Alaska Stat. § 08.80.159
This is the official text of Alaska Stat. § 08.80.159, part of Alaska’s Stat — part of the compiled statutory law of Alaska, published by the state as "Stat." Browse the sections below, each linked to its official government source.
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Licensing and inspection of facilities outside of state.
Official statutory text
(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.
(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.
Status: in_force · Read it on the official government site
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