Bill Text: CA AB377 | 2011-2012 | Regular Session | Amended
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Pharmacy.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Passed) 2012-09-28 - Chaptered by Secretary of State - Chapter 687, Statutes of 2012. [AB377 Detail]
Download: California-2011-AB377-Amended.html
Bill Title: Pharmacy.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Passed) 2012-09-28 - Chaptered by Secretary of State - Chapter 687, Statutes of 2012. [AB377 Detail]
Download: California-2011-AB377-Amended.html
BILL NUMBER: AB 377 AMENDED
BILL TEXT
AMENDED IN SENATE AUGUST 6, 2012
AMENDED IN ASSEMBLY APRIL 14, 2011
INTRODUCED BY Assembly Member Solorio
FEBRUARY 14, 2011
An act to amend Sections Section
4029 and 4033 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, 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 outside of the
hospital in either another physical plant on the same premises or on
a separate premises, located within a 100-mile radius of the
hospital, that is regulated under a hospital's license, but would
impose limitations on the services provided by a centralized hospital
pharmacy. 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 hospital 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.
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.
Vote: majority. Appropriation: no 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 ,
licensed by the board, that may be located outside of the
hospital , in either another
physical plant on the same premises or on a separate
premises, located within a 100-mile radius of the hospital,
that is regulated under a hospital's consolidated license
. A centralized hospital pharmacy may only provide
pharmaceutical services to its own patients who are either admitted
or registered patients of a hospital within the same health care
system. 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.
(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 limit the obligation of a
hospital pharmacy, hospital, or pharmacist to comply with all
applicable federal and state laws.
SEC. 2. Article 7.6 (comm encing 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 lot 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. 2. 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 compounding 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. 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.
