BILL NUMBER: AB 1370 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY JANUARY 4, 2010
INTRODUCED BY Assembly Member Solorio
FEBRUARY 27, 2009
An act to amend Section 111385 of the Health and Safety
Code, relating to public health. 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 Busi ness and
Professions Code, relating to pharmacies, and making an appropriation
therefor.
LEGISLATIVE COUNSEL'S DIGEST
AB 1370, as amended, Solorio. Drugs and devices:
labeling: expiration date: best before date.
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 inpatients within its own
general acute care hospital and one or more general acute care
hospitals if the hospitals are under common ownership. 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 the
expiration date for drugs prepared in advance of receipt of a patient
specific prescription shall not exceed 72 hours, 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.
Existing law, the Sherman Food, Drug, and Cosmetic Law, requires
the State Department of Public Health to regulate manufacture, sale,
labeling, and advertising activities related to food, drugs, devices,
and cosmetics in conformity with the federal Food, Drug, and
Cosmetic Act. A violation of these provisions is a crime.
Existing law classifies a drug or device as misbranded if the
department determines that the drug or device is liable to
deterioration and the drug or device is not packaged and labeled in a
form and manner and set forth in regulations of the department.
This bill would require that the label contain a "best before"
date in addition to the expiration date of the effectiveness of the
drug or device. By expanding the definition of an existing crime,
this 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 am ended 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
inpatients within its own general acute care hospital and one or more
general acute care hospital if the hospitals are under common
ownership.
(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 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 inpatients
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 inpatients of the general acute care
hospital based on a documented history of prescriptions for that
patient population. The expiration date for these drugs shall not
exceed 72 hours.
4128.4. Any unit dose medication produced by a centralized
hospital packaging pharmacy shall be barcoded to be readable at the
inpatient's bedside. A reading of the barcode shall display all of
the following:
(a) The date the medication was prepared.
(b) The components used in the drug product.
(c) The lot number or control number.
(d) The National Drug Code Directory number.
(e) 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 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.
SECTION 1. Section 111385 of the Health and
Safety Code is amended to read:
111385. Any drug or device is misbranded if the department
determines that the drug or device is liable to deterioration, unless
it is packaged in that form and manner and its label bears a
statement of the precautions, as the department, by regulation, may
require as necessary for the protection of public health, including,
but not limited to, "best before" date in addition to the expiration
date of the effectiveness of the drug or device. The regulations
shall not be established for any drug or device recognized in an
official compendium, unless the department has informed the
appropriate body, charged with the revision of the official
compendium, of the need for that packaging or labeling requirements
and that body has not prescribed the requirements in a reasonable
length of time.
SEC. 2. 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.