Sterile compounding and nonresident pharmacies.

Existing law, the Pharmacy Law, provides for the licensure and regulation of pharmacies in this state by the California State Board of Pharmacy. A violation of these provisions is a crime. Existing law provides that a pharmacy located outside this state that ships, mails, or delivers, in any manner, controlled substances, dangerous drugs, or dangerous devices into this state shall be considered a nonresident pharmacy. Existing law prohibits a person from acting as a nonresident pharmacy unless he or she has obtained a license from the board, and authorizes the board to register a nonresident pharmacy that is organized as a limited liability company in the state in which it is licensed. The law also prohibits a resident or nonresident pharmacy from compounding injectable sterile drug products for shipment into this state without a license issued by the board, and authorizes a license to compound injectable sterile drug products to be issued only for a location that is licensed as a resident or nonresident pharmacy. This bill would require a resident or a nonresident pharmacy that issues a recall notice regarding a sterile compounded drug to contact the recipient pharmacy, prescriber, or patient of the recalled drug and the board as soon as possible within 12 hours of the recall notice if use of or exposure to the recalled drug may cause serious adverse health consequences or death and if the recalled drug was dispensed or is intended for use in this state. Because a violation of these requirements would be a crime, the bill would impose a state-mandated local program. The bill would also provide that if the home state pharmacy license of a nonresident pharmacy is canceled, revoked, or suspended for any reason, any license issued pursuant to the provisions governing the licensing and registration of nonresident pharmacies or authorizing a nonresident pharmacy to compound injectable sterile drug products shall be immediately canceled, revoked, or suspended by operation of law. 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.