Scope Of Practice And Exemptions - Pharmacy - Business & Professions - CA

Section § 4050

Pharmacy is officially recognized as a profession in California. Pharmacists are not just dispensers of medication; they play an essential role in health care by using their knowledge to improve patients' health through proper drug use and therapy. They are seen as health care providers with the authority to offer a range of health services.

(a) 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.

(b) Pharmacy practice is a dynamic, patient-oriented health service that applies a scientific body of knowledge to improve and promote patient health by means of appropriate drug use, drug-related therapy, and communication for clinical and consultative purposes. Pharmacy practice is continually evolving to include more sophisticated and comprehensive patient care activities.

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

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Section § 4051

This law makes it illegal for anyone who is not a qualified pharmacist to manufacture, sell, or dispense dangerous drugs or devices. However, pharmacists can start prescriptions and offer clinical advice, as long as they meet certain conditions. These include providing advice to a healthcare professional or patient, having access to the necessary medical information, and ensuring that this information is kept secure from unauthorized access.

(a) 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 he or she is a pharmacist under this chapter.

(b) Notwithstanding any other law, a pharmacist may authorize the initiation of a prescription, pursuant to Section 4052.1, 4052.2, 4052.3, 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.

(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.

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Section § 4052

This law explains the various responsibilities and powers a pharmacist in California can have beyond just filling prescriptions. Pharmacists can prepare custom drug mixtures for doctors to use in their offices, transmit prescriptions to other pharmacists, and administer drugs that have been ordered by a prescriber. They're also allowed to do specific tasks in health care facilities and home health agencies. The law lets pharmacists give advice about medication and health, and they can even provide certain types of contraceptives and HIV prevention medications without a prior diagnosis. They are also allowed to give vaccines and order tests required for managing drug treatments. Pharmacists can start, adjust, or stop medication plans under agreements with prescriptive authority providers and offer medication-assisted treatments according to federal guidelines. However, they must ensure medical records confidentiality and have a registered DEA number if they deal with controlled substances.

(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 in a licensed health care facility as authorized by Section 4052.1.

(5) Perform procedures or functions as part of the care provided by a health care facility, a licensed home health agency, 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, as authorized by Section 4052.2.

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

(7) 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.

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

(10) Furnish the medications described in subparagraph (A) in accordance with subparagraph (B):

(A)

(i) Emergency contraception drug therapy, over-the-counter contraceptives, and self-administered prescription-only hormonal contraceptives, as authorized by Section 4052.3.

(ii) Nicotine replacement products, as authorized by Section 4052.9.

(iii) Prescription medications not requiring a diagnosis that are recommended by the federal Centers for Disease Control and Prevention for individuals traveling outside of the United States.

(iv) HIV preexposure prophylaxis, as authorized by Section 4052.02.

(v) HIV postexposure prophylaxis, as authorized by Section 4052.03.

(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.

(11) Administer immunizations pursuant to a protocol with a prescriber.

(12) Order and interpret tests for the purpose of monitoring and managing the efficacy and toxicity of drug therapies. A pharmacist who orders and interprets tests pursuant to this paragraph 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.

(13) Initiate, adjust, or discontinue drug therapy for a patient under 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.

(14) Provide medication-assisted treatment pursuant to a state protocol, to the extent authorized by federal law.

(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.

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Section § 4052.01

This law allows pharmacists in California to provide opioid antagonists, like naloxone, to people without a prescription to help reverse opioid overdoses. Pharmacists must follow protocols developed by the relevant medical boards and ensure that individuals receiving the drug are educated on using it, recognizing overdoses, and seeking medical help. Pharmacists must also inform primary care providers, with patient consent, and cannot skip the required consultation. They are required to undergo specific training on opioid antagonists. The law authorizes the boards to enforce compliance and create emergency regulations to implement these procedures promptly.

(a) Notwithstanding any other provision of law, a pharmacist may furnish federal Food and Drug Administration-approved opioid antagonist in accordance with standardized procedures or protocols developed and approved by both the board and the Medical Board of California, in consultation with the California Society of Addiction Medicine, the California Pharmacists Association, and other appropriate entities. In developing those standardized procedures or protocols, the board and the Medical Board of California shall include the following:

(1) Procedures to ensure education of the person to whom the drug is furnished, including, but not limited to, opioid overdose prevention, recognition, and response, safe administration of opioid antagonists, potential side effects or adverse events, and the imperative to seek emergency medical care for the patient.

(2) Procedures to ensure the education of the person to whom the drug is furnished regarding the availability of drug treatment programs.

(3) Procedures for the notification of the patient’s primary care provider with patient consent of any drugs or devices furnished to the patient, or entry of appropriate information in a patient record system shared with the primary care provider, as permitted by that primary care provider, and with patient consent.

(b) A pharmacist furnishing an opioid antagonist pursuant to this section shall not permit the person to whom the drug is furnished to waive the consultation required by the board and the Medical Board of California.

(c) Prior to performing a procedure authorized under this section, a pharmacist shall complete a training program on the use of opioid antagonists that consists of at least one hour of approved continuing education on the use of opioid antagonists.

(d) The board and the Medical Board of California are each authorized to ensure compliance with this section. Each board is specifically charged with enforcing this section with respect to its respective licensees. This section does not expand the authority of a pharmacist to prescribe any prescription medication.

(e) The board may adopt emergency regulations to establish the standardized procedures or protocols. The adoption of regulations pursuant to this subdivision shall be deemed to be an emergency and necessary for the immediate preservation of the public peace, health, safety, or general welfare. The emergency regulations authorized by this subdivision are exempt from review by the Office of Administrative Law. The emergency regulations authorized by this subdivision shall be submitted to the Office of Administrative Law for filing with the Secretary of State and shall remain in effect until the earlier of 180 days following their effective date or the effective date of regulations adopted pursuant to subdivision (a).

opioid antagonist naloxone pharmacists ...

Section § 4052.1

This California law section allows pharmacists in health care facilities to perform certain tasks usually associated with doctors and nurses, like checking patient vitals, ordering lab tests for drug therapy, giving injections, and adjusting medication plans. However, these activities must follow guidelines developed by the health facility's staff, including doctors and nurses, and they have to be approved by the facility's administrator. Pharmacies must also make sure their pharmacists get the right training before doing these tasks.

(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.

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Section § 4052.02

This law allows pharmacists to start and provide medication to prevent HIV, known as preexposure prophylaxis (PrEP), to patients without a doctor's prescription. Before doing this, pharmacists must complete a special training program. They can give up to a 90-day supply if the patient meets certain conditions, like confirming they are HIV-negative and don’t show signs of HIV. Pharmacists must also tell patients that continuing the medication may require visits to a primary care provider. They must keep records and inform the patient’s doctor if the patient agrees. The law also provides guidelines if a pharmacist is to offer more than a 90-day supply. New rules will be adopted by October 2024 to ensure these processes align with national health guidelines.

(a) Notwithstanding any other law, a pharmacist may initiate and furnish HIV preexposure prophylaxis in accordance with this section.

(b) For purposes of this section, “preexposure prophylaxis” means a prescription drug approved by the federal Food and Drug Administration or recommended by the federal Centers for Disease Control and Prevention to reduce a person’s chance of contracting HIV.

(c) For purposes of this section, “CDC guidelines” means the “2017 Preexposure Prophylaxis for the Prevention of HIV Infection in the United States–2017 Update: A Clinical Practice Guideline,” or any subsequent guidelines or recommendations published by the federal Centers for Disease Control and Prevention.

(d) Before furnishing preexposure prophylaxis to a patient, a pharmacist shall complete a training program approved by the board, in consultation with the Medical Board of California, on the use of preexposure prophylaxis and postexposure prophylaxis. The training shall include information about financial assistance programs for preexposure prophylaxis and postexposure prophylaxis, including the HIV prevention program described in Section 120972 of the Health and Safety Code. The board shall consult with the Medical Board of California as well as relevant stakeholders, including, but not limited to, the Office of AIDS, within the State Department of Public Health, on training programs that are appropriate to meet the requirements of this subdivision.

(e) A pharmacist may furnish up to a 90-day course of preexposure prophylaxis if all of the following conditions are met:

(1) The patient is HIV negative, as documented by a negative HIV test result obtained consistent with CDC guidelines. If the patient does not provide evidence of a negative HIV test in accordance with this paragraph, the pharmacist shall order an HIV test. If the test results are not transmitted directly to the pharmacist, the pharmacist shall verify the test results to the pharmacist’s satisfaction. If the patient tests positive for HIV infection, the pharmacist or person administering the test shall direct the patient to a primary care provider and provide a list of providers and clinics in the region.

(2) The patient does not report any signs or symptoms of acute HIV infection on a self-reported checklist of acute HIV infection signs and symptoms.

(3) The patient does not report taking any contraindicated medications.

(4) The pharmacist provides counseling to the patient on the ongoing use of preexposure prophylaxis, which may include education about side effects, safety during pregnancy and breastfeeding, adherence to recommended dosing, and the importance of timely testing and treatment, as applicable, for HIV, renal function, hepatitis B, hepatitis C, sexually transmitted diseases, and pregnancy for individuals of childbearing capacity.

(5) The pharmacist notifies the patient that the patient may need to be seen by a primary care provider to receive subsequent prescriptions for preexposure prophylaxis and that a pharmacist may not furnish a 90-day course of preexposure prophylaxis to a single patient more than once every two years unless the pharmacist ensures that the patient receives testing and followup care consistent with CDC guidelines.

(6) The pharmacist documents, to the extent possible, the services provided by the pharmacist in the patient’s record in the record system maintained by the pharmacy. The pharmacist shall maintain records of preexposure prophylaxis furnished to each patient.

(7) The pharmacist does not furnish more than a 90-day course of preexposure prophylaxis to a single patient more than once every two years, unless directed otherwise by a prescriber.

(8) The pharmacist notifies the patient’s primary care provider that the pharmacist completed the requirements specified in this subdivision. If the patient does not have a primary care provider, or refuses consent to notify the patient’s primary care provider, the pharmacist shall provide the patient a list of primary care providers in the region.

(f)

(1) A pharmacist may furnish preexposure prophylaxis beyond a 90-day course if all of the following conditions are met:

(A) The pharmacist ensures that the patient receives testing and followup care consistent with CDC guidelines, which may include timely testing and treatment, as applicable, for HIV, renal function, hepatitis B, hepatitis C, sexually transmitted diseases, and pregnancy for individuals of childbearing capacity.

(B) The pharmacist documents, to the extent possible, the services provided by the pharmacist in the patient’s record in the record system maintained by the pharmacy. The pharmacist shall maintain records of preexposure prophylaxis furnished to each patient.

(C) The pharmacist notifies the patient’s primary care provider that the pharmacist completed the requirements specified in this subdivision. If the patient does not have a primary care provider, or refuses consent to notify the patient’s primary care provider, the pharmacist shall provide the patient a list of primary care providers in the region.

(2) Notwithstanding paragraph (1), this section shall not be construed to expand the scope of practice of a pharmacist beyond that which is authorized by Sections 4052 and 4052.4.

(g) A pharmacist initiating or furnishing preexposure prophylaxis shall not permit the person to whom the drug is furnished to waive the consultation required by the board.

(h) The board, by October 31, 2024, shall adopt emergency regulations to implement this section in accordance with CDC guidelines. The adoption of regulations pursuant to this subdivision shall be deemed to be an emergency and necessary for the immediate preservation of the public peace, health, safety, or general welfare. The board shall consult with the Medical Board of California in developing regulations pursuant to this subdivision.

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Section § 4052.2

This law allows pharmacists in California to perform specific health procedures under certain conditions. A pharmacist can check vital signs, order lab tests related to medications, administer injections, and adjust medication plans as long as there’s a written order from a doctor. Pharmacists have to follow set procedures agreed upon by healthcare professionals like doctors and nurses. They need to notify a patient's doctor within 24 hours if they make any medication changes. Pharmacists must work as part of a healthcare team and need prior clinical training or experience before performing these tasks.

(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.

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Section § 4052.03

This law allows pharmacists in California to prescribe and provide HIV postexposure prophylaxis (PEP) to patients. It specifies the drug combinations that can be used, aligning with CDC guidelines. To offer PEP, pharmacists must complete specific training and meet conditions like confirming recent exposure and offering HIV testing. They must counsel patients on PEP usage and notify their primary care provider or offer follow-up care options if no provider is available. This law aims to ensure quick and accessible treatment for HIV exposure, emphasizing patient education and support.

(a) Notwithstanding any other law, a pharmacist may initiate and furnish HIV postexposure prophylaxis in accordance with this section.

(b) For purposes of this section, “postexposure prophylaxis” means any of the following:

(1) Tenofovir disoproxil fumarate (TDF) (300 mg) with emtricitabine (FTC) (200 mg), taken once daily, in combination with either raltegravir (400 mg), taken twice daily, or dolutegravir (50 mg), taken once daily.

(2) Tenofovir disoproxil fumarate (TDF) (300 mg) and emtricitabine (FTC) (200 mg), taken once daily, in combination with darunavir (800 mg) and ritonavir (100 mg), taken once daily.

(3) Another drug or drug combination determined by the board to meet the same clinical eligibility recommendations provided in CDC guidelines.

(c) For purposes of this section, “CDC guidelines” means the “Updated Guidelines for Antiretroviral Postexposure Prophylaxis After Sexual, Injection Drug Use, or Other Nonoccupational Exposure to HIV–United States, 2016,” or any subsequent guidelines, published by the federal Centers for Disease Control and Prevention.

(d) Before furnishing postexposure prophylaxis to a patient, a pharmacist shall complete a training program approved by the board, in consultation with the Medical Board of California, on the use of preexposure prophylaxis and postexposure prophylaxis. The training shall include information about financial assistance programs for preexposure prophylaxis and postexposure prophylaxis, including the HIV prevention program described in Section 120972 of the Health and Safety Code. The board shall consult with the Medical Board of California as well as relevant stakeholders, including, but not limited to, the Office of AIDS, within the State Department of Public Health, on training programs that are appropriate to meet the requirements of this subdivision.

(e) A pharmacist shall furnish a complete course of postexposure prophylaxis if all of the following conditions are met:

(1) The pharmacist screens the patient and determines the exposure occurred within the previous 72 hours and the patient otherwise meets the clinical criteria for postexposure prophylaxis consistent with CDC guidelines.

(2) The pharmacist provides HIV testing that is classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a) or determines the patient is willing to undergo HIV testing consistent with CDC guidelines. If the patient refuses to undergo HIV testing but is otherwise eligible for postexposure prophylaxis under this section, the pharmacist may furnish postexposure prophylaxis.

(3) The pharmacist provides counseling to the patient on the use of postexposure prophylaxis consistent with CDC guidelines, which may include education about side effects, safety during pregnancy and breastfeeding, adherence to recommended dosing, and the importance of timely testing and treatment, as applicable, for HIV and sexually transmitted diseases. The pharmacist shall also inform the patient of the availability of preexposure prophylaxis for persons who are at substantial risk of acquiring HIV.

(4) The pharmacist notifies the patient’s primary care provider of the postexposure prophylaxis treatment. If the patient does not have a primary care provider, or refuses consent to notify the patient’s primary care provider, the pharmacist shall provide the patient a list of physicians and surgeons, clinics, or other health care service providers to contact regarding followup care for postexposure prophylaxis.

(f) A pharmacist initiating or furnishing postexposure prophylaxis shall not permit the person to whom the drug is furnished to waive the consultation required by the board.

(g) The board, by July 1, 2020, shall adopt emergency regulations to implement this section in accordance with CDC guidelines. The adoption of regulations pursuant to this subdivision shall be deemed to be an emergency and necessary for the immediate preservation of the public peace, health, safety, or general welfare. The board shall consult with the Medical Board of California in developing regulations pursuant to this subdivision.

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Section § 4052.3

This law allows pharmacists in California to provide self-administered hormonal contraceptives and emergency contraception under specific guidelines. Pharmacists can use approved protocols developed with medical boards and need to follow a process that includes assessing the patient's risk and providing referrals if needed. They are also allowed to provide emergency contraception after completing a training program and can charge a small fee for this service. Patients must receive a factsheet with information about the contraception. Over-the-counter contraceptives can be provided without the protocols needed for prescription options. Pharmacists are not allowed to require unnecessary medical information, and they must disclose the total price of the contraception upon request.

(a)

(1) Notwithstanding any other law, a pharmacist may furnish self-administered prescription-only hormonal contraceptives in accordance with standardized procedures or protocols developed and approved by both the board and the Medical Board of California in consultation with the American Congress of Obstetricians and Gynecologists, the California Pharmacists Association, and other appropriate entities. The standardized procedure or protocol shall require that the patient use a self-screening tool that will identify patient risk factors for use of self-administered hormonal contraceptives, based on the current United States Medical Eligibility Criteria (USMEC) for Contraceptive Use developed by the federal Centers for Disease Control and Prevention, and that the pharmacist refer the patient to the patient’s primary care provider or, if the patient does not have a primary care provider, to nearby clinics, upon furnishing a self-administered hormonal contraceptive pursuant to this subdivision, or if it is determined that use of a self-administered hormonal contraceptive is not recommended.

(2) The board and the Medical Board of California are both authorized to ensure compliance with this subdivision, and each board is specifically charged with the enforcement of this subdivision with respect to its respective licensees. This subdivision does not expand the authority of a pharmacist to prescribe any prescription medication.

(b)

(1) Notwithstanding any other law, a pharmacist may furnish emergency contraception drug therapy in accordance with either of the following:

(A) Standardized procedures or protocols developed by the pharmacist and an authorized prescriber who is acting within their scope of practice.

(B) Standardized procedures or protocols developed and approved by both the board and the Medical Board of California in consultation with the American Congress of Obstetricians and Gynecologists, the California Pharmacists Association, and other appropriate entities. The board and the Medical Board of California are both authorized to ensure compliance with this clause, and each board is specifically charged with the enforcement of this provision with respect to its respective licensees. This subdivision does not expand the authority of a pharmacist to prescribe any prescription medication.

(2) Prior to performing a procedure authorized under this subdivision, a pharmacist shall complete a training program on emergency contraception that consists of at least one hour of approved continuing education on emergency contraception drug therapy.

(3) A pharmacist, pharmacist’s employer, or pharmacist’s agent shall not directly charge a patient a separate consultation fee for emergency contraception drug therapy services initiated pursuant to this subdivision, but may charge an administrative fee not to exceed ten dollars ($10) above the retail cost of the drug. Upon an oral, telephonic, electronic, or written request from a patient or customer, a pharmacist or pharmacist’s employee shall disclose the total retail price that a consumer would pay for emergency contraception drug therapy. As used in this paragraph, total retail price includes providing the consumer with specific information regarding the price of the emergency contraception drugs and the price of the administrative fee charged. This limitation is not intended to interfere with other contractually agreed-upon terms between a pharmacist, a pharmacist’s employer, or a pharmacist’s agent, and a health care service plan or insurer. Patients who are insured or covered and receive a pharmacy benefit that covers the cost of emergency contraception shall not be required to pay an administrative fee. These patients shall be required to pay copayments pursuant to the terms and conditions of their coverage. This paragraph shall become inoperative for dedicated emergency contraception drugs if these drugs are reclassified as over-the-counter products by the federal Food and Drug Administration.

(4) 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.

(c) Notwithstanding any other law, a pharmacist may furnish over-the-counter contraceptives without the standardized procedures or protocols that subdivision (a) requires for prescription-only self-administered hormonal contraceptives.

(d) For each emergency contraception drug therapy or self-administered prescription-only hormonal contraception initiated pursuant to this section, the pharmacist shall provide the recipient of the drug with a standardized factsheet that includes, but is not limited to, the indications and contraindications for use of the drug, the appropriate method for using the drug, the need for medical followup, and other appropriate information. The board shall develop this form in consultation with the State Department of Public Health, the American Congress of Obstetricians and Gynecologists, the California Pharmacists Association, and other health care organizations. This section does not preclude the use of existing publications developed by nationally recognized medical organizations.

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Section § 4052.04

This law allows pharmacists to provide COVID-19 oral medications if a person tests positive for the virus. Before doing so, they must follow FDA guidelines. Pharmacists need to inform the patient’s primary doctor or document the medication in a shared system. If the person doesn't have a regular doctor, they should get a written record of the medication and be advised to see a doctor. They must keep records of what they give out and any related services for three years. The law defines these oral medications as drugs approved by the FDA for COVID-19 and ends on 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.

(f) This section shall remain in effect only until January 1, 2026, and as of that date is repealed.

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Section § 4052.4

This California law allows pharmacists to perform certain medical tests, including ones that involve skin punctures, as part of routine patient assessments or if the tests are approved by federal regulations. These tests can include checking for conditions like COVID-19, strep throat, or diabetes, among others, and are classified as 'waived' meaning they are simple to perform and not high-risk. The pharmacist must use an adequately licensed pharmacy lab, complete required training, and report results to the patient and their designated physician. Specimens collected by vaginal swab, venipuncture, or seminal fluid are not included.

(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.

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Section § 4052.05

A pharmacist in California can independently give vaccines to anyone aged three or older if the vaccine was recommended by the CDC's Advisory Committee on Immunization Practices as of January 1, 2025. This applies even if the vaccine is not for routine use or if the state health department has made changes to the recommendation.

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.

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Section § 4052.5

This law allows pharmacists to choose a different form of a medication than what is originally prescribed, as long as it has the same active ingredients, strength, and treatment duration, to help patients follow their treatment plan better. However, if the doctor specifies 'Do not substitute,' the pharmacist must follow that instruction. Pharmacists have responsibility for their substitutions, but doctors aren't liable for pharmacists' decisions. This applies to all prescriptions, including those under federal assistance programs like Medi-Cal. If a substitution is made, the patient must be told, and the new medication must be listed on the label. Substitutions between long-acting and short-acting drugs or combining two or more products are not allowed.

(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.

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Section § 4052.6

An advanced practice pharmacist in California can assess patients, order and interpret tests related to medications, refer patients to other healthcare providers, and help manage diseases alongside other providers. They can also start, change, or stop medications. When they change or stop a medicine, they have to inform the original doctor who made the diagnosis. To start a new medication, they need to inform the patient's main doctor. This doesn't change any doctor's orders regarding prescriptions. Before working with controlled substances, the pharmacist must be registered with the DEA. Any tests they order should be coordinated with the patient's primary doctor, and the results should be shared properly with the doctor's consent.

(a) A pharmacist recognized by the board as an advanced practice pharmacist 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.

advanced practice pharmacist patient assessments drug therapy tests ...

Section § 4052.7

If a patient asks, a pharmacy can repackage a medication that was already given to them. The pharmacy must have procedures for repackaging and must label the package with specific details, such as the information required by another law (Section 4076), and the names and addresses of both the repackaging pharmacy and the one that originally dispensed the medication. Each pharmacy is responsible only for its own actions when providing the drug.

(a) A pharmacy may, at a patient’s request, repackage a drug previously dispensed to the patient or to the patient’s agent pursuant to a prescription.

(b) Any pharmacy providing repackaging services shall have in place policies and procedures for repackaging these drugs and shall label the repackaged prescription container with the following:

(1) All the information required by Section 4076.

(2) The name and address of the pharmacy repackaging the drug and the name and address of the pharmacy that initially dispensed the drug to the patient.

(c) The repackaging pharmacy and the pharmacy that initially dispensed the drug shall only be liable for its own actions in providing the drug to the patient or the patient’s agent.

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Section § 4052.8

Pharmacists in California can independently start and give vaccines approved by the FDA for individuals aged three and older, as long as there's a CDC recommendation for them. To do this, pharmacists must complete a CDC-endorsed immunization training that covers proper injection methods and emergency reactions treatment, maintain their training, be certified in basic life support, and adhere to all relevant record-keeping laws. They must also document vaccinations with the patient's primary care provider and the state's immunization registry. Additionally, pharmacists can give injections of epinephrine or diphenhydramine to treat severe allergic reactions.

(a) In addition to the authority provided in paragraph (11) of subdivision (a) of Section 4052, a pharmacist may independently initiate and administer any vaccine that has been approved or authorized by the federal Food and Drug Administration and received a federal Advisory Committee on Immunization Practices individual vaccine recommendation published by the federal Centers for Disease Control and Prevention (CDC) for persons three years of age and older.

(b) In order to initiate and administer an immunization described in subdivision (a), a pharmacist shall do all of the following:

(1) Complete an immunization training program endorsed by the CDC or the Accreditation Council for Pharmacy Education that, at a minimum, includes hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines, and shall maintain that training.

(2) Be certified in basic life support.

(3) Comply with all state and federal recordkeeping and reporting requirements, including providing documentation to the patient’s primary care provider and entering information in the appropriate immunization registry designated by the immunization branch of the State Department of Public Health.

(c) A pharmacist administering immunizations pursuant to this section, or paragraph (11) of subdivision (a) of Section 4052, may also initiate and administer epinephrine or diphenhydramine by injection for the treatment of a severe allergic reaction.

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Section § 4052.9

This law allows pharmacists to provide nicotine replacement products, like patches or gum, as part of a smoking cessation program, but only if they follow certain rules. They must keep records for at least three years and inform the patient's doctor or give the patient a record if no doctor is available. Pharmacists must also be certified in smoking cessation and continue their education every two years to maintain this ability. The law is enforced by the professional boards of pharmacists and doctors, but it does not let pharmacists prescribe other medications.

(a) A pharmacist may furnish nicotine replacement products approved by the federal Food and Drug Administration for use by prescription only in accordance with standardized procedures and protocols developed and approved by both the board and the Medical Board of California in consultation with other appropriate entities and provide smoking cessation services if all of the following conditions are met:

(1) The pharmacist maintains records of all prescription drugs and devices furnished for a period of at least three years for purposes of notifying other health care providers and monitoring the patient.

(2) The pharmacist notifies the patient’s primary care provider of any drugs or devices furnished to the patient, or enters 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 provides the patient with a written record of the drugs or devices furnished and advises the patient to consult a physician of the patient’s choice.

(3) The pharmacist is certified in smoking cessation therapy by an organization recognized by the board.

(4) The pharmacist completes one hour of continuing education focused on smoking cessation therapy biennially.

(b) The board and the Medical Board of California are both authorized to ensure compliance with this section, and each board is specifically charged with the enforcement of this section with respect to their respective licensees. Nothing in this section shall be construed to expand the authority of a pharmacist to prescribe any other prescription medication.

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Section § 4052.10

This law allows pharmacists in California to partially fill prescriptions for Schedule II controlled substances, like certain pain medications, if the patient or doctor requests it. The pharmacy must keep the original prescription with a note on how much has been filled and must finish dispensing it within 30 days of the prescription date. If not fully dispensed in 30 days, the prescription expires, and more can't be given without a new prescription. Pharmacists have to record each fill in a state database, including the dispensing details and can charge a fee for the service. This regulation does not override other rules regarding Schedule II drugs.

(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.

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Section § 4053

This law allows the board to issue a special license, known as a 'designated representative' license, to people managing the handling, storage, and shipping of dangerous drugs and devices in a wholesaler or vet supply store. To qualify, applicants must be at least 18, have a high school diploma, have relevant work experience, and complete a specific training program. The law emphasizes the need for these premises to have either a pharmacist or a designated representative present. It also specifies that only these individuals can handle tasks like labeling animal drugs. Laboratories under another specific federal law are not subject to these requirements.

(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).

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Section § 4053.1

This law allows a board to give a designated representative-3PL license to someone to oversee the safe handling of dangerous drugs and devices at a logistics provider's business. To get this license, you must be over 18, have a high school or equivalent education, and either have work experience in logistics or related fields or meet the qualifications to take the pharmacy licensure exam. You also need to complete a board-approved training program that covers drug laws, distribution, quality control, and storage standards. The logistics business must have at least one such licensed person at each location.

(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.

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Section § 4053.2

This law allows the board to issue a special license to individuals acting as designated representatives for reverse distributors, who handle outdated or unsaleable dangerous drugs and devices. To qualify, applicants must be at least 18, have a high school diploma (or equivalent), and either have relevant work experience or meet pharmacist exam prerequisites. They must also complete a board-approved training program covering drug laws, safety standards, and waste disposal. Each reverse distributor location must have at least one licensed representative.

(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.

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Section § 4054

This law states that certain rules in Section 4051 do not apply to manufacturers or wholesalers supplying dialysis drugs and devices directly to patients.

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

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Section § 4055

This law says that devices can be sold to certain health facilities like clinics, nursing homes, home health agencies, and hospices if they have the right licenses. The catch is that these devices must be given out only if there's a prescription or order from a doctor, dentist, or foot doctor (podiatrist).

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.

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Section § 4056

This law outlines how small hospitals in California, with 100 beds or fewer and no full-time pharmacist, can buy drugs at wholesale for patients. These drugs can be given under a doctor's direction to inpatients, emergency cases, or outpatients in specific rural circumstances. The hospital must keep records of all drug purchases and uses, and only gets this privilege after getting a specific license, which must be renewed yearly. A doctor can directly give drugs to outpatients if it's in the patient's best interest and no pharmacy is nearby. The law limits the amount of drugs a physician can dispense under these conditions to a 72-hour supply. Small hospitals must hire a pharmacist consultant to monitor drug use. Lastly, this law works alongside other health code requirements.

(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.

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Section § 4057

This law outlines exceptions to certain pharmaceutical regulations. It states that the rules don't apply to nonprescription drugs sold in their original packaging by the manufacturer, as long as they follow federal and state labeling laws. For dangerous drugs and devices, the law doesn't apply when they are sold or provided to licensed medical professionals, licensed healthcare facilities, correctional clinics, home health agencies, or hospices, provided they adhere to all applicable regulations. Retail sales of vitamins and dietary supplements in their original containers are also exempt. Additionally, dangerous drugs and devices can be supplied to nursing schools for educational purposes, as long as controlled substances are not included and they are not used to treat patients.

(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.

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Section § 4058

If you have a license to run a business at a specific location, you must keep both the original and current renewal licenses visible to the public at that location.

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.

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Section § 4059

This section of the law outlines who can provide dangerous drugs and devices, with a focus on medical professionals and their prescriptions. Drugs and devices can generally only be given out with a prescription from specific licensed professionals like doctors and dentists, and there are specific rules about supplying these items between manufacturers, wholesalers, and pharmacies. It also sets guidelines for pharmacists giving certain supplies to dialysis and physical therapy patients, with safeguards to ensure safety and proper training. Additionally, it specifies how veterinary drugs for animals can be distributed and mandates thorough record-keeping for all distributions.

(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.

dangerous drugs prescription physician ...

Section § 4059.5

This law outlines the proper handling and delivery procedures for dangerous drugs and devices in California. Generally, these items must be ordered by a licensed entity and signed for by a pharmacist. Specific exceptions allow designated representatives or representatives of reverse distributors to receive deliveries. Within hospitals, delivery can go to a central location but must reach the pharmacy within a day for inventory. Authorized professionals, like doctors or veterinarians, can also order these items. They can't be delivered out-of-state unless all relevant laws are followed. Pharmacy deliveries to closed facilities must be securely stored and monitored. Remote pharmacy sites can receive deliveries through registered pharmacy technicians with specific video documentation requirements.

(a) Except as otherwise provided in this chapter, dangerous drugs or dangerous devices may only be ordered by an entity licensed by the board and shall be delivered to the licensed premises and signed for and received by a pharmacist. Where a licensee is permitted to operate through a designated representative, or in the case of a reverse distributor a designated representative-reverse distributor, that individual shall sign for and receive the delivery.

(b) A dangerous drug or dangerous device transferred, sold, or delivered to a person within this state shall be transferred, sold, or delivered only to an entity licensed by the board, to a manufacturer, or to an ultimate user or the ultimate user’s agent.

(c) Notwithstanding subdivisions (a) and (b), deliveries to a hospital pharmacy may be made to a central receiving location within the hospital. However, the dangerous drugs or dangerous devices shall be delivered to the licensed pharmacy premises within one working day following receipt by the hospital, and the pharmacist on duty at that time shall immediately inventory the dangerous drugs or dangerous devices.

(d) Notwithstanding any other law, a dangerous drug or dangerous device may be ordered by and provided to a manufacturer, physician, dentist, podiatrist, optometrist, veterinarian, naturopathic doctor pursuant to Section 3640.7, or laboratory, or a physical therapist acting within the scope of his or her license. A person or entity receiving delivery of a dangerous drug or dangerous device, or a duly authorized representative of the person or entity, shall sign for the receipt of the dangerous drug or dangerous device.

(e) A dangerous drug or dangerous device shall not be transferred, sold, or delivered to a person outside this state, whether foreign or domestic, unless the transferor, seller, or deliverer does so in compliance with the laws of this state and of the United States and of the state or country to which the dangerous drugs or dangerous devices are to be transferred, sold, or delivered. Compliance with the laws of this state and the United States and of the state or country to which the dangerous drugs or dangerous devices are to be delivered shall include, but not be limited to, determining that the recipient of the dangerous drugs or dangerous devices is authorized by law to receive the dangerous drugs or dangerous devices.

(f) Notwithstanding subdivision (a), a pharmacy may take delivery of dangerous drugs and dangerous devices when the pharmacy is closed and no pharmacist is on duty if all of the following requirements are met:

(1) The drugs are placed in a secure storage facility in the same building as the pharmacy.

(2) Only the pharmacist-in-charge or a pharmacist designated by the pharmacist-in-charge has access to the secure storage facility after dangerous drugs or dangerous devices have been delivered.

(3) The secure storage facility has a means of indicating whether it has been entered after dangerous drugs or dangerous devices have been delivered.

(4) The pharmacy maintains written policies and procedures for the delivery of dangerous drugs and dangerous devices to a secure storage facility.

(5) The agent delivering dangerous drugs and dangerous devices pursuant to this subdivision leaves documents indicating the name and amount of each dangerous drug or dangerous device delivered in the secure storage facility.

The pharmacy shall be responsible for the dangerous drugs and dangerous devices delivered to the secure storage facility. The pharmacy shall also be responsible for obtaining and maintaining records relating to the delivery of dangerous drugs and dangerous devices to a secure storage facility.

(g) Notwithstanding subdivision (a), dangerous drugs and devices and controlled substances may be ordered by a remote dispensing site pharmacy licensed by the board and may be signed for and received by a registered pharmacy technician, who meets the qualifications of Section 4132, at the remote site. A controlled substance signed for by a pharmacy technician under this section shall be stored separately from existing inventory until the time the controlled substance is reviewed and countersigned by a pharmacist. Any receipt and storage of a controlled substance by a pharmacy technician pursuant to this section shall be captured on video, and that video shall be made accessible to the supervising pharmacy and maintained by the remote dispensing site pharmacy for 120 days.

dangerous drugs delivery licensee ...

Section § 4060

This law states that no one is allowed to have controlled substances unless it was given to them with a prescription from a medical professional like a doctor, dentist, or other specified practitioners. It also mentions that certain health professionals and entities, like pharmacies and manufacturers, can possess these substances if properly labeled. Additionally, some healthcare providers are not allowed to order their own stock of dangerous drugs and devices.

A person shall not possess any controlled substance, except that furnished to a person upon the prescription of a physician, dentist, podiatrist, optometrist, veterinarian, nurse practitioner practicing pursuant to Section 2837.103 or 2837.104, or naturopathic doctor pursuant to Section 3640.7, or furnished pursuant to a drug order issued by a certified nurse-midwife pursuant to Section 2746.51, a nurse practitioner practicing pursuant to Section 2836.1, a physician assistant pursuant to Section 3502.1, a naturopathic doctor pursuant to Section 3640.5, or a pharmacist pursuant to Section 4052.1, 4052.2, or 4052.6. This section does not apply to the possession of any controlled substance by a manufacturer, wholesaler, third-party logistics provider, pharmacy, pharmacist, physician, podiatrist, dentist, optometrist, veterinarian, naturopathic doctor, certified nurse-midwife, nurse practitioner, or physician assistant, if in stock in containers correctly labeled with the name and address of the supplier or producer.

This section does not authorize a certified nurse-midwife, a nurse practitioner practicing pursuant to Section 2836.1, a physician assistant, or a naturopathic doctor, to order their own stock of dangerous drugs and devices.

controlled substances prescription physician ...

Section § 4061

This law states that sales representatives can't give out free samples of certain drugs or devices without a written request from authorized healthcare professionals like doctors or dentists. Nurse practitioners, nurse-midwives, physician assistants, and naturopathic doctors can request and receive these samples if they follow their standardized procedures, which must be approved by a doctor. The written request must include specific details like the supplier, receiver, the drug or device requested, and keep records accordingly. However, this law doesn't allow these practitioners to expand their scope beyond what they're legally allowed to do.

(a) No manufacturer’s sales representative shall distribute any dangerous drug or dangerous device as a complimentary sample without the written request of a physician, dentist, podiatrist, optometrist, veterinarian, nurse practitioner practicing pursuant to Section 2837.103 or 2837.104, or naturopathic doctor pursuant to Section 3640.7. However, a certified nurse-midwife who functions pursuant to a standardized procedure or protocol described in Section 2746.51, a nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1, or protocol, a physician assistant who functions pursuant to a protocol described in Section 3502.1, or a naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, may sign for the request and receipt of complimentary samples of a dangerous drug or dangerous device that has been identified in the standardized procedure, protocol, or practice agreement. Standardized procedures, protocols, and practice agreements shall include specific approval by a physician. A review process, consistent with the requirements of Section 2725, 3502.1, or 3640.5, of the complimentary samples requested and received by a nurse practitioner practicing pursuant to Section 2836.1, certified nurse-midwife, physician assistant, or naturopathic doctor, shall be defined within the standardized procedure, protocol, or practice agreement.

(b) Each written request shall contain the names and addresses of the supplier and the requester, the name and quantity of the specific dangerous drug desired, the name of the certified nurse-midwife, nurse practitioner, physician assistant, or naturopathic doctor, if applicable, receiving the samples pursuant to this section, the date of receipt, and the name and quantity of the dangerous drugs or dangerous devices provided. These records shall be preserved by the supplier with the records required by Section 4059.

(c) Nothing in this section is intended to expand the scope of practice of a certified nurse-midwife, nurse practitioner, physician assistant, or naturopathic doctor.

manufacturer’s sales representative dangerous drug complimentary sample ...

Section § 4062

This law allows pharmacists and licensed clinics to provide dangerous drugs or devices without a prescription during emergencies to protect public health. They must keep records and inform the patient’s doctor. The pharmacy board can waive certain regulations during emergencies and permit mobile pharmacies to operate if specific conditions are met, such as maintaining records and security. Pharmacies damaged by disasters can relocate without it counting as a transfer if they follow rules and notify the board. During emergencies, the board can extend waivers for up to 90 days after the emergency ends if needed for public health.

(a) Notwithstanding Section 4059 or any other law, a pharmacist or a clinic licensed and acting under Section 4180 may, in good faith, furnish a dangerous drug or dangerous device in reasonable quantities without a prescription during a federal, state, or local emergency, to further the health and safety of the public. A record containing the date, name, and address of the person to whom the drug or device is furnished, and the name, strength, and quantity of the drug or device furnished shall be maintained. The pharmacist or clinic shall communicate this information to the patient’s attending physician as soon as possible. Notwithstanding Section 4060 or any other law, a person may possess a dangerous drug or dangerous device furnished without prescription pursuant to this section.

(b) During a declared federal, state, or local emergency, the board may waive application of any provisions of this chapter or the regulations adopted pursuant to it if, in the board’s opinion, the waiver will aid in the protection of public health or the provision of patient care.

(c) During a declared federal, state, or local emergency, the board shall allow for the employment of a mobile pharmacy or clinic in impacted areas in order to ensure the continuity of patient care, if all of the following conditions are met:

(1) The mobile pharmacy or clinic shares common ownership with at least one currently licensed pharmacy or clinic in good standing.

(2) The mobile pharmacy or clinic retains records of dispensing, as required by subdivision (a).

(3) A licensed pharmacist, or, in the case of a clinic, a professional director, is on the premises and the mobile pharmacy is under the control and management of a pharmacist, or, in the case of a clinic, a professional director, while the drugs are being dispensed.

(4) Reasonable security measures are taken to safeguard the drug supply maintained in the mobile pharmacy or clinic.

(5) The mobile pharmacy or clinic is located within the declared emergency area or affected areas.

(6) The mobile pharmacy or clinic ceases the provision of services within 48 hours following the termination of the declared emergency.

(d) Notwithstanding any other law, the board may elect to continue to waive application of any provision of this chapter for up to 90 days following the termination of the declared emergency if, in the board’s opinion, the continued waiver will aid in the protection of the public health or in the provision of patient care.

(e)

(1) A pharmacy that is destroyed or severely damaged as a result of a natural disaster or due to events that led to a declared federal, state, or local emergency, may be relocated. The relocation shall not be considered a transfer of ownership or location under Section 4110, if no changes are made to the management and control, or ownership, of the pharmacy and all applicable laws and regulations are followed. Notification of the relocation shall be provided to the board immediately upon identification of the new location.

(2) For purposes of this section, “severely damaged” means damage that renders the premises unsafe or unfit for entry or occupation.

pharmacist emergency prescription dangerous drugs ...

Section § 4063

This law says that you can't refill a prescription for a dangerous drug or device without the prescriber's approval. This approval can be given when the prescription is first written or later, and can be verbal. Also, prescriptions for controlled substances can't be marked as refillable on an as-needed basis.

No prescription for any dangerous drug or dangerous device may be refilled except upon authorization of the prescriber. The authorization may be given orally or at the time of giving the original prescription. No prescription for any dangerous drug that is a controlled substance may be designated refillable as needed.

dangerous drugs dangerous device prescription refills ...

Section § 4064

This section allows pharmacists to refill prescriptions for dangerous drugs or devices without the prescriber's authorization if they are unavailable to approve it, and if not refilling could harm the patient's health. The pharmacist must try to contact the prescriber, document their actions and judgments, inform the patient and prescriber of the refill, and the prescriber won't be held liable for it. In emergencies, pharmacists or clinics can refill prescriptions even if they can't reach the prescriber.

(a) A prescription for a dangerous drug or dangerous device may be refilled without the prescriber’s authorization if the prescriber is unavailable to authorize the refill and if, in the pharmacist’s professional judgment, failure to refill the prescription might interrupt the patient’s ongoing care and have a significant adverse effect on the patient’s well-being.

(b) The pharmacist shall inform the patient that the prescription was refilled pursuant to this section.

(c) The pharmacist shall inform the prescriber within a reasonable period of time of any refills dispensed pursuant to this section.

(d) Prior to refilling a prescription pursuant to this section, the pharmacist shall make every reasonable effort to contact the prescriber. The pharmacist shall make an appropriate record, including the basis for proceeding under this section.

(e) The prescriber shall not incur any liability as the result of a refilling of a prescription pursuant to this section.

(f) Notwithstanding Section 4060 or any other law, a person may possess a dangerous drug or dangerous device furnished without prescription pursuant to this section.

(g) During a proclaimed state of emergency, nothing in either this section or any other provision of this chapter prohibits a pharmacist, a clinic licensed under Section 4180, or a mobile pharmacy or clinic described in subdivision (c) of Section 4062 from refilling a prescription if the prescriber is unavailable, or if after a reasonable effort has been made, the pharmacist, clinic, or mobile pharmacy is unable to contact the prescriber.

pharmacist refill authorization dangerous drug refill prescriber's unavailability ...

Section § 4064.5

This law allows pharmacists to dispense up to a 90-day supply of certain non-controlled drugs even if a prescription says less, as long as specific conditions like completing a 30-day initial supply and the prescriber not restricting it are met. If it’s the same medication as before, the initial supply requirement is waived. Pharmacists must notify prescribers if they increase the quantity, and prescribers can prevent any increased supply by noting 'No change to quantity.' Additionally, this law permits pharmacists to provide up to a 12-month supply of self-administered hormonal contraceptives upon request, but it doesn't mandate insurance coverage against a patient's plan. Exceptions include psychotropic drugs and anything that could breach another law.

(a) A pharmacist may dispense not more than a 90-day supply of a dangerous drug other than a controlled substance pursuant to a valid prescription that specifies an initial quantity of less than a 90-day supply followed by periodic refills of that amount if all of the following requirements are satisfied:

(1) The patient has completed an initial 30-day supply of the dangerous drug.

(2) The total quantity of dosage units dispensed does not exceed the total quantity of dosage units authorized by the prescriber on the prescription, including refills.

(3) The prescriber has not specified on the prescription that dispensing the prescription in an initial amount followed by periodic refills is medically necessary.

(4) The pharmacist is exercising their professional judgment.

(b) For purposes of this section, if the prescription continues the same medication as previously dispensed in a 90-day supply, the initial 30-day supply under paragraph (1) of subdivision (a) is not required.

(c) A pharmacist dispensing an increased supply of a dangerous drug pursuant to this section shall notify the prescriber of the increase in the quantity of dosage units dispensed.

(d) In no case shall a pharmacist dispense a greater supply of a dangerous drug pursuant to this section if the prescriber personally indicates, either orally or in their own handwriting, “No change to quantity,” or words of similar meaning. Nothing in this subdivision shall prohibit a prescriber from checking a box on a prescription marked “No change to quantity,” provided that the prescriber personally initials the box or checkmark. To indicate that an increased supply shall not be dispensed pursuant to this section for an electronic data transmission prescription as defined in subdivision (c) of Section 4040, a prescriber may indicate “No change to quantity,” or words of similar meaning, in the prescription as transmitted by electronic data, or may check a box marked on the prescription “No change to quantity.” In either instance, it shall not be required that the prohibition on an increased supply be manually initialed by the prescriber.

(e) This section shall not apply to psychotropic medication or psychotropic drugs as described in subdivision (d) of Section 369.5 of the Welfare and Institutions Code.

(f) Except for the provisions of subdivision (d), this section does not apply to FDA-approved, self-administered hormonal contraceptives.

(1) A pharmacist shall dispense, at a patient’s request, up to a 12-month supply of an FDA-approved, self-administered hormonal contraceptive pursuant to a valid prescription that specifies an initial quantity followed by periodic refills.

(2) A pharmacist furnishing an FDA-approved, self-administered prescription-only hormonal contraceptive pursuant to Section 4052.3 under protocols developed by the California State Board of Pharmacy or an over-the-counter contraceptive may furnish, at the patient’s request, up to a 12-month supply at one time.

(3) Nothing in this subdivision shall be construed to require a pharmacist to dispense or furnish a drug if it would result in a violation of Section 733.

(g) Nothing in this section shall be construed to require a health care service plan, health insurer, workers’ compensation insurance plan, pharmacy benefits manager, or any other person or entity, including, but not limited to, a state program or state employer, to provide coverage for a dangerous drug in a manner inconsistent with a beneficiary’s plan benefit.

90-day drug supply prescription refills pharmacist judgment ...

Section § 4065

This section describes rules for a health facility to use an "injection card system" to manage outpatient injections of controlled substances. The card includes detailed information like the drug's name, dosage, and who is receiving and administering it. The facility needs to maintain detailed medical records and have written protocols created by health professionals for using the system. These protocols cover drug identification, safety evaluations, and recordkeeping. The injection card must always remain at the facility and become part of the patient's permanent medical record within 15 days after the last dose. This section does not change rules for injection card systems for non-controlled substances.

(a) “Injection card system,” as used in this section, means a system that enables a facility to authorize an outpatient to receive injections of controlled substances at the facility pursuant to a prior written order by a physician, through the use of a card that is maintained at the location in the facility where the injections are administered.

(1) The injection card shall include, at a minimum, the following information: the date of authorization, the number and frequency of injections authorized, the name of the drug including the strength and amount authorized, the names of the prescribing physician and the patient, the date and time of each injection, and the signature of the person administering the injection.

(2) In addition, the patient’s medical record maintained by the facility shall contain all of the information required under Sections 4040 and 4070 and Chapter 1 (commencing with Section 70001) of Division 5 of Title 22 of the California Code of Regulations.

(b) Notwithstanding any other provision of law, a licensed health care facility may provide for the administration of controlled substances through the use of an injection card system for controlled substances.

(c) A facility that employs an injection card system shall have a written protocol for the use of this system. The protocol shall be developed by a team of health care professionals, including at least one physician, one registered nurse, and one pharmacist. The protocol shall provide for, but not be limited to, the following:

(1) Identification of drugs to be included in the injection card system.

(2) Distinction among classes of drugs.

(3) Periodic review of the efficacy of the injection card system, including, but not limited to, its effectiveness and safety for different classes of drugs.

(4) Determination as to whether each drug included in the injection card system requires the presence of a physician or only the ready availability of a physician.

(5) Implementation of recordkeeping systems that, at a minimum, record each injection and each visit, provide for the immediate entry of the injection in the patient’s medical record, provide a system for discontinuance of the order by the prescribing physician, and allow for ready identification of patterns of possible or actual patient abuse of controlled substances and other potential adverse drug interactions.

(6) Retention of the injection card by the facility at all times when a controlled substance is being administered.

(7) Adequate initial evaluation of patients, including, but not limited to, a determination as to whether each patient is a proper subject for the injection card system.

(8) Ongoing medical evaluation of the patient’s response to the injection card system.

(9) That all injection cards shall become a permanent part of the patient’s medical record within 15 days from the date the last authorized dose is administered.

(d) Nothing in this section shall be construed to prohibit the use, or impose new requirements on the use, of an injection card system for noncontrolled substances.

injection card system controlled substances outpatient injections ...

Section § 4066

This law says that a wholesaler or pharmacy can provide dangerous drugs to the master or first officer of a ship if they have a written prescription. The request has to be on the ship's official letterhead and signed by the first officer. These drugs are to be kept on the ship and used according to procedures set by a medical officer. The drugs must be in sealed containers and given to the first officer with proper identification, or delivered directly to the ship. Wholesalers or pharmacies doing this must inform the relevant board within 30 days. If the drugs are controlled substances, they must follow specific federal rules.

(a) Notwithstanding Section 4059, a wholesaler or pharmacy may furnish dangerous drugs to the master or first officer of an ocean vessel, pursuant to a written prescription. The requisition shall be on the vessel’s official stationery, signed by the vessel’s first officer. The drugs shall be maintained on board the vessel and dispensed from medicine chests, first aid packets, or dispensaries, pursuant to standardized procedures established by a registered medical officer.

(b) Dangerous drugs shall be furnished in a sealed container to the vessel’s first officer, on proper identification, or delivered aboard the vessel.

(c) Wholesalers or pharmacies engaging in the activities authorized by this section shall give notice to the board within 30 days of undertaking the activity.

(d) Distribution of controlled substances shall be in accordance with federal requirements contained in Section 1301.28 of Title 21 of the Code of Federal Regulations.

dangerous drugs ocean vessel written prescription ...

Section § 4067

This law makes it illegal to dispense prescription drugs or medical devices over the internet to people in California unless there's been a proper medical examination beforehand. If someone breaks this rule, they might have to pay a hefty fine of up to $25,000 for each time they do it. The Attorney General can take action to enforce these penalties. If the fines are not paid, the state can take the money from things like tax refunds or lottery winnings. This law also emphasizes that you cannot practice pharmacy without a license and does not limit other regulations the board may enforce.

(a) No person or entity shall dispense or furnish, or cause to be dispensed or furnished, dangerous drugs or dangerous devices, as defined in Section 4022, on the internet for delivery to any person in this state without a prescription issued pursuant to a good faith prior examination of a human or animal for whom the prescription is meant if the person or entity either knew or reasonably should have known that the prescription was not issued pursuant to a good faith prior examination of a human or animal, or if the person or entity did not act in accordance with Section 1761 of Title 16 of the California Code of Regulations.

(b) Notwithstanding any other provision of law, a violation of this section may subject the person or entity that has committed the violation to either a fine of up to twenty-five thousand dollars ($25,000) per occurrence pursuant to a citation issued by the board or a civil penalty of twenty-five thousand dollars ($25,000) per occurrence.

(c) The Attorney General may bring an action to enforce this section and to collect the fines or civil penalties authorized by subdivision (b).

(d) For notifications made on and after January 1, 2002, the Franchise Tax Board, upon notification by the Attorney General or the board of a final judgment in an action brought under this section, shall subtract the amount of the fine or awarded civil penalties from any tax refunds or lottery winnings due to the person who is a defendant in the action using the offset authority under Section 12419.5 of the Government Code, as delegated by the Controller, and the processes as established by the Franchise Tax Board for this purpose. That amount shall be forwarded to the board for deposit in the Pharmacy Board Contingent Fund.

(e) Nothing in this section shall be construed to permit the unlicensed practice of pharmacy, or to limit the authority of the board to enforce any other provision of this chapter.

(f) For the purposes of this section, “good faith prior examination” includes the requirements for a physician and surgeon in Section 2242 and the requirements for a veterinarian in Section 4826.6.

internet prescription dangerous drugs dangerous devices ...

Section § 4068

This law allows doctors to give emergency room patients certain dangerous drugs, including controlled substances, even when the hospital pharmacy is closed. To do this, the hospital must already have the drug, a pharmacist isn't available on-site, and the doctor records the dispensing details for the pharmacy to review later. If the drug is a controlled substance, details must also be reported to the Department of Justice. The doctor can only prescribe enough medication to last until an outside pharmacy is accessible, and it's capped at a 72-hour supply. The medication must have a proper label, and the doctor is responsible for any mistakes made in this process.

(a) Notwithstanding any provision of this chapter, a prescriber may dispense a dangerous drug, including a controlled substance, to an emergency room patient if all of the following apply:

(1) The hospital pharmacy is closed and there is no pharmacist available in the hospital.

(2) The dangerous drug is acquired by the hospital pharmacy.

(3) The dispensing information is recorded and provided to the pharmacy when the pharmacy reopens.

(4) The hospital pharmacy retains the dispensing information and, if the drug is a schedule II, schedule III, or schedule IV controlled substance, reports the dispensing information to the Department of Justice pursuant to Section 11165 of the Health and Safety Code.

(5) The prescriber determines that it is in the best interest of the patient that a particular drug regimen be immediately commenced or continued, and the prescriber reasonably believes that a pharmacy located outside the hospital is not available and accessible at the time of dispensing to the patient.

(6) The quantity of drugs dispensed to any patient pursuant to this section are limited to that amount necessary to maintain uninterrupted therapy during the period when pharmacy services outside the hospital are not readily available or accessible, but shall not exceed a 72-hour supply.

(7) The prescriber shall ensure that the label on the drug contains all the information required by Section 4076.

(b) The prescriber shall be responsible for any error or omission related to the drugs dispensed.

emergency room dispensing hospital pharmacy closure controlled substances ...

Section § 4069

If a pharmacist provides a prescription drug for a pet based on a veterinarian's instructions, they must offer the pet owner or representative documentation that is specifically made for veterinary use.

A pharmacist who dispenses or furnishes a dangerous drug, as defined in Section 4022, pursuant to a veterinary prescription shall include, as part of the consultation, the option for a representative of an animal patient to also receive drug documentation specifically designed for veterinary drugs.

pharmacist veterinary prescription dangerous drug ...

Pharmacy

PharmacyScope of Practice and Exemptions

Section § 4050

Section § 4051

Section § 4052

Section § 4052.01

Section § 4052.1

Section § 4052.02

Section § 4052.2

Section § 4052.03

Section § 4052.3

Section § 4052.04

Section § 4052.4

Section § 4052.05

Section § 4052.5

Section § 4052.6

Section § 4052.7

Section § 4052.8

Section § 4052.9

Section § 4052.10

Section § 4053

Section § 4053.1

Section § 4053.2

Section § 4054

Section § 4055

Section § 4056

Section § 4057

Section § 4058

Section § 4059

Section § 4059.5

Section § 4060

Section § 4061

Section § 4062

Section § 4063

Section § 4064

Section § 4064.5

Section § 4065

Section § 4066

Section § 4067

Section § 4068

Section § 4069

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