BILL NUMBER: AB 486 CHAPTERED
BILL TEXT
CHAPTER 241
FILED WITH SECRETARY OF STATE SEPTEMBER 2, 2015
APPROVED BY GOVERNOR SEPTEMBER 2, 2015
PASSED THE SENATE AUGUST 17, 2015
PASSED THE ASSEMBLY MAY 14, 2015
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, 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.
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 Section 4128.4.
(2) Preparing sterile compounded unit dose drugs for
administration to inpatients, if each compounded unit dose drug is
barcoded pursuant to Section 4128.4.
(3) Preparing compounded unit dose drugs for administration to
inpatients, if each unit dose package is barcoded pursuant to 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 using barcode medication administration
software.
(b) The 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 right dose, and via the right route of
administration. The software shall verify that the medication
satisfies these criteria by reading the barcode on the medication and
comparing the information retrieved to the electronic medical record
of the inpatient.
(c) For purposes of this section, "barcode medication
administration software" means a computerized system designed to
prevent medication errors in health care settings.
SEC. 3. Section 4128.5 of the Business and Professions Code is
amended to read:
4128.5. (a) Any label for each unit dose medication produced by a
centralized hospital packaging pharmacy shall display a
human-readable label that contains all of the following:
(1) The date that the medication was prepared.
(2) The beyond-use date.
(3) The established name of the drug.
(4) The quantity of each active ingredient.
(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.