Title BPC — California Bus. & Prof. Code

The board shall administer and enforce this chapter and the Uniform Controlled Substances Act (Division 10 (commencing with Section 11000) of the Health and Safety Code).

The board shall upon request furnish any person with a copy of the laws or regulations relating to dangerous drugs, the furnishing or possession of which is restricted by this article or by further rules of the board.

(a) Any facility licensed by the board shall join the board’s email notification list within 60 days of obtaining a license or at the time of license renewal. (b) Any facility licensed by the board shall update its email address with the board’s email notification list within 30 …

(a) The board shall have exclusive authority to interpret and enforce the provisions of this chapter regarding the practice of pharmacy and the licensing of pharmacists and pharmacies. (b) Any violation of this chapter by a licensee of the board shall be determined exclusively by…

For purposes of this chapter, the definitions of the terms in this article shall govern the construction of this chapter, unless otherwise indicated.

“Administer” means the direct application of a drug or device to the body of a patient or research subject by injection, inhalation, ingestion, or other means.

“Advanced pharmacist practitioner” means a licensed pharmacist who has been recognized as an advanced pharmacist practitioner by the board, pursuant to Section 4210. A board-recognized advanced pharmacist practitioner is entitled to practice advanced practice pharmacy, as describ…

“Authorized officers of the law” means inspectors of the California State Board of Pharmacy, inspectors of the Food and Drug Branch of the State Department of Public Health, and investigators of the department’s Division of Investigation or peace officers engaged in official inve…

(a) 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 i…

“Board” means the California State Board of Pharmacy.

An “order,” entered on the chart or medical record of a patient registered in a hospital or a patient under emergency treatment in the hospital, by or on the order of a practitioner authorized by law to prescribe drugs, shall be authorization for the administration of the drug fr…

“Controlled substance” means any substance listed in Chapter 2 (commencing with Section 11053) of Division 10 of the Health and Safety Code.

(a) “Correctional pharmacy” means a pharmacy, licensed by the board, for the purpose of providing drugs and pharmaceutical care to inmates of the Department of Corrections and Rehabilitation. (b) As part of its pharmaceutical care, a correctional pharmacy may dispense or administ…

“Dangerous drug” or “dangerous device” means any drug or device unsafe for self-use in humans or animals, and includes the following: (a) Any drug that bears the legend: “Caution: federal law prohibits dispensing without prescription,” “Rx only,” or words of similar import. (b) A…

(a) “Designated representative” means an individual to whom a license has been granted pursuant to Section 4053. A pharmacist fulfilling the duties of Section 4053 shall not be required to obtain a license as a designated representative. (b) “Designated representative-in-charge” …

“Designated representative-reverse distributor” means an individual to whom a license has been granted pursuant to Section 4053.2, who is responsible for supervision over a licensed wholesaler that only acts as a reverse distributor. A pharmacist fulfilling the duties of Section …

(a) “Designated representative-3PL” means an individual to whom a license has been granted pursuant to Section 4053.1. A pharmacist fulfilling the duties of Section 4053.1 shall not be required to obtain a license as a designated representative-3PL. (b) “Responsible manager” mean…

“Device” means any instrument, apparatus, machine, implant, in vitro reagent, or contrivance, including its components, parts, products, or the byproducts of a device, and accessories that are used or intended for either of the following: (a) Use in the diagnosis, cure, mitigatio…

For the purposes of this chapter, “direct supervision and control” means that a pharmacist is on the premises at all times and is fully aware of all activities performed by either a pharmacy technician or intern pharmacist.

(a) Except as provided in subdivision (b), “dispense” means the furnishing of drugs or devices upon a prescription from a physician, nurse practitioner practicing pursuant to Section 2837.103 or 2837.104, dentist, optometrist, podiatrist, veterinarian, or naturopathic doctor purs…

“Drug” means any of the following: (a) Articles recognized in the official United States Pharmacopoeia, official National Formulary or official Homeopathic Pharmacopoeia of the United States, or any supplement of any of them. (b) Articles intended for use in the diagnosis, cure, …

“Nonprescription drug” means a drug which may be sold without a prescription and which is labeled for use by the consumer in accordance with the requirements of the laws and rules of this state and the federal government.

“Nonprescription diabetes test device” means a glucose meter or test strip for use in the treatment of prediabetic or diabetic individuals that may be sold without a prescription and that is labeled for use by the consumer in accordance with the requirements of the laws and rules…

“Furnish” means to supply by any means, by sale or otherwise.

“Good standing” means a license issued by the board that is unrestricted by disciplinary action taken pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.

(a) As used in this chapter, the terms “skilled nursing facility,” “intermediate care facility,” and other references to health facilities shall be construed with respect to the definitions contained in Article 1 (commencing with Section 1250) of Chapter 2 of Division 2 of the He…

“Licensed hospital” means an institution, place, building, or agency that maintains and operates organized facilities for one or more persons for the diagnosis, care, and treatment of human illnesses to which persons may be admitted for overnight stay, and includes any institutio…

(a) “Hospital pharmacy” means and includes a pharmacy, licensed by the board, located within any licensed hospital, institution, or establishment that maintains and operates organized facilities for the diagnosis, care, and treatment of human illnesses to which persons may be adm…

“Intern pharmacist” means a person issued a license pursuant to Section 4208.

“Laboratory” means a research, teaching, or testing laboratory not engaged in the dispensing or furnishing of drugs or devices but using dangerous drugs or dangerous devices for scientific or teaching purposes. Every laboratory shall maintain an established place of business and …

“License” means and includes any license, permit, registration, certificate, or exemption issued by the board and includes the process of applying for and renewing the same.

(a) (1) “Manufacturer” means and includes every person who prepares, derives, produces, compounds, or repackages any drug or device except a pharmacy that manufactures on the immediate premises where the drug or device is sold to the ultimate consumer. (2) Notwithstanding paragra…

“Outsourcing facility” means a facility that meets all of the following: (a) Is located within the United States of America at one address that is engaged in the compounding of sterile drugs and nonsterile drugs. (b) Has registered as an outsourcing facility with the federal Food…

An “emergency medical services automated drug delivery system” or “EMSADDS” means an automated drug delivery system that stores and distributes drugs for the sole purpose of restocking a secured emergency pharmaceutical supplies container that is used by an emergency medical serv…

“Person” includes, but is not limited to, firm, association, partnership, corporation, limited liability company, state governmental agency, trust, or political subdivision.

“Pharmacist” means a natural person to whom a license has been issued by the board, under Section 4200, except as specifically provided otherwise in this chapter. The holder of an unexpired and active pharmacist license issued by the board is entitled to practice pharmacy as defi…

“Pharmacist-in-charge” means a pharmacist proposed by a pharmacy and approved by the board as the supervisor or manager responsible for ensuring the pharmacy’s compliance with all state and federal laws and regulations pertaining to the practice of pharmacy.

(a) “Pharmacy” means an area, place, or premises licensed by the board in which the profession of pharmacist is practiced and where prescriptions are compounded. “Pharmacy” includes, but is not limited to, any area, place, or premises described in a license issued by the board wh…

(a) “Pharmacy technician” means an individual who assists a pharmacist in a pharmacy in the performance of their pharmacy related duties, as specified in Section 4115. (b) A “pharmacy technician trainee” is a person who is enrolled in a pharmacy technician training program operat…

“Physicians,” “dentists,” “optometrists,” “pharmacists,” “doctors of podiatric medicine,” “veterinarians,” “veterinary surgeons,” “registered nurses,” “naturopathic doctors,” and “physician assistants” are persons authorized by a currently valid and unrevoked license to practice …

(a) “Prescription” means an oral, written, or electronic transmission order that is both of the following: (1) Given individually for the person or persons for whom ordered that includes all of the following: (A) The name or names and address of the patient or patients. (B) The n…

“Reverse distributor” means every person who acts as an agent for pharmacies, drug wholesalers, third-party logistics providers, manufacturers, and other entities by receiving, inventorying, warehousing, and managing the disposition of outdated or nonsaleable dangerous drugs or d…

“Self-assessment process” means the process of self-evaluation of a facility’s compliance with state and federal laws as a means to promote compliance through self-examination and education. The self-assessment process shall be performed on a form approved by the board in consult…

“Veterinary food-animal drug retailer” is an area, place, or premises, other than a pharmacy, that holds a valid license from the Board of Pharmacy of the State of California as a wholesaler and, in and from which veterinary drugs for food-producing animals are dispensed pursuant…

“Veterinary food-animal drugs” as used in this chapter shall include the following: (a) Any drug to be used in food-producing animals bearing the legend, “Caution, federal law restricts this drug to use by or on the order of a licensed veterinarian” or words of similar import. (b…

“Wholesaler” means and includes a person who acts as a wholesale merchant, broker, jobber, customs broker, reverse distributor, agent, or a nonresident wholesaler, who sells for resale, or negotiates for distribution, or takes possession of, any drug or device included in Section…

“Repackager” means a person or entity that is registered with the federal Food and Drug Administration as a repackager and operates an establishment that packages finished drugs from bulk or that repackages dangerous drugs into different containers, excluding shipping containers.

(a) “Remote dispensing site pharmacy” means a licensed pharmacy located in this state that is exclusively overseen and operated by a supervising pharmacy and staffed by one or more qualified registered pharmacy technicians, as defined in Section 4132, where pharmaceutical care se…

“Reverse third-party logistics provider” means an entity that processes or manages the disposition of an outdated or nonsaleable dangerous drug or dangerous device on behalf of a manufacturer, wholesaler, or dispenser of the dangerous drug or dangerous device, but does not take o…

(a) “Supervising pharmacy” means a licensed pharmacy located in this state that is owned and operated by a person or persons where the majority of the beneficial interest in, as well as the management and control, resides with at least one board-licensed pharmacist, as defined in…