California Legislature—2013–14 Regular Session

Assembly Bill No. 396

Introduced by Assembly Member Fox

February 15, 2013

An act to amend Sections 4040 and 4076 of the Business and Professions Code, relating to pharmacy.

LEGISLATIVE COUNSEL’S DIGEST

AB 396, as introduced, Fox. Prescriptions.

Existing law, the Pharmacy Law, provides for the licensure and regulation of pharmacists by the California State Board of Pharmacy and provides that a knowing violation of the law is a crime. Existing law requires every prescription, as defined, to include a legible, clear notice of the condition or purpose for which the drug is prescribed, if requested by the patient. Existing law prohibits a pharmacist from dispensing any prescription unless it is in a specified container that is correctly labeled to include, among other information, the condition or purpose for which the drug was prescribed if the condition or purpose is indicated on the prescription.

This bill would instead require that every prescription include a legible, clear notice of the condition or purpose for which the drug is prescribed, unless the patient or prescriber requests that this information be omitted. The bill would also require that every prescription container be correctly labeled to include that information, if so indicated on the prescription, unless the patient or prescriber requests that this information be omitted.

By revising these requirements, the knowing violation of which would be a crime, the bill 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 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 or purpose for which
the drug is being prescribed, begin delete if requested by end delete begin insert unless end insert the patient or
patients begin insert , or the prescriber, requests that this information be
omitted end insert .

(F) If in writing, signed by the prescriber issuing the order, or
the certified nurse-midwife, nurse practitioner, physician assistant,
or naturopathic doctor who issues a drug order pursuant to Section
2746.51, 2836.1, 3502.1, or 3640.5, respectively, or the pharmacist
who issues a drug order pursuant to either Section 4052.1 or
4052.2.

(2) Issued by a physician, dentist, optometrist, podiatrist,
veterinarian, or naturopathic doctor pursuant to Section 3640.7 or,
if a drug order is issued pursuant to Section 2746.51, 2836.1,
3502.1, or 3460.5, by a certified nurse-midwife, nurse practitioner,
physician assistant, or naturopathic doctor licensed in this state,
or pursuant to either Section 4052.1 or 4052.2 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 (2) of subdivision (a) 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 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 Section 4052.1 or 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
Section 4052.1 or 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 condition or purpose for which the drug was prescribed begin insert , end insert
if the condition or purpose is indicated on the prescription begin insert , end insert begin insert unless
the patient or patients, or the prescriber, requests that this
information be omitted end insert .

(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
begin delete facility licensed pursuant to end delete begin insert health facility, as defined in end insert 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 Section 4052.1 or 4052.2.

(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. 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.