BILL NUMBER: AB 2605	INTRODUCED
	BILL TEXT


INTRODUCED BY   Assembly Member Bonilla

                        FEBRUARY 21, 2014

   An act to amend Section 4127.2 of the Business and Professions
Code, relating to pharmacy.


	LEGISLATIVE COUNSEL'S DIGEST


   AB 2605, as introduced, 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.
   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.
   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 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
 may only   shall  be issued  only
 for a location that is licensed as a nonresident pharmacy.
Furthermore, the license to compound injectable sterile drug products
 may only   shall  be issued  only
 to the owner of the nonresident pharmacy license at that
location. A license to compound injectable sterile drug products
 may   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.