BILL NUMBER: SB 587	INTRODUCED
	BILL TEXT


INTRODUCED BY   Senator Stone

                        FEBRUARY 26, 2015

   An act to amend Section 4127.1 of the Business and Professions
Code, relating to pharmacy.


	LEGISLATIVE COUNSEL'S DIGEST


   SB 587, as introduced, Stone. Pharmacy: compounding.
   Existing law, the Pharmacy Law, provides for the licensure and
regulation of pharmacists and pharmacy corporations in this state by
the California State Board of Pharmacy. The law prohibits a pharmacy
from compounding sterile drug products unless the pharmacy has
obtained a sterile compounding pharmacy license from the board, and
prohibits the board from issuing or renewing that license until the
board has, among other things, reviewed a current copy of the
pharmacy's procedures and policies for sterile compounding.
   This bill would make a nonsubstantive change to that licensing
provision.
   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 4127.1 of the Business and Professions Code, as
added by Section 5 of Chapter 565 of the Statutes of 2013, is
amended to read:
   4127.1.  (a) A pharmacy shall not compound sterile drug products
unless the pharmacy has obtained a sterile compounding pharmacy
license from the board pursuant to this section. The license shall be
renewed annually and is not transferable.
   (b) A license to compound sterile drug products shall be issued
only to a location that is licensed as a pharmacy and shall be issued
only to the owner of the pharmacy licensed at that location.
   (c) A license to compound sterile drug products shall not be
issued or renewed until the location is inspected by the board and
found in compliance with this article and regulations adopted by the
board.
   (d) A license to compound sterile drug products shall not be
issued or renewed until the board does all of the following:
   (1) Reviews a current copy of the pharmacy's  policies and
 procedures  and policies  for sterile
compounding.
   (2) Reviews the pharmacy's completed self-assessment form required
by Section 1735.2 of Title 16 of the California Code of Regulations.

   (3) Is provided with copies of all inspection reports conducted of
the pharmacy's premises, and any reports from a private accrediting
agency, conducted in the prior 12 months documenting the pharmacy's
operations.
   (4) Receives a list of all sterile medications compounded by the
pharmacy since the last license renewal.
   (e) A pharmacy licensed pursuant to this section shall do all of
the following:
   (1) Provide to the board a copy of any disciplinary or other
action taken by another state within 10 days of the action.
   (2) Notify the board within 10 days of the suspension of any
accreditation held by the pharmacy.
   (3) Provide to the board, within 12 hours, any recall notice
issued by the pharmacy for sterile drug products it has compounded.
   (f) Adverse effects reported or potentially attributable to a
pharmacy's sterile drug product shall be reported to the board within
12 hours and immediately reported to the MedWatch program of the
federal Food and Drug Administration.
   (g) The reconstitution of a sterile powder shall not require a
license pursuant to this section if both of the following
requirements are met:
   (1) The sterile powder was obtained from a manufacturer.
   (2) The drug is reconstituted for administration to patients by a
health care professional licensed to administer drugs by injection
pursuant to this division.
   (h) This section shall become operative on July 1, 2014.