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.
Pharmacy practice is continually evolving to include more
sophisticated and comprehensive patient care activities.
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 4052.1, 4052.2, or
4052.3, 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 drug product 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 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 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, as authorized by Section 4052.2.
(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) Furnish emergency contraception drug therapy as authorized by
Section 4052.3.
(9) Administer immunizations pursuant to a protocol with a
prescriber.
(b) A pharmacist who is authorized to issue an order to initiate
or adjust a controlled substance therapy pursuant to this section
shall personally register with the federal Drug Enforcement
Administration.
(c) 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. (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. (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, 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 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 clinic, health care service plan, or physician.
Adjusting the drug regimen does not include substituting or selecting
a different drug, except as authorized by the protocol. The
pharmacist shall provide written notification to the patient's
treating prescriber, or enter the appropriate information in an
electronic patient record system shared by the prescriber, of any
drug regimen initiated pursuant to this paragraph within 24 hours.
(b) A patient's treating prescriber may prohibit, by written
instruction, any adjustment or change in the patient's drug regimen
by the pharmacist.
(c) The policies, procedures, or protocols referred to in this
subdivision shall be developed by health care professionals,
including physicians, pharmacists, and registered nurses, and shall,
at a minimum, do all of the following:
(1) Require that the pharmacist function as part of a
multidisciplinary group that includes physicians and direct care
registered nurses. The multidisciplinary group shall determine the
appropriate participation of the pharmacist and the direct care
registered nurse.
(2) Require that the medical records of the patient be available
to both the patient's treating prescriber and the pharmacist.
(3) Require that the procedures to be performed by the pharmacist
relate to a condition for which the patient has first been seen by a
physician.
(4) Except for procedures or functions provided by a health care
facility, a licensed 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. (a) Notwithstanding any other provision of law, a
pharmacist may furnish emergency contraception drug therapy in
accordance with either of the following:
(1) Standardized procedures or protocols developed by the
pharmacist and an authorized prescriber who is acting within his or
her scope of practice.
(2) Standardized procedures or protocols developed and approved by
both the board and the Medical Board of California in consultation
with the American College of Obstetricians and Gynecologists, the
California Pharmacist Association, and other appropriate entities.
Both the board and the Medical Board of California shall have
authority to ensure compliance with this clause, and both boards are
specifically charged with the enforcement of this provision with
respect to their respective licensees. Nothing in this clause shall
be construed to expand the authority of a pharmacist to prescribe any
prescription medication.
(b) Prior to performing a procedure authorized under this
paragraph, 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.
(c) A pharmacist, pharmacist's employer, or pharmacist's agent may
not directly charge a patient a separate consultation fee for
emergency contraception drug therapy services initiated pursuant to
this paragraph, 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 subparagraph, 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.
The provisions of this subparagraph shall cease to be operative for
dedicated emergency contraception drugs when these drugs are
reclassified as over-the-counter products by the federal Food and
Drug Administration.
(d) A pharmacist may 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
section.
(e) For each emergency contraception drug therapy initiated
pursuant to this section, the pharmacist shall provide the recipient
of the emergency contraception drugs with a standardized factsheet
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 Public
Health, 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.
4052.4. 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) 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 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) 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, 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) 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 California law and federal law
relating to the distribution of dangerous drugs and dangerous
devices.
(B) Knowledge and understanding of California law and federal law
relating to the distribution of controlled substances.
(C) Knowledge and understanding of quality control systems.
(D) Knowledge and understanding of the United States Pharmacopoeia
standards relating to the safe storage and handling of drugs.
(E) Knowledge and understanding of prescription terminology,
abbreviations, dosages and format.
(4) The board may, by regulation, require training programs to
include additional material.
(5) The board may not issue a license as a designated
representative until the applicant provides proof of completion of
the required training to the board.
(c) The veterinary food-animal drug retailer or wholesaler shall
not operate without a pharmacist or a designated representative on
its premises.
(d) Only a pharmacist or a designated representative shall prepare
and affix the label to veterinary food-animal drugs.
(e) Section 4051 shall not apply to any laboratory licensed under
Section 351 of Title III of the Public Health Service Act (Public Law
78-410).
4054. Section 4051 shall not apply to a manufacturer or wholesaler
that provides dialysis drugs and devices directly to patients.
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,
veterinarian, or naturopathic doctor pursuant to Section 3640.7. A
person may not furnish any dangerous device, except upon the
prescription of a physician, dentist, podiatrist, optometrist,
veterinarian, or naturopathic doctor pursuant to Section 3640.7.
(b) This section does not apply to the furnishing of any dangerous
drug or dangerous device by a manufacturer, wholesaler, or pharmacy
to each other or to a physician, dentist, podiatrist, optometrist,
veterinarian, or naturopathic doctor pursuant to Section 3640.7, or
to a laboratory under sales and purchase records that correctly give
the date, the names and addresses of the supplier and the buyer, the
drug or device, and its quantity. This section does not apply to the
furnishing of any dangerous device by a manufacturer, wholesaler, or
pharmacy to a physical therapist acting within the scope of his or
her license under sales and purchase records that correctly provide
the date the device is provided, the names and addresses of the
supplier and the buyer, a description of the device, and the quantity
supplied.
(c) A pharmacist, or a person exempted pursuant to Section 4054,
may distribute dangerous drugs and dangerous devices directly to
dialysis patients pursuant to regulations adopted by the board. The
board shall adopt any regulations as are necessary to ensure the safe
distribution of these drugs and devices to dialysis patients without
interruption thereof. A person who violates a regulation adopted
pursuant to this subdivision shall be liable upon order of the board
to surrender his or her personal license. These penalties shall be in
addition to penalties that may be imposed pursuant to Section 4301.
If the board finds any dialysis drugs or devices distributed pursuant
to this subdivision to be ineffective or unsafe for the intended
use, the board may institute immediate recall of any or all of the
drugs or devices distributed to individual patients.
(d) Home dialysis patients who receive any drugs or devices
pursuant to subdivision (c) shall have completed a full course of
home training given by a dialysis center licensed by the State
Department of Public Health. The physician prescribing the dialysis
products shall submit proof satisfactory to the manufacturer or
wholesaler that the patient has completed the program.
(e) A pharmacist may furnish a dangerous drug authorized for use
pursuant to Section 2620.3 to a physical therapist. A record
containing the date, name and address of the buyer, and name and
quantity of the drug shall be maintained. This subdivision shall not
be construed to authorize the furnishing of a controlled substance.
(f) A pharmacist may furnish electroneuromyographic needle
electrodes or hypodermic needles used for the purpose of placing wire
electrodes for kinesiological electromyographic testing to physical
therapists who are certified by the Physical Therapy Board of
California to perform tissue penetration in accordance with Section
2620.5.
(g) Nothing in this section shall be construed as permitting a
licensed physical therapist to dispense or furnish a dangerous device
without a prescription of a physician, dentist, podiatrist,
optometrist, or veterinarian.
(h) A veterinary food-animal drug retailer shall dispense,
furnish, transfer, or sell veterinary food-animal drugs only to
another veterinary food-animal drug retailer, a pharmacy, a
veterinarian, or to a veterinarian's client pursuant to a
prescription from the veterinarian for food-producing animals.
4059.5. (a) Except as otherwise provided in this chapter, dangerous
drugs or dangerous devices may only be ordered by an entity licensed
by the board and shall be delivered to the licensed premises and
signed for and received by a pharmacist. Where a licensee is
permitted to operate through a designated representative, the
designated representative shall sign for and receive the delivery.
(b) A dangerous drug or dangerous device transferred, sold, or
delivered to a person within this state shall be transferred, sold,
or delivered only to an entity licensed by the board, to a
manufacturer, or to an ultimate user or the ultimate user's agent.
(c) Notwithstanding subdivisions (a) and (b), deliveries to a
hospital pharmacy may be made to a central receiving location within
the hospital. However, the dangerous drugs or dangerous devices shall
be delivered to the licensed pharmacy premises within one working
day following receipt by the hospital, and the pharmacist on duty at
that time shall immediately inventory the dangerous drugs or
dangerous devices.
(d) Notwithstanding any other provision of law, a dangerous drug
or dangerous device may be ordered by and provided to a manufacturer,
physician, dentist, podiatrist, optometrist, veterinarian,
naturopathic doctor pursuant to Section 3640.7, or laboratory, or a
physical therapist acting within the scope of his or her license. A
person or entity receiving delivery of a dangerous drug or dangerous
device, or a duly authorized representative of the person or entity,
shall sign for the receipt of the dangerous drug or dangerous device.
(e) A dangerous drug or dangerous device shall not be transferred,
sold, or delivered to a person outside this state, whether foreign
or domestic, unless the transferor, seller, or deliverer does so in
compliance with the laws of this state and of the United States and
of the state or country to which the dangerous drugs or dangerous
devices are to be transferred, sold, or delivered. Compliance with
the laws of this state and the United States and of the state or
country to which the dangerous drugs or dangerous devices are to be
delivered shall include, but not be limited to, determining that the
recipient of the dangerous drugs or dangerous devices is authorized
by law to receive the dangerous drugs or dangerous devices.
(f) Notwithstanding subdivision (a), a pharmacy may take delivery
of dangerous drugs and dangerous devices when the pharmacy is closed
and no pharmacist is on duty if all of the following requirements are
met:
(1) The drugs are placed in a secure storage facility in the same
building as the pharmacy.
(2) Only the pharmacist-in-charge or a pharmacist designated by
the pharmacist-in-charge has access to the secure storage facility
after dangerous drugs or dangerous devices have been delivered.
(3) The secure storage facility has a means of indicating whether
it has been entered after dangerous drugs or dangerous devices have
been delivered.
(4) The pharmacy maintains written policies and procedures for the
delivery of dangerous drugs and dangerous devices to a secure
storage facility.
(5) The agent delivering dangerous drugs and dangerous devices
pursuant to this subdivision leaves documents indicating the name and
amount of each dangerous drug or dangerous device delivered in the
secure storage facility.
The pharmacy shall be responsible for the dangerous drugs and
dangerous devices delivered to the secure storage facility. The
pharmacy shall also be responsible for obtaining and maintaining
records relating to the delivery of dangerous drugs and dangerous
devices to a secure storage facility.
4060. No person shall possess any controlled substance, except that
furnished to a person upon the prescription of a physician, dentist,
podiatrist, optometrist, veterinarian, or naturopathic doctor
pursuant to Section 3640.7, or furnished pursuant to a drug order
issued by a certified nurse-midwife pursuant to Section 2746.51, a
nurse practitioner pursuant to Section 2836.1, a physician assistant
pursuant to Section 3502.1, a naturopathic doctor pursuant to Section
3640.5, or a pharmacist pursuant to either Section 4052.1 or 4052.2.
This section shall not apply to the possession of any controlled
substance by a manufacturer, wholesaler, pharmacy, pharmacist,
physician, podiatrist, dentist, optometrist, veterinarian,
naturopathic doctor, 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, a physician assistant, or a naturopathic doctor,
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,
optometrist, veterinarian, or naturopathic doctor pursuant to Section
3640.7. However, a certified nurse-midwife who functions pursuant to
a standardized procedure or protocol described in Section 2746.51, a
nurse practitioner who functions pursuant to a standardized
procedure described in Section 2836.1, or protocol, a physician
assistant who functions pursuant to a protocol described in Section
3502.1, or a naturopathic doctor who functions pursuant to a
standardized procedure or protocol described in Section 3640.5, may
sign for the request and receipt of complimentary samples of a
dangerous drug or dangerous device that has been identified in the
standardized procedure, protocol, or practice agreement. Standardized
procedures, protocols, and practice agreements shall include
specific approval by a physician. A review process, consistent with
the requirements of Section 2725, 3502.1, or 3640.5, of the
complimentary samples requested and received by a nurse practitioner,
certified nurse-midwife, physician assistant, or naturopathic
doctor, shall be defined within the standardized procedure, protocol,
or practice agreement.
(b) Each written request shall contain the names and addresses of
the supplier and the requester, the name and quantity of the specific
dangerous drug desired, the name of the certified nurse-midwife,
nurse practitioner, physician assistant, or naturopathic doctor, if
applicable, receiving the samples pursuant to this section, the date
of receipt, and the name and quantity of the dangerous drugs or
dangerous devices provided. These records shall be preserved by the
supplier with the records required by Section 4059.
(c) Nothing in this section is intended to expand the scope of
practice of a certified nurse-midwife, nurse practitioner, physician
assistant, or naturopathic doctor.
4062. (a) 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.
(b) During a declared federal, state, or local emergency, the
board may waive application of any provisions of this chapter or the
regulations adopted pursuant to it if, in the board's opinion, the
waiver will aid in the protection of public health or the provision
of patient care.
(c) During a declared federal, state, or local emergency, the
board shall allow for the employment of a mobile pharmacy in impacted
areas in order to ensure the continuity of patient care, if all of
the following conditions are met:
(1) The mobile pharmacy shares common ownership with at least one
currently licensed pharmacy in good standing.
(2) The mobile pharmacy retains records of dispensing, as required
by subdivision (a).
(3) A licensed pharmacist is on the premises and the mobile
pharmacy is under the control and management of a pharmacist while
the drugs are being dispensed.
(4) Reasonable security measures are taken to safeguard the drug
supply maintained in the mobile pharmacy.
(5) The mobile pharmacy is located within the declared emergency
area or affected areas.
(6) The mobile pharmacy ceases the provision of services within 48
hours following the termination of the declared emergency.
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 of a human or animal for whom the
prescription is meant if the person or entity either knew or
reasonably should have known that the prescription was not issued
pursuant to a good faith prior examination of a human or animal, or
if the person or entity did not act in accordance with Section 1761
of Title 16 of the California Code of Regulations.
(b) Notwithstanding any other provision of law, a violation of
this section may subject the person or entity that has committed the
violation to either a fine of up to twenty-five thousand dollars
($25,000) per occurrence pursuant to a citation issued by the board
or a civil penalty of twenty-five thousand dollars ($25,000) per
occurrence.
(c) The Attorney General may bring an action to enforce this
section and to collect the fines or civil penalties authorized by
subdivision (b).
(d) For notifications made on and after January 1, 2002, the
Franchise Tax Board, upon notification by the Attorney General or the
board of a final judgment in an action brought under this section,
shall subtract the amount of the fine or awarded civil penalties from
any tax refunds or lottery winnings due to the person who is a
defendant in the action using the offset authority under Section
12419.5 of the Government Code, as delegated by the Controller, and
the processes as established by the Franchise Tax Board for this
purpose. That amount shall be forwarded to the board for deposit in
the Pharmacy Board Contingent Fund.
(e) Nothing in this section shall be construed to permit the
unlicensed practice of pharmacy, or to limit the authority of the
board to enforce any other provision of this chapter.
(f) For the purposes of this section, "good faith prior
examination" includes the requirements for a physician and surgeon in
Section 2242 and the requirements for a veterinarian in Section
2032.1 of Title 16 of the California Code of Regulations.
4068. (a) Notwithstanding any provision of this chapter, a
prescriber may dispense a dangerous drug, including a controlled
substance, to an emergency room patient if all of the following
apply:
(1) The hospital pharmacy is closed and there is no pharmacist
available in the hospital.
(2) The dangerous drug is acquired by the hospital pharmacy.
(3) The dispensing information is recorded and provided to the
pharmacy when the pharmacy reopens.
(4) The hospital pharmacy retains the dispensing information and,
if the drug is a schedule II, schedule III, or schedule IV controlled
substance, reports the dispensing information to the Department of
Justice pursuant to Section 11165 of the Health and Safety Code.
(5) The prescriber determines that it is in the best interest of
the patient that a particular drug regimen be immediately commenced
or continued, and the prescriber reasonably believes that a pharmacy
located outside the hospital is not available and accessible at the
time of dispensing to the patient.
(6) The quantity of drugs dispensed to any patient pursuant to
this section are limited to that amount necessary to maintain
uninterrupted therapy during the period when pharmacy services
outside the hospital are not readily available or accessible, but
shall not exceed a 72-hour supply.
(7) The prescriber shall ensure that the label on the drug
contains all the information required by Section 4076.
(b) The prescriber shall be responsible for any error or omission
related to the drugs dispensed.
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.
Pharmacy practice is continually evolving to include more
sophisticated and comprehensive patient care activities.
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 4052.1, 4052.2, or
4052.3, 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 drug product 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 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 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, as authorized by Section 4052.2.
(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) Furnish emergency contraception drug therapy as authorized by
Section 4052.3.
(9) Administer immunizations pursuant to a protocol with a
prescriber.
(b) A pharmacist who is authorized to issue an order to initiate
or adjust a controlled substance therapy pursuant to this section
shall personally register with the federal Drug Enforcement
Administration.
(c) 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. (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. (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, 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 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 clinic, health care service plan, or physician.
Adjusting the drug regimen does not include substituting or selecting
a different drug, except as authorized by the protocol. The
pharmacist shall provide written notification to the patient's
treating prescriber, or enter the appropriate information in an
electronic patient record system shared by the prescriber, of any
drug regimen initiated pursuant to this paragraph within 24 hours.
(b) A patient's treating prescriber may prohibit, by written
instruction, any adjustment or change in the patient's drug regimen
by the pharmacist.
(c) The policies, procedures, or protocols referred to in this
subdivision shall be developed by health care professionals,
including physicians, pharmacists, and registered nurses, and shall,
at a minimum, do all of the following:
(1) Require that the pharmacist function as part of a
multidisciplinary group that includes physicians and direct care
registered nurses. The multidisciplinary group shall determine the
appropriate participation of the pharmacist and the direct care
registered nurse.
(2) Require that the medical records of the patient be available
to both the patient's treating prescriber and the pharmacist.
(3) Require that the procedures to be performed by the pharmacist
relate to a condition for which the patient has first been seen by a
physician.
(4) Except for procedures or functions provided by a health care
facility, a licensed 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. (a) Notwithstanding any other provision of law, a
pharmacist may furnish emergency contraception drug therapy in
accordance with either of the following:
(1) Standardized procedures or protocols developed by the
pharmacist and an authorized prescriber who is acting within his or
her scope of practice.
(2) Standardized procedures or protocols developed and approved by
both the board and the Medical Board of California in consultation
with the American College of Obstetricians and Gynecologists, the
California Pharmacist Association, and other appropriate entities.
Both the board and the Medical Board of California shall have
authority to ensure compliance with this clause, and both boards are
specifically charged with the enforcement of this provision with
respect to their respective licensees. Nothing in this clause shall
be construed to expand the authority of a pharmacist to prescribe any
prescription medication.
(b) Prior to performing a procedure authorized under this
paragraph, 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.
(c) A pharmacist, pharmacist's employer, or pharmacist's agent may
not directly charge a patient a separate consultation fee for
emergency contraception drug therapy services initiated pursuant to
this paragraph, 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 subparagraph, 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.
The provisions of this subparagraph shall cease to be operative for
dedicated emergency contraception drugs when these drugs are
reclassified as over-the-counter products by the federal Food and
Drug Administration.
(d) A pharmacist may 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
section.
(e) For each emergency contraception drug therapy initiated
pursuant to this section, the pharmacist shall provide the recipient
of the emergency contraception drugs with a standardized factsheet
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 Public
Health, 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.
4052.4. 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) 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 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) 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, 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) 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 California law and federal law
relating to the distribution of dangerous drugs and dangerous
devices.
(B) Knowledge and understanding of California law and federal law
relating to the distribution of controlled substances.
(C) Knowledge and understanding of quality control systems.
(D) Knowledge and understanding of the United States Pharmacopoeia
standards relating to the safe storage and handling of drugs.
(E) Knowledge and understanding of prescription terminology,
abbreviations, dosages and format.
(4) The board may, by regulation, require training programs to
include additional material.
(5) The board may not issue a license as a designated
representative until the applicant provides proof of completion of
the required training to the board.
(c) The veterinary food-animal drug retailer or wholesaler shall
not operate without a pharmacist or a designated representative on
its premises.
(d) Only a pharmacist or a designated representative shall prepare
and affix the label to veterinary food-animal drugs.
(e) Section 4051 shall not apply to any laboratory licensed under
Section 351 of Title III of the Public Health Service Act (Public Law
78-410).
4054. Section 4051 shall not apply to a manufacturer or wholesaler
that provides dialysis drugs and devices directly to patients.
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,
veterinarian, or naturopathic doctor pursuant to Section 3640.7. A
person may not furnish any dangerous device, except upon the
prescription of a physician, dentist, podiatrist, optometrist,
veterinarian, or naturopathic doctor pursuant to Section 3640.7.
(b) This section does not apply to the furnishing of any dangerous
drug or dangerous device by a manufacturer, wholesaler, or pharmacy
to each other or to a physician, dentist, podiatrist, optometrist,
veterinarian, or naturopathic doctor pursuant to Section 3640.7, or
to a laboratory under sales and purchase records that correctly give
the date, the names and addresses of the supplier and the buyer, the
drug or device, and its quantity. This section does not apply to the
furnishing of any dangerous device by a manufacturer, wholesaler, or
pharmacy to a physical therapist acting within the scope of his or
her license under sales and purchase records that correctly provide
the date the device is provided, the names and addresses of the
supplier and the buyer, a description of the device, and the quantity
supplied.
(c) A pharmacist, or a person exempted pursuant to Section 4054,
may distribute dangerous drugs and dangerous devices directly to
dialysis patients pursuant to regulations adopted by the board. The
board shall adopt any regulations as are necessary to ensure the safe
distribution of these drugs and devices to dialysis patients without
interruption thereof. A person who violates a regulation adopted
pursuant to this subdivision shall be liable upon order of the board
to surrender his or her personal license. These penalties shall be in
addition to penalties that may be imposed pursuant to Section 4301.
If the board finds any dialysis drugs or devices distributed pursuant
to this subdivision to be ineffective or unsafe for the intended
use, the board may institute immediate recall of any or all of the
drugs or devices distributed to individual patients.
(d) Home dialysis patients who receive any drugs or devices
pursuant to subdivision (c) shall have completed a full course of
home training given by a dialysis center licensed by the State
Department of Public Health. The physician prescribing the dialysis
products shall submit proof satisfactory to the manufacturer or
wholesaler that the patient has completed the program.
(e) A pharmacist may furnish a dangerous drug authorized for use
pursuant to Section 2620.3 to a physical therapist. A record
containing the date, name and address of the buyer, and name and
quantity of the drug shall be maintained. This subdivision shall not
be construed to authorize the furnishing of a controlled substance.
(f) A pharmacist may furnish electroneuromyographic needle
electrodes or hypodermic needles used for the purpose of placing wire
electrodes for kinesiological electromyographic testing to physical
therapists who are certified by the Physical Therapy Board of
California to perform tissue penetration in accordance with Section
2620.5.
(g) Nothing in this section shall be construed as permitting a
licensed physical therapist to dispense or furnish a dangerous device
without a prescription of a physician, dentist, podiatrist,
optometrist, or veterinarian.
(h) A veterinary food-animal drug retailer shall dispense,
furnish, transfer, or sell veterinary food-animal drugs only to
another veterinary food-animal drug retailer, a pharmacy, a
veterinarian, or to a veterinarian's client pursuant to a
prescription from the veterinarian for food-producing animals.
4059.5. (a) Except as otherwise provided in this chapter, dangerous
drugs or dangerous devices may only be ordered by an entity licensed
by the board and shall be delivered to the licensed premises and
signed for and received by a pharmacist. Where a licensee is
permitted to operate through a designated representative, the
designated representative shall sign for and receive the delivery.
(b) A dangerous drug or dangerous device transferred, sold, or
delivered to a person within this state shall be transferred, sold,
or delivered only to an entity licensed by the board, to a
manufacturer, or to an ultimate user or the ultimate user's agent.
(c) Notwithstanding subdivisions (a) and (b), deliveries to a
hospital pharmacy may be made to a central receiving location within
the hospital. However, the dangerous drugs or dangerous devices shall
be delivered to the licensed pharmacy premises within one working
day following receipt by the hospital, and the pharmacist on duty at
that time shall immediately inventory the dangerous drugs or
dangerous devices.
(d) Notwithstanding any other provision of law, a dangerous drug
or dangerous device may be ordered by and provided to a manufacturer,
physician, dentist, podiatrist, optometrist, veterinarian,
naturopathic doctor pursuant to Section 3640.7, or laboratory, or a
physical therapist acting within the scope of his or her license. A
person or entity receiving delivery of a dangerous drug or dangerous
device, or a duly authorized representative of the person or entity,
shall sign for the receipt of the dangerous drug or dangerous device.
(e) A dangerous drug or dangerous device shall not be transferred,
sold, or delivered to a person outside this state, whether foreign
or domestic, unless the transferor, seller, or deliverer does so in
compliance with the laws of this state and of the United States and
of the state or country to which the dangerous drugs or dangerous
devices are to be transferred, sold, or delivered. Compliance with
the laws of this state and the United States and of the state or
country to which the dangerous drugs or dangerous devices are to be
delivered shall include, but not be limited to, determining that the
recipient of the dangerous drugs or dangerous devices is authorized
by law to receive the dangerous drugs or dangerous devices.
(f) Notwithstanding subdivision (a), a pharmacy may take delivery
of dangerous drugs and dangerous devices when the pharmacy is closed
and no pharmacist is on duty if all of the following requirements are
met:
(1) The drugs are placed in a secure storage facility in the same
building as the pharmacy.
(2) Only the pharmacist-in-charge or a pharmacist designated by
the pharmacist-in-charge has access to the secure storage facility
after dangerous drugs or dangerous devices have been delivered.
(3) The secure storage facility has a means of indicating whether
it has been entered after dangerous drugs or dangerous devices have
been delivered.
(4) The pharmacy maintains written policies and procedures for the
delivery of dangerous drugs and dangerous devices to a secure
storage facility.
(5) The agent delivering dangerous drugs and dangerous devices
pursuant to this subdivision leaves documents indicating the name and
amount of each dangerous drug or dangerous device delivered in the
secure storage facility.
The pharmacy shall be responsible for the dangerous drugs and
dangerous devices delivered to the secure storage facility. The
pharmacy shall also be responsible for obtaining and maintaining
records relating to the delivery of dangerous drugs and dangerous
devices to a secure storage facility.
4060. No person shall possess any controlled substance, except that
furnished to a person upon the prescription of a physician, dentist,
podiatrist, optometrist, veterinarian, or naturopathic doctor
pursuant to Section 3640.7, or furnished pursuant to a drug order
issued by a certified nurse-midwife pursuant to Section 2746.51, a
nurse practitioner pursuant to Section 2836.1, a physician assistant
pursuant to Section 3502.1, a naturopathic doctor pursuant to Section
3640.5, or a pharmacist pursuant to either Section 4052.1 or 4052.2.
This section shall not apply to the possession of any controlled
substance by a manufacturer, wholesaler, pharmacy, pharmacist,
physician, podiatrist, dentist, optometrist, veterinarian,
naturopathic doctor, 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, a physician assistant, or a naturopathic doctor,
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,
optometrist, veterinarian, or naturopathic doctor pursuant to Section
3640.7. However, a certified nurse-midwife who functions pursuant to
a standardized procedure or protocol described in Section 2746.51, a
nurse practitioner who functions pursuant to a standardized
procedure described in Section 2836.1, or protocol, a physician
assistant who functions pursuant to a protocol described in Section
3502.1, or a naturopathic doctor who functions pursuant to a
standardized procedure or protocol described in Section 3640.5, may
sign for the request and receipt of complimentary samples of a
dangerous drug or dangerous device that has been identified in the
standardized procedure, protocol, or practice agreement. Standardized
procedures, protocols, and practice agreements shall include
specific approval by a physician. A review process, consistent with
the requirements of Section 2725, 3502.1, or 3640.5, of the
complimentary samples requested and received by a nurse practitioner,
certified nurse-midwife, physician assistant, or naturopathic
doctor, shall be defined within the standardized procedure, protocol,
or practice agreement.
(b) Each written request shall contain the names and addresses of
the supplier and the requester, the name and quantity of the specific
dangerous drug desired, the name of the certified nurse-midwife,
nurse practitioner, physician assistant, or naturopathic doctor, if
applicable, receiving the samples pursuant to this section, the date
of receipt, and the name and quantity of the dangerous drugs or
dangerous devices provided. These records shall be preserved by the
supplier with the records required by Section 4059.
(c) Nothing in this section is intended to expand the scope of
practice of a certified nurse-midwife, nurse practitioner, physician
assistant, or naturopathic doctor.
4062. (a) 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.
(b) During a declared federal, state, or local emergency, the
board may waive application of any provisions of this chapter or the
regulations adopted pursuant to it if, in the board's opinion, the
waiver will aid in the protection of public health or the provision
of patient care.
(c) During a declared federal, state, or local emergency, the
board shall allow for the employment of a mobile pharmacy in impacted
areas in order to ensure the continuity of patient care, if all of
the following conditions are met:
(1) The mobile pharmacy shares common ownership with at least one
currently licensed pharmacy in good standing.
(2) The mobile pharmacy retains records of dispensing, as required
by subdivision (a).
(3) A licensed pharmacist is on the premises and the mobile
pharmacy is under the control and management of a pharmacist while
the drugs are being dispensed.
(4) Reasonable security measures are taken to safeguard the drug
supply maintained in the mobile pharmacy.
(5) The mobile pharmacy is located within the declared emergency
area or affected areas.
(6) The mobile pharmacy ceases the provision of services within 48
hours following the termination of the declared emergency.
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 of a human or animal for whom the
prescription is meant if the person or entity either knew or
reasonably should have known that the prescription was not issued
pursuant to a good faith prior examination of a human or animal, or
if the person or entity did not act in accordance with Section 1761
of Title 16 of the California Code of Regulations.
(b) Notwithstanding any other provision of law, a violation of
this section may subject the person or entity that has committed the
violation to either a fine of up to twenty-five thousand dollars
($25,000) per occurrence pursuant to a citation issued by the board
or a civil penalty of twenty-five thousand dollars ($25,000) per
occurrence.
(c) The Attorney General may bring an action to enforce this
section and to collect the fines or civil penalties authorized by
subdivision (b).
(d) For notifications made on and after January 1, 2002, the
Franchise Tax Board, upon notification by the Attorney General or the
board of a final judgment in an action brought under this section,
shall subtract the amount of the fine or awarded civil penalties from
any tax refunds or lottery winnings due to the person who is a
defendant in the action using the offset authority under Section
12419.5 of the Government Code, as delegated by the Controller, and
the processes as established by the Franchise Tax Board for this
purpose. That amount shall be forwarded to the board for deposit in
the Pharmacy Board Contingent Fund.
(e) Nothing in this section shall be construed to permit the
unlicensed practice of pharmacy, or to limit the authority of the
board to enforce any other provision of this chapter.
(f) For the purposes of this section, "good faith prior
examination" includes the requirements for a physician and surgeon in
Section 2242 and the requirements for a veterinarian in Section
2032.1 of Title 16 of the California Code of Regulations.
4068. (a) Notwithstanding any provision of this chapter, a
prescriber may dispense a dangerous drug, including a controlled
substance, to an emergency room patient if all of the following
apply:
(1) The hospital pharmacy is closed and there is no pharmacist
available in the hospital.
(2) The dangerous drug is acquired by the hospital pharmacy.
(3) The dispensing information is recorded and provided to the
pharmacy when the pharmacy reopens.
(4) The hospital pharmacy retains the dispensing information and,
if the drug is a schedule II, schedule III, or schedule IV controlled
substance, reports the dispensing information to the Department of
Justice pursuant to Section 11165 of the Health and Safety Code.
(5) The prescriber determines that it is in the best interest of
the patient that a particular drug regimen be immediately commenced
or continued, and the prescriber reasonably believes that a pharmacy
located outside the hospital is not available and accessible at the
time of dispensing to the patient.
(6) The quantity of drugs dispensed to any patient pursuant to
this section are limited to that amount necessary to maintain
uninterrupted therapy during the period when pharmacy services
outside the hospital are not readily available or accessible, but
shall not exceed a 72-hour supply.
(7) The prescriber shall ensure that the label on the drug
contains all the information required by Section 4076.
(b) The prescriber shall be responsible for any error or omission
related to the drugs dispensed.
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.
Pharmacy practice is continually evolving to include more
sophisticated and comprehensive patient care activities.
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 4052.1, 4052.2, or
4052.3, 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 drug product 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 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 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, as authorized by Section 4052.2.
(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) Furnish emergency contraception drug therapy as authorized by
Section 4052.3.
(9) Administer immunizations pursuant to a protocol with a
prescriber.
(b) A pharmacist who is authorized to issue an order to initiate
or adjust a controlled substance therapy pursuant to this section
shall personally register with the federal Drug Enforcement
Administration.
(c) 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. (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. (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, 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 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 clinic, health care service plan, or physician.
Adjusting the drug regimen does not include substituting or selecting
a different drug, except as authorized by the protocol. The
pharmacist shall provide written notification to the patient's
treating prescriber, or enter the appropriate information in an
electronic patient record system shared by the prescriber, of any
drug regimen initiated pursuant to this paragraph within 24 hours.
(b) A patient's treating prescriber may prohibit, by written
instruction, any adjustment or change in the patient's drug regimen
by the pharmacist.
(c) The policies, procedures, or protocols referred to in this
subdivision shall be developed by health care professionals,
including physicians, pharmacists, and registered nurses, and shall,
at a minimum, do all of the following:
(1) Require that the pharmacist function as part of a
multidisciplinary group that includes physicians and direct care
registered nurses. The multidisciplinary group shall determine the
appropriate participation of the pharmacist and the direct care
registered nurse.
(2) Require that the medical records of the patient be available
to both the patient's treating prescriber and the pharmacist.
(3) Require that the procedures to be performed by the pharmacist
relate to a condition for which the patient has first been seen by a
physician.
(4) Except for procedures or functions provided by a health care
facility, a licensed 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. (a) Notwithstanding any other provision of law, a
pharmacist may furnish emergency contraception drug therapy in
accordance with either of the following:
(1) Standardized procedures or protocols developed by the
pharmacist and an authorized prescriber who is acting within his or
her scope of practice.
(2) Standardized procedures or protocols developed and approved by
both the board and the Medical Board of California in consultation
with the American College of Obstetricians and Gynecologists, the
California Pharmacist Association, and other appropriate entities.
Both the board and the Medical Board of California shall have
authority to ensure compliance with this clause, and both boards are
specifically charged with the enforcement of this provision with
respect to their respective licensees. Nothing in this clause shall
be construed to expand the authority of a pharmacist to prescribe any
prescription medication.
(b) Prior to performing a procedure authorized under this
paragraph, 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.
(c) A pharmacist, pharmacist's employer, or pharmacist's agent may
not directly charge a patient a separate consultation fee for
emergency contraception drug therapy services initiated pursuant to
this paragraph, 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 subparagraph, 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.
The provisions of this subparagraph shall cease to be operative for
dedicated emergency contraception drugs when these drugs are
reclassified as over-the-counter products by the federal Food and
Drug Administration.
(d) A pharmacist may 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
section.
(e) For each emergency contraception drug therapy initiated
pursuant to this section, the pharmacist shall provide the recipient
of the emergency contraception drugs with a standardized factsheet
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 Public
Health, 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.
4052.4. 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) 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 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) 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, 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) 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 California law and federal law
relating to the distribution of dangerous drugs and dangerous
devices.
(B) Knowledge and understanding of California law and federal law
relating to the distribution of controlled substances.
(C) Knowledge and understanding of quality control systems.
(D) Knowledge and understanding of the United States Pharmacopoeia
standards relating to the safe storage and handling of drugs.
(E) Knowledge and understanding of prescription terminology,
abbreviations, dosages and format.
(4) The board may, by regulation, require training programs to
include additional material.
(5) The board may not issue a license as a designated
representative until the applicant provides proof of completion of
the required training to the board.
(c) The veterinary food-animal drug retailer or wholesaler shall
not operate without a pharmacist or a designated representative on
its premises.
(d) Only a pharmacist or a designated representative shall prepare
and affix the label to veterinary food-animal drugs.
(e) Section 4051 shall not apply to any laboratory licensed under
Section 351 of Title III of the Public Health Service Act (Public Law
78-410).
4054. Section 4051 shall not apply to a manufacturer or wholesaler
that provides dialysis drugs and devices directly to patients.
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,
veterinarian, or naturopathic doctor pursuant to Section 3640.7. A
person may not furnish any dangerous device, except upon the
prescription of a physician, dentist, podiatrist, optometrist,
veterinarian, or naturopathic doctor pursuant to Section 3640.7.
(b) This section does not apply to the furnishing of any dangerous
drug or dangerous device by a manufacturer, wholesaler, or pharmacy
to each other or to a physician, dentist, podiatrist, optometrist,
veterinarian, or naturopathic doctor pursuant to Section 3640.7, or
to a laboratory under sales and purchase records that correctly give
the date, the names and addresses of the supplier and the buyer, the
drug or device, and its quantity. This section does not apply to the
furnishing of any dangerous device by a manufacturer, wholesaler, or
pharmacy to a physical therapist acting within the scope of his or
her license under sales and purchase records that correctly provide
the date the device is provided, the names and addresses of the
supplier and the buyer, a description of the device, and the quantity
supplied.
(c) A pharmacist, or a person exempted pursuant to Section 4054,
may distribute dangerous drugs and dangerous devices directly to
dialysis patients pursuant to regulations adopted by the board. The
board shall adopt any regulations as are necessary to ensure the safe
distribution of these drugs and devices to dialysis patients without
interruption thereof. A person who violates a regulation adopted
pursuant to this subdivision shall be liable upon order of the board
to surrender his or her personal license. These penalties shall be in
addition to penalties that may be imposed pursuant to Section 4301.
If the board finds any dialysis drugs or devices distributed pursuant
to this subdivision to be ineffective or unsafe for the intended
use, the board may institute immediate recall of any or all of the
drugs or devices distributed to individual patients.
(d) Home dialysis patients who receive any drugs or devices
pursuant to subdivision (c) shall have completed a full course of
home training given by a dialysis center licensed by the State
Department of Public Health. The physician prescribing the dialysis
products shall submit proof satisfactory to the manufacturer or
wholesaler that the patient has completed the program.
(e) A pharmacist may furnish a dangerous drug authorized for use
pursuant to Section 2620.3 to a physical therapist. A record
containing the date, name and address of the buyer, and name and
quantity of the drug shall be maintained. This subdivision shall not
be construed to authorize the furnishing of a controlled substance.
(f) A pharmacist may furnish electroneuromyographic needle
electrodes or hypodermic needles used for the purpose of placing wire
electrodes for kinesiological electromyographic testing to physical
therapists who are certified by the Physical Therapy Board of
California to perform tissue penetration in accordance with Section
2620.5.
(g) Nothing in this section shall be construed as permitting a
licensed physical therapist to dispense or furnish a dangerous device
without a prescription of a physician, dentist, podiatrist,
optometrist, or veterinarian.
(h) A veterinary food-animal drug retailer shall dispense,
furnish, transfer, or sell veterinary food-animal drugs only to
another veterinary food-animal drug retailer, a pharmacy, a
veterinarian, or to a veterinarian's client pursuant to a
prescription from the veterinarian for food-producing animals.
4059.5. (a) Except as otherwise provided in this chapter, dangerous
drugs or dangerous devices may only be ordered by an entity licensed
by the board and shall be delivered to the licensed premises and
signed for and received by a pharmacist. Where a licensee is
permitted to operate through a designated representative, the
designated representative shall sign for and receive the delivery.
(b) A dangerous drug or dangerous device transferred, sold, or
delivered to a person within this state shall be transferred, sold,
or delivered only to an entity licensed by the board, to a
manufacturer, or to an ultimate user or the ultimate user's agent.
(c) Notwithstanding subdivisions (a) and (b), deliveries to a
hospital pharmacy may be made to a central receiving location within
the hospital. However, the dangerous drugs or dangerous devices shall
be delivered to the licensed pharmacy premises within one working
day following receipt by the hospital, and the pharmacist on duty at
that time shall immediately inventory the dangerous drugs or
dangerous devices.
(d) Notwithstanding any other provision of law, a dangerous drug
or dangerous device may be ordered by and provided to a manufacturer,
physician, dentist, podiatrist, optometrist, veterinarian,
naturopathic doctor pursuant to Section 3640.7, or laboratory, or a
physical therapist acting within the scope of his or her license. A
person or entity receiving delivery of a dangerous drug or dangerous
device, or a duly authorized representative of the person or entity,
shall sign for the receipt of the dangerous drug or dangerous device.
(e) A dangerous drug or dangerous device shall not be transferred,
sold, or delivered to a person outside this state, whether foreign
or domestic, unless the transferor, seller, or deliverer does so in
compliance with the laws of this state and of the United States and
of the state or country to which the dangerous drugs or dangerous
devices are to be transferred, sold, or delivered. Compliance with
the laws of this state and the United States and of the state or
country to which the dangerous drugs or dangerous devices are to be
delivered shall include, but not be limited to, determining that the
recipient of the dangerous drugs or dangerous devices is authorized
by law to receive the dangerous drugs or dangerous devices.
(f) Notwithstanding subdivision (a), a pharmacy may take delivery
of dangerous drugs and dangerous devices when the pharmacy is closed
and no pharmacist is on duty if all of the following requirements are
met:
(1) The drugs are placed in a secure storage facility in the same
building as the pharmacy.
(2) Only the pharmacist-in-charge or a pharmacist designated by
the pharmacist-in-charge has access to the secure storage facility
after dangerous drugs or dangerous devices have been delivered.
(3) The secure storage facility has a means of indicating whether
it has been entered after dangerous drugs or dangerous devices have
been delivered.
(4) The pharmacy maintains written policies and procedures for the
delivery of dangerous drugs and dangerous devices to a secure
storage facility.
(5) The agent delivering dangerous drugs and dangerous devices
pursuant to this subdivision leaves documents indicating the name and
amount of each dangerous drug or dangerous device delivered in the
secure storage facility.
The pharmacy shall be responsible for the dangerous drugs and
dangerous devices delivered to the secure storage facility. The
pharmacy shall also be responsible for obtaining and maintaining
records relating to the delivery of dangerous drugs and dangerous
devices to a secure storage facility.
4060. No person shall possess any controlled substance, except that
furnished to a person upon the prescription of a physician, dentist,
podiatrist, optometrist, veterinarian, or naturopathic doctor
pursuant to Section 3640.7, or furnished pursuant to a drug order
issued by a certified nurse-midwife pursuant to Section 2746.51, a
nurse practitioner pursuant to Section 2836.1, a physician assistant
pursuant to Section 3502.1, a naturopathic doctor pursuant to Section
3640.5, or a pharmacist pursuant to either Section 4052.1 or 4052.2.
This section shall not apply to the possession of any controlled
substance by a manufacturer, wholesaler, pharmacy, pharmacist,
physician, podiatrist, dentist, optometrist, veterinarian,
naturopathic doctor, 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, a physician assistant, or a naturopathic doctor,
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,
optometrist, veterinarian, or naturopathic doctor pursuant to Section
3640.7. However, a certified nurse-midwife who functions pursuant to
a standardized procedure or protocol described in Section 2746.51, a
nurse practitioner who functions pursuant to a standardized
procedure described in Section 2836.1, or protocol, a physician
assistant who functions pursuant to a protocol described in Section
3502.1, or a naturopathic doctor who functions pursuant to a
standardized procedure or protocol described in Section 3640.5, may
sign for the request and receipt of complimentary samples of a
dangerous drug or dangerous device that has been identified in the
standardized procedure, protocol, or practice agreement. Standardized
procedures, protocols, and practice agreements shall include
specific approval by a physician. A review process, consistent with
the requirements of Section 2725, 3502.1, or 3640.5, of the
complimentary samples requested and received by a nurse practitioner,
certified nurse-midwife, physician assistant, or naturopathic
doctor, shall be defined within the standardized procedure, protocol,
or practice agreement.
(b) Each written request shall contain the names and addresses of
the supplier and the requester, the name and quantity of the specific
dangerous drug desired, the name of the certified nurse-midwife,
nurse practitioner, physician assistant, or naturopathic doctor, if
applicable, receiving the samples pursuant to this section, the date
of receipt, and the name and quantity of the dangerous drugs or
dangerous devices provided. These records shall be preserved by the
supplier with the records required by Section 4059.
(c) Nothing in this section is intended to expand the scope of
practice of a certified nurse-midwife, nurse practitioner, physician
assistant, or naturopathic doctor.
4062. (a) 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.
(b) During a declared federal, state, or local emergency, the
board may waive application of any provisions of this chapter or the
regulations adopted pursuant to it if, in the board's opinion, the
waiver will aid in the protection of public health or the provision
of patient care.
(c) During a declared federal, state, or local emergency, the
board shall allow for the employment of a mobile pharmacy in impacted
areas in order to ensure the continuity of patient care, if all of
the following conditions are met:
(1) The mobile pharmacy shares common ownership with at least one
currently licensed pharmacy in good standing.
(2) The mobile pharmacy retains records of dispensing, as required
by subdivision (a).
(3) A licensed pharmacist is on the premises and the mobile
pharmacy is under the control and management of a pharmacist while
the drugs are being dispensed.
(4) Reasonable security measures are taken to safeguard the drug
supply maintained in the mobile pharmacy.
(5) The mobile pharmacy is located within the declared emergency
area or affected areas.
(6) The mobile pharmacy ceases the provision of services within 48
hours following the termination of the declared emergency.
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 of a human or animal for whom the
prescription is meant if the person or entity either knew or
reasonably should have known that the prescription was not issued
pursuant to a good faith prior examination of a human or animal, or
if the person or entity did not act in accordance with Section 1761
of Title 16 of the California Code of Regulations.
(b) Notwithstanding any other provision of law, a violation of
this section may subject the person or entity that has committed the
violation to either a fine of up to twenty-five thousand dollars
($25,000) per occurrence pursuant to a citation issued by the board
or a civil penalty of twenty-five thousand dollars ($25,000) per
occurrence.
(c) The Attorney General may bring an action to enforce this
section and to collect the fines or civil penalties authorized by
subdivision (b).
(d) For notifications made on and after January 1, 2002, the
Franchise Tax Board, upon notification by the Attorney General or the
board of a final judgment in an action brought under this section,
shall subtract the amount of the fine or awarded civil penalties from
any tax refunds or lottery winnings due to the person who is a
defendant in the action using the offset authority under Section
12419.5 of the Government Code, as delegated by the Controller, and
the processes as established by the Franchise Tax Board for this
purpose. That amount shall be forwarded to the board for deposit in
the Pharmacy Board Contingent Fund.
(e) Nothing in this section shall be construed to permit the
unlicensed practice of pharmacy, or to limit the authority of the
board to enforce any other provision of this chapter.
(f) For the purposes of this section, "good faith prior
examination" includes the requirements for a physician and surgeon in
Section 2242 and the requirements for a veterinarian in Section
2032.1 of Title 16 of the California Code of Regulations.
4068. (a) Notwithstanding any provision of this chapter, a
prescriber may dispense a dangerous drug, including a controlled
substance, to an emergency room patient if all of the following
apply:
(1) The hospital pharmacy is closed and there is no pharmacist
available in the hospital.
(2) The dangerous drug is acquired by the hospital pharmacy.
(3) The dispensing information is recorded and provided to the
pharmacy when the pharmacy reopens.
(4) The hospital pharmacy retains the dispensing information and,
if the drug is a schedule II, schedule III, or schedule IV controlled
substance, reports the dispensing information to the Department of
Justice pursuant to Section 11165 of the Health and Safety Code.
(5) The prescriber determines that it is in the best interest of
the patient that a particular drug regimen be immediately commenced
or continued, and the prescriber reasonably believes that a pharmacy
located outside the hospital is not available and accessible at the
time of dispensing to the patient.
(6) The quantity of drugs dispensed to any patient pursuant to
this section are limited to that amount necessary to maintain
uninterrupted therapy during the period when pharmacy services
outside the hospital are not readily available or accessible, but
shall not exceed a 72-hour supply.
(7) The prescriber shall ensure that the label on the drug
contains all the information required by Section 4076.
(b) The prescriber shall be responsible for any error or omission
related to the drugs dispensed.
