Section § 4015

Explanation

This section states that the definitions provided in this chapter are the ones to be used throughout, unless there's a specific note or context indicating otherwise.

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

Section § 4016

Explanation

In this context, "administer" refers to giving a drug or device directly to someone, whether by injection, inhaling, swallowing, or any other method.

“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.

Section § 4016.5

Explanation

This law defines what an 'advanced practice pharmacist' is. It's a licensed pharmacist who the board has officially recognized for having advanced skills and is allowed to perform more complex pharmacy-related tasks. These tasks can be done inside or outside of a traditional pharmacy setting, as long as they follow the specific rules set by the board.

“Advanced practice pharmacist” means a licensed pharmacist who has been recognized as an advanced practice pharmacist by the board, pursuant to Section 4210. A board-recognized advanced practice pharmacist is entitled to practice advanced practice pharmacy, as described in Section 4052.6, within or outside of a licensed pharmacy as authorized by this chapter.

Section § 4017

Explanation

This law explains that 'authorized officers of the law' include certain inspectors and investigators related to pharmacy and public health, as well as peace officers who are conducting official investigations.

“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 investigations.

Section § 4017.3

Explanation

This law defines three types of automated systems related to drug handling. An 'automated drug delivery system' (ADDS) is a machine that handles storing and dispensing drugs, but not mixing or giving them to patients. It must track all drug movements for security and accuracy. An 'automated unit dose system' (AUDS) is a type of ADDS used to store and retrieve single doses of medicine for patient use by authorized people. Finally, an 'automated patient dispensing system' (APDS) is a type of ADDS that stores and gives out prescribed drugs directly to patients once a pharmacist has approved it.

(a)CA Business & Professions Code § 4017.3(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 information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability.
(b)CA Business & Professions Code § 4017.3(b) 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)CA Business & Professions Code § 4017.3(c) 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.

Section § 4018

Explanation

This section defines the term "Board" as the California State Board of Pharmacy.

“Board” means the California State Board of Pharmacy.

Section § 4019

Explanation

This law states that a drug order written in a patient's chart at a hospital counts as a prescription when the medications are given by hospital staff. It allows the hospital pharmacy to provide these drugs from their supplies based on the order by a doctor or authorized practitioner. The law requires certain details to be included in the patient's records, and orders must be signed by the prescriber or attending physician, either at the time the medication is given or on the prescriber's next hospital visit if they're absent at the time.

An “order,” entered on the chart or medical record of a patient registered in a hospital or a patient under emergency treatment in the hospital, by or on the order of a practitioner authorized by law to prescribe drugs, shall be authorization for the administration of the drug from hospital floor or ward stocks furnished by the hospital pharmacy or under licensure granted under Section 4056, and shall be considered to be a prescription if the medication is to be furnished directly to the patient by the hospital pharmacy or another pharmacy furnishing prescribed drugs for hospital patients; provided that the chart or medical record of the patient contains all of the information required by Sections 4040 and 4070 and the order is signed by the practitioner authorized by law to prescribe drugs, if he or she is present when the drugs are given. If he or she is not present when the drugs are given, the order shall be signed either by the attending physician responsible for the patient’s care at the time the drugs are given to the patient or by the practitioner who ordered the drugs for the patient on the practitioner’s next visit to the hospital.

Section § 4021

Explanation

This section indicates that a 'controlled substance' refers to any drug or chemical listed in a specific part of the Health and Safety Code that deals with the regulation of certain drugs.

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

Section § 4021.5

Explanation

This law defines a 'correctional pharmacy' as a pharmacy licensed to provide medications and pharmaceutical care specifically to prison inmates. These pharmacies can dispense or give out medication based on a chart order or a proper prescription, following the rules of this chapter.

(a)CA Business & Professions Code § 4021.5(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)CA Business & Professions Code § 4021.5(b) As part of its pharmaceutical care, a correctional pharmacy may dispense or administer medication pursuant to a chart order, as defined in Section 4019, or other valid prescription consistent with this chapter.

Section § 4022

Explanation

This law defines what a 'dangerous drug' or 'dangerous device' is. It includes any drug or device that is not safe for people or animals to use by themselves. Specifically, it refers to drugs or devices that carry warnings like 'Rx only' or similar labels. Essentially, these are items that can only be dispensed or sold if there's a prescription due to federal or state law requirements.

“Dangerous drug” or “dangerous device” means any drug or device unsafe for self-use in humans or animals, and includes the following:
(a)CA Business & Professions Code § 4022(a) Any drug that bears the legend: “Caution: federal law prohibits dispensing without prescription,” “Rx only,” or words of similar import.
(b)CA Business & Professions Code § 4022(b) Any device that bears the statement: “Caution: federal law restricts this device to sale by or on the order of a ____,” “Rx only,” or words of similar import, the blank to be filled in with the designation of the practitioner licensed to use or order use of the device.
(c)CA Business & Professions Code § 4022(c) Any other drug or device that by federal or state law can be lawfully dispensed only on prescription or furnished pursuant to Section 4006.

Section § 4022.5

Explanation

This law defines what a 'designated representative' and 'designated representative-in-charge' are in the context of handling certain drugs. A designated representative is someone who has been licensed specifically for this role, while a pharmacist does not need this separate license to perform the same duties. A 'designated representative-in-charge' is a person, approved by the board, who supervises and ensures that a wholesaler or animal drug retailer follows all relevant laws and regulations. This role can be filled by a designated representative, a reverse distributor, or a licensed pharmacist from the home state.

(a)CA Business & Professions Code § 4022.5(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)CA Business & Professions Code § 4022.5(b) “Designated representative-in-charge” means a designated representative or designated representative-reverse distributor, or a pharmacist licensed in the home state proposed by a wholesaler or veterinary food-animal drug retailer and approved by the board as the supervisor or manager responsible for ensuring the wholesaler’s or veterinary food-animal drug retailer’s compliance with all state and federal laws and regulations pertaining to practice in the applicable license category.

Section § 4022.6

Explanation

This section clarifies who can be a 'designated representative-reverse distributor.' It's someone with a license who oversees a licensed wholesaler acting as a reverse distributor. Importantly, a pharmacist doing their typical tasks under another section doesn't need this specific license.

“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 4053.2 shall not be required to obtain a license as a designated representative-reverse distributor.

Section § 4022.7

Explanation

This law describes the roles of two individuals involved in third-party logistics of drugs and medical devices. A 'designated representative-3PL' is someone who gets a specific license, except if they're a pharmacist doing certain duties, they don't need this separate license. A 'responsible manager' is a person picked by a logistics company to ensure its operations comply with laws about handling potentially dangerous drugs or devices.

(a)CA Business & Professions Code § 4022.7(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)CA Business & Professions Code § 4022.7(b) “Responsible manager” means a designated representative-3PL selected by a third-party logistics provider and approved by the board as responsible for ensuring compliance of the licensed place of business with state and federal laws with respect to dangerous drugs and dangerous devices received by, stored in, or shipped from the licensed place of business of the third-party logistics provider.

Section § 4023

Explanation

This section defines what is considered a 'device' within a specific context. A device can be anything like an instrument, machine, or implant used to diagnose, treat, or prevent diseases in humans or animals. It also includes anything that affects the body's structure or functions. However, contact lenses and certain prosthetic or orthopedic devices that don't need a prescription are not classified as devices here.

“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)CA Business & Professions Code § 4023(a) Use in the diagnosis, cure, mitigation, treatment, or prevention of disease in a human or any other animal.
(b)CA Business & Professions Code § 4023(b) To affect the structure or any function of the body of a human or any other animal.
For purposes of this chapter, “device” does not include contact lenses, or any prosthetic or orthopedic device that does not require a prescription.

Section § 4023.5

Explanation
This law states that when a pharmacy technician or intern pharmacist is working, a fully aware pharmacist must be physically present to oversee their activities.
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.

Section § 4024

Explanation

This law defines what it means to "dispense" drugs or medical devices. "Dispense" generally involves giving out drugs or devices based on a prescription from qualified medical professionals like doctors or nurse practitioners. It can also mean giving them directly to a patient by those same professionals as long as they're acting within their authorized role or area of practice.

(a)CA Business & Professions Code § 4024(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 pursuant to Section 3640.7, or upon an order to furnish drugs or transmit a prescription from a certified nurse-midwife, nurse practitioner practicing pursuant to Section 2836.1, physician assistant, naturopathic doctor pursuant to Section 3640.5, or pharmacist acting within the scope of their practice.
(b)CA Business & Professions Code § 4024(b) “Dispense” also means and refers to the furnishing of drugs or devices directly to a patient by a physician, nurse practitioner practicing pursuant to Section 2837.103 or 2837.104, dentist, optometrist, podiatrist, or veterinarian, or by a certified nurse-midwife, nurse practitioner practicing pursuant to Section 2836.1, naturopathic doctor, or physician assistant acting within the scope of their practice.

Section § 4025

Explanation

This section defines what is considered a "drug". It includes items listed in recognized official medical references, those used to diagnose or treat diseases, items meant to alter body functions (besides food), and any parts or components of these articles.

“Drug” means any of the following:
(a)CA Business & Professions Code § 4025(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)CA Business & Professions Code § 4025(b) Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals.
(c)CA Business & Professions Code § 4025(c) Articles (other than food) intended to affect the structure or any function of the body of humans or other animals.
(d)CA Business & Professions Code § 4025(d) Articles intended for use as a component of any article specified in subdivision (a), (b), or (c).

Section § 4025.1

Explanation

This section defines a 'nonprescription drug' as a medication you can buy without needing a doctor's prescription, as long as it's properly labeled according to state and federal laws.

“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.

Section § 4025.2

Explanation

This law section defines a 'nonprescription diabetes test device' as a glucose meter or test strip that can be bought without a prescription. These devices are used by people with prediabetes or diabetes and must have proper labels following state and federal laws.

“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 of this state and the federal government.

Section § 4026

Explanation

The term "furnish" refers to supplying something, whether you're selling it or giving it in another way.

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

Section § 4026.5

Explanation

'Good standing' refers to a license that hasn't been limited or penalized due to disciplinary actions according to specific government rules.

“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.

Section § 4027

Explanation

This section clarifies the definitions of various health care facilities within certain legal contexts. It explains how different types of facilities, like skilled nursing and intermediate care facilities, are defined according to specific parts of the Health and Safety Code. It details what qualifies as a 'licensed health care facility' or 'health care facility' in related sections, indicating that these are typically places licensed or managed by health care service plans. It also specifies that licensed clinics and home health agencies have particular definitions under the Health and Safety Code.

(a)CA Business & Professions Code § 4027(a) As used in this chapter, the terms “skilled nursing facility,” “intermediate care facility,” and other references to health facilities shall be construed with respect to the definitions contained in Article 1 (commencing with Section 1250) of Chapter 2 of Division 2 of the Health and Safety Code.
(b)CA Business & Professions Code § 4027(b) As used in Section 4052.1, “licensed health care facility” means a facility licensed pursuant to Article 1 (commencing with Section 1250) of Chapter 2 of Division 2 of the Health and Safety Code or a facility, as defined in Section 1250 of the Health and Safety Code, operated by a health care service plan licensed pursuant to Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code.
(c)CA Business & Professions Code § 4027(c) As used in Section 4052.2, “health care facility” means a facility, other than a facility licensed under Division 2 (commencing with Section 1200) of the Health and Safety Code, that is owned or operated by a health care service plan licensed pursuant to Chapter 2.2 (commencing with Section 1340) of the Health and Safety Code, or by an organization under common ownership or control of the health care service plan; “licensed home health agency” means a private or public organization licensed by the State Department of Public Health pursuant to Chapter 8 (commencing with Section 1725) of Division 2 of the Health and Safety Code, as further defined in Section 1727 of the Health and Safety Code; and “licensed clinic” means a clinic licensed pursuant to Article 1 (commencing with Section 1200) of Chapter 1 of Division 2 of the Health and Safety Code.
(d)CA Business & Professions Code § 4027(d) “Licensed health care facility” or “facility,” as used in Section 4065, means a health facility licensed pursuant to Article 1 (commencing with Section 1250) of Chapter 2 of Division 2 of the Health and Safety Code or a facility that is owned or operated by a health care service plan licensed pursuant to Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code or by an organization under common ownership or control with the health care service plan.

Section § 4028

Explanation

A "licensed hospital" is a certified facility where people can stay overnight for the diagnosis, care, and treatment of illnesses. It must meet state health regulations and can be a general, specialized, maternity, or tuberculosis hospital. However, it specifically does not include facilities like sanitariums, rest homes, nursing or convalescent homes, maternity homes, or places that treat alcoholism.

“Licensed hospital” means an institution, place, building, or agency that maintains and operates organized facilities for one or more persons for the diagnosis, care, and treatment of human illnesses to which persons may be admitted for overnight stay, and includes any institution classified under regulations issued by the State Department of Public Health as a general or specialized hospital, as a maternity hospital, or as a tuberculosis hospital, but does not include a sanitarium, rest home, a nursing or convalescent home, a maternity home, or an institution for treating alcoholics.

Section § 4029

Explanation

This section describes what a hospital pharmacy is in California. It's a pharmacy located within a licensed hospital where patients are diagnosed, treated, and may stay overnight. Hospital pharmacies can also operate in other buildings associated with a general acute care hospital, but they can only serve patients in that building. Additionally, there's a concept called a 'hospital satellite compounding pharmacy.' These special areas can perform sterile compounding and are also associated with a general acute care hospital, but they might be in a different location than the main hospital.

(a)CA Business & Professions Code § 4029(a) “Hospital pharmacy” means and includes a pharmacy, licensed by the board, located within any licensed hospital, institution, or establishment that maintains and operates organized facilities for the diagnosis, care, and treatment of human illnesses to which persons may be admitted for overnight stay and that meets all of the requirements of this chapter and the rules and regulations of the board.
(b)CA Business & Professions Code § 4029(b) A hospital pharmacy may include a pharmacy that is located in any physical plant that is regulated under the license of a general acute care hospital as defined in subdivision (a) of Section 1250 of the Health and Safety Code. As a condition of licensure by the board, the pharmacy in another physical plant shall provide pharmaceutical services only to registered hospital patients who are on the premises of the same physical plant in which the pharmacy is located, except as provided in Article 7.6 (commencing with Section 4128). The pharmacy services provided shall be directly related to the services or treatment plan administered in the physical plant. Nothing in this subdivision shall be construed to restrict or expand the services that a hospital pharmacy may provide.
(c)CA Business & Professions Code § 4029(c) “Hospital satellite compounding pharmacy” means an area licensed by the board to perform sterile compounding that is separately licensed by the board pursuant to Section 4127.15 to perform that compounding and is located outside of the hospital in another physical plant that is regulated as a general acute care hospital as defined in subdivision (a) of Section 1250 of the Health and Safety Code.

Section § 4030

Explanation

An 'intern pharmacist' is someone who has been given a license as described in another section, specifically Section 4208.

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

Section § 4031

Explanation

This law explains what qualifies as a 'laboratory' in this context. It refers to places used for research, teaching, or testing, which do not dispense drugs but use dangerous drugs or devices for scientific purposes. Laboratories must have a fixed business location, keep purchase records, and are overseen by a governing board.

“Laboratory” means a research, teaching, or testing laboratory not engaged in the dispensing or furnishing of drugs or devices but using dangerous drugs or dangerous devices for scientific or teaching purposes. Every laboratory shall maintain an established place of business and keep purchase records. Every laboratory shall be subject to the jurisdiction of the board.

Section § 4032

Explanation

This section defines the term "license" as it relates to any official permit or certificate issued by a board, including the initial application and renewal process.

“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.

Section § 4033

Explanation

In this section, a 'manufacturer' refers to anyone involved in making or repackaging drugs or devices, except for pharmacies that produce drugs on-site for direct sale to customers. However, pharmacies that compound drugs for parenteral therapy to be delivered to other pharmacies, or that repackage drugs for patients based on their request, are not considered manufacturers. Additionally, the term also applies to any person or entity involved in handling dangerous drugs, devices, or cosmetics, and includes those with approved drug applications or those distributing privately labeled drugs.

(a)Copy CA Business & Professions Code § 4033(a)
(1)Copy CA Business & Professions Code § 4033(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)CA Business & Professions Code § 4033(a)(2) Notwithstanding paragraph (1), “manufacturer” shall not mean a pharmacy compounding a drug for parenteral therapy, pursuant to a prescription, for delivery to another pharmacy for the purpose of delivering or administering the drug to the patient or patients named in the prescription, provided that neither the components for the drug nor the drug are compounded, fabricated, packaged, or otherwise prepared prior to receipt of the prescription.
(3)CA Business & Professions Code § 4033(a)(3) Notwithstanding paragraph (1), “manufacturer” shall not mean a pharmacy that, at a patient’s request, repackages a drug previously dispensed to the patient, or to the patient’s agent, pursuant to a prescription.
(b)CA Business & Professions Code § 4033(b) Notwithstanding subdivision (a), “manufacturer” also means a person who prepares, derives, manufactures, produces, or repackages a dangerous drug, as defined in Section 4022, device, or cosmetic. Manufacturer also means the holder or holders of a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), or a Biologics License Application (BLA), provided that such application has been approved; a private label distributor (including colicensed partners) for whom the private label distributor’s prescription drugs are originally manufactured and labeled for the distributor and have not been repackaged; or the distributor agent for the manufacturer, contract manufacturer, or private label distributor, whether the establishment is a member of the manufacturer’s affiliated group (regardless of whether the member takes title to the drug) or is a contract distributor site.

Section § 4034

Explanation

An 'outsourcing facility' is a place in the U.S. that compounds both sterile and nonsterile drugs. It must be officially registered with the FDA as an outsourcing facility as per federal law and operate in or into California. Additionally, it needs to be licensed by the local board in California.

“Outsourcing facility” means a facility that meets all of the following:
(a)CA Business & Professions Code § 4034(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)CA Business & Professions Code § 4034(b) Has registered as an outsourcing facility with the federal Food and Drug Administration under Section 503B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 353b).
(c)CA Business & Professions Code § 4034(c) Is doing business within or into California.
(d)CA Business & Professions Code § 4034(d) Is licensed with the board as an outsourcing facility pursuant to Article 7.7 (commencing with Section 4129).

Section § 4034.5

Explanation

This section defines an 'emergency medical services automated drug delivery system' (EMSADDS) as a system that stores and distributes drugs specifically for restocking secure emergency medical supply containers used by emergency medical services.

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 services agency to provide emergency medical services.

Section § 4035

Explanation

In this section, the term "person" is defined broadly. It not only refers to an individual human being but also includes entities like companies, partnerships, government agencies, and other organized groups.

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

Section § 4036

Explanation

A pharmacist is someone who has a valid license from the board, allowing them to practice pharmacy. This license lets them work within a pharmacy or elsewhere, as long as it's permitted by the rules in this chapter.

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

Section § 4036.5

Explanation

A 'Pharmacist-in-charge' is a pharmacist chosen by a pharmacy and approved by the board to oversee and make sure that the pharmacy follows all related state and federal pharmacy laws and regulations.

“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.

Section § 4037

Explanation

A 'pharmacy' is defined as any licensed location where pharmacy is practiced and prescriptions are made, including places where controlled substances or dangerous drugs are handled or sold. However, it does not cover areas in health facilities where drugs are stored just for patient care like wards or emergency rooms.

(a)CA Business & Professions Code § 4037(a) “Pharmacy” means an area, place, or premises licensed by the board in which the profession of pharmacy is practiced and where prescriptions are compounded. “Pharmacy” includes, but is not limited to, any area, place, or premises described in a license issued by the board wherein controlled substances, dangerous drugs, or dangerous devices are stored, possessed, prepared, manufactured, derived, compounded, or repackaged, and from which the controlled substances, dangerous drugs, or dangerous devices are furnished, sold, or dispensed at retail.
(b)CA Business & Professions Code § 4037(b) “Pharmacy” shall not include any area in a facility licensed by the State Department of Public Health where floor supplies, ward supplies, operating room supplies, or emergency room supplies of dangerous drugs or dangerous devices are stored or possessed solely for treatment of patients registered for treatment in the facility or for treatment of patients receiving emergency care in the facility.

Section § 4038

Explanation

This law defines who is considered a pharmacy technician and a pharmacy technician trainee. A pharmacy technician is someone who helps a pharmacist with their pharmacy-related tasks. On the other hand, a pharmacy technician trainee is a person undergoing training in a recognized educational program to become a pharmacy technician.

(a)CA Business & Professions Code § 4038(a) “Pharmacy technician” means an individual who assists a pharmacist in a pharmacy in the performance of his or her pharmacy related duties, as specified in Section 4115.
(b)CA Business & Professions Code § 4038(b) A “pharmacy technician trainee” is a person who is enrolled in a pharmacy technician training program operated by a California public postsecondary education institution or by a private postsecondary vocational institution approved by the Bureau for Private Postsecondary and Vocational Education.

Section § 4039

Explanation

This law defines which medical professionals are recognized as practicing in California with valid licenses. It specifies that individuals like physicians, dentists, and nurses need an unrevoked license to work in their field. It also clarifies what 'physician' means under California law, including those with specific certifications and, under certain conditions, those practicing without a license but within legal guidelines.

“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 their respective professions in this state. “Physician” means and includes any person holding a valid and unrevoked physician’s and surgeon’s certificate or certificate to practice medicine and surgery, issued by the Medical Board of California or the Osteopathic Medical Board of California, and includes an unlicensed person lawfully practicing medicine pursuant to Section 2065, when acting within the scope of that section.

Section § 4040

Explanation

This section defines what counts as a "prescription" for medications and devices. A prescription can be oral, written, or electronic and must include details like the patient's name, address, medication details, and instructions. It must also show the prescriber's details, including license number if it's for a controlled substance. Prescriptions might also say why the medication is prescribed if the patient asks. Different professionals, like doctors or pharmacists, can issue these prescriptions under certain rules. Written prescriptions for certain dangerous drugs can be accepted if they meet basic requirements, and more details can be added later by the pharmacy. Additionally, electronic prescriptions can be sent as images (like via fax) or data to pharmacies. Using common abbreviations doesn't affect the validity of a prescription.

(a)CA Business & Professions Code § 4040(a) “Prescription” means an oral, written, or electronic transmission order that is both of the following:
(1)CA Business & Professions Code § 4040(a)(1) Given individually for the person or persons for whom ordered that includes all of the following:
(A)CA Business & Professions Code § 4040(a)(1)(A) The name or names and address of the patient or patients.
(B)CA Business & Professions Code § 4040(a)(1)(B) The name and quantity of the drug or device prescribed and the directions for use.
(C)CA Business & Professions Code § 4040(a)(1)(C) The date of issue.
(D)CA Business & Professions Code § 4040(a)(1)(D) Either rubber stamped, typed, or printed by hand or typeset, the name, address, and telephone number of the prescriber, the prescriber’s license classification, and the prescriber’s federal registry number, if a controlled substance is prescribed.
(E)CA Business & Professions Code § 4040(a)(1)(E) A legible, clear notice of the condition or purpose for which the drug is being prescribed, if requested by the patient or patients.
(F)CA Business & Professions Code § 4040(a)(1)(F) If in writing, signed by the prescriber issuing the order, or the certified nurse-midwife, nurse practitioner, physician assistant, or naturopathic doctor who issues a drug order pursuant to Section 2746.51, 2836.1, 3502.1, or 3640.5, respectively, or the pharmacist who issues a drug order pursuant to Section 4052.1, 4052.2, or 4052.6.
(2)CA Business & Professions Code § 4040(a)(2) Issued by a physician, dentist, optometrist, doctor of podiatric medicine, veterinarian, nurse practitioner practicing pursuant to Section 2837.103 or 2837.104, or naturopathic doctor pursuant to Section 3640.7 or, if a drug order is issued pursuant to Section 2746.51, 2836.1, 3502.1, or 3460.5, by a certified nurse-midwife, nurse practitioner, physician assistant, or naturopathic doctor licensed in this state, or pursuant to Section 4052.1, 4052.2, or 4052.6 by a pharmacist licensed in this state.
(b)CA Business & Professions Code § 4040(b) Notwithstanding subdivision (a), a written order of the prescriber for a dangerous drug, except for any Schedule II controlled substance, that contains at least the name and signature of the prescriber, the name and address of the patient in a manner consistent with paragraph (2) of subdivision (a) of Section 11164 of the Health and Safety Code, the name and quantity of the drug prescribed, directions for use, and the date of issue may be treated as a prescription by the dispensing pharmacist as long as any additional information required by subdivision (a) is readily retrievable in the pharmacy. In the event of a conflict between this subdivision and Section 11164 of the Health and Safety Code, Section 11164 of the Health and Safety Code shall prevail.
(c)CA Business & Professions Code § 4040(c) “Electronic transmission prescription” includes both image and data prescriptions. “Electronic image transmission prescription” means any prescription order for which a facsimile of the order is received by a pharmacy from a licensed prescriber. “Electronic data transmission prescription” means any prescription order, other than an electronic image transmission prescription, that is electronically transmitted from a licensed prescriber to a pharmacy.
(d)CA Business & Professions Code § 4040(d) The use of commonly used abbreviations shall not invalidate an otherwise valid prescription.

Section § 4040.5

Explanation

This section defines a "reverse distributor" as anyone who helps pharmacies and other businesses by handling old or unsellable medicine or medical devices, including tasks like receiving, storing, and managing them.

“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 dangerous devices.

Section § 4041

Explanation
This section defines a 'veterinary food-animal drug retailer' as a place that is not a pharmacy but has a special license to sell veterinary drugs for animals used for food. These drugs must be given out with a prescription from a licensed vet. These places can also handle the storage, repackaging, and selling of these drugs as approved by the Board of Pharmacy.
“Veterinary food-animal drug retailer” is an area, place, or premises, other than a pharmacy, that holds a valid license from the Board of Pharmacy of the State of California as a wholesaler and, in and from which veterinary drugs for food-producing animals are dispensed pursuant to a prescription from a licensed veterinarian. “Veterinary food-animal retailer” includes, but is not limited to, any area, place, or premises described in a permit issued by the board wherein veterinary food-animal drugs, as defined in Section 4042, are stored, possessed, or repackaged, and from which veterinary drugs are furnished, sold, or dispensed at retail pursuant to a prescription from a licensed veterinarian.

Section § 4042

Explanation

This section defines what "veterinary food-animal drugs" are. These include any drugs used in animals raised for food that have a label saying they're only for use under a veterinarian's guidance. It also includes other drugs that need a veterinarian's prescription, according to another specific law.

“Veterinary food-animal drugs” as used in this chapter shall include the following:
(a)CA Business & Professions Code § 4042(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)CA Business & Professions Code § 4042(b) Any other drug as defined in Section 14206 of the Food and Agricultural Code that is used in a manner that would require a veterinary prescription.

Section § 4043

Explanation

This law describes what a 'wholesaler' is in the context of selling and distributing drugs or medical devices. It covers various roles like merchants, brokers, and agents involved in the wholesale distribution of these items. Wholesalers can only store or warehouse these drugs at licensed locations unless the law allows otherwise.

“Wholesaler” means and includes a person who acts as a wholesale merchant, broker, jobber, customs broker, reverse distributor, agent, or a nonresident wholesaler, who sells for resale, or negotiates for distribution, or takes possession of, any drug or device included in Section 4022. Unless otherwise authorized by law, a wholesaler may not store, warehouse, or authorize the storage or warehousing of drugs with any person or at any location not licensed by the board.

Section § 4044

Explanation

A 'repackager' is someone or a company registered with the FDA that either packages finished drugs from bulk amounts or transfers dangerous drugs into new containers, not including shipping containers.

“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.

Section § 4044.3

Explanation

This law defines what a "remote dispensing site pharmacy" is in California. It explains that such a pharmacy is a licensed pharmacy run by a supervising pharmacy and staffed with qualified pharmacy technicians. These pharmacies provide services like storing and dispensing prescription drugs and controlled substances, reviewing drug regimens, and offering patient counseling. A licensed pharmacist oversees or provides these services remotely using telepharmacy technology. Additionally, remote dispensing site pharmacies must follow all relevant state and federal pharmacy laws unless specified otherwise.

(a)CA Business & Professions Code § 4044.3(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 services, including, but not limited to, the storage and dispensing of prescription drugs and controlled substances, drug regimen review, and patient counseling, are remotely monitored or provided, or both, by a licensed pharmacist through the use of telepharmacy technology.
(b)CA Business & Professions Code § 4044.3(b) Unless otherwise specified in this chapter, a remote dispensing site pharmacy shall comply with all state and federal laws regulating the practice of pharmacy.

Section § 4044.5

Explanation

This section defines a "reverse third-party logistics provider" as a company that helps manufacturers, wholesalers, or dispensers manage outdated or unsellable dangerous drugs or devices. However, these providers do not own or decide the sale or disposal of these drugs or devices. The same rules that apply to third-party logistics providers also apply to reverse third-party logistics providers unless stated otherwise.

“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 ownership of the dangerous drug or dangerous device nor have the responsibility to direct its sale or disposition. Unless otherwise specified in this chapter, every provision of this chapter that applies to a third-party logistics provider shall also apply to a reverse third-party logistics provider.

Section § 4044.6

Explanation

A 'supervising pharmacy' in California is a licensed pharmacy where at least one board-licensed pharmacist owns and manages it. This pharmacy is responsible for overseeing the operations of a remote dispensing site pharmacy. The supervising pharmacy is fully accountable for the remote site and its staff.

(a)CA Business & Professions Code § 4044.6(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 Section 4036, that exclusively oversees the operations of a remote dispensing site pharmacy.
(b)CA Business & Professions Code § 4044.6(b) A supervising pharmacy shall be exclusively responsible for the operation of the remote dispensing site pharmacy and its employees pursuant to Section 4131.

Section § 4044.7

Explanation

Telepharmacy is a system used by a main pharmacy to oversee the distribution of prescription drugs at a different location. This system also allows for drug reviews and patient counseling through electronic means, like video or audio calls, and imaging technology.

“Telepharmacy” means a system that is used by a supervising pharmacy for the purpose of monitoring the dispensing of prescription drugs by a remote dispensing site pharmacy and provides for related drug regimen review and patient counseling by an electronic method, including, but not limited to, the use of audio, visual, still image capture, and store and forward technology.

Section § 4045

Explanation

This section defines a 'third-party logistics provider' as a company that helps manage storage and transportation of dangerous drugs or devices for others, like manufacturers or pharmacies, without actually owning or deciding what happens to those drugs or devices.

“Third-party logistics provider” means an entity that provides or coordinates warehousing or other logistics services for a dangerous drug or dangerous device in intrastate or interstate commerce on behalf of a manufacturer, wholesaler, or dispenser of the dangerous drug or dangerous device, but does not take ownership of the dangerous drug or dangerous device, nor have responsibility to direct its sale or disposition.

Section § 4046

Explanation

This law defines what a "surplus medication collection and distribution intermediary" is. Essentially, it's any organization or government body that handles the collection and distribution of leftover medications to be used in certain health programs.

“Surplus medication collection and distribution intermediary” means a firm, association, partnership, corporation, limited liability company, state governmental agency, or political subdivision that performs the functions specified in Section 4169.5 for the purpose of a program established pursuant to Division 116 (commencing with Section 150200) of the Health and Safety Code.