California § 4129.2 - An outsourcing facility that is licensed with the federal Food and Drug Administr

§ 4129.2. 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) as an outsourcing facility and has an address outside of this state but in the United States of America is a nonresident outsourcing facility. A nonresident outsourcing facility shall not compound sterile drug products or nonsterile drug products for distribution or use into this state without an outsourcing license issued by the board pursuant to this section. The license shall be renewed annually and shall not be transferable. (b) A nonresident outsourcing facility shall compound all sterile products and nonsterile products to be distributed or used in this state in compliance with regulations of the board and with federal current good manufacturing practices applicable to outsourcing facilities. (c) A license for a nonresident outsourcing facility shall not be issued or renewed until the location is inspected by the board and found in compliance with this article and any regulations adopted by the board. The nonresident outsourcing facility shall reimburse the board for all actual and necessary costs incurred by the board in conducting an inspection of the nonresident outsourcing facility at least once annually pursuant to subdivision (x) of Section 4400. (d) A license for a nonresident outsourcing facility shall not be issued or renewed until the board: (1) Prior to inspection, reviews a current copy of the nonresident outsourcing facility’s policies and procedures for sterile compounding and nonsterile compounding. (2) (A) 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 nonresident outsourcing facility’s premises conducted in the prior 12 months. (B) For purposes of this paragraph, “state” refers to the state in which the nonresident outsourcing facility resides. (3) Prior to inspection, receives a list of all sterile drug products and nonsterile drug products compounded by the pharmacy as reported to the FDA within the prior 12 months. (e) A nonresident 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 nonresident outsourcing facility. (3) A copy of any 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 a nonresident outsourcing facility’s products.