BILL NUMBER: AB 2077 AMENDED
BILL TEXT
AMENDED IN SENATE JUNE 23, 2010
AMENDED IN ASSEMBLY MAY 10, 2010
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 , 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 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 , but would require
that any unit- dose medication produced by a
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: no yes .
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)
(d) Centralization of the packaging operations as a
licensed pharmacy under the license of a hospital, rather than as a
"manufacturer," ensures 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.
(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 obviate the obligation of a
hospital pharmacy, hospital, or pharmacist to comply with all
applicable federal and state laws.
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 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 compoundi ng 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. 4. 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.