Amended in Senate August 4, 2014

Amended in Senate July 2, 2014

Amended in Assembly April 10, 2014

California Legislature—2013–14 Regular Session

Assembly Bill No. 2757

Introduced by Assembly Member Bocanegra

March 24, 2014

An act to amend Sections 4128, 4128.4, and 4128.5 of the Business and Professions Code, relating to begin delete pharmacy. end delete begin insert pharmacy, and declaring the urgency thereof, to take effect immediately. end insert

LEGISLATIVE COUNSEL’S DIGEST

AB 2757, as amended, Bocanegra. 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 the date that the medication was prepared and the components used in the drug product.

This bill would instead require that this information be displayed on a human-readable label or be retrievable using the lot number or control number of the medication, rather than by reading the barcode. The bill would require that a 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.

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This bill would declare that it is to take effect immediately as an urgency statute.

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Vote:  begin delete majority end delete begin insert ²⁄₃ end insert . 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 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 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 the 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.

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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:

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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.

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