BILL NUMBER: AB 377 CHAPTERED
BILL TEXT
CHAPTER 687
FILED WITH SECRETARY OF STATE SEPTEMBER 28, 2012
APPROVED BY GOVERNOR SEPTEMBER 28, 2012
PASSED THE SENATE AUGUST 29, 2012
PASSED THE ASSEMBLY AUGUST 30, 2012
AMENDED IN SENATE AUGUST 24, 2012
AMENDED IN SENATE AUGUST 6, 2012
AMENDED IN ASSEMBLY APRIL 14, 2011
INTRODUCED BY Assembly Member Solorio
FEBRUARY 14, 2011
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 pharmacy, and making an
appropriation therefor.
LEGISLATIVE COUNSEL'S DIGEST
AB 377, 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.
This bill would authorize a centralized hospital packaging
pharmacy to prepare medications, by performing specified functions,
for administration only to inpatients within its own general acute
care hospital and one or more general acute care hospitals if the
hospitals are under common ownership, as defined, and within a
75-mile radius of each other. The bill would require a centralized
hospital packaging pharmacy to obtain a specialty license from the
board, and the bill would make these licenses subject to annual
renewal. 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 authorize a centralized hospital packaging pharmacy
to prepare and store a limited quantity of specified unit dose drugs
in advance of receipt of a patient-specific prescription in a
specified quantity. The bill would impose various requirements on
centralized hospital packaging pharmacies, including, but not limited
to, that medications be barcoded to be readable at the inpatient'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.
Appropriation: 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 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
inpatients within its own general acute care hospital and one or more
general acute care hospitals if the hospitals are under common
ownership and located within a 75-mile radius of each other:
(1) Preparing unit dose packages for single administration to
inpatients 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 inpatients, 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
inpatients, if each unit dose package is barcoded to contain at least
the information required by Section 4128.4.
(b) For purposes of this article, "common ownership" means that
the ownership information on file with the board pursuant to Section
4201 for the licensed pharmacy is consistent with the ownership
information on file with the board for the other licensed pharmacy or
pharmacies for purposes of preparing medications pursuant to this
section.
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 inpatients of the general acute care
hospital based on a documented history of prescriptions for that
patient population.
4128.4. Any unit dose medication produced by a centralized
hospital packaging pharmacy shall be barcoded to be readable at the
inpatient's bedside. Upon reading the barcode, the following
information shall be retrievable:
(a) The date the medication was prepared.
(b) The components used in the drug product.
(c) The lot number or control number.
(d) The expiration date.
(e) The National Drug Code Directory number.
(f) The name of the centralized hospital packaging pharmacy.
4128.5. The label for each unit dose medication produced by a
centralized hospital packaging pharmacy shall contain all of the
following:
(a) The expiration date.
(b) The established name of the drug.
(c) The quantity of the active ingredient.
(d) Special storage or handling requirements.
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 federal and state statutes and 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.