BILL NUMBER: SB 1095	AMENDED
	BILL TEXT

	AMENDED IN ASSEMBLY  JUNE 25, 2012

INTRODUCED BY   Senator Rubio
    (   Coauthor:   Senator   Wyland
  ) 

                        FEBRUARY 16, 2012

   An act to amend Sections 4190 and 4195 of, and to amend the
heading of Article 14 (commencing with Section 4190) of Chapter 9 of
Division 2 of, the Business and Professions Code, relating to
pharmacy.



	LEGISLATIVE COUNSEL'S DIGEST


   SB 1095, as amended, Rubio. Pharmacy: clinics.
   Existing law, the Pharmacy Law, provides for the licensure and
regulation of the practice of pharmacy by the California State Board
of Pharmacy and makes a knowing violation of its provisions a crime.
Existing law authorizes a surgical clinic, as defined, that is
licensed by the board to purchase drugs at wholesale for
administration or dispensing, under the direction of a physician and
surgeon, to patients registered for care at the surgical clinic.
Existing law prohibits a surgical clinic from operating without a
license issued by the board. Existing law requires these surgical
clinics to comply with various regulatory requirements and to
maintain specified records. Existing law authorizes the board to
inspect a surgical clinic at any time in order to determine whether a
surgical clinic is operating in compliance with certain
requirements.
   This bill would expand these provisions to additionally authorize
an outpatient setting or an ambulatory surgical center, as specified,
to purchase drugs at wholesale for administration or dispensing,
subject to the requirements applicable to surgical clinics. The bill
would delete the requirement that a surgical clinic be licensed by
the board  but would require the clinics described above to
be licensed in order to receive the benefits of these provisions
  in order to operate  . The bill would specify
that the board is authorized to inspect only  an outpatient
setting, an ambulatory surgical care center, or  a  surgical
 clinic that is licensed by the board.
   Because a knowing violation of these requirements by outpatient
settings and ambulatory surgical centers would be a crime, the bill
would impose a state-mandated local program.
    The California Constitution requires the state to reimburse local
agencies and school districts for certain costs mandated by the
state. Statutory provisions establish procedures for making that
reimbursement.
   This bill would provide that no reimbursement is required by this
act for a specified reason.
   Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: yes.


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

  SECTION 1.  This act shall be known and may be cited as the
California Outpatient Pharmacy Patient Safety and Improvement Act.
  SEC. 2.  The heading of Article 14 (commencing with Section 4190)
of Chapter 9 of Division 2 of the Business and Professions Code is
amended to read:

      Article 14.  Clinics


  SEC. 3.  Section 4190 of the Business and Professions Code is
amended to read:
   4190.  (a) For the purposes of this article, "clinic" means a
surgical clinic licensed pursuant to paragraph (1) of subdivision (b)
of Section 1204 of the Health and Safety Code, an outpatient setting
accredited by an accreditation agency, as defined in Section 1248 of
the Health and Safety Code, or an ambulatory surgical center
certified to participate in the Medicare Program under Title XVIII of
the federal Social Security Act (42 U.S.C. Sec. 1395 et seq.).
    (b)  Notwithstanding any provision of this chapter, a
  A  clinic  licensed by the board  may
purchase drugs at wholesale for administration or dispensing, under
the direction of a physician and surgeon, to patients registered for
care at the clinic, as provided in subdivision (c).  A separate
license shall be required for each clinic location. A clinic licensed
by the board shall notify the board of any change in the clinic's
address on a form furnished by the board.  The clinic shall keep
records of the kind and amounts of drugs purchased, administered,
and dispensed, and the records shall be available and maintained for
a minimum of three years for inspection by all properly authorized
personnel.
    (c) The drug distribution service of a clinic shall be limited to
the use of drugs for administration to the patients of the clinic
and to the dispensing of drugs for the control of pain and nausea for
patients of the clinic. Drugs shall not be dispensed in an amount
greater than that required to meet the patient's needs for 72 hours.
Drugs for administration shall be those drugs directly applied,
whether by injection, inhalation, ingestion, or any other means, to
the body of a patient for his or her immediate needs.
   (d) No clinic shall be entitled to the benefits of this section
until it has obtained a license from the board.  A separate
license shall be required for each clinic location. A clinic licensed
by the board shall notify the board of any change in the clinic's
address on a form furnished by the board. 
   (e) If a clinic is licensed by the board, any proposed change in
ownership or beneficial interest in the licensee shall be reported to
the board, on a form to be furnished by the board, at least 30 days
prior to the execution of any agreement to purchase, sell, exchange,
gift or otherwise transfer any ownership or beneficial interest or
prior to any transfer of ownership or beneficial interest, whichever
occurs earlier.
    (f) Nothing in this section shall limit the ability of a
physician and surgeon or a group medical practice to prescribe,
dispense, administer, or furnish drugs at a clinic as provided in
Sections 2241.5, 2242, and 4170.
  SEC. 4.  Section 4195 of the Business and Professions Code is
amended to read:
   4195.  The board shall have the authority to inspect a clinic that
is licensed pursuant to this article at any time in order to
determine whether the clinic is, or is not, operating in compliance
with this article and all other provisions of the law.
  SEC. 5.   No reimbursement is required by this act pursuant to
Section 6 of Article XIII B of the California Constitution because
the only costs that may be incurred by a local agency or school
district will be incurred because this act creates a new crime or
infraction, eliminates a crime or infraction, or changes the penalty
for a crime or infraction, within the meaning of Section 17556 of the
Government Code, or changes the definition of a crime within the
meaning of Section 6 of Article XIII B of the California
Constitution.