Amended in Senate April 24, 2013

Senate Bill No. 205

Introduced by Senator Corbett

February 8, 2013

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

LEGISLATIVE COUNSEL’S DIGEST

SB 205, as amended, Corbett. Prescription drugs: labeling.

The Pharmacy Law provides for the licensure and regulation of pharmacists by the California State Board of Pharmacy. 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. A violation of the Pharmacy Law is a crime.

This bill would require begin delete the end delete begin insert certain portions of the required end insert information on the prescription label begin insert , including the name of the patient or patients, end insert to be printed in at least a 12-point sans serif typeface. Because a violation of this requirement 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 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 begin delete labeled, in at least a 12-point sans serif
typeface, end delete begin insert labeled end insert 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
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.

begin insert

(b) The information required by paragraphs (1), (2), (3), (7),
and (10) of subdivision (a) shall be printed in at least a 12-point
sans serif typeface.

end insert begin delete

(b)

end delete

begin insert (c) end insert  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.

begin delete

(c)

end delete

begin insert (d) end insert  If a pharmacist dispenses a dangerous drug or device in a
health facility, as defined in 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.

begin delete

(d)

end delete

begin insert (e) end insert  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. 2.  

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.