Amended in Assembly March 18, 2014

California Legislature—2013–14 Regular Session

Assembly Bill No. 2605

Introduced by Assembly Member Bonilla

February 21, 2014

An act to amend Section begin delete 4127.2 end delete begin insert 4200.3 end insert of the Business and Professions Code, relating to pharmacy.

LEGISLATIVE COUNSEL’S DIGEST

AB 2605, as amended, Bonilla. Pharmacy: sterile drug products.

The Pharmacy Law provides for the licensure and regulation of pharmacists and pharmacy corporations in this state by the California State Board of Pharmacy. begin delete Existing law, until July 1, 2014, prohibits a nonresident pharmacy from compounding injectable sterile drug products for shipment into the state without a license issued by the board, and specifies the information the board is required to receive before issuing the license. Existing law, commencing July 1, 2014, expands that provision to apply to nonresident pharmacies that compound any sterile drug products, and specifies different information the board is required to receive before issuing the license. end delete begin insert Existing law requires an applicant for licensure to have, among other things, passed specified national and state examinations. Existing law requires the examination process to be regularly reviewed, as specified, and to meet certain national testing standards. Existing law requires the board to report to the Joint Committee on Boards, Commissions, and Consumer Protection and the Department of Consumer Affairs, as part of its next scheduled review, the pass rates of applicants who sat for the national examination compared with the pass rates of applicants who sat for the prior state examination, as specified. end insert

begin delete This bill would, with regard to the provisions that become inoperative July 1, 2014, prohibit the board from issuing a license to a nonresident pharmacy until the board receives any other information the board deems necessary. end delete begin insert This bill would instead require the board to report the pass rate information described above to the appropriate policy committees of the Legislature and the department. end insert

Vote: majority. Appropriation: no. Fiscal committee: no. State-mandated local program: no.

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

begin insert

begin insert SECTION 1. end insert   

end insert

begin insert Section 4200.3 of the end insert begin insert Business and Professions
Code end insert begin insert is amended to read: end insert

4200.3.  

(a) The examination process shall be regularly
reviewed pursuant to Section 139.

(b) The examination process shall meet the standards and
guidelines set forth in the Standards for Educational and
Psychological Testing and the Federal Uniform Guidelines for
Employee Selection Procedures. The board shall work with the
Office of Professional Examination Services of the department or
with an equivalent organization who shall certify at minimum once
every five years that the examination process meets these national
testing standards. If the department determines that the examination
process fails to meet these standards, the board shall terminate its
use of the North American Pharmacy Licensure Examination and
shall use only the written and practical examination developed by
the board.

(c) The examination shall meet the mandates of subdivision (a)
of Section 12944 of the Government Code.

(d) The board shall work with the Office of Professional
Examination Services or with an equivalent organization to develop
the state jurisprudence examination to ensure that applicants for
licensure are evaluated on their knowledge of applicable state laws
and regulations.

(e) The board shall annually publish the pass and fail rates for
the pharmacist’s licensure examination administered pursuant to
Section 4200, including a comparison of historical pass and fail
rates before utilization of the North American Pharmacist Licensure
Examination.

(f) The board shall report to the begin delete Joint Committee on Boards,
Commissions, and Consumer Protection end delete begin insert appropriate policy
committees of the Legislature end insert and the begin delete department end delete begin insert department, end insert as
part of its next scheduled review, the pass rates of applicants who
sat for the national examination compared with the pass rates of
applicants who sat for the prior state examination. This report shall
be a component of the evaluation of the examination process that
is based on psychometrically sound principles for establishing
minimum qualifications and levels of competency.

begin delete

SECTION 1.  

Section 4127.2 of the Business and Professions
Code is amended to read:

4127.2.  

(a) A nonresident pharmacy shall not compound
injectable sterile drug products for shipment into the State of
California without a license issued by the board pursuant to this
section. The license shall be renewed annually and shall not be
transferable.

(b) A license to compound injectable sterile drug products shall
be issued only for a location that is licensed as a nonresident
pharmacy. Furthermore, the license to compound injectable sterile
drug products shall be issued only to the owner of the nonresident
pharmacy license at that location. A license to compound injectable
sterile drug products shall not be issued or renewed until the board
receives the following from the nonresident pharmacy:

(1) A copy of an inspection report issued by the pharmacy’s
licensing agency, or a report from a private accrediting agency
approved by the board, in the prior 12 months documenting the
pharmacy’s compliance with board regulations regarding the
compounding of injectable sterile drug products.

(2) A copy of the nonresident pharmacy’s proposed policies
and procedures for sterile compounding.

(3) Any other documentation the board deems necessary.

(c) Nonresident pharmacies operated by entities that are licensed
as a hospital, home health agency, or a skilled nursing facility and
have current accreditation from the Joint Commission on
Accreditation of Healthcare Organizations, or other private
accreditation agencies approved by the board, are exempt from
the requirement to obtain a license pursuant to this section.

(d) On or before January 1, 2018, the board shall provide a
report to the Legislature regarding the regulation of nonresident
pharmacies. The report shall be submitted to the Legislature in the
manner required pursuant to Section 9795 of the Government
Code. At a minimum, the report shall address all of the following:

(1) A detailed description of board activities related to the
inspection and licensure of nonresident pharmacies.

(2) The status of proposed changes to federal law that are under
serious consideration and that would govern compounding
pharmacies, including legislation pending before the United States
Congress, administrative rules, regulations, or orders under
consideration by the federal Food and Drug Administration or
other appropriate federal agency, and cases pending before the
courts.

(3) If applicable, recommended modifications to the board’s
statutory duties related to nonresident pharmacies as a result of
changes to federal law or any additional modifications necessary
to protect the health and safety of the public.

(e) This section shall become inoperative on July 1, 2014, and,
as of January 1, 2015, is repealed, unless a later enacted statute,
that becomes operative on or before January 1, 2015, deletes or
extends the dates on which it becomes inoperative and is repealed.

end delete