Amended in Assembly June 27, 2013

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 translations of the directions for use in non-English languages published on the board’s Internet Web site to be used, as applicable, when labeling a prescription container. The bill would, notwithstanding these provisions, authorize a pharmacy to begin delete provide end delete begin insert use end insert its own translations of the begin insert board’s English language end insert directions for begin delete use established by regulation of the board in the non-English languages published on the board’s Internet Web site end delete begin insert use, as specified, if a trained and qualified translator or translation service, as defined, is utilized to complete the additional translations end insert . The bill would authorize the directions for use, as specified, to be translated into additional non-English languages if begin delete certified translation services are end delete begin insert a trained and qualified translator or translation service, as defined, is end insert utilized to complete the additional translations. The bill would authorize a pharmacist to begin delete provide end delete begin insert use end insert 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. begin insert The bill would require that the board’s English language directions for use be provided in each instance in which a non-English translation of the directions for use is used. end insert Because a violation of this requirement would be a crime, the bill would impose a state-mandated local program.

begin insert

This bill would define “translation” and “trained and qualified translator or translation service” for purposes of the provisions described above.

end insert

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

(b) The begin insert English language end insert directions for use established by
regulation of the board may be translated into additional
non-English languages if begin delete certified translation services are end delete begin insert a trained
and qualified translator or translation service is end insert utilized to
complete the additional translations.

(c) Notwithstanding subdivision (a), a pharmacy may begin delete provide end delete
begin insert use end insert 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 begin insert if a trained and qualified translator or
translation service is utilized end 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 begin delete provide end delete begin insert use end insert the English language
directions for use established by regulation of the board begin insert when
labeling a prescription container end insert pursuant to Section 4076.

(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.

begin insert

(f) The English language directions for use established by
regulation of the board shall be provided in each instance in which
a non-English translation of the directions for use is used pursuant
to this section.

end insert begin insert

(g) For purposes of this section, “translation” means the
conversion of written text to the corresponding written text in a
different language.

end insert begin insert

(h) For purposes of this section, “trained and qualified
translator or translation service” means any of the following:

end insert begin insert

(1) An individual certified by the American Translators
Association or any other nationally accredited or state-approved
program the board deems satisfactory.

end insert begin insert

(2) An individual trained in translation who has been assessed
as competent by a company specializing in translation that
employs, or has a contractual relationship with, the individual.

end insert begin insert

(3) An individual employed by a pharmacy who meets all of the
following requirements:

end insert begin insert

(A) He or she has written proficiency in both English and a
non-English language.

end insert begin insert

(B) He or she commits to abide by the American Translators
Association’s Code of Professional Conduct and Business
Practices.

end insert begin insert

(C) He or she exhibits sufficient knowledge and understanding
of required health care vocabulary and terminology related to the
practice of pharmacy.

end insert begin insert

A pharmacy shall establish internal policies to determine and
document an individual’s qualifications pursuant to subparagraphs
(A) to (C), inclusive, of this paragraph.

end insert begin delete

(f)

end delete

begin insert (i) 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.