Article 3 - Scope of Practice and Exemptions

California Business and Professions Code — §§ 4050-4069

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Sections (32)

Amended by Stats. 2025, Ch. 196, Sec. 11. (AB 1503) Effective January 1, 2026.

(a)For the purposes of this section, “state agency” includes every state office, officer, department, division, bureau, board, authority, and commission.

(b)In recognition of and consistent with the decisions of the appellate courts of this state, the Legislature hereby declares the practice of pharmacy to be a profession.

(c)Pharmacist practice is a dynamic, patient-oriented health service that applies a scientific body of knowledge to improve and promote patient health by means of patient-care activities to optimize appropriate drug use, drug-related therapy, disease management and prevention, and communication for

clinical and consultative purposes. Pharmacist practice is continually evolving to include more sophisticated and comprehensive patient care activities.

(d)The Legislature further declares that pharmacists are health care providers who have the authority to provide health care services.

(e)No state agency other than the board may define or interpret this chapter and its regulations for those licensed pursuant to this chapter or develop standardized procedures or protocols pursuant to this chapter, unless so authorized by this chapter, or specifically required under state or federal law.

§ 4051

Amended by Stats. 2025, Ch. 196, Sec. 12. (AB 1503) Effective January 1, 2026.

(a)For the purposes of this section, “accepted standard of care” means the degree of care a prudent and reasonable pharmacist licensed pursuant to this chapter, with similar education, training, experience, resources, and setting, would exercise in a similar situation.

(b)Except as otherwise provided in this chapter, it is unlawful for any person to manufacture, compound, furnish, sell, or dispense a dangerous drug or dangerous device, or to dispense or compound a prescription pursuant to Section 4040 of a prescriber unless they are a pharmacist under this chapter.

(c)Notwithstanding any other law, a pharmacist may authorize the

initiation of a prescription, pursuant to Section 4052, 4052.1, 4052.2, or 4052.6, and otherwise provide clinical advice, services, information, or patient consultation, as set forth in this chapter, if all of the following conditions are met:

(1)The clinical advice, services, information, or patient consultation is provided to a health care professional or to a patient or a patient’s agent.

(2)The pharmacist has access to prescription, patient profile, or other relevant medical information for purposes of patient and clinical consultation and advice.

(3)Access to the information described in paragraph (2) is secure from unauthorized access and use.

(4)The pharmacist provides the service or activity consistent with the accepted standard of care.

§ 4052

Amended by Stats. 2025, Ch. 196, Sec. 13. (AB 1503) Effective January 1, 2026.

(a)Notwithstanding any other law, a pharmacist may do all of the following:

(1)Furnish a reasonable quantity of compounded drug product to a prescriber for office use by the prescriber.

(2)Transmit a valid prescription to another pharmacist.

(3)Administer drugs and biological products that have been ordered by a prescriber.

(4)Perform procedures or functions as authorized by

Sections 4052.1 and 4052.2.

(5)Furnish epinephrine.

(6)Perform procedures or functions as authorized by Section 4052.6.

(7)Furnish, manufacture, measure, fit to the patient, or sell and repair dangerous devices, or furnish instructions to the patient or the patient’s representative concerning the use of those devices.

(8)Provide consultation, training, and education to patients about drug therapy, disease management, and disease prevention, and furnish over-the-counter medications if requested.

(9)Provide professional information, including clinical or pharmacological information, advice, or consultation to patients and health care professionals, and participate in multidisciplinary review of patient progress, including appropriate access to medical records.

(10)(A) Furnish FDA-approved or authorized medications as part of preventative health care services that do not require a diagnosis, including any of the following:

(i)Emergency contraception. A pharmacist shall not require a patient to provide individually identifiable medical information that is not specified in Section 1707.1 of Title 16 of the California Code of Regulations before initiating emergency contraception drug therapy pursuant to this subdivision.

(ii) Contraception.

(iii) Smoking cessation.

(iv) Travel medication.

(v)Anti-viral or anti-infective medications.

(B) The pharmacist shall notify the patient’s primary care provider of any drugs or devices furnished to the patient, or enter the appropriate information in a patient record system shared with the primary care provider, as permitted by that primary care provider. If the patient does not have a primary care provider, the pharmacist shall provide the patient with a written record of the drugs or devices furnished and advise the patient to consult a physician of the patient’s choice.

(C) Nothing in this section shall be construed as establishing an obligation on a pharmacist to report an over-the-counter medication sold to a patient that was not captured as a prescription.

(11)Order and interpret tests.

(12)Initiate, adjust, or discontinue drug therapy for a patient under either of the following:

(A)A collaborative practice agreement with any health care provider with prescriptive authority. The collaborative practice agreement may be between a single or multiple pharmacists and a single or multiple health care providers with prescriptive authority.

(B)An order or authorization made by the patient’s prescriber and in accordance with the policies, procedures, or protocols of the entity providing health care services, unless a patient’s treating prescriber otherwise prohibits the action.

(13)Furnish

medication used to reverse opioid overdose and medication used to treat substance use disorder to the extent authorized by federal law.

(14)Complete missing information on a prescription for a noncontrolled medication if there is evidence to support the change.

(15)Initiate and administer immunizations for persons three years of age and older pursuant to this article.

(b)A pharmacist who is authorized to issue an order to initiate or adjust a controlled substance therapy pursuant to this section shall personally register with the federal Drug Enforcement Administration.

(c)This section does not affect the applicable requirements of law relating to either of the following:

(1)Maintaining the confidentiality of medical records.

(2)The licensing of a health care facility.

(d)Nothing in this section

shall be construed as establishing an obligation on a pharmacist to perform or provide a service or function authorized by subdivision (a) if the pharmacist has made a professional determination that any of the following apply:

(1)The pharmacist lacks sufficient education, training, or expertise, or access to sufficient patient medical information, to perform the service or function properly or safely.

(2)Performing or providing the service or function would place a patient at risk.

(3)Pharmacist staffing at the pharmacy is insufficient to facilitate comprehensive patient care.

(e)A pharmacist shall notify a patient’s primary care provider of any drugs or devices

furnished to the patient, or enter the

appropriate information in a patient record system shared with the primary care provider, as permitted by that primary care provider. If the patient does not have a primary care provider or requests not to notify the primary care provider, the pharmacist shall provide the patient with a written or electronic record of the drugs or devices furnished and advise the patient to consult a physician of the patient’s choice.

(f)Nothing in this section shall be construed as establishing an obligation on a pharmacist to perform or provide authorized services without payment for the services, including payment directly by the patient, payment through a third-party payer, or payment of any required copayment by the patient.

§ 4052.04

Amended by Stats. 2025, Ch. 196, Sec. 17. (AB 1503) Effective January 1, 2026.

(a)In addition to the authority provided in Section 4052, a pharmacist may furnish COVID-19 oral therapeutics following a positive test for SARS-CoV-2, the virus that causes COVID-19.

(b)Prior to furnishing COVID-19 oral therapeutics pursuant to subdivision (a), a pharmacist shall utilize relevant and appropriate evidence-based clinical guidelines published by the federal Food and Drug Administration in providing these patient care services.

(c)A pharmacist who furnishes COVID-19 oral therapeutics shall notify the patient’s primary care provider, or enter the appropriate information in a patient record system shared

with the primary care provider, as permitted by that primary care provider. If the patient does not have a primary care provider, the pharmacist shall provide the patient with a written record of the drugs furnished and advise the patient to consult a physician of the patient’s choice.

(d)A pharmacist shall document, to the extent possible, the kind and amounts of COVID-19 oral therapeutics furnished pursuant to subdivision (a), as well as information regarding any testing services provided, in the patient’s record in the record system maintained by the pharmacy. The records shall be maintained for three years and shall be available for inspection by all properly authorized personnel of the board.

(e)For purposes of this section, “COVID-19 oral therapeutics” means drugs

that are approved or authorized by the United States Food and Drug Administration for the treatment of COVID-19 and administered orally.

§ 4052.05

Added by Stats. 2025, Ch. 105, Sec. 9. (AB 144) Effective September 17, 2025.

A pharmacist may independently initiate and administer an immunization that, on January 1, 2025, had in effect a recommendation from the Advisory Committee on Immunization Practices of the federal Centers for Disease Control and Prevention, regardless of whether the immunization is recommended for routine use, or as modified or supplemented by the State Department of Public Health pursuant to Section 120164 of the Health and Safety Code, to individuals three years of age or older.

§ 4052.1

Added by Stats. 2006, Ch. 777, Sec. 5. Effective January 1, 2007.

(a)Notwithstanding any other provision of law, a pharmacist may perform the following procedures or functions in a licensed health care facility in accordance with policies, procedures, or protocols developed by health professionals, including physicians, pharmacists, and registered nurses, with the concurrence of the facility administrator:

(1)Ordering or performing routine drug therapy-related patient assessment procedures including temperature, pulse, and respiration.

(2)Ordering drug therapy-related laboratory tests.

(3)Administering drugs and biologicals by injection pursuant to a prescriber’s order.

(4)Initiating or adjusting the drug regimen of a patient pursuant to an order or authorization made by the patient’s prescriber and in accordance with the policies, procedures, or protocols of the licensed health care facility.

(b)Prior to performing any procedure authorized by this section, a pharmacist shall have received appropriate training as prescribed in the policies and procedures of the licensed health care facility.

§ 4052.10

Added by Stats. 2017, Ch. 615, Sec. 1. (AB 1048) Effective January 1, 2018. Section operative July 1, 2018, by its own provisions.

(a)A pharmacist may dispense a Schedule II controlled substance, as listed in Section 11055 of the Health and Safety Code, as a partial fill if requested by the patient or the prescriber.

(b)If a pharmacist dispenses a partial fill on a prescription pursuant to this section, the pharmacy shall retain the original prescription, with a notation of how much of the prescription has been filled, until the prescription has been fully dispensed. The total quantity dispensed shall not exceed the total quantity prescribed.

(c)Subsequent fills, until the original prescription is completely dispensed, shall

occur at the pharmacy where the original prescription was partially filled. The full prescription shall be dispensed not more than 30 days after the date on which the prescription was written. Thirty-one days after the date on which the prescription was written, the prescription shall expire and no more of the drug shall be dispensed without a subsequent prescription.

(d)The pharmacist shall record in the state prescription drug monitoring program only the actual amounts of the drug dispensed.

(e)The pharmacist shall record the date and amount of each partial fill in a readily retrievable form and on the original prescription, and shall include the initials of the pharmacist who dispensed each partial fill.

(f)A

pharmacist may charge a professional dispensing fee to cover the actual supply and labor costs associated with dispensing each partial fill associated with the original prescription.

(g)This section shall not be construed to limit the authority of the Department of Managed Health Care, pursuant to Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code.

(h)This section is not intended to conflict with or supersede any other requirement established for the prescription of a Schedule II controlled substance.

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

(1)“Original prescription” means the prescription presented by the patient to the pharmacy or submitted electronically to the pharmacy.

(2)“Partial fill” means a part of a prescription filled that is of a quantity less than the entire prescription.

(j)This section shall become operative on July 1, 2018.

§ 4052.2

Amended by Stats. 2019, Ch. 497, Sec. 5. (AB 991) Effective January 1, 2020.

(a)Notwithstanding any other law, a pharmacist may perform the following procedures or functions as part of the care provided by a health care facility, a licensed home health agency, licensed correctional clinic, a licensed clinic in which there is physician oversight, a provider who contracts with a licensed health care service plan with regard to the care or services provided to the enrollees of that health care service plan, or a physician, in accordance with the policies, procedures, or protocols of that facility, home health agency, licensed correctional clinic, licensed clinic, health care service plan, or physician, and in accordance with subdivision (c):

(1)Ordering or performing routine drug therapy-related patient assessment procedures including

temperature, pulse, and respiration.

(2)Ordering drug therapy-related laboratory tests.

(3)Administering drugs and biologicals by injection pursuant to a prescriber’s order.

(4)Initiating or adjusting the drug regimen of a patient pursuant to a specific written order or authorization made by the individual patient’s treating prescriber, and in accordance with the policies, procedures, or protocols of the health care facility, home health agency, licensed correctional clinic, licensed clinic, health care service plan, or physician. Adjusting the drug regimen does not include substituting or selecting a different drug, except as authorized by the protocol. The pharmacist shall provide written notification to the patient’s treating prescriber, or enter the appropriate information in an electronic patient record

system shared by the prescriber, of any drug regimen initiated pursuant to this paragraph within 24 hours.

(b)A patient’s treating prescriber may prohibit, by written instruction, any adjustment or change in the patient’s drug regimen by the pharmacist.

(c)The policies, procedures, or protocols referred to in this subdivision shall be developed by health care professionals, including physicians, pharmacists, and registered nurses, and shall, at a minimum, do all of the following:

(1)Require that the pharmacist function as part of a multidisciplinary group that includes physicians and direct care registered nurses. The multidisciplinary group shall determine the appropriate participation of the pharmacist and the direct care registered nurse.

(2)Require that the medical records of the patient be available to both the patient’s treating prescriber and the pharmacist.

(3)Require that the procedures to be performed by the pharmacist relate to a condition for which the patient has first been seen by a physician.

(4)Except for procedures or functions provided by a health care facility, a licensed correctional clinic, as defined in Section 4187, a licensed clinic in which there is physician oversight, or a provider who contracts with a licensed health care plan with regard to the care or services provided to the enrollees of that health care service plan, require the procedures to be performed in accordance with a written, patient-specific protocol approved by the treating or supervising physician. Any change, adjustment, or modification of an approved preexisting treatment or drug therapy shall be provided

in writing to the treating or supervising physician within 24 hours.

(d)Prior to performing any procedure authorized by this section, a pharmacist shall have done either of the following:

(1)Successfully completed clinical residency training.

(2)Demonstrated clinical experience in direct patient care delivery.

§ 4052.4

Amended by Stats. 2021, Ch. 604, Sec. 3. (SB 409) Effective January 1, 2022.

(a)Notwithstanding Section 2038 or any other provision of law, a pharmacist may perform skin puncture in the course of performing routine patient assessment procedures or in the course of performing any procedure authorized under Section 1206.5 or 1206.6. For purposes of this section, “routine patient assessment procedures” means:

(a)procedures that a patient could, with or without a prescription, perform for themselves, or (b) clinical laboratory tests that are classified as waived pursuant to the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a) and the regulations adopted thereunder by the federal Health Care Financing Administration, as authorized by paragraph (11) of subdivision (a) of Section 1206.5 or

Section 1206.6. A pharmacist performing these functions shall report the results obtained from a test to the patient and any physician designated by the patient. Any pharmacist who performs the service authorized by this section shall not be in violation of Section 2052.

(b)A pharmacist may perform any aspect of any FDA-approved or -authorized test that is classified as waived pursuant to the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a) and the regulations adopted thereunder by the federal Health Care Financing Administration, under all of the following conditions:

(1)The test meets the criteria in subparagraph (A) or (B) and does not require the use of specimens collected by vaginal swab, venipuncture, or the collection of seminal

fluid.

(A)The test is used to detect or screen for any of the following illnesses, conditions, or diseases:

(i)SARS-CoV-2 or other respiratory illness, condition or disease.

(ii) Mononucleosis.

(iii) Sexually transmitted infection.

(iv) Strep throat.

(v)Anemia.

(vi) Cardiovasular health.

(vii) Conjunctivitis.

(viii) Urinary tract

infection.

(ix) Liver and kidney function or infection.

(x)Thyroid function.

(xi) Substance use disorder.

(xii) Diabetes.

(B) Other tests classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a) and the regulations adopted thereunder by the federal Health Care Financing Administration and approved by the board by regulation, in conjunction with the Medical Board of California and Laboratory

Field Services in the State Department of Public Health.

(2)The pharmacist completes the testing in a pharmacy laboratory that is appropriately licensed in California as a laboratory pursuant to Section 1265, unless otherwise authorized in law.

(3)The pharmacist has completed necessary training as specified in the pharmacy’s policies and procedures maintained pursuant to subdivision (b) of Section 4119.10, and that allows the pharmacist to demonstrate sufficient knowledge of the illness, condition,

or disease being tested, as applicable.

§ 4052.5

Added by Stats. 2001, Ch. 631, Sec. 1. Effective January 1, 2002.

(a)In addition to the authority allowed under Section 4073, a pharmacist filling a prescription order for a drug product may select a different form of medication with the same active chemical ingredients of equivalent strength and duration of therapy as the prescribed drug product when the change will improve the ability of the patient to comply with the prescribed drug therapy.

(b)In no case shall a selection be made pursuant to this section if the prescriber personally indicates, either orally or in his or her own handwriting, “Do not substitute” or words of similar meaning. Nothing in this subdivision shall prohibit a prescriber from checking a box on a prescription marked “Do not substitute” if the prescriber personally initials the box or checkmark.

(c)Selection pursuant to this section is within the discretion of the pharmacist, except as provided in subdivision (b). The pharmacist who selects the drug product to be dispensed pursuant to this section shall assume the same responsibility for selecting the dispensed drug product as would be incurred in filling a prescription for a drug product using the prescribed form of medication. There shall be no liability on the prescriber for an act or omission by a pharmacist in selecting, preparing, or dispensing a drug product pursuant to this section.

(d)This section shall apply to all prescriptions, including those presented by or on behalf of persons receiving assistance from the federal government or pursuant to the California Medical Assistance Program set forth in Chapter 7 (commencing with Section 14000) of Part 3 of Division 9 of the Welfare and Institutions Code.

(e)When a substitution is made pursuant to this section, the use of the different form of medication shall be communicated to the patient, and the name of the dispensed drug product shall be indicated on the prescription label, unless the prescriber orders otherwise.

(f)This section shall not permit substitution between long-acting and short-acting forms of a medication with the same chemical ingredients or between one drug product and two or more drug products with the same chemical ingredients.

§ 4052.6

Amended by Stats. 2025, Ch. 196, Sec. 19. (AB 1503) Effective January 1, 2026.

(a)A pharmacist recognized by the board as an advanced pharmacist practitioner may do all of the following:

(1)Perform patient assessments.

(2)Order and interpret drug therapy-related tests.

(3)Refer patients to other health care providers.

(4)Participate in the evaluation and management of diseases and health conditions in collaboration with other health care providers.

(5)Initiate, adjust, or discontinue drug therapy.

(b)A pharmacist who adjusts or discontinues drug therapy shall promptly transmit written notification to the patient’s diagnosing prescriber or enter the appropriate information in a patient record system shared with the prescriber, as permitted by that prescriber. A pharmacist who initiates drug therapy shall promptly transmit written notification to, or enter the appropriate information into, a patient record system shared with the patient’s primary care provider or diagnosing provider, as permitted by that provider.

(c)This section shall not interfere with a physician’s order to dispense a prescription drug as written, or other order of similar meaning.

(d)Prior to initiating or adjusting a controlled substance therapy pursuant

to this section, a pharmacist shall personally register with the federal Drug Enforcement Administration.

(e)A pharmacist who orders and interprets tests pursuant to paragraph (2) of subdivision (a) shall ensure that the ordering of those tests is done in coordination with the patient’s primary care provider or diagnosing prescriber, as appropriate, including promptly transmitting written notification to the patient’s diagnosing prescriber or entering the appropriate information in a patient record system shared with the prescriber, when available and as permitted by that prescriber.

§ 4053

Amended by Stats. 2021, Ch. 629, Sec. 13. (AB 1533) Effective January 1, 2022.

(a)Notwithstanding Section 4051, the board may issue a license as a designated representative to provide sufficient and qualified supervision in a wholesaler or veterinary food-animal drug retailer. The designated representative shall protect the public health and safety in the handling, storage, and shipment of dangerous drugs and dangerous devices in the wholesaler or veterinary food-animal drug retailer.

(b)An individual who is at least 18 years of age may apply for a designated representative license. In order to obtain and maintain that license, the individual shall meet all of the following requirements:

(1)The individual shall be a high school graduate, possess a general education development

certificate equivalent, or have earned a degree from an accredited postsecondary institution.

(2)The individual shall have a minimum of one year of paid work experience in a licensed pharmacy, or with a drug wholesaler, drug distributor, or drug manufacturer, in the past three years, related to the distribution or dispensing of dangerous drugs or dangerous devices or meet all of the prerequisites to take the examination required for licensure as a pharmacist by the board.

(3)The individual shall complete a training program approved by the board that, at a minimum, addresses each of the following subjects:

(A)Knowledge and understanding of California law and federal law relating to the distribution of dangerous drugs and dangerous devices.

(B)Knowledge and understanding of California law and federal law relating to the distribution of controlled substances.

(C)Knowledge and understanding of quality control systems.

(D)Knowledge and understanding of the United States Pharmacopoeia standards relating to the safe storage and handling of drugs.

(E)Knowledge and understanding of prescription terminology, abbreviations, dosages, and format.

(4)The board may, by regulation, require training programs to include additional material.

(5)The board shall not issue a license as a designated representative until the applicant provides proof of completion of the required training to the board.

(c)The veterinary food-animal drug retailer or wholesaler shall not operate without a pharmacist or a designated representative on its premises.

(d)Only a pharmacist or a designated representative shall prepare and affix the label to veterinary food-animal drugs.

(e)Section 4051 shall not apply to any laboratory licensed under Section 351 of Title III of the Public Health Service Act (Public Law 78-410).

§ 4053.1

Amended by Stats. 2021, Ch. 629, Sec. 14. (AB 1533) Effective January 1, 2022.

(a)Notwithstanding Section 4051, the board may issue a license to a qualified individual as a designated representative-3PL to provide sufficient and qualified supervision of a third-party logistics provider’s place of business. The designated representative-3PL shall protect the public health and safety in the handling, storage, warehousing, distribution, and shipment of dangerous drugs and dangerous devices in the third-party logistics provider’s place of business.

(b)An individual who is at least 18 years of age may apply for a designated representative-3PL license. In order to obtain and maintain that license, the individual shall meet all of the following requirements:

(1)The individual shall

be a high school graduate, possess a general education development certificate equivalent, or have earned a degree from an accredited postsecondary institution.

(2)The individual shall meet one of the following requirements:

(A)Have a minimum of one year of paid work experience in the past three years with a third-party logistics provider.

(B)Have a minimum of one year of paid work experience in the past three years in a licensed pharmacy, or with a drug wholesaler, drug distributor, or drug manufacturer, performing duties related to the distribution or dispensing of dangerous drugs or dangerous devices.

(C)Meet all of the prerequisites to take the examination required for licensure as a pharmacist by the board.

(3)(A) The individual shall complete a training program approved by the board that, at a minimum, addresses each of the following subjects:

(i)Knowledge and understanding of California law and federal law relating to the distribution of dangerous drugs and dangerous devices.

(ii) Knowledge and understanding of California law and federal law relating to the distribution of controlled substances.

(iii) Knowledge and understanding of quality control systems.

(iv) Knowledge and understanding of the United States Pharmacopoeia or federal Food and Drug Administration standards relating to the safe storage, handling, and transport of dangerous drugs and dangerous devices.

(B) The board may, by regulation, require the training program required under this paragraph to include additional material.

(C) The board shall not issue a license as a designated representative-3PL until the applicant provides proof of completion of the training required by this paragraph to the board.

(c)A third-party logistics provider shall not operate without at least one designated representative-3PL present at each of its licensed places of business as required under Section 4160.

§ 4053.2

Amended by Stats. 2021, Ch. 629, Sec. 15. (AB 1533) Effective January 1, 2022.

(a)Notwithstanding Sections 4051 and 4053, the board may issue a designated representative-reverse distributor license to a qualified individual who shall provide sufficient and qualified supervision over a licensed wholesaler that only acts as a reverse distributor. The designated representative-reverse distributor shall protect the public health and safety in the handling, storage, warehousing, and destruction of outdated or nonsaleable dangerous drugs and dangerous devices.

(b)An individual who is at least 18 years of age may apply for a designated representative-reverse distributor license. In order to obtain and maintain that license, the individual shall meet all of the following requirements:

(1)The individual shall be a high school graduate, possess a general education development certificate equivalent, or have earned a degree from an accredited postsecondary institution.

(2)The individual shall meet one of the following requirements:

(A)Have a minimum of one year of paid work experience in the past three years with a licensed wholesaler, third-party logistics provider, or pharmacy performing duties related to the distribution, dispensing, or destruction of dangerous drugs or dangerous devices.

(B)Have a minimum of one year of paid work experience in the destruction of outdated or nonsaleable dangerous drugs or dangerous devices pharmaceutical waste.

(C)Meet all of the prerequisites to take the examination required for

licensure as a pharmacist by the board.

(3)(A) The individual shall complete a training program approved by the board that, at a minimum, addresses each of the following subjects:

(i)Knowledge and understanding of California law and federal law relating to the distribution of dangerous drugs and dangerous devices.

(ii) Knowledge and understanding of California law and federal law relating to the distribution of controlled substances.

(iii) Knowledge and understanding of California law and federal law relating to the removal and destruction of dangerous drugs, dangerous devices, and pharmaceutical waste.

(iv) Knowledge and understanding of the United States

Pharmacopoeia or federal Food and Drug Administration standards relating to the safe storage, handling, and transport of dangerous drugs and dangerous devices.

(B) The board may, by regulation, require the training program required under this paragraph to include additional material.

(C) The board shall not issue a license as a designated representative-reverse distributor until the applicant provides proof of completion of the training required by this paragraph to the board.

(c)A reverse distributor shall not operate without at least one designated representative or designated representative-reverse distributor present at each of its licensed places of business as required under Section 4160.

§ 4054

Amended by Stats. 2004, Ch. 857, Sec. 9. Effective January 1, 2005.

Section 4051 shall not apply to a manufacturer or wholesaler that provides dialysis drugs and devices directly to patients.

§ 4055

Amended by Stats. 1997, Ch. 549, Sec. 33. Effective January 1, 1998.

Nothing in this chapter, nor any other law, shall prohibit the sale of devices to clinics that have been issued a clinic license pursuant to Article 13 (commencing with Section 4180) of this chapter, or to skilled nursing facilities or intermediate care facilities licensed pursuant to Chapter 2 (commencing with Section 1250) of, or to home health agencies licensed pursuant to Chapter 8 (commencing with Section 1725) of, or to hospices licensed pursuant to Chapter 8.5 (commencing with Section 1745) of, Division 2 of, the Health and Safety Code, as long as the devices are furnished only upon the prescription or order of a physician, dentist, or podiatrist.

§ 4056

Amended by Stats. 1999, Ch. 900, Sec. 1. Effective October 10, 1999.

(a)Notwithstanding any provision of this chapter, a licensed hospital that contains 100 beds or fewer, and that does not employ a full-time pharmacist, may purchase drugs at wholesale for administration, under the direction of a physician, or for dispensation by a physician, to persons registered as inpatients of the hospital, to emergency cases under treatment in the hospital, or, under the conditions described in subdivision (f), to persons registered as outpatients in a rural hospital as defined in Section 124840 of the Health and Safety Code. The hospital shall keep records of the kind and amounts of drugs so purchased and administered or dispensed, and the records shall be available for inspection by all properly authorized personnel of the board.

(b)No hospital shall be entitled to the benefits of subdivision (a) until it has obtained a license from the board. Each license shall be issued to a specific hospital and for a specific location.

(c)Each application for a license under this section shall be made on a form furnished by the board. Upon the filing of the application and payment of the fee prescribed in subdivision (a) of Section 4400, the executive officer of the board shall issue a license authorizing the hospital to which it is issued to purchase drugs at wholesale pursuant to subdivision (a). The license shall be renewed annually on or before November 1 of each year upon payment of the renewal fee prescribed in subdivision (b) of Section 4400 and shall not be transferable.

(d)The form of application for a license under this section shall contain the name and address of the applicant, the number of beds, whether the applicant is a licensed hospital, whether it does or does not employ a full-time pharmacist, the name of its chief medical officer, and the name of its administrator.

(e)The board may deny, revoke, or suspend a license issued under this section in the manner and for the grounds specified in Article 19 (commencing with Section 4300).

(f)A physician himself or herself may dispense drugs to outpatients directly pursuant to subdivision (a) only if the physician determines that it is in the best interest of the patient that a particular drug regimen be immediately commenced or continued, and the physician reasonably believes that a pharmacy located outside the hospital is not available and accessible at the time of dispensation to the patient within 30 minutes of the hospital pharmaceutical services or within a 30-mile radius from the hospital pharmaceutical services by means of the method of transportation the patient states that he or she intends to use. The quantity of drugs dispensed to any outpatient pursuant to this subdivision shall be limited to that amount necessary to maintain uninterrupted therapy during the period when pharmaceutical services outside the hospital are not readily available or accessible, but shall not exceed a 72-hour supply. The physician shall ensure that the label on the drug contains all the information required by Section 4076.

(g)A rural hospital, as defined in Section 124840 of the Health and Safety Code, shall obtain information regarding the hours of operation of each pharmacy located within the 30 minute or 30-mile radius of the hospital. The hospital shall update this information annually, and shall make this information available to its medical staff.

(h)A licensed hospital that contains 100 beds or fewer, does not employ a full-time pharmacist, and purchases drugs at wholesale for administration or dispensation pursuant to subdivision (a), shall retain the services of a pharmacist consultant to monitor and review the pharmaceutical services provided by the hospital to inpatients of the hospital, and the dispensing of drugs by physicians to outpatients pursuant to subdivision (f).

(i)This section shall not be construed to eliminate the requirements of Section 11164 or 11167 of the Health and Safety Code.

§ 4057

Amended by Stats. 2018, Ch. 36, Sec. 4. (AB 1812) Effective June 27, 2018.

(a)Except as provided in Section 4006, subdivision (d) of Section 4081, Section 4240, subdivisions (t) and (u) of Section 4301, and Section 4342, this chapter does not apply to the retail sale of nonprescription drugs that are not subject to Section 4022 and that are packaged or bottled in the manufacturer’s or distributor’s container and labeled in accordance with applicable federal and state drug labeling requirements.

(b)This chapter does not apply to specific dangerous drugs and dangerous devices listed in board regulations, where the sale or furnishing is made to any of the following:

(1)A physician, dentist, podiatrist, pharmacist, medical technician, medical technologist, optometrist, or

chiropractor holding a currently valid and unrevoked license and acting within the scope of his or her profession.

(2)A clinic, hospital, institution, or establishment holding a currently valid and unrevoked license or permit under Division 2 (commencing with Section 1200) of the Health and Safety Code, or Chapter 2 (commencing with Section 3300) of Division 3 of, or Part 2 (commencing with Section 6250) of Division 6 of, the Welfare and Institutions Code.

(3)A correctional clinic, as defined in Section 4187, holding a currently valid and unrevoked license or permit under Article 13.5 (commencing with Section 4187).

(c)This chapter shall not apply to a home health agency licensed under Chapter 8 (commencing

with Section 1725) of, or a hospice licensed under Chapter 8.5 (commencing with Section 1745) of, Division 2 of, the Health and Safety Code, when it purchases, stores, furnishes, or transports specific dangerous drugs and dangerous devices listed in board regulations in compliance with applicable law and regulations including:

(1)Dangerous devices described in subdivision (b) of Section 4022, as long as these dangerous devices are furnished only upon the prescription or order of a physician, dentist, or podiatrist.

(2)Hypodermic needles and syringes.

(3)Irrigation solutions of 50 cubic centimeters or greater.

(d)This chapter does not apply to the storage of devices in secure central or ward supply areas of a clinic, hospital, institution, or

establishment holding a currently valid and unrevoked license or permit pursuant to Division 2 (commencing with Section 1200) of the Health and Safety Code, or pursuant to Chapter 2 (commencing with Section 3300) of Division 3 of, or Part 2 (commencing with Section 6250) of Division 6 of, the Welfare and Institutions Code.

(e)This chapter does not apply to the retail sale of vitamins, mineral products, or combinations thereof or to foods, supplements, or nutrients used to fortify the diet of humans or other animals or poultry and labeled as such that are not subject to Section 4022 and that are packaged or bottled in the manufacturer’s or distributor’s container and labeled in accordance with applicable federal and state labeling requirements.

(f)This chapter does not apply to the furnishing of dangerous drugs and dangerous devices to recognized schools of nursing. These

dangerous drugs and dangerous devices shall not include controlled substances. The dangerous drugs and dangerous devices shall be used for training purposes only, and not for the cure, mitigation, or treatment of disease in humans. Recognized schools of nursing for purposes of this subdivision are those schools recognized as training facilities by the California Board of Registered Nursing.

§ 4058

Amended by Stats. 1997, Ch. 549, Sec. 36. Effective January 1, 1998.

Every person holding a license issued under this chapter to operate a premises shall display the original license and current renewal license upon the licensed premises in a place where it may be clearly read by the public.

§ 4059

Amended by Stats. 2010, Ch. 653, Sec. 24. (SB 1489) Effective January 1, 2011.

(a)A person may not furnish any dangerous drug, except upon the prescription of a physician, dentist, podiatrist, optometrist, veterinarian, or naturopathic doctor pursuant to Section 3640.7. A person may not furnish any dangerous device, except upon the prescription of a physician, dentist, podiatrist, optometrist, veterinarian, or naturopathic doctor pursuant to Section 3640.7.

(b)This section does not apply to the furnishing of any dangerous drug or dangerous device by a manufacturer, wholesaler, or pharmacy to each other or to a physician, dentist, podiatrist, optometrist, veterinarian, or naturopathic doctor pursuant to Section 3640.7, or to a laboratory under sales and

purchase records that correctly give the date, the names and addresses of the supplier and the buyer, the drug or device, and its quantity. This section does not apply to the furnishing of any dangerous device by a manufacturer, wholesaler, or pharmacy to a physical therapist acting within the scope of his or her license under sales and purchase records that correctly provide the date the device is provided, the names and addresses of the supplier and the buyer, a description of the device, and the quantity supplied.

(c)A pharmacist, or a person exempted pursuant to Section 4054, may distribute dangerous drugs and dangerous devices directly to dialysis patients pursuant to regulations adopted by the board. The board shall adopt any regulations as are necessary to ensure the safe distribution of these drugs and devices to dialysis patients without interruption thereof. A person who violates a regulation adopted pursuant to this subdivision

shall be liable upon order of the board to surrender his or her personal license. These penalties shall be in addition to penalties that may be imposed pursuant to Section 4301. If the board finds any dialysis drugs or devices distributed pursuant to this subdivision to be ineffective or unsafe for the intended use, the board may institute immediate recall of any or all of the drugs or devices distributed to individual patients.

(d)Home dialysis patients who receive any drugs or devices pursuant to subdivision (c) shall have completed a full course of home training given by a dialysis center licensed by the State Department of Public Health. The physician prescribing the dialysis products shall submit proof satisfactory to the manufacturer or wholesaler that the patient has completed the program.

(e)A pharmacist may furnish a dangerous drug authorized for use pursuant to Section

2620.3 to a physical therapist. A record containing the date, name and address of the buyer, and name and quantity of the drug shall be maintained. This subdivision shall not be construed to authorize the furnishing of a controlled substance.

(f)A pharmacist may furnish electroneuromyographic needle electrodes or hypodermic needles used for the purpose of placing wire electrodes for kinesiological electromyographic testing to physical therapists who are certified by the Physical Therapy Board of California to perform tissue penetration in accordance with Section 2620.5.

(g)Nothing in this section shall be construed as permitting a licensed physical therapist to dispense or furnish a dangerous device without a prescription of a physician, dentist, podiatrist, optometrist, or veterinarian.

(h)A veterinary

food-animal drug retailer shall dispense, furnish, transfer, or sell veterinary food-animal drugs only to another veterinary food-animal drug retailer, a pharmacy, a veterinarian, or to a veterinarian’s client pursuant to a prescription from the veterinarian for food-producing animals.

§ 4059.5