BILL NUMBER: AB 1276 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY APRIL 17, 2007
INTRODUCED BY Assembly Member Karnette
FEBRUARY 23, 2007
An act to amend Section 4076 of, and to add Section 4079 to, the
Business and Professions Code, relating to pharmacies.
LEGISLATIVE COUNSEL'S DIGEST
AB 1276, as amended, Karnette. Pharmacies: prescription
containers: labels.
Existing law, the Pharmacy Law, makes the California State Board
of Pharmacy responsible for the regulation of the practice of
pharmacy. Existing law generally makes it a misdemeanor to knowingly
violate the Pharmacy Law.
The Pharmacy Law prohibits a pharmacist from dispensing a
prescription except in a container that meets the requirements of
state and federal law and is correctly labeled with, among other
things, the condition for which the drug was prescribed if requested
by the patient and if the condition is indicated on the prescription.
This bill would eliminate the labeling requirement pertaining to
the condition for which the drug was prescribed, and would instead
require the container to be labeled with the intended purpose, as
defined, of the drug if indicated on the prescription. The bill
would, except for veterinarians on and after
January 1, 2009 , require a person who is authorized to write
or issue a prescription , other than a veterinarian, to
ask the a patient or his or her
authorized representative whether to indicate the intended purpose of
the prescription on the prescription's label , and would
subject a person who violates this requirement for a 2nd or
subsequent time to a citation and an administrative fine .
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.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: yes.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. 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, the
naturopathic doctor who functions pursuant to a standardized
procedure or protocol described in Section 3640.5, or the pharmacist
who functions pursuant to a policy, procedure, or protocol pursuant
to either paragraph (4) of subdivision (a) of Section 4052.1 or
paragraph (4) of subdivision (a) of Section 4052.2 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, the naturopathic doctor who
functions pursuant to a standardized procedure or protocol described
in Section 3640.5, or the pharmacist who functions pursuant to a
policy, procedure, or protocol pursuant to either paragraph (4) of
subdivision (a) of Section 4052.1 or paragraph (4) of subdivision (a)
of Section 4052.2.
(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 intended purpose of the drug or drugs, if indicated on
the prescription. As used in this section, "purpose" means a concise
description of the symptom or symptoms that the drug is, or the drugs
are, intended to treat.
(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, the naturopathic doctor who functions pursuant to
a standardized procedure or protocol described in Section 3640.5, or
the pharmacist who functions pursuant to a policy, procedure, or
protocol pursuant to either paragraph (4) of subdivision (a) of
Section 4052.1 or paragraph (4) of subdivision (a) of Section 4052.2.
(d) If a pharmacist dispenses a prescription drug for use in a
facility licensed pursuant to Chapter 2 (commencing with Section
1250) of Division 2 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. 2. Section 4079 is added to the Business and Professions
Code, to read:
4079. (a) A person described in paragraph
(2) of subdivision (a) of Section 4040 shall ask the patient, or the
patient's authorized representative if the patient is either
incapacitated or a minor who cannot provide informed consent, whether
to indicate the intended purpose of the prescription on the
prescription's label. This section does not apply to prescriptions
dispensed by veterinarians.
(b) A prescriber who violates this section for a second or
subsequent time may be cited and assessed an administrative fine. No
citation shall be issued and no fine shall be assessed upon a first
violation.
(c) This section shall become operative on January 1, 2009.
SEC. 3. 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.