Bill Text: CA AB1073 | 2015-2016 | Regular Session | Chaptered
Bill Title: Pharmacy: prescription drug labels.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Passed) 2015-10-11 - Chaptered by Secretary of State - Chapter 784, Statutes of 2015. [AB1073 Detail]
Download: California-2015-AB1073-Chaptered.html
BILL NUMBER: AB 1073 CHAPTERED
BILL TEXT
CHAPTER 784
FILED WITH SECRETARY OF STATE OCTOBER 11, 2015
APPROVED BY GOVERNOR OCTOBER 11, 2015
PASSED THE SENATE SEPTEMBER 9, 2015
PASSED THE ASSEMBLY SEPTEMBER 10, 2015
AMENDED IN SENATE SEPTEMBER 4, 2015
AMENDED IN SENATE SEPTEMBER 1, 2015
AMENDED IN SENATE JULY 8, 2015
AMENDED IN SENATE JUNE 9, 2015
AMENDED IN ASSEMBLY APRIL 28, 2015
AMENDED IN ASSEMBLY APRIL 6, 2015
INTRODUCED BY Assembly Member Ting
FEBRUARY 27, 2015
An act to amend Sections 4076 and 4199 of, and to add Section
4076.6 to, the Business and Professions Code, relating to pharmacy.
LEGISLATIVE COUNSEL'S DIGEST
AB 1073, Ting. Pharmacy: prescription drug labels.
The Pharmacy Law provides for the licensure and regulation of
pharmacists by the California State Board of Pharmacy. That law
requires a pharmacist to dispense a prescription in a container that,
among other things, is correctly labeled with the directions for use
of the drug, and requires the board to promulgate regulations that
require, on or before January 1, 2011, a standardized,
patient-centered, prescription drug label on all prescription
medicine dispensed to patients in California. Existing regulations of
the board implement that requirement, establishing standardized
directions for use to be used when applicable, and requiring that the
board publish on its Internet Web site translation of those
directions for use into at least 5 languages other than English. A
violation of that law is a crime.
This bill would require a pharmacist to use professional judgment
to provide a patient with directions for use of a prescription that
enhance the patient's understanding of those directions, consistent
with the prescriber's instructions. The bill would also require a
dispenser, excluding a veterinarian, upon the request of a patient or
patient's representative, to provide translated directions for use
as prescribed. The bill would authorize a dispenser to use
translations made available by the board pursuant to those existing
regulations. The bill would make a dispenser responsible for the
accuracy of English-language directions for use provided to the
patient. By imposing new requirements on dispensers, the violation of
which would be a crime, this bill would impose a state-mandated
local program.
The Pharmacy Law also provides for the licensure and regulation of
veterinary food-animal drug retailers by the board. That law
subjects to specific prescription drug labeling requirements any
veterinary food-animal drug dispensed pursuant to a prescription from
a licensed veterinarian for food-producing animals from a veterinary
food-animal drug retailer pursuant to that law.
This bill would also subject any veterinary food-animal drug so
dispensed to the above drug labeling requirements relating to
standardized directions for use.
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 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 when 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 Section 4052.1, 4052.2, or 4052.6 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 Section 4052.1, 4052.2, or
4052.6.
(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 or purpose for which the drug was prescribed if
the condition or purpose 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, 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 Section 4052.1, 4052.2, or 4052.6.
(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.
(e) A pharmacist shall use professional judgment to provide a
patient with directions for use that enhance the patient's
understanding of those directions, consistent with the prescriber's
instructions.
SEC. 2. Section 4076.6 is added to the Business and Professions
Code, to read:
4076.6. (a) Upon the request of a patient or patient's
representative, a dispenser shall provide translated directions for
use, which shall be printed on the prescription container, label, or
on a supplemental document. If translated directions for use appear
on a prescription container or label, the English-language version of
the directions for use shall also appear on the container or label,
whenever possible, and may appear on other areas of the label outside
the patient-centered area. When it is not possible for the
English-language directions for use to appear on the container or
label, it shall be provided on a supplemental document.
(b) A dispenser may use translations made available by the board
pursuant to subdivision (b) of Section 1707.5 of Title 16 of the
California Code of Regulations to comply with this section.
(c) A dispenser shall not be required to provide translated
directions for use beyond the languages that the board has made
available or beyond the directions that the board has made available
in translated form.
(d) A dispenser may provide his or her own translated directions
for use to comply with the requirements of this section, and nothing
in this section shall be construed to prohibit a dispenser from
providing translated directions for use in languages beyond those
that the board has made available or beyond the directions that the
board has made available in translated form.
(e) A dispenser shall be responsible for the accuracy of the
English-language directions for use provided to the patient. This
section shall not affect a dispenser's existing responsibility to
correctly label a prescription pursuant to Section 4076.
(f) For purposes of this section, a dispenser does not include a
veterinarian.
SEC. 3. Section 4199 of the Business and Professions Code is
amended to read:
4199. (a) Any veterinary food-animal drug dispensed pursuant to a
prescription from a licensed veterinarian for food producing animals
from a veterinary food-animal drug retailer pursuant to this chapter
is subject to the labeling requirements of Sections 4076, 4076.6,
and 4077.
(b) All prescriptions filled by a veterinary food-animal drug
retailer shall be kept on file and maintained for at least three
years in accordance with Section 4333.
SEC. 4. 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.
