California § 4129.1 - An outsourcing facility that is licensed with the federal Food and Drug Administr

§ 4129.1. An outsourcing facility that is licensed with the federal Food and Drug Administr

(a) An outsourcing facility that is licensed with the federal Food and Drug Administration (FDA) and with an address in this state shall also be licensed by the board as an outsourcing facility before doing business within this state. The license shall be renewed annually and is not transferable. (b) An outsourcing facility shall compound all sterile products and nonsterile products in compliance with regulations issued by the board and with federal current good manufacturing practices applicable to outsourcing facilities. (c) An outsourcing facility license shall not be issued or renewed until the location is inspected by the board and found in compliance with this article and regulations adopted by the board. (d) An outsourcing facility license shall not be issued or renewed until the board does all of the following: (1) Prior to inspection, reviews a current copy of the outsourcing facility’s policies and procedures for sterile compounding and nonsterile compounding. (2) Is provided with copies of all federal and state regulatory agency inspection reports, as well as accreditation reports, and certification reports of facilities or equipment of the outsourcing facility’s premises conducted in the prior 12 months. (3) Prior to inspection, receives a list of all sterile drugs and nonsterile drugs compounded by the outsourcing facility as reported to the FDA in the last 12 months. (e) An outsourcing facility licensed pursuant to this section shall provide the board with all of the following: (1) A copy of any disciplinary or other action taken by another state or the FDA within 10 days of the action. (2) Notice within 24 hours of any recall notice issued by the outsourcing facility. (3) A copy of any clinically related complaint it receives involving an outsourcing facility’s compounded products from or involving any provider, pharmacy, or patient in California within 72 hours of receipt. (4) Notice within 24 hours after learning of adverse effects reported or potentially attributable to the outsourcing facility’s products.