(a) Before shipping, mailing, or delivering prescription drugs to a licensee in the state or advertising in the state, a wholesale drug distributor, third-party logistics provider, or an outsourcing facility that is located outside the state shall

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Terms Used In Alaska Statutes 08.80.159

  • board: means the Board of Pharmacy. See Alaska Statutes 08.80.480
  • drug: means an article recognized as a drug in an official compendium, or supplement to an official compendium. See Alaska Statutes 08.80.480
  • outsourcing facility: means a facility at one geographic location or address that is engaged in the compounding of sterile drugs for a facility at another geographic location. See Alaska Statutes 08.80.480
  • state: means the State of Alaska unless applied to the different parts of the United States and in the latter case it includes the District of Columbia and the territories. See Alaska Statutes 01.10.060
  • third-party logistics provider: means an entity that provides or coordinates warehousing or other logistics services for a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of the product, and that does not take ownership of the product or have responsibility to direct the sale or disposition of the product. See Alaska Statutes 08.80.480
  • wholesale: means sale by a manufacturer, wholesale dealer, distributor, or jobber to a person who sells, or intends to sell, directly to the user. See Alaska Statutes 08.80.480
  • wholesale drug distributor: means anyone engaged in wholesale distribution of drugs, including manufacturers. See Alaska Statutes 08.80.480
(1) obtain a license under Alaska Stat. § 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 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.
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