The treatment of biological products for various purposes under the pharmacy practice law

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 drugs, including requirements that certain information be contained on the commercial container of a prescription drug. The bill creates a similar provision that applies only to biological products, which includes a requirement that certain information to be contained on the commercial container of the biological product, including the brand name, if any, of the biological product, and the proper name of the biological product.

The provisions newly created in the bill apply only to biological products. The bill modifies the provisions under current law that apply to drugs generally so that they apply only to drugs that are not biological products.