2005 California Business and Professions Code Sections 4127-4127.7 Article 7.5. Injectable Sterile Drug Products

4127.  The board shall adopt regulations establishing standards for
compounding injectable sterile drug products in a pharmacy.
4127.1.  (a) A pharmacy shall not compound injectable sterile drug
products in this state unless the pharmacy has obtained a license
from the board pursuant to this section.  The license shall be
renewed annually and is not transferable.
   (b) A license to compound injectable sterile drug products may
only be issued for a location that is licensed as a pharmacy.
Furthermore, the license to compound injectable sterile drug products
may only be issued to the owner of the pharmacy license at that
location.  A license to compound injectable sterile drug products may
not be issued until the location is inspected by the board and found
in compliance with this article and regulations adopted by the
board.
   (c) A license to compound injectable sterile drug products may not
be renewed until the location has been inspected by the board and
found to be in compliance with this article and regulations adopted
by the board.
   (d) Pharmacies operated by entities that are licensed by either
the board or the State Department of Health Services and that 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.
   (e) The reconstitution of a sterile powder shall not require a
license pursuant to this section if both of the following 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.
   (f)  This section shall become effective on the earlier of July 1,
2003, or the effective date of regulations adopted by the board
pursuant to Section 4127.
4127.2.  (a) A nonresident pharmacy may 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 be issued for a location that is licensed as a nonresident
pharmacy.  Furthermore, the license to compound injectable sterile
drug products may only be issued to the owner of the nonresident
pharmacy license at that location.  A license to compound injectable
sterile drug products may 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.
   (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) This section shall become effective on the earlier of July 1,
2003, or the effective date of regulations adopted by the board
pursuant to Section 4127.
4127.3.  (a) Whenever the board has a reasonable belief, based on
information obtained during an inspection or investigation by the
board, that a pharmacy compounding injectable sterile drug products
poses an immediate threat to the public health or safety, the
executive officer of the board may issue an order to the pharmacy to
immediately cease and desist from compounding injectable sterile drug
products.  The cease and desist order shall remain in effect for no
more than 30 days or the date of a hearing seeking an interim
suspension order, whichever is earlier.
   (b) Whenever the board issues a cease and desist order pursuant to
subdivision (a), the board shall immediately issue the owner a
notice setting forth the acts or omissions with which the owner is
charged, specifying the pertinent code section or sections.
   (c) The order shall provide that the owner, within 15 days of
receipt of the notice, may request a hearing before the president of
the board to contest the cease and desist order.  Consideration of
the owner's contest of the cease and desist order shall comply with
the requirements of Section 11425.10 of the Government Code.  The
hearing shall be held no later than five days from the date the
request of the owner is received by the board.  The president shall
render a written decision within five days of the hearing.  In the
absence of the president of the board, the vice president of the
board may conduct the hearing permitted by this subdivision.  Review
of the decision of the president of the board may be sought by the
owner or person in possession or control of the pharmacy pursuant to
Section 1094.5 of the Code of Civil Procedure.
   (d) Failure to comply with a cease and desist order issued
pursuant to this section shall be unprofessional conduct.
4127.4.  Notwithstanding any other provision of law, a violation of
this article, or regulations adopted pursuant thereto, may subject
the person or entity that committed the violation to a fine of up to
two thousand five hundred dollars ($2,500) per occurrence pursuant to
a citation issued by the board.
4127.5.  The fee for the issuance of a nongovernmental license, or
renewal of a license, to compound sterile drug products shall be five
hundred dollars ($500) and may be increased to six hundred dollars
($600).
4127.6.  This article shall become operative upon the allocation of
positions to the board for the implementation of the provisions of
this article in the annual Budget Act.
4127.7.  On and after July 1, 2005, a pharmacy shall compound
sterile injectable products from one or more nonsterile ingredients
in one of the following environments:
   (a) An ISO class 5 laminar airflow hood within an ISO class 7
cleanroom.  The cleanroom must have a positive air pressure
differential relative to adjacent areas.
   (b) An ISO class 5 cleanroom.
   (c) A barrier isolator that provides an ISO class 5 environment
for compounding.