Section 12 AAC 52.696 - Outsourcing facilities(a) An applicant for an outsourcing facility license shall submit the items required in (b) of this section for review and approval by the executive administrator. An application that does not clearly demonstrate qualifications for licensure must be reviewed and approved by the board. (b) An outsourcing facility license will be issued to an applicant who (1) submits a complete application on a form provided by the department; (2) pays the applicable fees required in 12 AAC 02.310; (3) provides the name of the designated representative; (4) submits an attestation that the applicant holds a license as an outsourcing facility in another jurisdiction and that the license is in good standing, if applicable; (5) submits an attestation that a self-inspection of the premises using the form provided by the department was completed within the last two years; and(6) submits the results of the most recent Good Manufacturing Practice (GMP) inspection by the United States Food and Drug Administration. (c) An outsourcing facility that has changed its name, physical address, or ownership must notify the board in writing not later than 30 days after the change. The notification must include an attestation that a new self-inspection will be completed not later than 30 days after the start of business. (d) When an outsourcing facility ceases operations, the designated representative must submit to the board a written notice of the cessation of operations. The written notice must be submitted not later than 30 days after the cessation of operations and include (1) the date the outsourcing facility ceased operations; and (2) arrangement for the records of the outsourcing facility to be retained for two years. (e) The outsourcing facility must be registered as an outsourcing facility and compliant with 21 U.S.C. 353b (sec. 503B, P.L. 113-54(Food Drug and Cosmetic Act, Drug Quality and Security Act, Compounding Quality Act)).Eff. 10/31/2019, Register 232, January 2020; am 12/28/2022, Register 244, January 2023; am 7/15/2023, Register 247, October 2023Authority:AS 08.80.005
AS 08.80.030
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