BILL NUMBER: AB 486 INTRODUCED
BILL TEXT
INTRODUCED BY Assembly Member Bonilla
FEBRUARY 23, 2015
An act to amend Sections 4128, 4128.4, and 4128.5 of the Business
and Professions Code, relating to pharmacy, and declaring the urgency
thereof, to take effect immediately.
LEGISLATIVE COUNSEL'S DIGEST
AB 486, as introduced, Bonilla. Centralized hospital packaging
pharmacies: medication labels.
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 authorizes a centralized hospital packaging pharmacy to
prepare medications for administration to inpatients within its own
general acute care hospital or certain other commonly owned
hospitals.
Existing law requires that these medications be barcoded to be
readable at the inpatient's bedside in order to retrieve certain
information, including, but not limited to, the date that the
medication was prepared and the components used in the drug product.
This bill would require that this information be displayed on a
human-readable unit-dose label, and that the information be
retrievable by the pharmacist using the medication lot number or
control number.
This bill would require that the medication's barcode be machine
readable, using medication administration software, and that the
software compare the information contained in the barcode to the
electronic medical record of the inpatient in order to verify that
the medication to be given is the correct medication, dosage, and
route of administration for that patient.
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 declare that it is to take effect immediately as
an urgency statute.
Vote: 2/3. Appropriation: no. Fiscal committee: yes.
State-mandated local program: yes.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 4128 of the Business and Professions Code is
amended to read:
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 pursuant to contain at least the
information required by Section 4128.4.
(2) Preparing sterile compounded unit dose drugs for
parenteral therapy for administration to
inpatients, if each compounded unit dose drug is barcoded
pursuant 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 pursuant
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.
SEC. 2. Section 4128.4 of the Business and Professions Code is
amended to read:
4128.4. (a) Any unit dose medication
produced by a centralized hospital packaging pharmacy shall be
barcoded to be machine readable at the inpatient's
bedside. Upon reading the barcode, the following information
shall be retrievable: bedside using barcode
medication administration software.
(a) The date the medication was prepared.
(b) The components used barcode medication
administration software shall permit health care practitioners to
ensure that, before a medication is administered to an inpatient, it
is the right medication, for the right inpatient, in the
drug product. right dose, and via the right
route of administration. The software shall verify that the medi
cation satisfies these criteria by reading the barcode on
the medication and comparing the information retrieved to the
electronic medical record of the inpatient.
(c) The lot number or control number. For
purposes of this section, "barcode medication administration software"
means a computerized system designed to prevent medication errors in
health care settings.
(d) The expiration date.
(e) The National Drug Code Directory number.
(f) The name of the centralized hospital packaging pharmacy.
SEC. 3. Section 4128.5 of the Business and Professions Code is
amended to read:
4128.5. The (a) Any
label for each unit dose medication produced by a centralized
hospital packaging pharmacy shall contain
display a human-readable label that contains all of the
following:
(a)
(1) The expiration date. date
that the medication was prepared.
(2) The beyond-use date.
(b)
(3) The established name of the drug.
(c)
(4) The quantity of the each
active ingredient.
(d)
(5) Special storage or handling requirements.
(6) The lot number or control number assigned by the centralized
hospital packaging pharmacy.
(7) The name of the centralized hospital packaging pharmacy.
(b) For quality control and investigative purposes, a pharmacist
shall be able to retrieve all of the following information using the
lot number or control number described in subdivision (a):
(1) The components used in the drug product.
(2) The expiration date of each of the drug's components.
(3) The National Drug Code Directory number.
SEC. 4. 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.
SEC. 5. This act is an urgency statute necessary for the
immediate preservation of the public peace, health, or safety within
the meaning of Article IV of the Constitution and shall go into
immediate effect. The facts constituting the necessity are:
To eliminate, at the earliest possible time, requirements that
exceed the current technological capabilities of hospitals and that
create overly burdensome administrative costs for the California
State Board of Pharmacy, it is necessary this act take effect
immediately.