient dispensing system at an address for which it has issued another site license.

(9) The board, within 30 days after receipt of an application for an automated patient dispensing system license, shall conduct a prelicensure inspection at the proposed location of the automated patient dispensing system. Relocation of the automated patient dispensing system shall require a new application for licensure. Replacement of an automated patient dispensing system shall require notice to the board within 30 days.

(10) The automated patient dispensing system license shall be canceled by operation of law if the underlying pharmacy license is not current, valid, and active. Upon reissuance or reinstatement of the underlying pharmacy license, a new application for an automated patient dispensing system license may be submitted to the board.

(11) A pharmacy that holds an automated patient dispensing system license shall advise the board in writing within 30 days if use of the automated patient dispensing system is discontinued.

(b) For purposes of this section, the following definitions shall apply:

(1) An “automated drug delivery system” (ADDS) means a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, dispensing, or distribution of drugs. An ADDS shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability.

(2) An “automated patient dispensing system” (APDS) is an ADDS for storage and dispensing of prescribed drugs directly to patients pursuant to prior authorization by a pharmacist.

(3) An “automated unit dose system” (AUDS) is an ADDS for storage and retrieval of unit doses of drugs for administration to patients by persons authorized to perform these functions.

(c) (1) An automated patient dispensing system shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability.

(2) Transaction information shall be made readily available in a downloadable format for review and inspection by individuals authorized by law. These records shall be maintained by the pharmacy for a minimum of three years.

(d) Drugs from the automated patient dispensing system may be dispensed directly to the patient, if all of the following requirements are met:

(1) The pharmacy shall develop, implement, and annually review written policies and procedures with respect to all of the following:

(A) Maintaining the security of the automated patient dispensing system and the dangerous drugs and devices within that automated patient dispensing system.

(B) Determining and applying inclusion criteria regarding which drugs and devices are appropriate for placement in the automated patient dispensing system and for which patients.

(C) Ensuring that patients are aware that consultation with a pharmacist is available for any prescription medication, including those delivered via the automated patient dispensing system.

(D) Describing assignment of responsibilities to, and training of, pharmacy personnel, and other personnel using the automated patient dispensing system at the location where the automated patient dispensing system is placed, regarding maintenance and filing procedures for the automated patient dispensing system.

(E) Orienting participating patients on the use of the automated patient dispensing system, notifying patients when expected prescription medications are not available in the automated patient dispensing system, and ensuring that patient use of the automated patient dispensing system does not interfere with delivery of drugs and devices.

(F) Ensuring delivery of drugs and devices to patients expecting to receive them from the automated patient dispensing system if the automated patient dispensing system is disabled or malfunctions.

(2) The automated patient dispensing system shall only be used for patients who have signed a written consent demonstrating their informed consent to receive prescribed drugs and devices from an automated patient dispensing system and whose use of the automated patient dispensing system meet the criteria pursuant to paragraph (1).

(3) The automated patient dispensing system shall have a means to identify each patient and only release the identified patient’s drugs and devices to the patient or the patient’s agent.

(4) A pharmacist shall perform all clinical services conducted as part of the dispensing process, including, but not limited to, drug utilization review and consultation.

(5) Drugs shall be dispensed from the automated patient dispensing system only upon authorization from a pharmacist after the pharmacist has reviewed the prescription and the patient’s profile for potential contraindications and adverse drug reactions.

(6) All prescribed drugs and devices dispensed from the automated patient dispensing system for the first time shall be accompanied by a consultation conducted by a pharmacist licensed by the board via a telecommunications link that has two-way audio and video.

(7) The automated patient dispensing system shall include a notice, prominently posted on the automated patient dispensing system, that provides the name, address, and telephone number of the pharmacy that holds the automated patient dispensing system license for that automated patient dispensing system.

(8) The labels on all drugs dispensed by the automated patient dispensing system shall comply with Section 4076 of this code and with Section 1707.5 of Title 16 of the California Code of Regulations.

(9) Any complaint, error, or omission involving the automated patient dispensing system shall be reviewed as part of the pharmacy’s quality assurance program pursuant to Section 4125.

(10) The board shall not issue a pharmacy more than 15 licenses for automated patient dispensing system units under this section. Consistent with Section 4001.1, the board may adopt regulations to reduce the number of automated patient dispensing system licenses that may be issued to a pharmacy.

(11) The pharmacy holding the license for the automated patient dispensing system shall maintain the policies and procedures developed pursuant to paragraph (1) for three years after the last date of use of that automated patient dispensing system.

(e) Access to the automated patient dispensing system shall be controlled and tracked using an identification or password system or biosensor. A system that is accessed via a password system shall include a camera that records a picture of the individual accessing the machine. Picture records shall be maintained for a minimum of 180 days.

(f) The automated patient dispensing system shall make a complete and accurate record of all transactions that will include all users accessing the system and all drugs added to, or removed from, the system.

(g) The stocking of an automated patient dispensing system shall be performed by a pharmacist. If the automated patient dispensing system utilizes removable pockets, cards, drawers, similar technology, or unit of use or single dose containers as defined by the United States Pharmacopeia, the stocking system may be done outside of the facility and be delivered to the facility, if all of the following conditions are met:

(1) The task of placing drugs into the removable pockets, cards, drawers, similar technology, or unit of use or single dose containers is performed by a pharmacist, or by an intern pharmacist or a pharmacy technician working under the direct supervision of a pharmacist.

(2) The removable pockets, cards, drawers, similar technology, or unit of use or single dose containers are transported between the pharmacy and the facility in a secure tamper-evident container.

(3) The pharmacy, in conjunction with the covered entity, has developed policies and procedures to ensure that the removable pockets, cards, drawers, similar technology, or unit of use or single dose containers are properly placed into the automated patient dispensing system.

(h) Review of the drugs contained within, and the operation and maintenance of, the automated patient dispensing system shall be done in accordance with law and shall be the responsibility of the pharmacy. A pharmacist shall conduct the review on a monthly basis, which shall include a physical inspection of the drugs in the automated patient dispensing system, an inspection of the automated patient dispensing system machine for cleanliness, and a review of all transaction records in order to verify the security and accountability of the system.

(i) A pharmacy holding an automated patient dispensing system license shall complete a self-assessment, performed pursuant to Section 1715 of Title 16 of the California Code of Regulations, evaluating the pharmacy’s compliance with pharmacy law relating to the use of the automated patient dispensing system. All information regarding operation, maintenance, compliance, error, omissions, or complaints pertaining to the automated patient dispensing system shall be included in the self-assessment.

(j) The pharmacy shall comply with all recordkeeping and quality assurance requirements pursuant to this chapter, and shall maintain those records within the pharmacy holding the automated patient dispensing system license and separately from other pharmacy records.

(k) This section shall become operative on January 1, 2025.

history: (History: Repealed (in Sec. 6) and added by Stats. 2023, Ch. 723, Sec. 7. (SB 816) Effective January 1, 2024. Operative January 1, 2025, by its own provisions.)

article: 7. Pharmacies


kind: section

code: BPC

citation: BPC § 4120

text:
(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.

history: (History: Amended by Stats. 2015, Ch. 303, Sec. 6. (AB 731) Effective January 1, 2016.)

division: 2. HEALING ARTS

chapter: 9. Pharmacy

article: 7. Pharmacies

path: 2. HEALING ARTS > 9. Pharmacy > 7. Pharmacies


citation: BPC § 4121

text:
(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.

history: (History: Repealed and added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.)

article: 7. Pharmacies


citation: BPC § 4122

text:
(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.

history: (History: Amended by Stats. 2007, Ch. 130, Sec. 11. Effective January 1, 2008.)

article: 7. Pharmacies


citation: BPC § 4123

text: 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.

article: 7. Pharmacies


citation: BPC § 4124

text:
(a) Notwithstanding Section 2543, a pharmacist may dispense replacement contact lenses pursuant to a valid prescription of a physician or optometrist. Nothing in this section authorizes a pharmacist to conduct an examination of the eyes or to fit or adjust contact lenses. For purposes of this section, “replacement contact lenses” means soft contact lenses that require no fitting or adjustment, and that are dispensed as packaged and sealed by the manufacturer.

(b) No replacement contact lenses may be sold or dispensed except pursuant to a prescription that meets all of the following requirements:

(1) Conforms to state and federal statutes and regulations governing those prescriptions and includes the name, address, and state license number of the prescribing practitioner.

(2) Explicitly states an expiration date of not more than one year from the date of the last prescribing examination.

(3) Explicitly states that the prescription is for contact lenses and includes the lens brand name, type, and tint, including all specifications necessary for the ordering of lenses.

(c) The contact lenses that are dispensed shall be the exact contact lenses that have been prescribed, and no substitutions shall be made.

(d) Any pharmacist and pharmacy that dispenses replacement contact lenses shall direct the patient to confer with his or her eyecare practitioner in the event of any eye problem or reaction to the lenses.

(e) Any pharmacist and pharmacy that sells replacement contact lenses shall provide the following or substantially equivalent written notification to the patient whenever contact lenses are supplied:

WARNING: IF YOU ARE HAVING ANY UNEXPLAINED EYE DISCOMFORT, WATERING, VISION CHANGE, OR REDNESS, REMOVE YOUR LENSES IMMEDIATELY AND CONSULT YOUR EYE CARE PRACTITIONER BEFORE WEARING YOUR LENSES AGAIN.

(f) Any pharmacy and pharmacist dispensing replacement contact lenses shall be subject to all statutes, regulations, and ordinances governing the advertisement of contact lenses. In addition, any advertisement by a pharmacy or pharmacist that mentions replacement contact lenses shall include within the advertisement all fees, charges, and costs associated with the purchase of the lenses from that pharmacy and pharmacist.

(g) Any pharmacy dispensing replacement contact lenses shall register with the Medical Board of California at the time of initial application for a license or at the time of annual renewal of that license.

(h) All nonresident pharmacies shall maintain records of replacement contact lenses shipped, mailed, or delivered to persons in California for a period of at least three years. The records shall be available for inspection upon request by the board or the Division of Licensing of the Medical Board of California.

(i) The requirements of this section are applicable to nonresident pharmacies as defined in subdivision (a) of Section 4112. A nonresident pharmacy may dispense contact lenses only as provided in this section.

article: 7. Pharmacies


citation: BPC § 4125

text:
(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.

history: (History: Added by Stats. 2000, Ch. 677, Sec. 1. Effective January 1, 2001. Section operative January 1, 2002, by its own provisions.)

article: 7. Pharmacies


citation: BPC § 4126

text:
(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.

history: (History: Added by Stats. 2001, Ch. 631, Sec. 2. Effective January 1, 2002.)

article: 7. Pharmacies


text:
(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.

history: (History: Amended by Stats. 2018, Ch. 716, Sec. 4. (AB 2576) Effective January 1, 2019.)

article: 7. Pharmacies


text: 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.

history: (History: Added by Stats. 2019, Ch. 184, Sec. 1. (AB 973) Effective January 1, 2020.)

article: 7. Pharmacies


text:
(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.

history: (History: Added by Stats. 2016, Ch. 484, Sec. 22. (SB 1193) Effective January 1, 2017.)

article: 7. Pharmacies


text:
(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).

history: (History: Amended by Stats. 2022, Ch. 28, Sec. 5. (SB 1380) Effective January 1, 2023.)

article: 7. Pharmacies


citation: BPC § 4127

text:
(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).

history: (History: Amended by Stats. 2016, Ch. 484, Sec. 23. (SB 1193) Effective January 1, 2017.)

article: 7.5. Sterile Drug Products

path: 2. HEALING ARTS > 9. Pharmacy > 7.5. Sterile Drug Products


text:
(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.

history: (History: 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.)

article: 7.5. Sterile Drug Products


text:
(a) A nonresident pharmacy shall not compound sterile drug products for shipment into this state without a sterile compounding pharmacy license issued by the board pursuant to this section. The license shall be renewed annually and shall not be transferable.

(b) A license to compound sterile drug products shall be issued only to a location that is licensed as a nonresident pharmacy and shall be issued only to the owner of the nonresident pharmacy licensed at that location.

(c) A license to compound sterile drug products shall not be issued or renewed until the location is inspected by the board and found in compliance with this article and any regulations adopted by the board. The nonresident pharmacy shall reimburse the board for all actual and necessary costs incurred by the board in conducting an inspection of the pharmacy at least once annually pursuant to subdivision (v) of Section 4400.

(d) A license to compound sterile drug products shall not be issued or renewed until the board does all of the following:

(1) Reviews a current copy of the nonresident pharmacy’s policies and procedures for sterile compounding.

(2) 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 nonresident pharmacy’s premises, and any reports from a private accrediting agency, conducted in the prior 12 months documenting the nonresident pharmacy’s operations.

(4) Receives a list of all sterile drug products compounded by the pharmacy within the prior 12 months.

(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 its state of residence or another state within 10 days of the action.

(2) Notify the board within 10 days of the suspension of any accreditation held by the pharmacy.

(3) Provide to the board, within 12 hours, any recall notice issued by the pharmacy for sterile drug products it has compounded that have been shipped into, or dispensed in, California.

(4) Advise the board of any complaint it receives from a provider, pharmacy, or patient in California.

(f) Adverse effects reported or potentially attributable to a nonresident pharmacy’s sterile compounded drug product shall be reported to the board within 12 hours and immediately reported to the MedWatch program of the federal Food and Drug Administration.

(g) On or before January 1, 2018, the board shall provide a report to the Legislature regarding the regulation of nonresident pharmacies. The report shall be submitted to the Legislature in the manner required pursuant to Section 9795 of the Government Code. At a minimum, the report shall address all of the following:

(1) A detailed description of board activities related to the inspection and licensure of nonresident pharmacies.

(2) Whether fee revenue collected pursuant to subdivision (v) of Section 4400 and travel cost reimbursements collected pursuant to subdivision (c) of this section provide revenue in an amount sufficient to support the board’s activities related to the inspection and licensure of nonresident pharmacies.

(3) The status of proposed changes to federal law that are under serious consideration and that would govern compounding pharmacies, including legislation pending before the United States Congress, administrative rules, regulations, or orders under consideration by the federal Food and Drug Administration or other appropriate federal agency, and cases pending before the courts.

(4) If applicable, recommended modifications to the board’s statutory duties related to nonresident pharmacies as a result of changes to federal law or any additional modifications necessary to protect the health and safety of the public.

(h) The requirement for submitting a report imposed under subdivision (g) is inoperative on January 1, 2022, pursuant to Section 10231.5 of the Government Code.

(i) This section shall become operative on July 1, 2014.

history: (History: Repealed (in Sec. 6) and added by Stats. 2013, Ch. 565, Sec. 7. (SB 294) Effective January 1, 2014. Section operative July 1, 2014, by its own provisions.)

article: 7.5. Sterile Drug Products


text:
(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.

history: (History: Amended by Stats. 2021, Ch. 629, Sec. 19. (AB 1533) Effective January 1, 2022.)

article: 7.5. Sterile Drug Products


text: 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.

history: (History: Added by Stats. 2001, Ch. 827, Sec. 2. Effective January 1, 2002. Section operative September 5, 2002, pursuant to Section 4127.6.)

article: 7.5. Sterile Drug Products


text: 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.

history: (History: 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.)

article: 7.5. Sterile Drug Products


text: The board may, at its discretion, issue a temporary license to compound sterile drug products upon the conditions and for any periods of time as the board determines to be in the public interest. A temporary license fee shall be required in an amount established by the board as specified in subdivision (u) of Section 4400. When needed to protect public safety, a temporary license may be issued for a period not to exceed 180 days, and may be issued subject to terms and conditions the board deems necessary. If the board determines a temporary license was issued by mistake or denies the application for a permanent license, the temporary license shall terminate upon either personal service of the notice of termination upon the licenseholder or service by certified mail, return receipt requested at the licenseholder’s address of record with the board, whichever comes first. Neither for purposes of retaining a temporary license nor for purposes of any disciplinary or license denial proceeding before the board shall the temporary licenseholder be deemed to have a vested property right or interest in the license.

history: (History: Added by renumbering Section 4127.8 by Stats. 2017, Ch. 649, Sec. 2. (SB 510) Effective January 1, 2018.)

article: 7.5. Sterile Drug Products


text:
(a) A pharmacy licensed pursuant to Section 4127.1 or 4127.2 that issues a recall notice regarding a sterile compounded drug shall, in addition to any other duties, contact the recipient pharmacy, prescriber, or patient of the recalled drug and the board as soon as possible within 12 hours of the recall notice if both of the following apply:

(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, who shall notify the prescriber or patient, as appropriate. If the pharmacy notifies the prescriber, the prescriber shall ensure the patient is notified.

history: (History: Added by renumbering Section 4127.9 by Stats. 2017, Ch. 649, Sec. 3. (SB 510) Effective January 1, 2018.)

article: 7.5. Sterile Drug Products


text:
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.

history: (History: Added by Stats. 2017, Ch. 623, Sec. 2. (SB 351) Effective January 1, 2018.)

article: 7.5. Sterile Drug Products


citation: BPC § 4128

text:
(a) Notwithstanding Section 4029, a centralized hospital packaging pharmacy may prepare medications, by performing the following specialized functions, for administration only to inpatients within its own general acute care hospital and one or more general acute care hospitals if the hospitals are under common ownership and located within a 75-mile radius of each other:

(1) Preparing unit dose packages for single administration to inpatients from bulk containers, if each unit dose package is barcoded pursuant to Section 4128.4.

(2) Preparing sterile compounded unit dose drugs for administration to inpatients, if each compounded unit dose drug is barcoded pursuant to Section 4128.4.

(3) Preparing compounded unit dose drugs for administration to inpatients, if each unit dose package is barcoded pursuant to Section 4128.4.

(b) For purposes of this article, “common ownership” means that the ownership information on file with the board pursuant to Section 4201 for the licensed pharmacy is consistent with the ownership information on file with the board for the other licensed pharmacy or pharmacies for purposes of preparing medications pursuant to this section.

history: (History: Amended by Stats. 2015, Ch. 241, Sec. 1. (AB 486) Effective September 2, 2015.)

path: 2. HEALING ARTS > 9. Pharmacy > 7.6. Centralized Hospital Packaging Pharmacies


text:
(a) In addition to the pharmacy license requirement described in Section 4110, a centralized hospital packaging pharmacy shall obtain a specialty license from the board prior to engaging in the functions described in Section 4128.

(b) An applicant seeking a specialty license pursuant to this article shall apply to the board on forms established by the board.

(c) Before issuing the specialty license, the board shall inspect the pharmacy and ensure that the pharmacy is in compliance with this article and regulations established by the board.

(d) A license to perform the functions described in Section 4128 may only be issued to a pharmacy that is licensed by the board as a hospital pharmacy.

(e) A license issued pursuant to this article shall be renewed annually and is not transferrable.

(f) An applicant seeking renewal of a specialty license shall apply to the board on forms established by the board.

(g) A license to perform the functions described in Section 4128 shall not be renewed until the pharmacy has been inspected by the board and found to be in compliance with this article and regulations established by the board.

(h) This section shall become operative on January 1, 2025.

history: (History: Repealed (in Sec. 8) and added by Stats. 2023, Ch. 723, Sec. 9. (SB 816) Effective January 1, 2024. Operative January 1, 2025, by its own provisions.)

article: 7.6. Centralized Hospital Packaging Pharmacies


text: A centralized hospital packaging pharmacy may prepare and store a limited quantity of the unit dose drugs authorized by Section 4128 in advance of receipt of a patient-specific prescription in a quantity as is necessary to ensure continuity of care for an identified population of inpatients of the general acute care hospital based on a documented history of prescriptions for that patient population.

history: (History: Added by Stats. 2012, Ch. 687, Sec. 2. (AB 377) Effective January 1, 2013.)


text:
(a) Any unit dose medication produced by a centralized hospital packaging pharmacy shall be barcoded to be machine readable at the inpatient’s bedside using barcode medication administration software.

(b) The barcode medication administration software shall permit health care practitioners to ensure that, before a medication is administered to an inpatient, it is the right medication, for the right inpatient, in the right dose, and via the right route of administration. The software shall verify that the medication satisfies these criteria by reading the barcode on the medication and comparing the information retrieved to the electronic medical record of the inpatient.

(c) For purposes of this section, “barcode medication administration software” means a computerized system designed to prevent medication errors in health care settings.

history: (History: Amended by Stats. 2015, Ch. 241, Sec. 2. (AB 486) Effective September 2, 2015.)


text:
(a) Any label for each unit dose medication produced by a centralized hospital packaging pharmacy shall display a human-readable label that contains all of the following:

(1) The date that the medication was prepared.

(2) The beyond-use date.

(3) The established name of the drug.

(4) The quantity of each active ingredient.

(5) Special storage or handling requirements.

(6) The lot number or control number assigned by the centralized hospital packaging pharmacy.

(7) The name of the centralized hospital packaging pharmacy.

(b) For quality control and investigative purposes, a pharmacist shall be able to retrieve all of the following information using the lot number or control number described in subdivision (a):

(1) The components used in the drug product.

(2) The expiration date of each of the drug’s components.

(3) The National Drug Code Directory number.

history: (History: Amended by Stats. 2015, Ch. 241, Sec. 3. (AB 486) Effective September 2, 2015.)


text: All compounding and packaging functions specified in Section 4128 shall be performed only in the licensed centralized hospital packaging pharmacy and that pharmacy shall comply with all applicable federal and state statutes and regulations, including, but not limited to, regulations regarding compounding and, when appropriate, sterile compounding.

history: (History: Amended by Stats. 2016, Ch. 484, Sec. 28. (SB 1193) Effective January 1, 2017.)


text: A centralized hospital packaging pharmacy and the pharmacists working in the pharmacy shall be responsible for the integrity, potency, quality, and labeled strength of any unit dose drug product prepared by the centralized hospital packaging pharmacy.


citation: BPC § 4129

text:
(a) A facility registered as an outsourcing facility with the federal Food and Drug Administration (FDA) shall be concurrently licensed with the board as an outsourcing facility if it compounds sterile medication or nonsterile medication for nonpatient-specific distribution within or into California.

(b) A facility premises licensed with the board as a sterile compounding pharmacy shall not be concurrently licensed with the board as an outsourcing facility at the same location.

(c) The board may adopt regulations in accordance with the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code) to establish policies, guidelines, and procedures to implement this article.

(d) The board shall review any formal requirements or guidance documents developed by the FDA regarding outsourcing facilities within 90 days after their release in order to determine whether revisions are necessary for any regulations promulgated by the board.

(e) An outsourcing facility licensed by the board dispensing patient-specific compounded preparations pursuant to a prescription for an individual patient shall not be required to be licensed as a pharmacy, but shall otherwise comply with the same requirements of a pharmacy.

history: (History: Amended by Stats. 2021, Ch. 629, Sec. 20. (AB 1533) Effective January 1, 2022.)

article: 7.7. Outsourcing Facilities

path: 2. HEALING ARTS > 9. Pharmacy > 7.7. Outsourcing Facilities


text:
(a) An outsourcing facility that is licensed with the federal Food and Drug Administration (FDA) and with an address in this state shall also be licensed by the board as an outsourcing facility before doing business within this state. The license shall be renewed annually and is not transferable.

(b) An outsourcing facility shall compound all sterile products and nonsterile products in compliance with regulations issued by the board and with federal current good manufacturing practices applicable to outsourcing facilities.

(c) An outsourcing facility license shall not be issued or renewed until the location is inspected by the board and found in compliance with this article and regulations adopted by the board.

(d) An outsourcing facility license shall not be issued or renewed until the board does all of the following:

(1) Prior to inspection, reviews a current copy of the outsourcing facility’s policies and procedures for sterile compounding and nonsterile compounding.

(2) Is provided with copies of all federal and state regulatory agency inspection reports, as well as accreditation reports, and certification reports of facilities or equipment of the outsourcing facility’s premises conducted in the prior 12 months.

(3) Prior to inspection, receives a list of all sterile drugs and nonsterile drugs compounded by the outsourcing facility as reported to the FDA in the last 12 months.

(e) An outsourcing facility licensed pursuant to this section shall provide the board with all of the following:

(1) A copy of any disciplinary or other action taken by another state or the FDA within 10 days of the action.

(2) Notice within 24 hours of any recall notice issued by the outsourcing facility.

(3) A copy of any clinically related complaint it receives involving an outsourcing facility’s compounded products from or involving any provider, pharmacy, or patient in California within 72 hours of receipt.

(4) Notice within 24 hours after learning of adverse effects reported or potentially attributable to the outsourcing facility’s products.

history: (History: Added by Stats. 2016, Ch. 484, Sec. 29. (SB 1193) Effective January 1, 2017.)

article: 7.7. Outsourcing Facilities


text:
(a) An outsourcing facility that is licensed with the federal Food and Drug Administration (FDA) as an outsourcing facility and has an address outside of this state but in the United States of America is a nonresident outsourcing facility. A nonresident outsourcing facility shall not compound sterile drug products or nonsterile drug products for distribution or use into this state without an outsourcing license issued by the board pursuant to this section. The license shall be renewed annually and shall not be transferable.

(b) A nonresident outsourcing facility shall compound all sterile products and nonsterile products to be distributed or used in this state in compliance with regulations of the board and with federal current good manufacturing practices applicable to outsourcing facilities.

(c) A license for a nonresident outsourcing facility shall not be issued or renewed until the location is inspected by the board and found in compliance with this article and any regulations adopted by the board. The nonresident outsourcing facility shall reimburse the board for all actual and necessary costs incurred by the board in conducting an inspection of the nonresident outsourcing facility at least once annually pursuant to subdivision (x) of Section 4400.

(d) A license for a nonresident outsourcing facility shall not be issued or renewed until the board:

(1) Prior to inspection, reviews a current copy of the nonresident outsourcing facility’s policies and procedures for sterile compounding and nonsterile compounding.

(2) (A) Is provided with copies of all federal and state regulatory agency inspection reports, as well as accreditation reports, and certification reports of facilities or equipment of the nonresident outsourcing facility’s premises conducted in the prior 12 months.

(B) For purposes of this paragraph, “state” refers to the state in which the nonresident outsourcing facility resides.

(3) Prior to inspection, receives a list of all sterile drug products and nonsterile drug products compounded by the pharmacy as reported to the FDA within the prior 12 months.

(e) A nonresident outsourcing facility licensed pursuant to this section shall provide the board with all of the following:

(1) A copy of any disciplinary or other action taken by another state or the FDA within 10 days of the action.

(2) Notice within 24 hours of any recall notice issued by the nonresident outsourcing facility.

(3) A copy of any complaint it receives involving an outsourcing facility’s compounded products from or involving any provider, pharmacy, or patient in California within 72 hours of receipt.

(4) Notice within 24 hours after learning of adverse effects reported or potentially attributable to a nonresident outsourcing facility’s products.

article: 7.7. Outsourcing Facilities


text:
(a) On or before January 1, 2018, the board shall provide a report to the Legislature regarding the regulation of nonresident outsourcing facilities. The report shall be submitted to the Legislature in the manner required pursuant to Section 9795 of the Government Code. At a minimum, the report shall address all of the following:

(1) A detailed description of board activities related to the inspection and licensure of nonresident outsourcing facilities.

(2) Whether fee revenue collected pursuant to subdivision (x) of Section 4400 and travel cost reimbursements collected pursuant to subdivision (c) of Section 4129.2 provide revenue in an amount sufficient to support the board’s activities related to the inspection and licensure of nonresident outsourcing facilities.

(3) The status of proposed changes to federal law that are under serious consideration and that would govern outsourcing facilities and compounding pharmacies, including, but not limited to, legislation pending before Congress, administrative rules, regulations or orders under consideration by the FDA or other appropriate federal agency, and cases pending before the courts.

(4) If applicable, recommended modifications to the board’s statutory duties related to nonresident outsourcing facilities as a result of changes to federal law or any additional modifications necessary to protect the health and safety of the public.

(b) The requirement for submitting a report imposed under subdivision (a) is inoperative on January 1, 2022, pursuant to Section 10231.5 of the Government Code.

article: 7.7. Outsourcing Facilities


text:
(a) Whenever the board has a reasonable belief, based on information obtained during an inspection or investigation by the board, that an outsourcing facility compounding sterile drug products or nonsterile drug products poses an immediate threat to the public health or safety, the executive officer of the board may issue an order to the outsourcing facility to immediately cease and desist compounding sterile drug products or nonsterile drug products. The cease and desist order shall remain in effect for no more than 30 days or the date of a hearing seeking an interim suspension order, whichever is earlier.

(b) Whenever the board issues a cease and desist order pursuant to subdivision (a), the board shall immediately issue a notice to the owner setting forth the acts or omissions with which the owner is charged, specifying the pertinent code section or sections and any regulations.

(c) The cease and desist order shall state that the owner, within 15 days of receipt of the notice, may request a hearing before the president of the board to contest the cease and desist order. 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 after the date the request of the owner is received by the board. The president shall render a written decision within five business days after the hearing. In the absence of the president of the board, the vice president of the board may conduct the hearing permitted by this subdivision. The owner or person in possession or control of the outsourcing facility may seek review of the decision 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.

history: (History: Amended by Stats. 2021, Ch. 629, Sec. 21. (AB 1533) Effective January 1, 2022.)

article: 7.7. Outsourcing Facilities


text: Notwithstanding any other law, a violation of this article, or regulation adopted pursuant thereto, may subject the person or entity that committed the violation to a fine of up to five thousand dollars ($5,000) per occurrence pursuant to a citation issued by the board.

article: 7.7. Outsourcing Facilities


text: The board, at its discretion, may issue a temporary license to an outsourcing facility upon the conditions and for any periods of time as the board determines to be in the public interest. A temporary license fee shall be required as specified in subdivision (w) of Section 4400. When needed to protect public safety, a temporary license may be issued for a period not to exceed 180 days, and may be issued subject to terms and conditions the board deems necessary. If the board determines a temporary license was issued by mistake or denies the application for a permanent license, the temporary license shall terminate upon the earlier of personal service of the notice of termination upon the licenseholder or service by certified mail with return receipt requested at the licenseholder’s address of record with the board. The temporary licenseholder shall not be deemed to have a vested property right or interest in the license for purposes of retaining a temporary license or for purposes of any disciplinary or license denial proceeding before the board.

article: 7.7. Outsourcing Facilities


text:
(a) An outsourcing facility licensed pursuant to Section 4129.1 or 4129.2 that issues a recall notice for a sterile drug or nonsterile drug compounded by the outsourcing facility, in addition to any other duties, shall contact the recipient pharmacy, prescriber, or patient of the recalled drug and the board as soon as possible within 24 hours of the recall notice if both of the following apply:

(1) Use of or exposure to the recalled drug may cause serious adverse health consequences or death.

(2) The recalled drug was dispensed, or is intended for use, in this state.

(b) A recall notice issued pursuant to subdivision (a) shall be made as follows:

(1) If the recalled drug was dispensed directly to the prescriber, the notice shall be made to the prescriber and the prescriber shall ensure the patient is notified.

(2) If the recalled drug was dispensed directly to a pharmacy, the notice shall be made to the pharmacy and that pharmacy shall notify the prescriber or patient, as appropriate. If the pharmacy notifies the prescriber, the prescriber shall ensure the patient is notified.

article: 7.7. Outsourcing Facilities


citation: BPC § 4130

text:
(a) A telepharmacy system shall be used for the dispensing of prescription drugs and providing related drug regimen review and patient counseling services at a remote dispensing site pharmacy.

(b) If all of the requirements of this article and other relevant provisions of this chapter are met, the board shall issue a remote dispensing site pharmacy license for the purpose of increasing access to dispensing or pharmaceutical care services in the geographic area in which the remote dispensing site pharmacy is to be located.

(c) (1) A remote dispensing site pharmacy shall only be located in a medically underserved area unless otherwise approved by the board. For purposes of this section, a “medically underserved area” means a location that does not have a pharmacy that serves the general public within 10 road miles of the remote dispensing site.

(2) Notwithstanding paragraph (1), if a pharmacy serving the general public is later established within 10 road miles of a remote dispensing site pharmacy, the remote dispensing site pharmacy may continue to operate.

(d) A remote dispensing site pharmacy shall only be staffed by pharmacists or pharmacy technicians, or both, and shall not employ any unlicensed personnel.

(e) A remote dispensing site pharmacy license shall be issued only to the supervising pharmacy. A supervising pharmacy shall not obtain more than one remote dispensing site pharmacy license.

(f) A remote dispensing site pharmacy shall not be operated by the state and shall not be located in any state facility, including, but not limited to, correctional facilities, state hospitals, or developmental centers. This section shall not be construed to preclude a pharmacist who is otherwise eligible to operate a remote dispensing site pharmacy pursuant to this section from leasing space in property owned by the state, provided it is not for the purpose of serving individuals otherwise served by pharmacists and pharmacy technicians employed by the state.

(g) A remote dispensing site pharmacy shall not be located or operated for the purpose of displacing state employees.

(h) If a remote dispensing site pharmacy dispenses more than 225 prescriptions per day, calculated each calendar year, it shall cease to be a remote dispensing site pharmacy and may become a full-service pharmacy licensed under Section 4110 with a pharmacist onsite if it meets all the requirements for licensure for a pharmacy.

history: (History: Added by Stats. 2017, Ch. 548, Sec. 7. (AB 401) Effective January 1, 2018.)

path: 2. HEALING ARTS > 9. Pharmacy > 8. Telepharmacy Systems and Remote Dispensing Site Pharmacies


citation: BPC § 4131

text:
(a) A supervising pharmacy shall provide telepharmacy services for only one remote dispensing site pharmacy.

(b) A supervising pharmacy shall not be located greater than 150 road miles from a remote dispensing site pharmacy, unless otherwise approved by the board.

(c) A supervising pharmacy and remote dispensing site pharmacy shall be under common ownership.

(d) Unless staffed by a pharmacist, a remote dispensing site pharmacy shall be staffed by at least one registered pharmacy technician meeting the qualifications of Section 4132. A technician shall remain under the direct supervision and control of a pharmacist at the supervising pharmacy at all times that the remote dispensing site pharmacy is operational. For the purposes of this article, direct supervision and control does not require the pharmacist to be physically present at the remote dispensing site pharmacy, but the pharmacist shall use a telepharmacy system to supervise operations through audio and visual technology from the supervising pharmacy.

(e) Notwithstanding any other law, a pharmacist may serve as the pharmacist-in-charge for a pharmacy in addition to serving as pharmacist-in-charge of a supervising pharmacy. The designated pharmacist-in-charge of the supervising pharmacy shall also serve as the designated pharmacist-in-charge at the remote dispensing site pharmacy.

(f) Notwithstanding any other law, the pharmacist-in-charge of the remote dispensing site pharmacy and the pharmacist-on-duty at the supervising pharmacy shall be responsible for ensuring that both the supervising pharmacy and remote dispensing site pharmacy are sufficiently staffed to allow for appropriate supervision, which is supervision that would not be reasonably expected to result in an unreasonable risk of harm to public health, safety, or welfare.

article: 8. Telepharmacy Systems and Remote Dispensing Site Pharmacies


citation: BPC § 4132

text:
(a) In addition to the requirements of Section 4202, a pharmacy technician shall satisfy each of the following requirements before working at a remote dispensing site pharmacy:

(1) Possess a pharmacy technician license that is in good standing.

(2) Possess and maintain a certification issued by a board-approved pharmacy technician certification program.

(3) Possess one of the following:

(A) A minimum of an associate degree in pharmacy technology.

(B) A minimum of a bachelor’s degree in any subject.

(C) A certificate of completion from a course of training specified by regulations adopted by the board pursuant to Section 4202.

(4) Complete a minimum of 2,000 hours of experience working as a pharmacy technician within the two years preceding first commencing work in the remote dispensing site pharmacy.

(b) Notwithstanding Section 4115, a registered pharmacy technician may perform order entry, packaging, manipulative, repetitive, and other nondiscretionary tasks at a remote dispensing site pharmacy under the supervision of a pharmacist at a supervising pharmacy using a telepharmacy system.

(c) A pharmacy technician at a remote dispensing site pharmacy shall not do any of the following:

(1) Receive a new prescription order orally from a prescriber or other person authorized to prescribe by law.

(2) Consult with a patient or their agent regarding a prescription, either before or after dispensing, or regarding any medical information contained in a patient medication record system or patient chart.

(3) Identify, evaluate, or interpret a prescription.

(4) Interpret the clinical data in a patient medication record system or patient chart.

(5) Consult with any prescriber, nurse, or other health care professional or authorized agent thereof.

(6) Supervise the packaging of drugs and check the packaging procedure and product upon completion.

(7) Perform any function that requires the professional judgment of a licensed pharmacist.

(8) Compound drug preparations.

(d) Notwithstanding Section 4115, a pharmacist at a supervising pharmacy may supervise up to two pharmacy technicians at each remote dispensing site pharmacy. This subdivision shall not be construed to alter a pharmacist’s ability to also supervise pharmacy technicians at the supervising pharmacy.

history: (History: Amended by Stats. 2019, Ch. 679, Sec. 2. (AB 690) Effective October 9, 2019.)


citation: BPC § 4133

text:
(a) A telepharmacy system shall maintain a video and audio communication system that provides for effective communication between the supervising pharmacy and the remote dispensing site pharmacy’s personnel and patients.

(b) A telepharmacy system shall facilitate adequate pharmacist supervision and allow the appropriate exchange of visual, verbal, and written communications for patient counseling and other matters involved in the lawful dispensing of drugs.

(c) Patient counseling shall be provided using audio-visual communication prior to all prescriptions being dispensed from a remote dispensing site pharmacy.

(d) A telepharmacy system shall be able to do all of the following:

(1) Identify and record the pharmacy technician preparing each prescription and the supervising pharmacist who reviewed and authorized the dispensing of the prescription.

(2) Require a pharmacist to review and compare the electronic image of any new prescription presented at the remote dispensing site pharmacy with the data entry record of the prescription.

(3) Require the pharmacy technician to use barcode technology to verify the accuracy of the drug to be dispensed.

(4) Require remote visual confirmation by a pharmacist at the supervising pharmacy of the drug stock bottle and the drug to be dispensed prior to dispensing.

(5) Ensure that a prescription is not sold or delivered to a patient prior to a pharmacist performing final verification of the accuracy of the prescription and releasing the prescription for sale and delivery.

(e) The video and audio communication system used to counsel and interact with each patient or patient’s caregiver shall be secure and compliant with the federal Health Insurance Portability and Accountability Act (Public Law 104-191).

(f) All records of prescriptions dispensed including the records of the actions performed through the telepharmacy system shall be maintained at the remote dispensing site pharmacy and shall be maintained for three years after the filling of the prescription.


citation: BPC § 4134

text:
(a) A pharmacist from the supervising pharmacy shall complete a monthly in-person, self-inspection of each remote dispensing site pharmacy using a form designated by the board and shall retain all inspection reports.

(b) A perpetual inventory shall be kept for all controlled substances stored at a remote dispensing site pharmacy.

(c) All controlled substances at a remote dispensing site pharmacy shall be stored in a secure cabinet or safe that is locked.

(d) A pharmacist from the supervising pharmacy shall perform inventory and inventory reconciliation functions at a remote dispensing site pharmacy to detect and prevent the loss of any controlled substance.

(e) The pharmacist-in-charge of a remote dispensing site pharmacy shall review all inventory and inventory reconciliation reports taken and shall establish and maintain secure methods to prevent losses of any controlled substance. The board shall develop written policies and procedures for performing the inventory reconciliation reports required by this section.

(f) A pharmacist from the supervising pharmacy shall compile an inventory reconciliation report of all Schedule II controlled substances at a remote dispensing site pharmacy at least once every three months. This compilation shall require all of the following:

(1) A physical count, not an estimate, of all quantities of Schedule II controlled substances at the remote dispensing site pharmacy. The biennial inventory of controlled substances as required under federal law may serve as one of the mandated inventories under this section in the year that the federal biennial inventory is performed, provided that the biennial inventory was taken no more than three months from the last inventory required by this section.

(2) A review of all acquisitions and dispositions of Schedule II controlled substances since the last inventory reconciliation report.

(3) A comparison of paragraphs (1) and (2) in order to determine if there are any variances.

(4) All records used to compile each inventory reconciliation report shall be maintained in the remote dispensing site pharmacy for at least three years in a readily retrievable form.

(g) A remote dispensing site pharmacy shall report to the board, in writing, any identified losses of controlled substances and possible causes of the loss within 30 days of discovering the loss unless the cause of loss is theft, diversion, or self-use in which case the report shall be made within 14 days of discovering the loss. If the remote dispensing site pharmacy is unable to identify the cause of the loss, the remote dispensing site pharmacy shall undertake further investigation to identify the cause of the loss and security improvements necessary to prevent any additional losses of controlled substances. The pharmacist-in-charge shall be responsible for submitting the report to the board.

(h) Possible causes of overages shall be identified in writing and incorporated into the inventory reconciliation report.

(i) The inventory reconciliation report shall be dated and signed by the individual or individuals performing the inventory and countersigned by the pharmacist-in-charge of the remote dispensing site pharmacy. A countersignature shall not be required if the pharmacist-in-charge personally completed the inventory reconciliation report. The inventory reconciliation report shall be maintained in the remote dispensing site pharmacy for at least three years in a readily retrievable form.


citation: BPC § 4135

text:
(a) While closed, a remote dispensing site pharmacy shall utilize an alarm or other comparable monitoring system to protect its equipment, records, and supply of drugs, devices, and other restricted sale items from unauthorized access, acquisition, or use.

(b) Unless a pharmacist is present at the remote dispensing site pharmacy, a remote dispensing site pharmacy shall not be open or its employees allowed access to it during times the supervising pharmacy is closed. The security system shall allow for tracking of entries into the remote dispensing site pharmacy and the pharmacist-in-charge shall periodically review the record of entries. Pharmacy services shall not be provided at a remote dispensing site pharmacy if the telepharmacy system is unavailable.

(c) The remote dispensing site pharmacy shall retain a recording of facility surveillance, excluding patient communications, for a minimum of 120 days.


citation: BPC § 4141

text: No person shall furnish hypodermic needles or syringes, by sale or otherwise, without a license issued by the board, except as otherwise provided by this article.

history: (History: Repealed and added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.)

article: 9. Hypodermic Needles and Syringes

path: 2. HEALING ARTS > 9. Pharmacy > 9. Hypodermic Needles and Syringes


citation: BPC § 4143

text: This article shall not apply to the sale of hypodermic syringes and needles at wholesale by pharmacies, drug wholesalers, drug manufacturers or manufacturers and dealers in surgical instruments to pharmacies, physicians, dentists, podiatrists, veterinarians, or persons to whom a license has been issued under this article.

history: (History: Amended by Stats. 1997, Ch. 549, Sec. 85. Effective January 1, 1998.)

article: 9. Hypodermic Needles and Syringes


text: A person may sell or obtain hypodermic needles and hypodermic syringes without a prescription or permit, for uses that the board determines are industrial, and that person shall not be required to comply with Section 4145.5 or 4146.

history: (History: Amended by Stats. 2014, Ch. 331, Sec. 2. (AB 1743) Effective January 1, 2015.)

article: 9. Hypodermic Needles and Syringes


text:
(a) Notwithstanding any other provision of law, a pharmacist or physician may, without a prescription or a permit, furnish hypodermic needles and syringes for human use, and a person may, without a prescription or license, obtain hypodermic needles and syringes from a pharmacist or physician for human use, if the furnisher has previously been provided a prescription or other proof of a legitimate medical need requiring a hypodermic needle or syringe to administer a medicine or treatment.

(b) Notwithstanding any other provision of law, as a public health measure intended to prevent the transmission of HIV, viral hepatitis, and other bloodborne diseases among persons who use syringes and hypodermic needles, and to prevent subsequent infection of sexual partners, newborn children, or other persons, a physician or pharmacist may, without a prescription or a permit, furnish hypodermic needles and syringes for human use to a person 18 years of age or older, and a person 18 years of age or older may, without a prescription or license, obtain hypodermic needles and syringes solely for personal use from a physician or pharmacist.

(c) Notwithstanding any other provision of law, a pharmacist, veterinarian, or person licensed pursuant to Section 4141 may, without a prescription or license, furnish hypodermic needles and syringes for use on animals, and a person may, without a prescription or license, obtain hypodermic needles and syringes from a pharmacist, veterinarian, or person licensed pursuant to Section 4141 for use on animals.

(d) A pharmacy that furnishes nonprescription hypodermic needles and syringes shall store hypodermic needles and syringes in a manner that ensures that they are available only to authorized personnel, and are not accessible to other persons.

(e) In order to provide for the safe disposal of hypodermic needles and syringes, a pharmacy or hypodermic needle and syringe exchange program that furnishes nonprescription hypodermic needles and syringes shall counsel consumers on safe disposal and provide consumers with one or more of the following disposal options:

(1) It shall establish an onsite, safe, hypodermic needle and syringe collection and disposal program that meets applicable state and federal standards for collection and disposal of medical sharps waste.

(2) It shall furnish, or make available, mail-back sharps containers authorized by the United States Postal Service that meet applicable state and federal requirements for the transport of medical sharps waste, and shall provide tracking forms to verify destruction at a certified disposal facility.

(3) It shall furnish, or make available, a sharps container that meets applicable state and federal standards for collection and disposal of medical sharps waste.

(f) A pharmacy that furnishes nonprescription syringes shall provide written information or verbal counseling to consumers at the time of furnishing or sale of nonprescription hypodermic needles or syringes on how to do the following:

(1) Access drug treatment.

(2) Access testing and treatment for HIV and hepatitis C.

(3) Safely dispose of sharps waste.

history: (History: Amended by Stats. 2025, Ch. 685, Sec. 1. (AB 309) Effective January 1, 2026.)

article: 9. Hypodermic Needles and Syringes


citation: BPC § 4146

text: A pharmacy may accept the return of needles and syringes from the public if contained in a sharps container, as defined in Section 117750 of the Health and Safety Code.

history: (History: Added by Stats. 2009, Ch. 307, Sec. 40. (SB 821) Effective January 1, 2010.)

article: 9. Hypodermic Needles and Syringes


citation: BPC § 4147

text:
(a) For the purposes of this section, “playground” means any park or outdoor recreational area specifically designed to be used by children that has play equipment installed or any similar facility located on public or private school grounds or county parks.

(b) Any hypodermic needle or syringe that is to be disposed of, shall be contained, treated, and disposed of, pursuant to Part 14 (commencing with Section 117600) of Division 104 of the Health and Safety Code.

(c) It is unlawful to discard or dispose of a hypodermic needle or syringe upon the grounds of a playground, beach, park, or any public or private elementary, vocational, junior high, or high school.

(d) A person who knowingly violates subdivision (c) is guilty of a misdemeanor, and upon conviction shall be punished by a fine of not less than two hundred dollars ($200) and not more than two thousand dollars ($2,000), or by imprisonment in a county jail for up to six months, or by both that fine and imprisonment.

(e) Subdivision (c) does not apply to the containment, treatment, and disposal of medical sharps waste from medical care or first aid services rendered on school grounds, nor to the containment, treatment, and disposal of hypodermic needles or syringes used for instructional or educational purposes on school grounds.

history: (History: Amended by Stats. 2004, Ch. 608, Sec. 3. Effective January 1, 2005.)

article: 9. Hypodermic Needles and Syringes


text: All stocks of hypodermic needles or syringes shall be confiscated if found outside the licensed premises of any person holding a permit under Section 4141 and found not in the possession or under the control of a person entitled to an exemption under Section 4143, 4144.5, or 4145.5, or under Section 11364, 121349, or 121349.1 of the Health and Safety Code.

history: (History: Amended by Stats. 2014, Ch. 331, Sec. 6. (AB 1743) Effective January 1, 2015.)

article: 9. Hypodermic Needles and Syringes


citation: BPC § 4149

text:
(a) A nonresident distributor shall not sell or distribute hypodermic needles or syringes in this state without obtaining a license from the board pursuant to Section 4141.

(b) Notwithstanding subdivision (a), a license is not required if the nonresident distributor sells or distributes solely through a person who is licensed as a wholesaler or third-party logistics provider pursuant to Section 4160.

(c) The Legislature, by enacting this section, does not intend a license issued to any nonresident distributor pursuant to this article to serve as evidence that the entity is doing business within this state.

history: (History: Amended by Stats. 2014, Ch. 507, Sec. 15. (AB 2605) Effective January 1, 2015.)

article: 9. Hypodermic Needles and Syringes


citation: BPC § 4150

text:
(a) A pharmacy corporation means a corporation that is authorized to render professional services, as defined in Section 13401 of the Corporations Code, so long as that corporation and its shareholders, officers, directors, and employees rendering professional services who are pharmacists are in compliance with the Moscone-Knox Professional Corporation Act, this article, and all other statutes and regulations now or hereafter enacted or adopted pertaining to the corporation and the conduct of its affairs.

(b) With respect to a pharmacy corporation, the governmental agency referred to in the Moscone-Knox Professional Corporation Act is the Board of Pharmacy of the State of California.

history: (History: Amended by Stats. 1997, Ch. 549, Sec. 87. Effective January 1, 1998.)

article: 10. Pharmacy Corporations

path: 2. HEALING ARTS > 9. Pharmacy > 10. Pharmacy Corporations


citation: BPC § 4151

text: Each shareholder, director, and officer of a pharmacy corporation, except an assistant secretary and an assistant treasurer, shall be a licensed person as defined in Section 13401 of the Corporations Code.

article: 10. Pharmacy Corporations


citation: BPC § 4152

text: The name of a pharmacy corporation and any name or names under which it may render professional services shall contain the word “pharmacist,” “pharmacy,” or “pharmaceutical” and wording or abbreviations denoting corporate existence.

article: 10. Pharmacy Corporations


citation: BPC § 4153

text: The income of a pharmacy corporation attributable to professional services rendered while a shareholder is a disqualified person, as defined in Section 13401 of the Corporations Code, shall not in any manner accrue to the benefit of the shareholder or his or her shares in the pharmacy corporation.

history: (History: Added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.)

article: 10. Pharmacy Corporations


citation: BPC § 4154

text: The board may adopt and enforce regulations to carry out the purposes and objectives of this article, including regulations requiring (a) that the bylaws of a pharmacy corporation shall include a provision whereby the capital stock of the corporation owned by a disqualified person, as defined in Section 13401 of the Corporations Code, or a deceased person, shall be sold to the corporation or to the remaining shareholders of the corporation within the time as the regulations may provide, and (b) that a pharmacy corporation shall provide adequate security by insurance or otherwise for claims against it by its patients or clients arising out of the rendering of professional services.

article: 10. Pharmacy Corporations


citation: BPC § 4155

text: Nothing in this article shall be construed as requiring the applicant or holder of a pharmacy permit pursuant to Section 4110 to be a pharmacy corporation.

article: 10. Pharmacy Corporations


citation: BPC § 4156

text: A pharmacy corporation shall not do, or fail to do, any act where doing or failing to do the act would constitute unprofessional conduct under any statute or regulation. In the conduct of its practice, a pharmacy corporation shall observe and be bound by the laws and regulations that apply to a person licensed under this chapter.

article: 10. Pharmacy Corporations


citation: BPC § 4160

text:
(a) A person shall not act as a wholesaler or third-party logistics provider of any dangerous drug or dangerous device unless he or she has obtained a license from the board.

(b) Upon approval by the board and the payment of the required fee, the board shall issue a license to the applicant.

(c) (1) A separate license shall be required for each place of business owned or operated by a wholesaler or third-party logistics provider. Each place of business may only be issued a single license by the board, except as provided in paragraph (2). Each license shall be renewed annually and shall not be transferable. At all times during which a place of business is open for business, at least one designated representative, in the case of a wholesaler, or designated representative-3PL in the case of a third-party logistics provider, shall be present. A wholesaler that only acts as a reverse distributor may use either a designated representative or a designated representative-reverse distributor to fulfill this requirement.

(2) A wholesaler and a third-party logistics provider under common ownership may be licensed at the same place of business provided that all of the following requirements are satisfied:

(A) The wholesaler and the third-party logistics provider each separately maintain the records required under Section 4081.

(B) Dangerous drugs and dangerous devices owned by the wholesaler are not commingled with the dangerous drugs and dangerous devices handled by the third-party logistics provider.

(C) Any individual acting as a designated representative for the wholesaler is not concurrently acting as a designated representative-3PL on behalf of the third-party logistics provider. Nothing in this subparagraph shall be construed to prohibit an individual from concurrently holding a license to act as a designated representative and to act as a designated representative-3PL.

(D) The wholesaler has its own designated representative-in-charge responsible for the operations of the wholesaler and the third-party logistics provider has its own responsible manager responsible for the operations of the third-party logistics provider. The same individual shall not concurrently serve as the responsible manager and the designated representative-in-charge for a wholesaler and a third-party logistics provider licensed at the same place of business.

(E) The third-party logistics provider does not handle the prescription drugs or prescription devices owned by a prescriber.

(F) The third-party logistics provider is not a reverse third-party logistics provider.

(G) The wholesaler is not acting as a reverse distributor.

(d) Every wholesaler shall be supervised or managed by a designated representative-in-charge. The designated representative-in-charge shall be responsible for the wholesaler’s compliance with state and federal laws governing wholesalers. As part of its initial application for a license, and for each renewal, each wholesaler shall, on a form designed by the board, provide identifying information and the California license number for a designated representative or pharmacist proposed to serve as the designated representative-in-charge. The proposed designated representative-in-charge shall be subject to approval by the board. The board shall not issue or renew a wholesaler license without identification of an approved designated representative-in-charge for the wholesaler. The designated representative-in-charge shall maintain an active license as a designated representative with the board at all times during which he or she is designated as the designated representative-in-charge. A wholesaler that only acts as a reverse distributor may identify and allow a designated representative-reverse distributor to perform in this capacity. That individual shall maintain an active license as a designated representative-reverse distributor.

(e) Each place of business of a third-party logistics provider shall be supervised and managed by a responsible manager. The responsible manager shall be responsible for the compliance of the place of business with state and federal laws governing third-party logistics providers and with the third-party logistics provider’s customer specifications, except where the customer’s specifications conflict with state or federal laws. As part of its initial application for a license, and for each renewal, each third-party logistics provider shall, on a form designated by the board, provide identifying information and the California license number for a designated representative-3PL proposed to serve as the responsible manager. The proposed responsible manager shall be subject to approval by the board. The board shall not issue or renew a third-party logistics provider license without identification of an approved responsible manager for the third-party logistics provider. The responsible manager shall maintain an active license as a designated representative-3PL with the board at all times during which he or she is designated as the responsible manager.

(f) A wholesaler shall notify the board in writing, on a form designed by the board, within 30 days of the date when a designated representative-in-charge ceases to act as the designated representative-in-charge, and shall on the same form propose another authorized licensee to take over as the designated representative-in-charge. The proposed replacement designated representative-in-charge shall be subject to approval by the board. If disapproved, the wholesaler shall propose another replacement within 15 days of the date of disapproval, and shall continue to name proposed replacements until a designated representative-in-charge is approved by the board.

(g) A third-party logistics provider shall notify the board in writing, on a form designed by the board, within 30 days of the date when a responsible manager ceases to act as the responsible manager, and shall on the same form propose another designated representative-3PL to take over as the responsible manager. The proposed replacement responsible manager shall be subject to approval by the board. If disapproved, the third-party logistics provider shall propose another replacement within 15 days of the date of disapproval, and shall continue to name proposed replacements until a responsible manager is approved by the board.

(h) A drug manufacturer premises licensed by the Food and Drug Administration or licensed pursuant to Section 111615 of the Health and Safety Code that only distributes dangerous drugs and dangerous devices of its own manufacture is exempt from this section and Section 4161.

(i) The board may issue a temporary license, upon conditions and for periods of time as the board determines to be in the public interest. A temporary license fee shall be required in an amount established by the board as specified in subdivision (f) of Section 4400. When needed to protect public safety, a temporary license may be issued for a period not to exceed 180 days, subject to terms and conditions that the board deems necessary. If the board determines that a temporary license was issued by mistake or denies the application for a permanent license, the temporary license shall terminate upon either personal service of the notice of termination upon the licenseholder or service by certified mail, return receipt requested, at the licenseholder’s address of record with the board, whichever occurs first. For purposes of retaining a temporary license, or for purposes of any disciplinary or license denial proceeding before the board, the temporary licenseholder shall not be deemed to have a vested property right or interest in the license.

history: (History: Amended by Stats. 2017, Ch. 598, Sec. 7. (SB 752) Effective January 1, 2018.)

path: 2. HEALING ARTS > 9. Pharmacy > 11. Wholesalers, Third-Party Logistics Providers, and Manufacturers


text: Within 30 days of the effective date of the act adding this section, a manufacturer of a nonprescription diabetes test device shall make the names of its authorized distributors available on its Internet Web site and shall provide the board with the names of its authorized distributors. Within 30 days of receiving that information from a manufacturer of a nonprescription diabetes test device, the board shall post the names of authorized distributors of nonprescription diabetes test devices on the board’s Internet Web site. A manufacturer of a nonprescription diabetes test device shall, within 30 days of making changes to its authorized distributors, update its Internet Web site and inform the board of changes to its authorized distributors. Within 30 days of receiving notice of any change from a manufacturer of a nonprescription diabetes test device, the board shall post the updated list of the manufacturer’s authorized distributors on its Internet Web site.

history: (History: Added by Stats. 2017, Ch. 139, Sec. 5. (AB 602) Effective July 31, 2017.)

article: 11. Wholesalers, Third-Party Logistics Providers, and Manufacturers