Amended in Assembly April 6, 2015

California Legislature—2015–16 Regular Session

Assembly Bill No. 1073

Introduced by Assembly Member Ting

February 27, 2015

An act to begin delete amend end delete begin insert add end insert Section begin delete 4076.5 of end delete begin insert 4076.6 to end insert the Business and Professions Code, begin insert and to add Section 1714.20 to the Civil Code, end insert relating to pharmacy.

LEGISLATIVE COUNSEL’S DIGEST

AB 1073, as amended, Ting. Pharmacy: prescription drug labels.

The Pharmacy Law provides for the licensure and regulation of pharmacists by the California State Board of Pharmacy. That law requires the board to promulgate regulations that require, on or before January 1, 2011, a standardized, patient-centered, prescription drug label on all prescription medicine dispensed to patients in California. Existing regulations of the board implement that requirement. begin insert A violation of that law is a crime. end insert

This bill would begin delete remove that obsolete date. end delete begin insert require a dispenser to use a standardized direction for use on the label of the prescription container from a list in existing regulations. The bill would require the board to make available translations, in a minimum of 5 languages other than English, of those standardized directions for use and post the translated standardized directions for use on its Internet Web site. The bill would require a dispenser, upon request of a patient for a translated direction for use, to select the appropriate translated standardized direction for use, if available, and append it to the label on the patient’s prescription container or provide it on a supplemental document. The bill would authorize a dispenser to provide his or her own translated directions as an alternative to the above-described procedure. By imposing new requirements on dispensers, the violation of which would be a crime, this bill would impose a state-mandated local program. end insert

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The bill would exempt from civil liability a dispenser who complies with the requirement to select the appropriate translated standardized direction for use, if available, and append it to the label, for any error that results from the inability of the dispenser to understand a translated direction for use in a language other than English.

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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.

end insert begin insert

This bill would provide that no reimbursement is required by this act for a specified reason.

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Vote: majority. Appropriation: no. Fiscal committee:  begin delete no end delete begin insert yes end insert . State-mandated local program:  begin delete no end delete begin insert yes end insert .

The people of the State of California do enact as follows:

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begin insert SECTION 1. end insert   

end insert

begin insert Section 4076.6 is added to the end insert begin insert Business and
Professions Code end insert begin insert , to read: end insert

begin insert

begin insert 4076.6. end insert   

end insert begin insert

(a) For all dangerous drugs dispensed to patients in
this state, when applicable, a dispenser shall use a standardized
direction for use on the label of the prescription container from
the list in subdivision (a) of Section 1707.5 of Title 16 of the
California Code of Regulations.

end insert begin insert

(b) The board shall make available translations, in a minimum
of five languages other than English, of the standardized directions
for use that are listed in subdivision (a) of Section 1707.5 of Title
16 of the California Code of Regulations. These translations shall
be approved by qualified translators, as determined by the board.
The board shall post these translated standardized directions for
use on its Internet Web site.

end insert begin insert

(c) Upon the request of a patient for a translated direction for
use, a dispenser shall select the appropriate translated
standardized direction for use from those established in accordance
with subdivision (b), if available, and append it to the label on the
patient’s prescription container or provide it on a supplemental
document. If a translated direction for use appears on a
prescription container label, the English version of the direction
shall also appear on the label. The translated direction for use
shall appear in the patient-centered area of the label in accordance
with subdivision (a) of Section 1707.5 of Title 16 of the California
Code of Regulations. The English version may appear in an area
of the label outside the patient-centered area.

end insert begin insert

(d) A dispenser may provide his or her own translated directions
as an alternative to the procedure established in subdivisions (a)
to (c), inclusive. The translated directions for use shall appear in
the patient-centered area of the label in accordance with
subdivision (a) of Section 1707.5 of Title 16 of the California Code
of Regulations or a supplemental document. The English version
may appear in other areas of the label outside the patient-centered
area.

end insert

begin insert

begin insert SEC. 2. end insert   

end insert

begin insert Section 1714.20 is added to the end insert begin insert Civil Code end insert begin insert , end insert immediately
following Section 1714.2 begin insert , to read: end insert

begin insert

begin insert 1714.20. end insert   

end insert begin insert

A dispenser who complies with subdivision (c) of
Section 4076.6 of the Business and Professions Code shall not be
liable for civil damages for any error that results from the inability
of the dispenser to understand a translated direction for use in a
language other than English.

end insert

begin insert

begin insert SEC. 3. end insert   

end insert begin insert

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.

end insert

begin delete

SECTION 1.  

Section 4076.5 of the Business and Professions
Code is amended to read:

4076.5.  

(a) The board shall promulgate regulations that require
a standardized, patient-centered, prescription drug label on all
prescription medicine dispensed to patients in California.

(b) To ensure maximum public comment, the board shall hold
public meetings statewide that are separate from its normally
scheduled hearings in order to seek information from groups
representing consumers, seniors, pharmacists or the practice of
pharmacy, other health care professionals, and other interested
parties.

(c) When developing the requirements for prescription drug
labels, the board shall consider all of the following factors:

(1) Medical literacy research that points to increased
understandability of labels.

(2) Improved directions for use.

(3) Improved font types and sizes.

(4) Placement of information that is patient-centered.

(5) The needs of patients with limited English proficiency.

(6) The needs of senior citizens.

(7) Technology requirements necessary to implement the
standards.

(d) The board may exempt from the regulations promulgated
pursuant to subdivision (a) prescriptions dispensed to a patient in
a health facility, as defined in Section 1250 of the Health and
Safety Code, if the prescriptions are administered by a licensed
health care professional. Prescriptions dispensed to a patient in a
health facility that will not be administered by a licensed health
care professional or that are provided to the patient upon discharge
from the facility shall be subject to this section and the regulations
promulgated pursuant to subdivision (a). Nothing in this
subdivision shall alter or diminish existing statutory and regulatory
informed consent, patients’ rights, or pharmaceutical labeling and
storage requirements, including, but not limited to, Section 1418.9
of the Health and Safety Code or Section 72357, 72527, or 72528
of Title 22 of the California Code of Regulations.

(e) (1) The board may exempt from the regulations promulgated
pursuant to subdivision (a) a prescription dispensed to a patient if
all of the following apply:

(A) The drugs are dispensed by a JCAHO-accredited home
infusion or specialty pharmacy.

(B) The patient receives health-professional-directed education
before the beginning of therapy by a nurse or pharmacist.

(C) The patient receives weekly or more frequent followup
contacts by a nurse or pharmacist.

(D) Care is provided under a formal plan of care based upon a
physician and surgeon’s orders.

(2) For purposes of paragraph (1), home infusion and specialty
therapies include parenteral therapy or other forms of
administration that require regular laboratory and patient
monitoring.

end delete