AB 679

This bill makes a number of changes to the pharmacy practice laws regarding

the prescribing and dispensing of biological products, including changes to address

the dispensing of interchangeable biological products.

Current state law contains a number of provisions that address the dispensing

of drug product equivalents in lieu of the specific drug product described.

Specifically, current law allows a pharmacist to dispense the “drug product

equivalent” of a drug prescribed if the drug product equivalent is lower in price to the

consumer than the drug product prescribed, unless the prescribing practitioner

specifically indicates on the prescription order that no substitution of the drug

product prescribed may be made. Current law defines “drug product equivalent” as

a drug product that the federal Food and Drug Administration, which regulates

drugs pursuant to the Federal Food, Drug, and Cosmetic Act, has determined is

therapeutically equivalent to the drug product prescribed. Current law also provides

that if a pharmacist, pursuant to a prescription order that specifies a drug product

by its brand name, dispenses the drug product equivalent of the drug product

specified in the prescription order, the label required for the drug may include both

the generic name of the drug product equivalent and the brand name specified in the

prescription order, unless the prescribing practitioner requests that the brand name

be omitted from the label.

This bill creates provisions similar to those described above that apply with

respect to biological products, which are regulated somewhat differently from other

drugs by the FDA under the federal Public Health Service Act. Specifically, the bill

allows a pharmacist to dispense an interchangeable biological product in lieu of the

biological product prescribed if the interchangeable biological product is lower in

price to the consumer than the biological product prescribed, unless the prescribing

practitioner specifically indicates on the prescription order that no substitution of

the biological product prescribed may be made. The bill defines “interchangeable

biological product” as a biological product that the FDA has determined is

therapeutically equivalent to the biological product prescribed or that the FDA has

licensed and determined meets standards for interchangeability pursuant to

provisions in federal law. The bill further establishes requirements for pharmacists

who dispense biological products to make an entry into an electronic records system

or to otherwise communicate to the prescribing practitioner regarding the biological

product dispensed, subject to certain exceptions. The bill provides that if a

pharmacist, pursuant to a prescription order that specifies a biological product by its

brand name, dispenses the interchangeable biological product of the biological

product specified in the prescription order, the label required for the drug may

include both the proper name of the interchangeable biological product and the

brand name specified in the prescription order.

Current law also contains provisions regarding the labeling of prescription