Bill Text: CA AB2605 | 2013-2014 | Regular Session | Amended

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

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Bill Title: Pharmacy: third-party logistics providers.

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Passed) 2014-09-20 - Chaptered by Secretary of State - Chapter 507, Statutes of 2014. [AB2605 Detail]

Download: California-2013-AB2605-Amended.html

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BILL NUMBER: AB 2605	AMENDED
	BILL TEXT

	AMENDED IN ASSEMBLY  MARCH 18, 2014

INTRODUCED BY   Assembly Member Bonilla

                        FEBRUARY 21, 2014

   An act to amend Section  4127.2   4200.3
 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.  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.   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.

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


THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:

   SECTION 1.    Section 4200.3 of the  
Business and Professions Code   is amended to read: 
   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  Joint Committee on
Boards, Commissions, and Consumer Protection  
appropriate policy committees of the Legislature  and the
 department   department,  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. 
  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.