BILL NUMBER: AB 2077 INTRODUCED
BILL TEXT
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.
LEGISLATIVE COUNSEL'S DIGEST
AB 2077, as introduced, Solorio. Centralized hospital packaging
pharmacies.
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.
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.
Vote: majority. Appropriation: yes. 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 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
paragraph 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.