SB 351: Hospital satellite compounding pharmacy: license: requirements.

Existing law, the Pharmacy Law, provides for the licensure and regulation of pharmacists and pharmacies by the California State Board of Pharmacy. A knowing violation of the Pharmacy Law is a crime. Existing law prohibits the operation of a pharmacy without a license and a separate license is required for each pharmacy location.

Under existing law, a hospital pharmacy means and includes a pharmacy, licensed by the board, located within any licensed hospital that maintains and operates organized facilities for the diagnosis, care, and treatment of human illnesses to which persons may be admitted for overnight stay and that meets specified requirements. A hospital pharmacy also includes a pharmacy that may be located outside of the hospital in another physical plant that is regulated under a hospitals consolidated license as a general acute care hospital that includes more than one physical plant maintained and operated on separate premises or that has multiple licenses for a single health facility on the same premises. As a condition of licensure by the board, the pharmacy in another physical plant is required to provide pharmaceutical services only to registered hospital patients who are on the premises of the same physical plant in which the pharmacy is located, except as specified. Existing law requires a pharmacy compounding sterile drug products to possess a sterile compounding pharmacy license.

With respect to a hospital pharmacy located outside of the hospital in another physical plant, this bill would redefine a hospital pharmacy to include a pharmacy that is located in any physical plant that is regulated as a general acute care hospital.

This bill would authorize the board to issue a license to a hospital satellite compounding pharmacy meeting specified requirements. The bill would make a license subject to a fee and an annual renewal fee, as specified. The bill would define a hospital satellite compounding pharmacy as an area licensed by the board to perform sterile compounding that is separately licensed by the board to perform that compounding and located outside of the hospital in another physical plant that is regulated as a general acute care hospital. The bill would require a hospital satellite compounding pharmacy to compound sterile drug products for administration only to registered hospital patients who are on the premises of the same physical plant in which the hospital satellite compounding pharmacy is located. The bill would also require the services to be directly related to the services or treatment plan administered in the physical plant. The bill would require a hospital satellite compounding pharmacy to comply with specified requirements relating to, among other things, purchasing, supervision, and recall and adverse effect notices.

By imposing new requirements on these pharmacies, the knowing violation of which would be a crime, the bill would impose a state-mandated local program.

This bill would incorporate additional changes to Section 4400 of the Business and Professions Code proposed by SB 752, that would become operative only if SB 752 and this bill are both chaptered and become effective on or before January 1, 2018, and this bill is chaptered last.

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.