Section 12 AAC 52.698 - Manufacturer license(a) An applicant for a manufacturer 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) A manufacturer 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 set out under 12 AAC 02.310; (3) provides the name of the designated representative who will manage the manufacture of drugs or devices for the wholesale drug facility; (4) submits an attestation that (A) a self-inspection of the premises using the form provided by the department was completed within the last two years; or(B) an inspection of the premises by a third party was completed within the last two years;(5) submits an attestation that the applicant holds a license as a manufacturer in another jurisdiction and that the license is in good standing, if applicable; and(6) submits the results of the applicant's most recent Good Manufacturing Practice (GMP) inspection by the United States Food and Drug Administration. (c) A manufacturer operating as a virtual manufacturer must indicate on the application that it operates as a virtual manufacturer within the meaning given in 12 AAC 52.995. (d) A manufacturer 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 of a change of physical address must include an attestation that a new self-inspection will be completed not later than 30 days after the start of business. (e) When a manufacturer ceases operations, the designated representative of the manufacturer shall notify the board in writing of the cessation of operations. The form must be submitted not later than 30 days after the cessation of operations. (f) A manufacturer that distributes drugs and devices that it does not directly manufacture must hold a separate wholesale drug distributor license.(g) A manufacturer that provides logistics services must hold a separate third-party logistics provider license.Eff. 7/15/2023, Register 247, October 2023; am 9/28/2024, Register 251, October 2024Authority:AS 08.80.005
AS 08.80.030
AS 08.80.157
AS 08.80.480