AB 602: Pharmacy: nonprescription diabetes test devices.

The Pharmacy Law provides for the licensing and regulation of the practice of pharmacy by the California State Board of Pharmacy within the Department of Consumer Affairs. That law authorizes the board to take disciplinary action against any holder of a license who is guilty of unprofessional conduct, as described, or whose license has been issued by mistake. That law also requires the records of manufacture and of sale, acquisition, receipt, shipment, or disposition of dangerous drugs or dangerous devices to be open for inspection during business hours and preserved for at least 3 years, as specified. That law authorizes a board inspector to embargo any dangerous drug or dangerous device that the board inspector finds or has probable cause to believe is adulterated, misbranded, or counterfeit. Under that law, a person who fails to maintain or produce those records and who violates any provision of that law, when no other penalty is provided, is guilty of a crime.

This bill would make it unprofessional conduct for a licensee to acquire a nonprescription diabetes test device from a person that the licensee knew or should have known was not the nonprescription diabetes test devices manufacturer or manufacturers authorized distributor or to submit to specified persons a claim for reimbursement for a nonprescription diabetes test device when the licensee knew or should have known that the diabetes test device was not purchased directly from the manufacturer or from a manufacturers authorized distributor. The bill would authorize the board to embargo any nonprescription diabetes test device that a board inspector finds or has probable cause to believe was not purchased directly from the manufacturer or from a manufacturers authorized distributor, as specified. The bill would require pharmacies that dispense nonprescription diabetes test devices pursuant to prescriptions to retain records of acquisition and sale of those nonprescription diabetes test devices for at least 3 years and keep those records open to inspection during business hours, as described above. The bill would require a manufacturer of nonprescription diabetes test devices to make the names of its authorized distributors available on its Internet Web site, to provide those names to the board, and to, within 30 days of making changes, update its Internet Web site and inform the board of the changes, as specified. The bill would require the board to post the names of authorized distributors on the boards Internet Web site, as specified. By expanding the scope 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.

This bill would declare that it is to take effect immediately as an urgency statute.