Sec. 08.80.159. Licensing and inspection of facilities outside of state.
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Sec. 08.80.159. Licensing and inspection of facilities outside of state.
(a)Before shipping, mailing, distributing, or delivering a prescription drug to a person in the state or advertising in the state, a pharmacy, manufacturer, wholesale drug distributor, third-party logistics provider, or an outsourcing facility that is located outside the state shall
(1)obtain a license under AS 08.80.157 ;
(2)appoint an agent on whom process can be served in the state; and
(3)authorize inspection of the facility by a designee of the board under
(c)of this section.
(b)In addition to the requirements of
(a)of this section, an outsourcing facility shall
(1)register as an outsourcing facility with the United States Food and Drug Administration; and
(2)comply with the requirements of 21 U.S.C. 353b (Drug Quality and Security Act).
(c)Upon application by a pharmacy, manufacturer, wholesale drug distributor, third-party logistics provider, or an outsourcing facility for a license under this section, the board may
(1)require an inspection of the applicant's facility located outside the state; and
(2)approve a designee to conduct the inspection.
(d)The board shall adopt regulations necessary to implement this section.