AB 1073: Pharmacy: prescription drug labels.

The Pharmacy Law provides for the licensure and regulation of pharmacists by the California State Board of Pharmacy. That law requires a pharmacist to dispense a prescription in a container that, among other things, is correctly labeled with the directions for use of the drug, and requires the board to promulgate regulations that require, on or before January 1, 2011, a standardized, patient-centered, prescription drug label on all prescription medicine dispensed to patients in California. Existing regulations of the board implement that requirement, establishing standardized directions for use to be used when applicable, and requiring that the board publish on its Internet Web site translation of those directions for use into at least 5 languages other than English. A violation of that law is a crime.

This bill would require a pharmacist to use professional judgment to provide a patient with directions for use of a prescription that enhance the patients understanding of those directions, consistent with the prescribers instructions. The bill would also require a dispenser, excluding a veterinarian, upon the request of a patient or patients representative, to provide translated directions for use as prescribed. The bill would authorize a dispenser to use translations made available by the board pursuant to those existing regulations. The bill would make a dispenser responsible for the accuracy of English-language directions for use provided to the patient. By imposing new requirements on dispensers, the violation of which would be a crime, this bill would impose a state-mandated local program.

The Pharmacy Law also provides for the licensure and regulation of veterinary food-animal drug retailers by the board. That law subjects to specific prescription drug labeling requirements any veterinary food-animal drug dispensed pursuant to a prescription from a licensed veterinarian for food-producing animals from a veterinary food-animal drug retailer pursuant to that law.

This bill would also subject any veterinary food-animal drug so dispensed to the above drug labeling requirements relating to standardized directions for use.

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.