SB 1447: Pharmacy: automated drug delivery systems.

Existing law, the Pharmacy Law, establishes the California State Board of Pharmacy, within the Department of Consumer Affairs, to license and regulate the practice of pharmacy. Existing law makes any violation of the Pharmacy Law punishable as a crime.

Existing law generally requires a pharmacy that owns or provides dangerous drugs or dangerous devices dispensed through an automated drug delivery system (ADDS) to register the system, as provided, and authorizes the pharmacy to use the ADDS only if certain conditions are satisfied. Existing law authorizes the board to prohibit a pharmacy from using an ADDS if the board determines that those conditions are not satisfied. Existing law exempts from these requirements an ADDS operated by a licensed hospital pharmacy for doses administered in a facility operated under a consolidated license. Existing law specifies additional conditions for an ADDS located in a licensed clinic, a correctional clinic, or a health facility, as defined. Existing law authorizes a pharmacy or licensed wholesaler that is also an emergency medical services provider agency to restock dangerous drugs or dangerous devices into an emergency medical services automated drug delivery system that is licensed by the board, as provided. Existing law authorizes an inspector employed by the board to enter specified locations to inspect those locations for compliance with the Pharmacy Law.

This bill, beginning on July 1, 2019, would repeal the general ADDS provisions and the additional conditions for an ADDS located in a health facility. The bill instead would require an ADDS, as defined, to meet specified requirements in order to be installed, leased, owned, or operated in the state, including a license for the ADDS issued by the board to the holder of a current, valid, and active pharmacy license of a pharmacy located and licensed in the state. The bill would limit the placement and operation of an ADDS to specified locations, including the licensed pharmacy holding that ADDS license, a licensed health facility, a licensed clinic, or a specified medical office if the ADDS is an automated patient dispensing system (APDS), as defined. The bill would require the pharmacy holding the ADDS license to own or lease the ADDS and the drugs and devices located within it, as provided, and would require that pharmacy to supervise the operation of the ADDS. The bill would prescribe specified stocking and transfer requirements for those drugs and devices. The bill would require the pharmacy holding the ADDS license to provide training on the operation and use of that ADDS to specified individuals and would require the pharmacy to complete periodic self-assessments. The bill would also authorize a pharmacy inspector employed by the board to enter the location, or proposed location, of an ADDS to inspect the ADDS or the location pursuant to these provisions. This bill would require additional conditions for an APDS. The bill would exempt an automated unit dose system (AUDS) from licensure under these provisions if the AUDS is operated by a licensed hospital pharmacy and used to provide doses to specified patients, but would require the AUDS to comply with all other ADDS requirements described above.

This bill would require, on or before January 1, 2024, the board to report to the appropriate policy committees of the Legislature on the regulation of ADDS units, as provided. Because a violation of the Pharmacy Law is punishable as a crime, the bill would expand the scope of an existing crime, thereby imposing 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.