Prescribers: dispensing of samples.

Existing law, the Pharmacy Law, regulates prescribers, as defined, and the dispensing of drugs. Existing law prohibits a prescriber from dispensing drugs or dangerous devices to patients in his or her office unless certain requirements are met. Existing law also authorizes prescribers to furnish a limited quantity of samples if (1) the samples are dispensed in the manufacturer's package, (2) there is no charge to the patient, and (3) an appropriate record is entered in the patient's chart. A knowing violation of the Pharmacy Law is a crime. This bill would require a prescriber dispensing a drug sample or a starter kit to either (1) provide the patient with a copy of the FDA-approved package insert for the drug sample or starter kit or (2) ensure that the manufacturer's warnings are affixed to the package containing the drug sample or starter kit. Because this bill would impose a new requirement under the Pharmacy Law, the knowing violation of which would be a crime, it 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.