12 Alaska Admin. Code § 52.610

Current through December 21, 2024
Section 12 AAC 52.610 - Wholesale drug distributor license
(a) An applicant for a wholesale drug distributor 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 wholesale drug distributor license will be issued to an applicant who
(1) submits a completed 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 who will manage the wholesale distribution 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) a Verification Accredited Wholesale Distributors (VAWD) inspection has been completed; and
(5) submits a copy of a current valid license, permit, or registration to conduct operations in the jurisdiction in which it is located, as applicable.
(c) A wholesale drug distributor that has changed its name, physical address, or ownership must notify the board in writing not later than 30 days after the change. A 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.
(d) When a wholesale drug distributor ceases operations, the designated representative of the wholesale drug distributor shall notify the board in writing of the cessation of operations. The written notice must be submitted not later than 30 days after the cessation of operations.

12 AAC 52.610

Eff. 1/16/98, Register 145; am 8/21/2002, Register 163; am 1/17/2007, Register 181; am 6/29/2018, Register 226, July 2018; am 10/31/2019, Register 232, January 2020; am 12/28/2022, Register 244, January 2023; am 7/15/2023, Register 247, October 2023

Authority:AS 08.80.005

AS 08.80.030

AS 08.80.157

AS 08.80.159

AS 08.80.480