Bill Text: CA SB204 | 2013-2014 | Regular Session | Amended

California Senate Bill 204 (Prior Session Legislation)

NOTE: There are more recent revisions of this legislation. Read Latest Draft

Bill Title: Prescription drugs: labeling.

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Vetoed) 2014-09-28 - In Senate. Consideration of Governor's veto pending. [SB204 Detail]

Download: California-2013-SB204-Amended.html

BILL NUMBER: SB 204	AMENDED
	BILL TEXT

	AMENDED IN ASSEMBLY  JUNE 27, 2013
	AMENDED IN SENATE  MAY 23, 2013
	AMENDED IN SENATE  APRIL 24, 2013

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  provide  
use  its own translations of the  board's English language
 directions for  use established by regulation of the
board in the non-English languages published on the board's Internet
Web site   use, as specified, if a trained and qualified
translator or translation service, as defined, is utilized to
complete the additional translations  . The bill would authorize
the directions for use, as specified, to be translated into
additional non-English languages if  certified translation
services are   a trained and qualified translator or
translation service, as defined, is  utilized to complete the
additional translations. The bill would authorize a pharmacist to
 provide   use  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.  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.  Because a violation of this requirement would
be a crime, the bill would impose a state-mandated local program.

   This bill would define "translation" and "trained and qualified
translator or translation service" for purposes of the provisions
described above. 
   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  English language  directions for use established
by regulation of the board may be translated into additional
non-English languages if  certified translation services are
  a trained and qualified translator or  
translation service is  utilized to complete the additional
translations.
   (c) Notwithstanding subdivision (a), a pharmacy may 
provide   use  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  if a
trained and qualified translator or translation service is utilized
 .
   (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   use 
the English language directions for use established by regulation of
the board  when labeling a prescription container  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. 
   (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.  
   (g) For purposes of this section, "translation" means the
conversion of written text to the corresponding written text in a
different language.  
   (h) For purposes of this section, "trained and qualified
translator or translation service" means any of the following: 

   (1) An individual certified by the American Translators
Association or any other nationally accredited or state-approved
program the board deems satisfactory.  
   (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.  
   (3) An individual employed by a pharmacy who meets all of the
following requirements:  
   (A) He or she has written proficiency in both English and a
non-English language.  
   (B) He or she commits to abide by the American Translators
Association's Code of Professional Conduct and Business Practices.
 
   (C) He or she exhibits sufficient knowledge and understanding of
required health care vocabulary and terminology related to the
practice of pharmacy.  
   A pharmacy shall establish internal policies to determine and
document an individual's qualifications pursuant to subparagraphs (A)
to (C), inclusive, of this paragraph.  
   (f) 
    (i)  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.