BUSINESS AND PROFESSIONS CODE
SECTION 4050-4067
4050. (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.
4051. (a) Except as otherwise provided in this chapter, it is
unlawful for any person to manufacture, compound, furnish, sell, or
dispense any dangerous drug or dangerous device, or to dispense or
compound any 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, and otherwise
provide clinical advice or information or patient consultation if
all of the following conditions are met:
(1) The clinical advice or 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. (a) Notwithstanding any other provision of law, a pharmacist
may:
(1) Furnish a reasonable quantity of compounded medication to a
prescriber for office use by the prescriber.
(2) Transmit a valid prescription to another pharmacist.
(3) Administer, orally or topically, drugs and biologicals
pursuant to a prescriber's order.
(4) 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:
(A) Ordering or performing routine drug therapy-related patient
assessment procedures including temperature, pulse, and respiration.
(B) Ordering drug therapy-related laboratory tests.
(C) Administering drugs and biologicals by injection pursuant to a
prescriber's order (the administration of immunizations under the
supervision of a prescriber may also be performed outside of a
licensed health care facility).
(D) 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.
(5) (A) Perform the following 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 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, as
applicable, with policies, procedures, or protocols of that facility,
the home health agency, the licensed clinic, the health care service
plan, or that physician, in accordance with subparagraph (C):
(i) Ordering or performing routine drug therapy-related patient
assessment procedures including temperature, pulse, and respiration.
(ii) Ordering drug therapy-related laboratory tests.
(iii) Administering drugs and biologicals by injection pursuant to
a prescriber's order (the administration of immunizations under the
supervision of a prescriber may also be performed outside of a
licensed health care facility).
(iv) Initiating or adjusting the drug regimen of a patient
pursuant to a specific written order or authorization made by the
patient's prescriber for the individual patient, and in accordance
with the policies, procedures, or protocols of the health care
facility, home health agency, 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 prescriber, or enter the appropriate information in an
electronic patient record system shared by the prescriber, of any
drug regimen initiated pursuant to this clause within 24 hours.
(B) A patient's 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
paragraph shall be developed by health care professionals, including
physicians, pharmacists, and registered nurses, and, at a minimum,
meet all of the following requirements:
(i) 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.
(ii) Require that the medical records of the patient be available
to both the patient's prescriber and the pharmacist.
(iii) 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.
(iv) Except for procedures or functions provided by a health care
facility, 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.
(6) 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.
(7) Provide consultation to patients and professional information,
including clinical or pharmacological information, advice, or
consultation to other health care professionals.
(8) Initiate emergency contraception drug therapy in accordance
with standardized procedures or protocols developed by the pharmacist
and an authorized prescriber who is acting within his or her scope
of practice. Prior to performing any procedure authorized under this
paragraph, a pharmacist shall have completed a training program on
emergency contraception, which includes, but is not limited to,
conduct of sensitive communications, quality assurance, referral to
additional services, and documentation.
(b) (1) Prior to performing any procedure authorized by paragraph
(4) of subdivision (a), a pharmacist shall have received appropriate
training as prescribed in the policies and procedures of the licensed
health care facility.
(2) Prior to performing any procedure authorized by paragraph (5)
of subdivision (a), a pharmacist shall have either (1) successfully
completed clinical residency training or (2) demonstrated clinical
experience in direct patient care delivery.
(3) For each emergency contraception drug therapy initiated
pursuant to paragraph (8) of subdivision (a), the pharmacist shall
provide the recipient of the emergency contraception drugs with a
standardized fact sheet that includes, but is not limited to, the
indications 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 Health Services, the American College of
Obstetricians and Gynecologists, the California Pharmacists
Association, and other health care organizations. The provisions of
this section do not preclude the use of existing publications
developed by nationally recognized medical organizations.
(c) Nothing in this section shall affect the requirements of
existing law relating to maintaining the confidentiality of medical
records.
(d) Nothing in this section shall affect the requirements of
existing law relating to the licensing of a health care facility.
4052.1. 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. For purposes of this
section, "routine patient assessment procedures" means: (a)
procedures that a patient could, with or without a prescription,
perform for himself or herself, 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. 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.
4052.5. (a) In addition to the authority allowed under Section
4073, a pharmacist filling a prescription order for a drug product
may select a different form of medication with the same active
chemical ingredients of equivalent strength and duration of therapy
as the prescribed drug product when the change will improve the
ability of the patient to comply with the prescribed drug therapy.
(b) In no case shall a selection be made pursuant to this section
if the prescriber personally indicates, either orally or in his or
her own handwriting, "Do not substitute" or words of similar meaning.
Nothing in this subdivision shall prohibit a prescriber from
checking a box on a prescription marked "Do not substitute" if the
prescriber personally initials the box or checkmark.
(c) Selection pursuant to this section is within the discretion of
the pharmacist, except as provided in subdivision (b). The
pharmacist who selects the drug product to be dispensed pursuant to
this section shall assume the same responsibility for selecting the
dispensed drug product as would be incurred in filling a prescription
for a drug product using the prescribed form of medication. There
shall be no liability on the prescriber for an act or omission by a
pharmacist in selecting, preparing, or dispensing a drug product
pursuant to this section.
(d) This section shall apply to all prescriptions, including those
presented by or on behalf of persons receiving assistance from the
federal government or pursuant to the California Medical Assistance
Program set forth in Chapter 7 (commencing with Section 14000) of
Part 3 of Division 9 of the Welfare and Institutions Code.
(e) When a substitution is made pursuant to this section, the use
of the different form of medication shall be communicated to the
patient, and the name of the dispensed drug product shall be
indicated on the prescription label, unless the prescriber orders
otherwise.
(f) This section shall not permit substitution between long-acting
and short-acting forms of a medication with the same chemical
ingredients or between one drug product and two or more drug products
with the same chemical ingredients.
4052.7. (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.
4053. (a) Subdivision (a) of Section 4051 shall not apply to a
manufacturer, veterinary food-animal drug retailer, or wholesaler if
the board shall find that sufficient, qualified supervision is
employed by the manufacturer, veterinary food-animal drug retailer,
or wholesaler to adequately safeguard and protect the public health,
nor shall Section 4051 apply to any laboratory licensed under Section
351 of Title III of the Public Health Service Act (Public Law
78-410).
(b) An individual employed by a manufacturer, veterinary
food-animal drug retailer, or wholesaler may apply for an exemption
from Section 4051. In order to obtain and maintain that exemption,
the individual shall meet the following requirements:
(1) He or she shall be a high school graduate or possess a general
education development equivalent.
(2) He or she shall have a minimum of one year of paid work
experience 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) He or she shall complete a training program approved by the
board that, at a minimum, addresses each of the following subjects:
(A) Knowledge and understanding of state and federal law relating
to the distribution of dangerous drugs and dangerous devices.
(B) Knowledge and understanding of state 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 may, by regulation, require training programs to
include additional material.
(6) The board shall not issue a certificate of exemption until the
applicant provides proof of completion of the required training to
the board.
(c) The manufacturer, veterinary food-animal drug retailer, or
wholesaler shall not operate without a pharmacist or an individual in
possession of a certificate of exemption on its premises.
(d) Only a pharmacist or an individual in possession of a
certificate of exemption shall prepare and affix the label to
veterinary food-animal drugs.
4054. Section 4051 shall not apply to a manufacturer, wholesaler,
or other supplier of dialysis drugs and devices distributed directly
to patients if the board finds that sufficient, qualified supervision
is employed by the manufacturer, wholesaler, or supplier adequately
to safeguard and protect the public health.
4055. 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. (a) Notwithstanding any provision of this chapter, a licensed
hospital that contains 100 beds or fewer, and that does not employ a
full-time pharmacist, may purchase drugs at wholesale for
administration, under the direction of a physician, or for
dispensation by a physician, to persons registered as inpatients of
the hospital, to emergency cases under treatment in the hospital, or,
under the conditions described in subdivision (f), to persons
registered as outpatients in a rural hospital as defined in Section
124840 of the Health and Safety Code. The hospital shall keep
records of the kind and amounts of drugs so purchased and
administered or dispensed, and the records shall be available for
inspection by all properly authorized personnel of the board.
(b) No hospital shall be entitled to the benefits of subdivision
(a) until it has obtained a license from the board. Each license
shall be issued to a specific hospital and for a specific location.
(c) Each application for a license under this section shall be
made on a form furnished by the board. Upon the filing of the
application and payment of the fee prescribed in subdivision (a) of
Section 4400, the executive officer of the board shall issue a
license authorizing the hospital to which it is issued to purchase
drugs at wholesale pursuant to subdivision (a). The license shall be
renewed annually on or before November 1 of each year upon payment of
the renewal fee prescribed in subdivision (b) of Section 4400 and
shall not be transferable.
(d) The form of application for a license under this section shall
contain the name and address of the applicant, the number of beds,
whether the applicant is a licensed hospital, whether it does or does
not employ a full-time pharmacist, the name of its chief medical
officer, and the name of its administrator.
(e) The board may deny, revoke, or suspend a license issued under
this section in the manner and for the grounds specified in Article
19 (commencing with Section 4300).
(f) A physician himself or herself may dispense drugs to
outpatients directly pursuant to subdivision (a) only if the
physician determines that it is in the best interest of the patient
that a particular drug regimen be immediately commenced or continued,
and the physician reasonably believes that a pharmacy located
outside the hospital is not available and accessible at the time of
dispensation to the patient within 30 minutes of the hospital
pharmaceutical services or within a 30-mile radius from the hospital
pharmaceutical services by means of the method of transportation the
patient states that he or she intends to use. The quantity of drugs
dispensed to any outpatient pursuant to this subdivision shall be
limited to that amount necessary to maintain uninterrupted therapy
during the period when pharmaceutical services outside the hospital
are not readily available or accessible, but shall not exceed a
72-hour supply. The physician shall ensure that the label on the
drug contains all the information required by Section 4076.
(g) A rural hospital, as defined in Section 124840 of the Health
and Safety Code, shall obtain information regarding the hours of
operation of each pharmacy located within the 30 minute or 30-mile
radius of the hospital. The hospital shall update this information
annually, and shall make this information available to its medical
staff.
(h) A licensed hospital that contains 100 beds or fewer, does not
employ a full-time pharmacist, and purchases drugs at wholesale for
administration or dispensation pursuant to subdivision (a), shall
retain the services of a pharmacist consultant to monitor and review
the pharmaceutical services provided by the hospital to inpatients of
the hospital, and the dispensing of drugs by physicians to
outpatients pursuant to subdivision (f).
(i) This section shall not be construed to eliminate the
requirements of Section 11164 or 11167 of the Health and Safety Code.
4057. (a) Except as provided in Sections 4006, 4240, and 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.
(c) This chapter shall not apply to a home health agency licensed
under Chapter 8 (commencing with Section 1725) of, or a hospice
licensed under Chapter 8.5 (commencing with Section 1745) of,
Division 2 of, the Health and Safety Code, when it purchases, stores,
furnishes, or transports specific dangerous drugs and dangerous
devices listed in board regulations in compliance with applicable law
and regulations including:
(1) Dangerous devices described in subdivision (b) of Section
4022, as long as these dangerous devices are furnished only upon the
prescription or order of a physician, dentist, or podiatrist.
(2) Hypodermic needles and syringes.
(3) Irrigation solutions of 50 cubic centimeters or greater.
(d) This chapter does not apply to the storage of devices in
secure central or ward supply areas of a clinic, hospital,
institution, or establishment holding a currently valid and unrevoked
license or permit pursuant to Division 2 (commencing with Section
1200) of the Health and Safety Code, or pursuant to Chapter 2
(commencing with Section 3300) of Division 3 of, or Part 2
(commencing with Section 6250) of Division 6 of, the Welfare and
Institutions Code.
(e) This chapter does not apply to the retail sale of vitamins,
mineral products, or combinations thereof or to foods, supplements,
or nutrients used to fortify the diet of humans or other animals or
poultry and labeled as such that are not subject to Section 4022 and
that are packaged or bottled in the manufacturer's or distributor's
container and labeled in accordance with applicable federal and state
labeling requirements.
(f) This chapter does not apply to the furnishing of dangerous
drugs and dangerous devices to recognized schools of nursing. These
dangerous drugs and dangerous devices shall not include controlled
substances. The dangerous drugs and dangerous devices shall be used
for training purposes only, and not for the cure, mitigation, or
treatment of disease in humans. Recognized schools of nursing for
purposes of this subdivision are those schools recognized as training
facilities by the California Board of Registered Nursing.
4058. Every person holding a license issued under this chapter to
operate a premises shall display the original license and current
renewal license upon the licensed premises in a place where it may be
clearly read by the public.
4059. (a) A person may not furnish any dangerous drug, except upon
the prescription of a physician, dentist, podiatrist, optometrist, or
veterinarian. A person may not furnish any dangerous device, except
upon the prescription of a physician, dentist, podiatrist,
optometrist, or veterinarian.
(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, or
veterinarian, 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 Health Services. 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 or may furnish
topical pharmaceutical agents authorized for use pursuant to
paragraph (5) of subdivision (a) of Section 3041 to an optometrist.
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 Examining
Committee 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, 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.
(i) This section shall become operative on July 1, 2001.
4059.5. (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 must be delivered to the licensed premises and
signed for and received by the pharmacist-in-charge or, in his or her
absence, another pharmacist designated by the pharmacist-in-charge.
Where a licensee is permitted to operate through an exemptee, the
exemptee may sign for and receive the delivery.
(b) A dangerous drug or dangerous device transferred, sold, or
delivered to any 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 drugs or devices.
(d) Notwithstanding any other provision of law, a dangerous drug
or dangerous device may be ordered by and provided to a manufacturer,
physician, dentist, podiatrist, optometrist, veterinarian, or
laboratory, or a physical therapist acting within the scope of his or
her license. Any person or entity receiving delivery of any
dangerous drugs or devices, or a duly authorized representative of
the person or entity, shall sign for the receipt of the dangerous
drugs or dangerous devices.
(e) A dangerous drug or dangerous device shall not be transferred,
sold, or delivered to any 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 drugs or 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
drugs or devices are to be delivered shall include, but not be
limited to, determining that the recipient of the drugs or devices is
authorized by law to receive the drugs or devices.
4060. No person shall possess any controlled substance, except that
furnished to a person upon the prescription of a physician, dentist,
podiatrist, or veterinarian, or furnished pursuant to a drug order
issued by a certified nurse-midwife pursuant to Section 2746.51, a
nurse practitioner pursuant to Section 2836.1, or a physician
assistant pursuant to Section 3502.1. This section shall not apply
to the possession of any controlled substance by a manufacturer,
wholesaler, pharmacy, physician, podiatrist, dentist, veterinarian,
certified nurse-midwife, nurse practitioner, or physician assistant,
when in stock in containers correctly labeled with the name and
address of the supplier or producer.
Nothing in this section authorizes a certified nurse-midwife, a
nurse practitioner, or a physician assistant to order his or her own
stock of dangerous drugs and devices.
4061. (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, or
veterinarian. 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, or a
physician assistant who functions pursuant to a protocol described
in Section 3502.1, 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 or 3502.1,
of the complimentary samples requested and received by a nurse
practitioner, certified nurse-midwife, or physician assistant 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, or physician assistant, 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, or
physician assistant.
4062. Notwithstanding Section 4059 or any other provision of law, a
pharmacist 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 shall communicate this information to the
patient's attending physician as soon as possible. Notwithstanding
Section 4060 or any other provision of law, a person may possess a
dangerous drug or dangerous device furnished without prescription
pursuant to this section.
4063. 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.
4064. (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.
4065. (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.
4066. (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.
4067. (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 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, 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.