BILL NUMBER: AB 377 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY APRIL 14, 2011
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 amended, 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 , but
would impose limitations on the services provided by a centralized
hospital pharmacy . 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 on the same premises or on a separate premises,
located within a 100 mile 100-mile
radius of the hospital, that is regulated under a hospital's license.
A centralized hospital pharmacy may only provide pharmaceutical
services to its own patients who are either admitted or registered
patients of a hospital within the same health care system.
Nothing in this 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 or
oral therapy in a hospital for delivery to another pharmacy or
hospital under common ownership for the purpose of dispensing or
administering the drug, pursuant to a prescription or order, to the
patient or patients named in the prescription or order. A pharmacy
compounding or repackaging a drug as described in this paragraph
shall notify the board in writing of the location where the
compounding or repackaging is being performed within 30 days of
initiating the compounding or repackaging. The pharmacy shall report
any change in that information to the board in writing within 30 days
of the 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 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.