Pharmacy: outsourcing facilities: licensure.

Existing law, the Pharmacy Law, provides for the licensure and regulation of pharmacists and pharmacy corporations in this state by the California State Board of Pharmacy. The law prohibits a pharmacy from compounding sterile drug products unless the pharmacy has obtained a sterile compounding pharmacy license from the board, and prohibits the board from issuing or renewing that license until the board has, among other things, reviewed a current copy of the pharmacy's procedures and policies for sterile compounding. Existing law provides that fees collected on behalf of the board are credited to the Pharmacy Board Contingent Fund, a continuously appropriated fund. This bill would require the board to license an outsourcing facility, as defined, and would prohibit an outsourcing facility to be concurrently licensed with the board as a sterile compounding pharmacy at the same location. The bill would require an outsourcing facility to be licensed with the board before doing business within or into the state, and would require an outsourcing facility to, among other things, notify the board of any disciplinary or other action taken by another state or the federal Food and Drug Administration within 10 days of the action. The bill would require the board to, among other things, inspect the location of an outsourcing facility to ensure that the outsourcing facility is in compliance with all laws and regulations before issuing or renewing an outsourcing facility's license. The bill would make a violation of any of these provisions or regulations adopted thereto punishable by a fine of up to $5,000 per occurrence. The bill would, on or after January 1, 2018, require the board to provide a report, as specified, to the Legislature regarding the regulation of nonresident outsourcing facilities. The bill would also authorize the board to collect a fee of $780 for the issuance and renewal of an outsourcing license and a fee of $715 for a temporary license, as specified. By increasing the amount of money deposited into a continuously appropriated fund, the bill would make an appropriation.