2022 LAWBOOK FOR PHARMACY

hospital, as a maternity hospital, or as a tuberculosis hospital, but

does not include a sanitarium, rest home, a nursing or

convalescent home, a maternity home, or an institution for

treating alcoholics.

4029. Hospital Pharmacy

(a) "Hospital pharmacy" means and includes a pharmacy,

licensed by the board, located within any licensed hospital,

institution, or establishment that maintains and operates

organized facilities for the diagnosis, care, and treatment of

human illnesses to which persons may be admitted for overnight

stay and that meets all of the requirements of this chapter and

the rules and regulations of the board.

(b) A hospital pharmacy may include a pharmacy that is located

in any physical plant that is regulated under the license of a

general acute care hospital as defined in subdivision (a) of

Section 1250 of the Health and Safety Code. As a condition of

licensure by the board, the pharmacy in another physical plant

shall provide pharmaceutical services only to registered hospital

patients who are on the premises of the same physical plant in

which the pharmacy is located, except as provided in Article 7.6

(commencing with Section 4128). The pharmacy services

provided shall be directly related to the services or treatment

plan administered in the physical plant. Nothing in this

subdivision shall be construed to restrict or expand the services

that a hospital pharmacy may provide.

licensed by the board to perform sterile compounding that is

separately licensed by the board pursuant to Section 4127.15 to

perform that compounding and is located outside of the hospital

in another physical plant that is regulated as a general acute care

hospital as defined in subdivision (a) of Section 1250 of the

Health and Safety Code.

4030. Intern Pharmacist

"Intern pharmacist" means a person issued a license pursuant to

Section 4208.

4031. Laboratory

"Laboratory" means a research, teaching, or testing laboratory

not engaged in the dispensing or furnishing of drugs or devices

but using dangerous drugs or dangerous devices for scientific or

teaching purposes. Every laboratory shall maintain an

established place of business and keep purchase records. Every

laboratory shall be subject to the jurisdiction of the board.

4032. License

"License" means and includes any license, permit, registration,

certificate, or exemption issued by the board and includes the

process of applying for and renewing the same.

4033. Manufacturer

(a) (1) "Manufacturer" means and includes every person who

prepares, derives, produces, compounds, or repackages any drug

or device except a pharmacy that manufactures on the

immediate premises where the drug or device is sold to the

ultimate consumer.

(2) Notwithstanding paragraph (1), "manufacturer" shall not

mean a pharmacy compounding a drug for parenteral therapy,

pursuant to a prescription, for delivery to another pharmacy for

the purpose of delivering or administering the drug to the patient

or patients named in the prescription, provided that neither the

components for the drug nor the drug are compounded,

fabricated, packaged, or otherwise prepared prior to receipt of

the prescription.

(3) Notwithstanding paragraph (1), "manufacturer" shall not

mean a pharmacy that, at a patient's request, repackages a drug

previously dispensed to the patient, or to the patient's agent,

pursuant to a prescription.

(b) Notwithstanding subdivision (a), as used in Sections 4034,

4163, 4163.1, 4163.2, 4163.3, 4163.4, and 4163.5,

"manufacturer" means a person who prepares, derives,

manufactures, produces, or repackages a dangerous drug, as

defined in Section 4022, device, or cosmetic. Manufacturer also

means the holder or holders of a New Drug Application (NDA), an

Abbreviated New Drug Application (ANDA), or a Biologics License

Application (BLA), provided that such application has been

approved; a manufacturer's third party logistics provider; a

private label distributor (including colicensed partners) for whom

the private label distributor's prescription drugs are originally

manufactured and labeled for the distributor and have not been

repackaged; or the distributor agent for the manufacturer,

contract manufacturer, or private label distributor, whether the

establishment is a member of the manufacturer's affiliated group

(regardless of whether the member takes title to the drug) or is a

contract distributor site.

4034. Outsourcing Facility

“Outsourcing facility” means a facility that meets all of the

following:

(a) Is located within the United States of America at one address

that is engaged in the compounding of sterile drugs and

nonsterile drugs.

(b) Has registered as an outsourcing facility with the federal

Food and Drug Administration under Section 503B of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 353b).

(d) Is licensed with the board as an outsourcing facility pursuant

to Article 7.7 (commencing with Section 4129).

4034.5. Emergency Medical Service Automated Drug Delivery

System

An “emergency medical services automated drug delivery

system” or “EMSADDS” means an automated drug delivery

system that stores and distributes drugs for the sole purpose of

restocking a secured emergency pharmaceutical supplies

container that is used by an emergency medical services agency

to provide emergency medical services.

4035. Person

“Person” includes, but is not limited to, firm, association,

partnership, corporation, limited liability company, state

governmental agency, trust, or political subdivision.

4036. Pharmacist

"Pharmacist" means a natural person to whom a license has

been issued by the board, under Section 4200, except as

specifically provided otherwise in this chapter. The holder of an

unexpired and active pharmacist license issued by the board is

entitled to practice pharmacy as defined by this chapter, within

or outside of a licensed pharmacy as authorized by this chapter.

4036.5. Pharmacist-in-Charge

“Pharmacist-in-charge” means a pharmacist proposed by a

pharmacy and approved by the board as the supervisor or

manager responsible for ensuring the pharmacy’s compliance

with all state and federal laws and regulations pertaining to the

practice of pharmacy.

4037. Pharmacy

(a) "Pharmacy" means an area, place, or premises licensed by

the board in which the profession of pharmacy is practiced and

where prescriptions are compounded. "Pharmacy" includes, but

is not limited to, any area, place, or premises described in a

license issued by the board wherein controlled substances,

dangerous drugs, or dangerous devices are stored, possessed,

prepared, manufactured, derived, compounded, or repackaged,

and from which the controlled substances, dangerous drugs, or

dangerous devices are furnished, sold, or dispensed at retail.

(b) "Pharmacy" shall not include any area in a facility licensed by

the State Department of Public Health where floor supplies,

ward supplies, operating room supplies, or emergency room

supplies of dangerous drugs or dangerous devices are stored or

possessed solely for treatment of patients registered for

treatment in the facility or for treatment of patients receiving

emergency care in the facility.

4038. Pharmacy Technician

(a) "Pharmacy technician" means an individual who assists a

pharmacist in a pharmacy in the performance of his or her

pharmacy related duties, as specified in Section 4115.

(b) A "pharmacy technician trainee" is a person who is enrolled

in a pharmacy technician training program operated by a

California public postsecondary education institution or by a

private postsecondary vocational institution approved by the

Bureau for Private Postsecondary and Vocational Education.

4039. Physician; Other Practitioners Defined

“Physicians,” “dentists,” “optometrists,” “pharmacists,” “doctors

of podiatric medicine,” “veterinarians,” “veterinary surgeons,”

“registered nurses,” “naturopathic doctors,” and “physician

assistants” are persons authorized by a currently valid and

unrevoked license to practice their respective professions in this

state. “Physician” means and includes any person holding a valid

and unrevoked physician’s and surgeon’s certificate or certificate

to practice medicine and surgery, issued by the Medical Board of

California or the Osteopathic Medical Board of California, and

includes an unlicensed person lawfully practicing medicine

pursuant to Section 2065, when acting within the scope of that

section.

4040. Prescription; Content Requirements

(a) “Prescription” means an oral, written, or electronic

transmission order that is both of the following:

(1) Given individually for the person or persons for whom

ordered that includes all of the following:

(A) The name or names and address of the patient or patients.

(B) The name and quantity of the drug or device prescribed and

the directions for use.

(D) Either rubber stamped, typed, or printed by hand or typeset,

the name, address, and telephone number of the prescriber, the

prescriber’s license classification, and the prescriber’s federal

registry number, if a controlled substance is prescribed.

(E) A legible, clear notice of the condition or purpose for which

the drug is being prescribed, if requested by the patient or

patients.

(F) If in writing, signed by the prescriber issuing the order, or the

certified nurse-midwife, nurse practitioner, physician assistant, or

naturopathic doctor who issues a drug order pursuant to Section

2746.51, 2836.1, 3502.1, or 3640.5, respectively, or the

pharmacist who issues a drug order pursuant to Section 4052.1,

4052.2, or 4052.6.

(2) Issued by a physician, dentist, optometrist, doctor of

podiatric medicine, veterinarian, or naturopathic doctor pursuant

to Section 3640.7 or, if a drug order is issued pursuant to Section

2746.51, 2836.1, 3502.1, or 3460.5, by a certified nurse-midwife,

nurse practitioner, physician assistant, or naturopathic doctor

licensed in this state, or pursuant to Section 4052.1, 4052.2, or

4052.6 by a pharmacist licensed in this state.

(b) Notwithstanding subdivision (a), a written order of the

prescriber for a dangerous drug, except for any Schedule II

controlled substance, that contains at least the name and

signature of the prescriber, the name and address of the patient

in a manner consistent with paragraph (2) of subdivision (a) of

Section 11164 of the Health and Safety Code, the name and

quantity of the drug prescribed, directions for use, and the date

of issue may be treated as a prescription by the dispensing

pharmacist as long as any additional information required by

subdivision (a) is readily retrievable in the pharmacy. In the event

of a conflict between this subdivision and Section 11164 of the

Health and Safety Code, Section 11164 of the Health and Safety

Code shall prevail.

and data prescriptions. “Electronic image transmission

prescription” means any prescription order for which a facsimile

of the order is received by a pharmacy from a licensed prescriber.

“Electronic data transmission prescription” means any

prescription order, other than an electronic image transmission

prescription, that is electronically transmitted from a licensed

prescriber to a pharmacy.

(d) The use of commonly used abbreviations shall not invalidate

an otherwise valid prescription.

4040.5. Reverse Distributor

“Reverse distributor” means every person who acts as an agent

for pharmacies, drug wholesalers, third-party logistics providers,

manufacturers, and other entities by receiving, inventorying,

warehousing, and managing the disposition of outdated or

nonsaleable dangerous drugs or dangerous devices.

4041. Veterinary Food-Animal Drug Retailer

"Veterinary food-animal drug retailer" is an area, place, or

premises, other than a pharmacy, that holds a valid license from

the Board of Pharmacy of the State of California as a wholesaler

and, in and from which veterinary drugs for food-producing

animals are dispensed pursuant to a prescription from a licensed

veterinarian. "Veterinary food-animal retailer" includes, but is

not limited to, any area, place, or premises described in a permit

issued by the board wherein veterinary food-animal drugs, as

defined in Section 4042, are stored, possessed, or repackaged,

and from which veterinary drugs are furnished, sold, or

dispensed at retail pursuant to a prescription from a licensed

veterinarian.

4042. Veterinary Food-Animal Drugs

"Veterinary food-animal drugs" as used in this chapter shall

include the following:

(a) Any drug to be used in food-producing animals bearing the

legend, "Caution, federal law restricts this drug to use by or on

the order of a licensed veterinarian" or words of similar import.

(b) Any other drug as defined in Section 14206 of the Food and

Agricultural Code that is used in a manner that would require a

veterinary prescription.

4043. Wholesaler

“Wholesaler” means and includes a person who acts as a

wholesale merchant, broker, jobber, customs broker, reverse

distributor, agent, or a nonresident wholesaler, who sells for

resale, or negotiates for distribution, or takes possession of, any

drug or device included in Section 4022. Unless otherwise

authorized by law, a wholesaler may not store, warehouse, or

authorize the storage or warehousing of drugs with any person or

at any location not licensed by the board.

4044. Repackager

"Repackager" means a person or entity that is registered with

the federal Food and Drug Administration as a repackager and

operates an establishment that packages finished drugs from

bulk or that repackages dangerous drugs into different

containers, excluding shipping containers.

4044.3. Remote Dispensing Site Pharmacy

(a) “Remote dispensing site pharmacy” means a licensed

pharmacy located in this state that is exclusively overseen and

operated by a supervising pharmacy and staffed by one or more

qualified registered pharmacy technicians, as defined in Section

4132, where pharmaceutical care services, including, but not

limited to, the storage and dispensing of prescription drugs and

controlled substances, drug regimen review, and patient

counseling, are remotely monitored or provided, or both, by a

licensed pharmacist through the use of telepharmacy technology.

(b) Unless otherwise specified in this chapter, a remote

dispensing site pharmacy shall comply with all state and federal

laws regulating the practice of pharmacy.

4044.5. Reverse Third-Party Logistics Provider

“Reverse third-party logistics provider” means an entity that

processes or manages the disposition of an outdated or

nonsaleable dangerous drug or dangerous device on behalf of a

manufacturer, wholesaler, or dispenser of the dangerous drug or

dangerous device, but does not take ownership of the dangerous

drug or dangerous device nor have the responsibility to direct its

sale or disposition. Unless otherwise specified in this chapter,

every provision of this chapter that applies to a third-party

logistics provider shall also apply to a reverse third-party logistics

provider.

4044.6. Supervising Pharmacy

(a) “Supervising pharmacy” means a licensed pharmacy located

in this state that is owned and operated by a person or persons

where the majority of the beneficial interest in, as well as the

management and control, resides with at least one board-

licensed pharmacist, as defined in Section 4036, that exclusively

oversees the operations of a remote dispensing site pharmacy.

(b) A supervising pharmacy shall be exclusively responsible for

the operation of the remote dispensing site pharmacy and its

employees pursuant to Section 4131.

4044.7. Telepharmacy

“Telepharmacy” means a system that is used by a supervising

pharmacy for the purpose of monitoring the dispensing of

prescription drugs by a remote dispensing site pharmacy and

provides for related drug regimen review and patient counseling

by an electronic method, including, but not limited to, the use of

audio, visual, still image capture, and store and forward

technology.

4045. Third-Party Logistics Provider

“Third-party logistics provider” means an entity that provides or

coordinates warehousing or other logistics services for a

dangerous drug or dangerous device in intrastate or interstate

commerce on behalf of a manufacturer, wholesaler, or dispenser

of the dangerous drug or dangerous device, but does not take

ownership of the dangerous drug or dangerous device, nor have

responsibility to direct its sale or disposition.

4046. Surplus Medication Collection and Distribution

Intermediary

“Surplus medication collection and distribution intermediary”

means a firm, association, partnership, corporation, limited

liability company, state governmental agency, or political

subdivision that performs the functions specified in Section

4169.5 for the purpose of a program established pursuant to

Division 116 (commencing with section 150200) of the Health

and Safety Code.

Article 3. Scope of Practice and Exemptions

4050. Legislative Declaration

(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.

care providers who have the authority to provide health care

services.

4051. Conduct Limited to Pharmacist; Conduct Authorized by

Pharmacist

(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.

4052. Furnishing to Prescriber; Permitted Procedures by

Pharmacist

(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 and self-

administered 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.

law relating to either of the following:

(1) Maintaining the confidentiality of medical records.

(2) The licensing of a health care facility.

4052.01. Furnishing of Naloxone Hydrochloride; Permitted

Procedures by Pharmacist

(a) Notwithstanding any other provision of law, a pharmacist

may furnish naloxone hydrochloride 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

naloxone hydrochloride, 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 naloxone hydrochloride 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.

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 naloxone

hydrochloride.

(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).

4052.02. Initiating and Furnishing of HIV Preexposure

Prophylaxis by Pharmacist

(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 fixed-dose combination of tenofovir disoproxil fumarate

(TDF) (300 mg) with emtricitabine (FTC) (200 mg), or another

drug or drug combination determined by the board to meet the

same clinical eligibility recommendations provided in CDC

guidelines.

“2017 Preexposure Prophylaxis for the Prevention of HIV

Infection in the United States-2017 Update: A Clinical Practice

Guideline,” or any subsequent guidelines, 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 shall furnish at least a 30-day supply, and up to

a 60-day supply, 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 within the previous seven days from an

HIV antigen/antibody test or antibody-only test or from a rapid,

point-of-care fingerstick blood test approved by the federal Food

and Drug Administration. 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 child-bearing capacity.

The pharmacist shall notify the patient that the patient must be

seen by a primary care provider to receive subsequent

prescriptions for preexposure prophylaxis and that a pharmacist

may not furnish a 60-day supply of preexposure prophylaxis to a

single patient more than once every two years.

(5) 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.

(6) The pharmacist does not furnish more than a 60-day supply

of preexposure prophylaxis to a single patient more than once

every two years, unless directed otherwise by a prescriber.

(7) 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 physicians and

surgeons, clinics, or other health care service providers to

contact regarding ongoing care for preexposure prophylaxis.

(f) 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.

(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.

4052.03. Initiating and Furnishing of HIV Postexposure

Prophylaxis by Pharmacist

(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.

“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.

4052.1. Permitted Pharmacist Procedures in Licensed Health

Care Facility

(a) Notwithstanding any other provision of law, a pharmacist

may perform the following procedures or functions in a licensed

health care facility in accordance with policies, procedures, or

protocols developed by health professionals, including

physicians, pharmacists, and registered nurses, with the

concurrence of the facility administrator:

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

assessment procedures including temperature, pulse, and

respiration.

(2) Ordering drug therapy-related laboratory tests.

(3) Administering drugs and biologicals by injection pursuant to

a prescriber's order.

(4) Initiating or adjusting the drug regimen of a patient pursuant

to an order or authorization made by the patient's prescriber and

in accordance with the policies, procedures, or protocols of the

licensed health care facility.

(b) Prior to performing any procedure authorized by this

section, a pharmacist shall have received appropriate training as

prescribed in the policies and procedures of the licensed health

care facility.

4052.2. Permitted Pharmacist Procedures in Health Care

Facility; Home Health Agency or Clinic with Physician Oversight

(a) Notwithstanding any other provision of 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 center, a licensed clinic in which

there is a 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.

subdivision shall be developed by health care professionals,

including physicians, pharmacists, and registered nurses, and

shall, at a minimum, do all of the following:

(1) Require that the pharmacist function as part of a

multidisciplinary group that includes physicians and direct care

registered nurses. The multidisciplinary group shall determine

the appropriate participation of the pharmacist and the direct

care registered nurse.

(2) Require that the medical records of the patient be available

to both the patient's treating prescriber and the pharmacist.

(3) Require that the procedures to be performed by the

pharmacist relate to a condition for which the patient has first

been seen by a physician.

(4) Except for procedures or functions provided by a health care

facility, a licensed correctional clinic, as defined in Section 4187, a

licensed clinic in which there is physician oversight, or a provider

who contracts with a licensed health care plan with regard to the

care or services provided to the enrollees of that health care

service plan, require the procedures to be performed in

accordance with a written, patient-specific protocol approved by

the treating or supervising physician. Any change, adjustment, or

modification of an approved preexisting treatment or drug

therapy shall be provided in writing to the treating or supervising

physician within 24 hours.

(d) Prior to performing any procedure authorized by this

section, a pharmacist shall have done either of the following:

(1) Successfully completed clinical residency training.

(2) Demonstrated clinical experience in direct patient care

delivery.

4052.3. Emergency Contraception Drug Therapy; Requirements

and Limitations

(a) (1) Notwithstanding any other law, a pharmacist may furnish

self-administered 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 his

or her 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.

administered 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.

4052.4. Conditions Permitting Pharmacists to Perform Skin

Puncture and CLIA-Waived Tests

(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) Cardiovascular health.

(vii) Conjunctivitis.

(viii) Urinary tract infection.

(ix) Liver and kidney function or infection.

(x) Thyroid function.

(xi) Substance use disorder.

(xii) Diabetes.

(B) Other tests classified as waived under the federal Clinical

Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec.

263a) and the regulations adopted thereunder by the federal

Health Care Financing Administration and approved by the board

by regulation, in conjunction with the Medical Board of California

and Laboratory Field Services in the State Department of Public

Health.

(2) The pharmacist completes the testing in a pharmacy

laboratory that is appropriately licensed in California as a

laboratory pursuant to Section 1265, unless otherwise authorized

in law.

(3) The pharmacist has completed necessary training as

specified in the pharmacy’s policies and procedures maintained

pursuant to subdivision (b) of Section 4119.10, and that allows

the pharmacist to demonstrate sufficient knowledge of the

illness, condition, or disease being tested, as applicable.

4052.5. Pharmacist May Select Different Form of Medication

with Same Active Chemical Ingredients

(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.

the pharmacist, except as provided in subdivision (b). The

pharmacist who selects the drug product to be dispensed

pursuant to this section shall assume the same responsibility for

selecting the dispensed drug product as would be incurred in

filling a prescription for a drug product using the prescribed form

of medication. There shall be no liability on the prescriber for an

act or omission by a pharmacist in selecting, preparing, or

dispensing a drug product pursuant to this section.

(d) This section shall apply to all prescriptions, including those

presented by or on behalf of persons receiving assistance from

the federal government or pursuant to the California Medical

Assistance Program set forth in Chapter 7 (commencing with

Section 14000) of Part 3 of Division 9 of the Welfare and

Institutions Code.

(e) When a substitution is made pursuant to this section, the

use of the different form of medication shall be communicated to

the patient, and the name of the dispensed drug product shall be

indicated on the prescription label, unless the prescriber orders

otherwise.

(f) This section shall not permit substitution between long-

acting and short-acting forms of a medication with the same

chemical ingredients or between one drug product and two or

more drug products with the same chemical ingredients.

4052.6. Advanced Practice Pharmacist; Permitted Procedures

(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.

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.

4052.7. Repackage Previously Dispensed Drug; Requirements

(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.

dispensed the drug shall only be liable for its own actions in

providing the drug to the patient or the patient's agent.

4052.8. Initiation and Administration of Vaccines;

Requirements

(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.

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.

4052.9. Pharmacist Furnishing Nicotine Replacement Products;

Requirements

(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.

4052.10. Partial Fills of Schedule II Controlled Substance

(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.

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.

4053. Designated Representative to Supervise Wholesaler or

Veterinary Food-Animal Drug Retailer

(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.

(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.

not operate without a pharmacist or a designated representative

on its premises.

(d) Only a pharmacist or a designated representative shall

prepare and affix the label to veterinary food-animal drugs.

(e) Section 4051 shall not apply to any laboratory licensed under

Section 351 of Title III of the Public Health Service Act (Public Law

78-410).

4053.1. Designated Representative 3-PL to Supervise Third-

Party Logistics Provider

(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.

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.

representative-3PL until the applicant provides proof of

completion of the training required by this paragraph to the

board.

least one designated representative-3PL present at each of its

licensed places of business as required under Section 4160.

4053.2. Designated Representative-Reverse Distributor -

Licensing; Requirements

(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) He or she shall be a high school graduate or possess a

general education development certificate equivalent.

(2) He or she 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.

required for licensure as a pharmacist by the board.

(3) (A) He or she 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.

representative-reverse distributor until the applicant provides

proof of completion of the training required by this paragraph to

the board.

designated representative or designated representative-reverse

distributor present at each of its licensed places of business as

required under Section 4160.

4054. Supply by Manufacturer, etc. of Certain Dialysis Drugs

and Devices

Section 4051 shall not apply to a manufacturer or wholesaler

that provides dialysis drugs and devices directly to patients.

4055. Sale of Devices to Licensed Clinics, etc.

Nothing in this chapter, nor any other law, shall prohibit the sale

of devices to clinics that have been issued a clinic license

pursuant to Article 13 (commencing with Section 4180) of this

chapter, or to skilled nursing facilities or intermediate care

facilities licensed pursuant to Chapter 2 (commencing with

Section 1250) of, or to home health agencies licensed pursuant to

Chapter 8 (commencing with Section 1725) of, or to hospices

licensed pursuant to Chapter 8.5 (commencing with Section

1745) of, Division 2 of, the Health and Safety Code, as long as the

devices are furnished only upon the prescription or order of a

physician, dentist, or podiatrist.

4056. Purchase of Drugs at Wholesale - Hospital Containing

100 Beds or Less

(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.

made on a form furnished by the board. Upon the filing of the

application and payment of the fee prescribed in subdivision (a)

of Section 4400, the executive officer of the board shall issue a

license authorizing the hospital to which it is issued to purchase

drugs at wholesale pursuant to subdivision (a). The license shall

be renewed annually on or before November 1 of each year upon

payment of the renewal fee prescribed in subdivision (b) of

Section 4400 and shall not be transferable.

(d) The form of application for a license under this section shall

contain the name and address of the applicant, the number of

beds, whether the applicant is a licensed hospital, whether it

does or does not employ a full-time pharmacist, the name of its

chief medical officer, and the name of its administrator.

(e) The board may deny, revoke, or suspend a license issued

under this section in the manner and for the grounds specified in

Article 19 (commencing with Section 4300).

(f) A physician himself or herself may dispense drugs to

outpatients directly pursuant to subdivision (a) only if the

physician determines that it is in the best interest of the patient

that a particular drug regimen be immediately commenced or

continued, and the physician reasonably believes that a

pharmacy located outside the hospital is not available and

accessible at the time of dispensation to the patient within 30

minutes of the hospital pharmaceutical services or within a 30-

mile radius from the hospital pharmaceutical services by means

of the method of transportation the patient states that he or she

intends to use. The quantity of drugs dispensed to any

outpatient pursuant to this subdivision shall be limited to that

amount necessary to maintain uninterrupted therapy during the

period when pharmaceutical services outside the hospital are not

readily available or accessible, but shall not exceed a 72-hour

supply. The physician shall ensure that the label on the drug

contains all the information required by Section 4076.

(g) A rural hospital, as defined in Section 124840 of the Health

and Safety Code, shall obtain information regarding the hours of

operation of each pharmacy located within the 30 minute or 30-

mile radius of the hospital. The hospital shall update this

information annually, and shall make this information available

to its medical staff.

(h) A licensed hospital that contains 100 beds or fewer, does not

employ a full-time pharmacist, and purchases drugs at wholesale

for administration or dispensation pursuant to subdivision (a),

shall retain the services of a pharmacist consultant to monitor

and review the pharmaceutical services provided by the hospital

to inpatients of the hospital, and the dispensing of drugs by

physicians to outpatients pursuant to subdivision (f).

(i) This section shall not be construed to eliminate the

requirements of Section 11164 or 11167 of the Health and Safety

Code.

4057. Exceptions to Application of this Chapter

(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).

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.

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