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.

---

Comments/questions on AB 1370 (Solorio): Centralized hospital packaging pharmacies.