Bill Text: CA AB377 | 2011-2012 | Regular Session | Introduced

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

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Bill Title: Pharmacy.

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Passed) 2012-09-28 - Chaptered by Secretary of State - Chapter 687, Statutes of 2012. [AB377 Detail]

Download: California-2011-AB377-Introduced.html

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BILL NUMBER: AB 377	INTRODUCED
	BILL TEXT


INTRODUCED BY   Assembly Member Solorio

                        FEBRUARY 14, 2011

   An act to amend Sections 4029 and 4033 of the Business and
Professions Code, relating to pharmacy.


	LEGISLATIVE COUNSEL'S DIGEST


   AB 377, as introduced, Solorio. Pharmacy.
   Existing law, the Pharmacy Law, provides for the licensure and
regulation of pharmacies, including hospital pharmacies, by the
California State Board of Pharmacy, and makes a knowing violation of
that law a crime. Existing law prohibits the operation of a pharmacy
without a license and a separate license is required for each
pharmacy location. Under existing law, a hospital pharmacy, as
defined, includes a pharmacy located outside of the hospital in
another physical plant. However, as a condition of licensure by the
board for these pharmacies, pharmaceutical services may only be
provided to registered hospital patients who are on the premises of
the same physical plant in which the pharmacy is located and those
services must be directly related to the services or treatment plan
administered in the physical plant. Existing law imposes various
requirements on manufacturers, as defined, and states that a
manufacturer does not mean a pharmacy compounding a drug for
parenteral therapy, pursuant to a prescription, for delivery to
another pharmacy for the purpose of delivering or administering the
drug to the patient or patients, provided that neither the components
for the drug nor the drug are compounded, fabricated, packaged, or
otherwise prepared prior to receipt of the prescription.
   This bill would provide that a hospital pharmacy also includes a
pharmacy, licensed by the board, that may be located outside of the
hospital in either another physical plant on the same premises or on
a separate premises, located within a 100-mile radius of the
hospital, that is regulated under a hospital's license. The bill
would eliminate the conditions of licensure by the board that limit
the services provided by the pharmacy in the other physical plant,
but would require that any unit-dose medication produced by a
hospital pharmacy under common ownership be barcoded to be readable
at the patient's bedside. The bill would authorize a hospital
pharmacy to prepare and store a limited quantity of unit-dose
medications in advance of a patient-specific prescription under
certain circumstances. The bill would also provide that a
"manufacturer" does not mean a pharmacy compounding or repackaging a
drug for parenteral therapy or oral therapy in a hospital for
delivery to another pharmacy or hospital under common ownership in
order to dispense or administer the drug to the patient or patients
pursuant to a prescription or order. The bill would require a
pharmacy compounding or repackaging a drug pursuant to this provision
to notify the board of the location of the compounding or
repackaging within a specified period of time. Because a knowing
violation of the bill's requirements 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.  Section 4029 of the Business and Professions Code is
amended to read:
   4029.  (a) "Hospital pharmacy" means and includes a pharmacy,
licensed by the board, located within any licensed hospital,
institution, or establishment that maintains and operates organized
facilities for the diagnosis, care, and treatment of human illnesses
to which persons may be admitted for overnight stay and that meets
all of the requirements of this chapter and the rules and regulations
of the board.
   (b) A hospital pharmacy also includes a pharmacy  , licensed
by the board,  that may be located outside of the hospital, in
 either  another physical plant  that is regulated
under a hospital's consolidated license issued pursuant to Section
1250.8 of the Health and Safety Code. As a condition of licensure by
the board, the pharmacy in another physical plant shall provide
pharmaceutical services only to registered hospital patients who are
on the premises of the same physical plant in which the pharmacy is
located. The pharmacy services provided shall be directly related to
the services or treatment plan administered in the physical plant
  on the same premises or on a separate premises,
located within a 100 mile radius of the hospital, that is regulated
under a hospital's license  . Nothing in this  paragraph
  subdivision  shall be construed to restrict or
expand the services that a hospital pharmacy may provide. 
   (c) Any unit-dose medication produced by a hospital pharmacy under
common ownership, as described in Section 4033, shall be barcoded to
be readable at the patient's bedside.  
   (d) A hospital pharmacy may prepare and store a limited quantity
of unit-dose medications in advance of receipt of a patient-specific
prescription in a quantity as is necessary to ensure continuity of
care for an identified population of patients of the hospital based
on a documented history of prescriptions for that patient population.
 
   (e) Nothing in this section shall limit the obligation of a
hospital pharmacy, hospital, or pharmacist to comply with all
applicable federal and state laws. 
  SEC. 2.  Section 4033 of the Business and Professions Code is
amended to read:
   4033.  (a) (1) "Manufacturer" means and includes every person who
prepares, derives, produces, compounds, or repackages any drug or
device except a pharmacy that manufactures on the immediate premises
where the drug or device is sold to the ultimate consumer.
   (2) Notwithstanding paragraph (1), "manufacturer" shall not mean a
pharmacy compounding  or repackaging  a drug for parenteral
therapy  , pursuant to   or oral therapy in
 a  prescription,   hospital  for
delivery to another pharmacy  or hospital under common ownership
 for the purpose of  delivering  
dispensing  or administering the drug  , pursuant to a
prescription or order,  to the patient or patients named in the
prescription  , provided that neither   or
order. A pharmacy compounding or repackaging a drug   as
described in this paragraph shall notify  the 
components for   board in writing of  the 
drug nor   location where  the  drug are
compounded, fabricated, packaged,   compounding  or
 otherwise prepared prior   repackaging is
being performed within 30 days of initiating the compounding or
repackaging. The pharmacy shall report any change in that information
 to  receipt   the board in writing within
30 days  of the  prescription   change
 .
   (3) Notwithstanding paragraph (1), "manufacturer" shall not mean a
pharmacy that, at a patient's request, repackages a drug previously
dispensed to the patient, or to the patient's agent, pursuant to a
prescription.
   (b) Notwithstanding subdivision (a), as used in Sections 4034,
4163, 4163.1, 4163.2, 4163.3, 4163.4, and 4163.5, "manufacturer"
means a person who prepares, derives, manufactures, produces, or
repackages a dangerous drug, as defined in Section 4022, device, or
cosmetic. Manufacturer also means the holder or holders of a New Drug
Application (NDA), an Abbreviated New Drug Application (ANDA), or a
Biologics License Application (BLA), provided that such application
has been approved; a manufacturer's  third party 
 third-party  logistics provider; a private label
distributor (including colicensed partners) for whom the private
label distributor's prescription drugs are originally manufactured
and labeled for the distributor and have not been repackaged; or the
distributor agent for the manufacturer, contract manufacturer, or
private label distributor, whether the establishment is a member of
the manufacturer's affiliated group (regardless of whether the member
takes title to the drug) or is a contract distributor site.
  SEC. 3.  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.