BILL NUMBER: AB 2077 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY APRIL 13, 2010
INTRODUCED BY Assembly Member Solorio
FEBRUARY 18, 2010
An act to amend Section 4029 of, and to add Article 7.6
(commencing with Section 4128) to Chapter 9 of Division 2 of, the
Business and Professions Code, relating to pharmacies, and making an
appropriation therefor. 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. Centralized hospital
packaging pharmacies. 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, p ursuant 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 . A knowing violation of the Pharmacy Law
is a crime.
This bill would authorize a centralized hospital packaging
pharmacy, as defined, to prepare medications, by performing specified
functions, for administration only to patients within its own
general acute care hospital and one or more general other acute care
hospitals if the hospitals are under common ownership, in California,
and within a 100 mile radius of the pharmacy. The bill would
prohibit a person from conducting a centralized hospital packaging
pharmacy without a specialty license from the board and would require
applicants to apply annually to the board on forms developed by the
board. The bill would condition both the issuance and renewal of a
specialty license on a board inspection of the centralized hospital
packaging pharmacy to ensure that the pharmacy is in compliance with
the bill's provisions and regulations established by the board. The
bill would impose specified issuance and annual renewal fees for a
specialty license and because these fees would be deposited into the
Pharmacy Board Contingent Fund, a continuously appropriated fund, the
bill would make an appropriation.
The bill would impose various requirements on centralized hospital
packaging pharmacies, including, but not limited to, that drugs
prepared in advance of receipt of a patient specific prescription
shall meet specified standards, that medications be barcoded to be
readable at the patient's bedside, and that medication labels contain
specified information. The bill would make these pharmacies and
pharmacists responsible for the integrity, potency, quality, and
labeled strength of any unit dose drug product prepared by the
packaging pharmacy. Because a knowing violation of these provisions
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.
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
repackaging a drug for parenteral therapy or oral therapy in a
hospital for delivery to another pharmacy or hospital in order to
dispense or administer the drug to the patient or patients pursuant
to a prescription or order.
Vote: majority. Appropriation: yes no
. Fiscal committee: yes. State-mandated local program:
yes 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 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 . Nothing
in this paragraph 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 , pursuant to a prescription,
or oral therapy in a hospital for delivery to another
pharmacy or hospital 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 the components for the drug nor the drug are compounded,
fabricated, packaged, or otherwise prepared prior to receipt of 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.
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 that may be
located outside of the hospital, in 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, except as provided in Article 7.6 (commencing
with Section 4128). The pharmacy services provided shall be directly
related to the services or treatment plan administered in the
physical plant. Nothing in this subdivision shall be construed to
restrict or expand the services that a hospital pharmacy may provide.
SEC. 2. Article 7.6 (commencing with Section
4128) is added to Chapter 9 of Division 2 of the Business and
Professions Code, to read:
Article 7.6. Centralized Hospital Packaging Pharmacies
4128. (a) Notwithstanding Section 4029, a centralized hospital
packaging pharmacy may prepare medications, by performing the
following specialized functions, for administration only to patients
within its own general acute care hospital and one or more other
general acute care hospitals if the hospitals are (1) under common
ownership, (2) in California, and (3) located within a 100 mile
radius of the centralized hospital packaging pharmacy.
(1) Preparing unit dose packages for single administration to
patients from bulk containers, if each unit dose package is barcoded
to contain at least the information required by Section 4128.4.
(2) Preparing compounded unit dose drugs for parenteral therapy
for administration to patients, if each compounded unit dose drug is
barcoded to contain at least the information required by Section
4128.4.
(3) Preparing compounded unit dose drugs for administration to
patients, if each unit dose package is barcoded to contain at least
the information required by Section 4128.4.
(b) For the purposes of this article, a "centralized hospital
packaging pharmacy" means a licensed hospital pharmacy located within
a general acute care hospital, as defined in subdivision (a) of
Section 1250 of the Health and Safety Code.
4128.1. (a) No person shall conduct a centralized hospital
packaging pharmacy unless it has obtained a specialty license from
the board.
(b) A licensed hospital pharmacy serving only its own patients
shall not be required to obtain a specialty license as described in
subdivision (a).
4128.2. (a) In addition to the pharmacy license requirement
described in Section 4110, a centralized hospital packaging pharmacy
shall obtain a specialty license from the board prior to engaging in
the functions described in Section 4128.
(b) An applicant seeking a specialty license pursuant to this
article shall apply to the board on forms established by the board.
(c) Before issuing the specialty license, the board shall inspect
the pharmacy and ensure that the pharmacy is in compliance with this
article and regulations established by the board.
(d) A license to perform the functions described in Section 4128
may only be issued to a pharmacy that is licensed by the board as a
hospital pharmacy.
(e) A license issued pursuant to this article shall be renewed
annually and is not transferrable.
(f) An applicant seeking renewal of a specialty license shall
apply to the board on forms established by the board.
(g) A license to perform the functions described in Section 4128
shall not be renewed until the pharmacy has been inspected by the
board and found to be in compliance with this article and regulations
established by the board.
(h) The fee for issuance or annual renewal of a centralized
hospital packaging pharmacy license shall be six hundred dollars
($600) and may be increased by the board to eight hundred dollars
($800).
4128.3. A centralized hospital packaging pharmacy may prepare and
store a limited quantity of the unit dose drugs authorized by
Section 4128 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 general acute care hospital
based on a documented history of prescriptions for that patient
population. The expiration date for these drugs shall meet
established compendium standards as stated in the United States
Pharmacopiea and other widely accepted references.
4128.4. Any unit dose medication produced by a centralized
hospital packaging pharmacy shall be barcoded to be readable at the
patient's bedside. The bar code shall contain at least the following
information:
(a) Expiration date.
(b) Lot number or control number.
(c) National Drug Code Directory number.
4128.5. The label for each unit dose medication produced by a
centralized hospital packaging pharmacy shall contain all of the
following information:
(a) Expiration date.
(b) Established name of the drug.
(c) Quantity of the active ingredient.
(d) Special storage or handling requirements.
(e) Name of the packaging pharmacy.
4128.6. All compounding and packaging functions specified in
Section 4128 shall be performed only in the licensed centralized
hospital packaging pharmacy and that pharmacy shall comply with all
applicable regulations, including, but not limited to, regulations
regarding compounding and when appropriate, sterile injectable
compounding.
4128.7. A centralized hospital packaging pharmacy and the
pharmacists working in the pharmacy shall be responsible for the
integrity, potency, quality, and labeled strength of any unit dose
drug product prepared by the centralized hospital packaging pharmacy.
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.