BILL NUMBER: AB 2077 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY APRIL 22, 2010
AMENDED IN ASSEMBLY APRIL 13, 2010
INTRODUCED BY Assembly Member Solorio
FEBRUARY 18, 2010
An act to amend Sections 4029 and 4033 of the Business and
Professions Code, relating to pharmacy.
LEGISLATIVE COUNSEL'S DIGEST
AB 2077, 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. 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 in another
physical plant on the same premises or on a separate premises
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. The bill would also
provide that a "manufacturer" does not mean a pharmacy compounding
or and 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.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: no.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. The Legislature makes the following findings and
declarations:
(a) Hospitals have been encouraged to move toward the use of
automation and bedside barcode checking to improve the safety and
efficiency of drug distribution and administration to patients. For
many hospitals, the technology to enable them to achieve this
patient-safety goal is cost prohibitive.
(b) Many drugs received from manufacturers are not in the proper
unit dose for immediate administration to patients, and are not
barcoded. As a result, individual hospitals must locally prepare and
package these drugs or contract with a packager, that is not licensed
by either the California State Board of Pharmacy or managed by a
pharmacist-in-charge who is licensed by the California State Board of
Pharmacy, to do so.
(c) The Business and Professions Code definition of drug
"manufacturer" allows one hospital pharmacy to compound and package
medications for another hospital only for specific patients, without
being licensed as a manufacturer. This restriction does not support
the most current hospital drug distribution processes, nor does it
accommodate innovations that will improve patient safety.
(d) The federal Food and Drug Administration (FDA) has amended its
position to allow hospitals under common control and operating
within a state to consolidate resources at a single location for
timely, economic repackaging and distribution with greater, more
dedicated expertise, without becoming federally registered
manufacturers for those products. This FDA action is in recognition
that the compounding and repackaging activity is not truly drug
manufacturing.
(e) A centralized pharmacy compounding and packaging operations
approach allows hospitals to take advantage of high-speed automated
equipment, economies of scale, space efficiencies, and more
consistent standardized quality control systems. Likewise, a
centralized licensed pharmacy approach allows for greater regulatory
control via the pharmacist-in-charge and greater assurance of safety
by concentrating the professional expertise among a centralized
management, staff, and quality assurance program.
(f) Centralization of the packaging operations as a licensed
pharmacy under the license of a hospital, rather than as a
"manufacturer," assures the patient-safety oversight of the
California State Board of Pharmacy and other hospital regulatory and
accreditation bodies, and adherence to the new stronger pharmacy
compounding regulations.
SEC. 2. 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 another
physical plant on the same premises or on a separate premises that is
regulated under a hospital's license. Nothing in this subdivision
shall be construed to restrict or expand the services that a hospital
pharmacy may provide.
SEC. 3. 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 and 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.
(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.