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

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

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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

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BILL NUMBER: SB 204	AMENDED
	BILL TEXT

	AMENDED IN ASSEMBLY  JUNE 10, 2014
	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  and rep   eal  Section 4076.3
 to   of  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.   Existing
regulations of the board provide   standardized directions
for use that are required to be used on drug container labels, as
specified.  
   This bill would require the board to conduct a survey of a
representative sample of licensed pharmacists to determine the usage
of the directions for use described above. The bill would require
this survey to address certain issues, including, but not limited to,
whether and how often the pharmacist utilizes the directions for
use, barriers to utilizing the directions for use, and other
directions for use utilized by the pharmacist. The bill would also
require the board to conduct a similar survey of vendors that provide
electronic health records (EHR) to pharmacies and prescribers to
determine the type of directions for use included in the vendor's EHR
programming, as specified. The bill would authorize these surveys to
be conducted with other routine surveys conducted by the board
during its regular course of business. The bill would require the
board to report the survey findings at its July 2016 board meeting
and to publish the findings on the board's Internet Web site, as
specified.  
   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 use its own translations of the
board's English language directions for 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 a trained and qualified
translator or translation service, as defined, is utilized to
complete the additional translations. The bill would authorize a
pharmacist to 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   no  .


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) The board shall conduct a survey of a representative
sample of licensed pharmacists to determine the utilization of the
standardized directions for use provided in paragraph (4) of
subdivision (a) of Section 1707.5 of Article 2 of Division 17 of
Title 16 of the California Code of Regulations. The survey shall
address, but not be limited to, all of the following issues:
   (1) Whether the pharmacist utilizes the standardized directions
for use.
   (2) How often the pharmacist utilizes the standardized directions
for use.
   (3) Challenges or barriers to utilizing the standardized
directions for use.
   (4) Other directions for use utilized by the pharmacist.
   (b) The board shall conduct a survey of vendors that provide
electronic health records (EHR) to pharmacies and prescribers to
determine the type of directions for use included in the vendor's EHR
programming. The survey shall address, but not be limited to, all of
the following issues:
   (1) Whether the standardized directions for use described in
subdivision (a) are included in the vendor's EHR programming.
   (2) Challenges or barriers to utilizing the standardized
directions for use in the vendor's EHR programming.
   (3) Other directions for use utilized by the vendor in its EHR
programming.
   (c) The surveys required by this section may be conducted with
other routine surveys conducted by the board during its regular
course of business.
   (d) The board shall report the findings of the surveys required by
this section in the aggregate at its July 2016 board meeting and
publish these findings on its Internet Web site.
   This section shall remain in effect only until January 1, 2020,
and as of that date is repealed, unless a later enacted statute, that
is enacted before January 1, 2020, deletes or extends that date.
 
  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 a trained and qualified translator or translation
service is utilized to complete the additional translations.
   (c) Notwithstanding subdivision (a), a pharmacy may 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 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.
   (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.