BILL NUMBER: AB 2660 CHAPTERED
BILL TEXT
CHAPTER 191
FILED WITH SECRETARY OF STATE JULY 23, 2004
APPROVED BY GOVERNOR JULY 23, 2004
PASSED THE SENATE JULY 12, 2004
PASSED THE ASSEMBLY APRIL 29, 2004
AMENDED IN ASSEMBLY APRIL 12, 2004
AMENDED IN ASSEMBLY MARCH 26, 2004
INTRODUCED BY Assembly Member Leno
FEBRUARY 20, 2004
An act to amend Sections 4040, 4052, 4060, 4076, and 4111 of the
Business and Professions Code, and to amend Section 11150 of the
Health and Safety Code, relating to pharmaceuticals.
LEGISLATIVE COUNSEL'S DIGEST
AB 2660, Leno. Prescriptions: issuance by a pharmacist.
Existing law, the Uniform Controlled Substances Act, authorizes a
pharmacist in specified circumstances to write or issue a
prescription. The Pharmacy Law, which provides for the licensure and
regulation by the California State Board of Pharmacy of pharmacy
practices, defines a prescription, in part, as being issued by
designated healing arts practitioners, not including a pharmacist.
The Pharmacy Law prohibits the board from issuing a pharmacy license
to, or renewing a pharmacy license of, specified persons, including
those who are authorized to write a prescription. A knowing
violation of the Pharmacy Law is a misdemeanor offense.
This bill would revise the definition of "prescription" to include
a drug order issued by a pharmacist pursuant to specified
conditions. The bill would also specify that the board is not
precluded from issuing or renewing a license for a pharmacy owned or
owned and operated by a pharmacist who is authorized to issue a
specified drug order.
Because the bill would specify additional requirements under the
Pharmacy Law, the violation of which would be a crime, it would
impose a state-mandated local program.
The California Constitution requires the state to reimburse local
agencies and school districts for certain costs mandated by the
state. Statutory provisions establish procedures for making that
reimbursement.
This bill would provide that no reimbursement is required by this
act for a specified reason.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 4040 of the Business and Professions Code is
amended to read:
4040. (a) "Prescription" means an oral, written, or electronic
transmission order that is both of the following:
(1) Given individually for the person or persons for whom ordered
that includes all of the following:
(A) The name or names and address of the patient or patients.
(B) The name and quantity of the drug or device prescribed and the
directions for use.
(C) The date of issue.
(D) Either rubber stamped, typed, or printed by hand or typeset,
the name, address, and telephone number of the prescriber, his or her
license classification, and his or her federal registry number, if a
controlled substance is prescribed.
(E) A legible, clear notice of the condition for which the drug is
being prescribed, if requested by the patient or patients.
(F) If in writing, signed by the prescriber issuing the order, or
the certified nurse-midwife, nurse practitioner, or physician
assistant who issues a drug order pursuant to Section 2746.51,
2836.1, or 3502.1, respectively, or the pharmacist who issues a drug
order pursuant to either subparagraph (D) of paragraph (4) of, or
clause (iv) of subparagraph (A) of paragraph (5) of, subdivision (a)
of Section 4052.
(2) Issued by a physician, dentist, optometrist, podiatrist, or
veterinarian or, if a drug order is issued pursuant to Section
2746.51, 2836.1, or 3502.1, by a certified nurse-midwife, nurse
practitioner, or physician assistant licensed in this state, or
pursuant to either subparagraph (D) of paragraph (4) of, or clause
(iv) of subparagraph (A) of paragraph (5) of, subdivision (a) of
Section 4052 by a pharmacist licensed in this state.
(b) Notwithstanding subdivision (a), a written order of the
prescriber for a dangerous drug, except for any Schedule II
controlled substance, that contains at least the name and signature
of the prescriber, the name and address of the patient in a manner
consistent with paragraph (3) of subdivision (b) of Section 11164 of
the Health and Safety Code, the name and quantity of the drug
prescribed, directions for use, and the date of issue may be treated
as a prescription by the dispensing pharmacist as long as any
additional information required by subdivision (a) is readily
retrievable in the pharmacy. In the event of a conflict between this
subdivision and Section 11164 of the Health and Safety Code, Section
11164 of the Health and Safety Code shall prevail.
(c) "Electronic transmission prescription" includes both image and
data prescriptions. "Electronic image transmission prescription"
means any prescription order for which a facsimile of the order is
received by a pharmacy from a licensed prescriber. "Electronic data
transmission prescription" means any prescription order, other than
an electronic image transmission prescription, that is electronically
transmitted from a licensed prescriber to a pharmacy.
(d) The use of commonly used abbreviations shall not invalidate an
otherwise valid prescription.
(e) Nothing in the amendments made to this section (formerly
Section 4036) at the 1969 Regular Session of the Legislature shall be
construed as expanding or limiting the right that a chiropractor,
while acting within the scope of his or her license, may have to
prescribe a device.
SEC. 2. Section 4052 of the Business and Professions Code is
amended to read:
4052. (a) Notwithstanding any other provision of law, a
pharmacist may:
(1) Furnish a reasonable quantity of compounded medication to a
prescriber for office use by the prescriber.
(2) Transmit a valid prescription to another pharmacist.
(3) Administer, orally or topically, drugs and biologicals
pursuant to a prescriber's order.
(4) Perform the following procedures or functions in a licensed
health care facility in accordance with policies, procedures, or
protocols developed by health professionals, including physicians,
pharmacists, and registered nurses, with the concurrence of the
facility administrator:
(A) Ordering or performing routine drug therapy-related patient
assessment procedures including temperature, pulse, and respiration.
(B) Ordering drug therapy-related laboratory tests.
(C) Administering drugs and biologicals by injection pursuant to a
prescriber's order (the administration of immunizations under the
supervision of a prescriber may also be performed outside of a
licensed health care facility).
(D) Initiating or adjusting the drug regimen of a patient pursuant
to an order or authorization made by the patient's prescriber and in
accordance with the policies, procedures, or protocols of the
licensed health care facility.
(5) (A) Perform the following procedures or functions as part of
the care provided by a health care facility, a licensed home health
agency, a licensed clinic in which there is a physician oversight, a
provider who contracts with a licensed health care service plan with
regard to the care or services provided to the enrollees of that
health care service plan, or a physician, in accordance, as
applicable, with policies, procedures, or protocols of that facility,
the home health agency, the licensed clinic, the health care service
plan, or that physician, in accordance with subparagraph (C):
(i) Ordering or performing routine drug therapy-related patient
assessment procedures including temperature, pulse, and respiration.
(ii) Ordering drug therapy-related laboratory tests.
(iii) Administering drugs and biologicals by injection pursuant to
a prescriber's order (the administration of immunizations under the
supervision of a prescriber may also be performed outside of a
licensed health care facility).
(iv) Initiating or adjusting the drug regimen of a patient
pursuant to a specific written order or authorization made by the
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 clause 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
paragraph shall be developed by health care professionals, including
physicians, pharmacists, and registered nurses, and, at a minimum,
meet all of the following requirements:
(i) Require that the pharmacist function as part of a
multidisciplinary group that includes physicians and direct care
registered nurses. The multidisciplinary group shall determine the
appropriate participation of the pharmacist and the direct care
registered nurse.
(ii) Require that the medical records of the patient be available
to both the patient's treating prescriber and the pharmacist.
(iii) Require that the procedures to be performed by the
pharmacist relate to a condition for which the patient has first been
seen by a physician.
(iv) Except for procedures or functions provided by a health care
facility, a licensed clinic in which there is physician oversight, or
a provider who contracts with a licensed health care plan with
regard to the care or services provided to the enrollees of that
health care service plan, require the procedures to be performed in
accordance with a written, patient-specific protocol approved by the
treating or supervising physician. Any change, adjustment, or
modification of an approved preexisting treatment or drug therapy
shall be provided in writing to the treating or supervising physician
within 24 hours.
(6) Manufacture, measure, fit to the patient, or sell and repair
dangerous devices or furnish instructions to the patient or the
patient's representative concerning the use of those devices.
(7) Provide consultation to patients and professional information,
including clinical or pharmacological information, advice, or
consultation to other health care professionals.
(8) (A) Furnish emergency contraception drug therapy in accordance
with either of the following:
(i) Standardized procedures or protocols developed by the
pharmacist and an authorized prescriber who is acting within his or
her scope of practice.
(ii) 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 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
paragraph.
(b) (1) Prior to performing any procedure authorized by paragraph
(4) of subdivision (a), a pharmacist shall have received appropriate
training as prescribed in the policies and procedures of the licensed
health care facility.
(2) Prior to performing any procedure authorized by paragraph (5)
of subdivision (a), a pharmacist shall have either (A) successfully
completed clinical residency training or (B) demonstrated clinical
experience in direct patient care delivery.
(3) For each emergency contraception drug therapy initiated
pursuant to paragraph (8) of subdivision (a), the pharmacist shall
provide the recipient of the emergency contraception drugs with a
standardized 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 Health Services, the American College of
Obstetricians and Gynecologists, the California Pharmacists
Association, and other health care organizations. The provisions of
this section do not preclude the use of existing publications
developed by nationally recognized medical organizations.
(c) 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.
(d) Nothing in this section shall affect the requirements of
existing law relating to maintaining the confidentiality of medical
records.
(e) Nothing in this section shall affect the requirements of
existing law relating to the licensing of a health care facility.
SEC. 3. Section 4060 of the Business and Professions Code is
amended to read:
4060. No person shall possess any controlled substance, except
that furnished to a person upon the prescription of a physician,
dentist, podiatrist, optometrist, or veterinarian, or furnished
pursuant to a drug order issued by a certified nurse-midwife pursuant
to Section 2746.51, a nurse practitioner pursuant to Section 2836.1,
a physician assistant pursuant to Section 3502.1, or a pharmacist
pursuant to either subparagraph (D) of paragraph (4) of, or clause
(iv) of subparagraph (A) of paragraph (5) of, subdivision (a) of
Section 4052. This section shall not apply to the possession of any
controlled substance by a manufacturer, wholesaler, pharmacy,
pharmacist, physician, podiatrist, dentist, optometrist,
veterinarian, certified nurse-midwife, nurse practitioner, or
physician assistant, when in stock in containers correctly labeled
with the name and address of the supplier or producer.
Nothing in this section authorizes a certified nurse-midwife, a
nurse practitioner, or a physician assistant to order his or her own
stock of dangerous drugs and devices.
SEC. 4. Section 4076 of the Business and Professions Code is
amended to read:
4076. (a) A pharmacist shall not dispense any prescription except
in a container that meets the requirements of state and federal law
and is correctly labeled with all of the following:
(1) Except where the prescriber or the certified nurse-midwife who
functions pursuant to a standardized procedure or protocol described
in Section 2746.51, the nurse practitioner who functions pursuant to
a standardized procedure described in Section 2836.1, or protocol,
the physician assistant who functions pursuant to Section 3502.1, or
the pharmacist who functions pursuant to a policy, procedure, or
protocol pursuant to either subparagraph (D) of paragraph (4) of, or
clause (iv) of subparagraph (A) of paragraph (5) of, subdivision (a)
of Section 4052 orders otherwise, either the manufacturer's trade
name of the drug or the generic name and the name of the
manufacturer. Commonly used abbreviations may be used. Preparations
containing two or more active ingredients may be identified by the
manufacturer's trade name or the commonly used name or the principal
active ingredients.
(2) The directions for the use of the drug.
(3) The name of the patient or patients.
(4) The name of the prescriber or, if applicable, the name of the
certified nurse-midwife who functions pursuant to a standardized
procedure or protocol described in Section 2746.51, the nurse
practitioner who functions pursuant to a standardized procedure
described in Section 2836.1, or protocol, the physician assistant who
functions pursuant to Section 3502.1, or the pharmacist who
functions pursuant to a policy, procedure, or protocol pursuant to
either subparagraph (D) of paragraph (4) of, or clause (iv) of
subparagraph (A) of paragraph (5) of, subdivision (a) of Section
4052.
(5) The date of issue.
(6) The name and address of the pharmacy, and prescription number
or other means of identifying the prescription.
(7) The strength of the drug or drugs dispensed.
(8) The quantity of the drug or drugs dispensed.
(9) The expiration date of the effectiveness of the drug
dispensed.
(10) The condition for which the drug was prescribed if requested
by the patient and the condition is indicated on the prescription.
(11) (A) Commencing January 1, 2006, the physical description of
the dispensed medication, including its color, shape, and any
identification code that appears on the tablets or capsules, except
as follows:
(i) Prescriptions dispensed by a veterinarian.
(ii) An exemption from the requirements of this paragraph shall be
granted to a new drug for the first 120 days that the drug is on the
market and for the 90 days during which the national reference file
has no description on file.
(iii) Dispensed medications for which no physical description
exists in any commercially available database.
(B) This paragraph applies to outpatient pharmacies only.
(C) The information required by this paragraph may be printed on
an auxiliary label that is affixed to the prescription container.
(D) This paragraph shall not become operative if the board, prior
to January 1, 2006, adopts regulations that mandate the same labeling
requirements set forth in this paragraph.
(b) If a pharmacist dispenses a prescribed drug by means of a unit
dose medication system, as defined by administrative regulation, for
a patient in a skilled nursing, intermediate care, or other health
care facility, the requirements of this section will be satisfied if
the unit dose medication system contains the aforementioned
information or the information is otherwise readily available at the
time of drug administration.
(c) If a pharmacist dispenses a dangerous drug or device in a
facility licensed pursuant to Section 1250 of the Health and Safety
Code, it is not necessary to include on individual unit dose
containers for a specific patient, the name of the certified
nurse-midwife who functions pursuant to a standardized procedure or
protocol described in Section 2746.51, the nurse practitioner who
functions pursuant to a standardized procedure described in Section
2836.1, or protocol, the physician assistant who functions pursuant
to Section 3502.1, or the pharmacist who functions pursuant to a
policy, procedure, or protocol pursuant to either subparagraph (D) of
paragraph (4) of, or clause (iv) of subparagraph (A) of paragraph
(5) of, subdivision (a) of Section 4052.
(d) If a pharmacist dispenses a prescription drug for use in a
facility licensed pursuant to Section 1250 of the Health and Safety
Code, it is not necessary to include the information required in
paragraph (11) of subdivision (a) when the prescription drug is
administered to a patient by a person licensed under the Medical
Practice Act (Chapter 5 (commencing with Section 2000)), the Nursing
Practice Act (Chapter 6 (commencing with Section 2700)), or the
Vocational Nursing Practice Act (Chapter 6.5 (commencing with Section
2840)), who is acting within his or her scope of practice.
SEC. 5. Section 4111 of the Business and Professions Code is
amended to read:
4111. (a) Except as otherwise provided in subdivision (b), (d),
or (e), the board shall not issue or renew a license to conduct a
pharmacy to any of the following:
(1) A person or persons authorized to prescribe or write a
prescription, as specified in Section 4040, in the State of
California.
(2) A person or persons with whom a person or persons specified in
paragraph (1) shares a community or other financial interest in the
permit sought.
(3) Any corporation that is controlled by, or in which 10 percent
or more of the stock is owned by a person or persons prohibited from
pharmacy ownership by paragraph (1) or (2).
(b) Subdivision (a) shall not preclude the issuance of a permit
for an inpatient hospital pharmacy to the owner of the hospital in
which it is located.
(c) The board may require any information the board deems is
reasonably necessary for the enforcement of this section.
(d) Subdivision (a) shall not preclude the issuance of a new or
renewal license for a pharmacy to be owned or owned and operated by a
person licensed on or before August 1, 1981, under the Knox-Keene
Health Care Service Plan Act of 1975 (Chapter 2.2 (commencing with
Section 1340) of Division 2 of the Health and Safety Code) and
qualified on or before August 1, 1981, under subsection (d) of
Section 1310 of Title XIII of the federal Public Health Service Act,
as amended, whose ownership includes persons defined pursuant to
paragraphs (1) and (2) of subdivision (a).
(e) Subdivision (a) shall not preclude the issuance of a new or
renewal license for a pharmacy to be owned or owned and operated by a
pharmacist authorized to issue a drug order pursuant to subparagraph
(D) of paragraph (4) of, or clause (iv) of subparagraph (A) of
paragraph (5) of, subdivision (a) of Section 4052.
SEC. 6. Section 11150 of the Health and Safety Code is amended to
read:
11150. No person other than a physician, dentist, podiatrist, or
veterinarian, or pharmacist acting within the scope of a project
authorized under Article 1 (commencing with Section 128125) of
Chapter 3 of Part 3 of Division 107 or within the scope of either
subparagraph (D) of paragraph (4) of, or clause (iv) of subparagraph
(A) of paragraph (5) of, subdivision (a) of Section 4052 of the
Business and Professions Code, a registered nurse acting within the
scope of a project authorized under Article 1 (commencing with
Section 128125) of Chapter 3 of Part 3 of Division 107, a certified
nurse-midwife acting within the scope of Section 2746.51 of the
Business and Professions Code, a nurse practitioner acting within the
scope of Section 2836.1 of the Business and Professions Code, a
physician assistant acting within the scope of a project authorized
under Article 1 (commencing with Section 128125) of Chapter 3 of Part
3 of Division 107 or Section 3502.1 of the Business and Professions
Code, or an optometrist acting within the scope of Section 3041 of
the Business and Professions Code, or an out-of-state prescriber
acting pursuant to Section 4005 of the Business and Professions Code
shall write or issue a prescription.
SEC. 7. No reimbursement is required by this act pursuant to
Section 6 of Article XIII B of the California Constitution because
the only costs that may be incurred by a local agency or school
district will be incurred because this act creates a new crime or
infraction, eliminates a crime or infraction, or changes the penalty
for a crime or infraction, within the meaning of Section 17556 of the
Government Code, or changes the definition of a crime within the
meaning of Section 6 of Article XIII B of the California
Constitution.