Amended in Senate May 23, 2013

Amended in Senate April 24, 2013

Senate Bill No. 204

Introduced by Senator Corbett

February 8, 2013

An act to add Section 4076.3 to the Business and Professions Code, relating to pharmacy.

LEGISLATIVE COUNSEL’S DIGEST

SB 204, 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 prohibits a pharmacist from dispensing any prescription unless it is in a specified container that is correctly labeled to include, among other information, the directions for the use of the drug. A violation of the Pharmacy Law is a crime.

This bill would, commencing January 1, 2016, require begin delete a pharmacist to end delete begin delete use end delete translations of the directions for use in non-English languages published on the board’s Internet Web site begin insert to be used end insert , as applicable, when labeling a prescription container. begin insert The bill would, notwithstanding these provisions, authorize a pharmacy to provide its own translations of the directions for use established by regulation of the board in the non-English languages published on the board’s Internet Web site. end insert The bill would authorize begin delete a pharmacist to translate end delete the directions for begin delete use end delete begin insert use, as specified, to be translated end insert into additional non-English languages if certified translation services are utilized to complete the additional translations. begin insert The bill would authorize a pharmacist to provide the English language directions for use, as specified, if he or she reasonably believes a translation of the directions for use contains an error due to software or equipment malfunction. The bill would also provide that a pharmacist that reasonably uses the translations of the directions for use in non-English languages published on the board’s Internet Web site has not breached his or her legal duty if the published translations contain an error and the pharmacist did not know, or did not have reason to know, of the error. end insert 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 4076.3 is added to the Business and
Professions Code, to read:

4076.3.  

(a)  begin delete A pharmacist shall use translations end delete begin insert Translations end insert
of the directions for use in non-English languages published on
the board’s Internet Web site begin insert shall be used end insert , as applicable, when
labeling a prescription container pursuant to Section 4076.

(b)  begin delete A pharmacist may translate the end delete begin insert The end insert directions for use
begin insert established by regulation of the board may be translated end insert into
additional non-English languages if certified translation services
are utilized to complete the additional translations.

begin insert

(c) Notwithstanding subdivision (a), a pharmacy may provide
its own translations of the directions for use established by
regulation of the board in the non-English languages published
on the board’s Internet Web site when labeling a prescription
container pursuant to Section 4076.

end insert begin insert

(d) If a pharmacist reasonably believes that a translation of the
directions for use contains an error due to software or equipment
malfunction, he or she may provide the English language directions
for use established by regulation of the board pursuant to Section
4076.

end insert begin insert

(e) A pharmacist that reasonably uses the translations of the
directions for use in non-English languages published on the
board’s Internet Web site has not breached his or her legal duty
if the published translations contain an error and the pharmacist
did not know, or did not have reason to know, of the error.

end insert begin delete

(c)

end delete

begin insert (f) end insert  This section shall become operative on January 1, 2016.

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.