37-7-605. Out-of-state licensing requirements. (1) An out-of-state wholesale distributor, third-party logistics provider, manufacturer, or repackager may not conduct business in this state without first obtaining a license from the board and paying the license fee established by the board.

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Terms Used In Montana Code 37-7-605

  • Board: means the board of pharmacy provided for in 2-15-1733. See Montana Code 37-7-101
  • Department: means the department of labor and industry provided for in Title 2, chapter 15, part 17. See Montana Code 37-7-101
  • Manufacturer: means :

    (a)a person approved by application to the FDA to manufacture a product as defined in section 360eee of the Drug Supply Chain Security Act, 21 U. See Montana Code 37-7-602

  • Person: includes an individual, partnership, corporation, association, or other legal entity. See Montana Code 37-7-101
  • Repackager: means a person who owns or operates an establishment that repacks and relabels a product or a package for:

    (a)further sale; or

    (b)distribution without a further transaction. See Montana Code 37-7-602

  • State: when applied to the different parts of the United States, includes the District of Columbia and the territories. See Montana Code 1-1-201
  • Wholesale: means a sale for the purpose of resale. See Montana Code 37-7-101
  • Wholesale distributor: means a person or entity, other than a manufacturer, a manufacturer's colicensed partner, a third-party logistics provider, or a repackager, who is engaged in wholesale distribution of prescription drugs. See Montana Code 37-7-602

(2)Application for a license under this section must be made on an approved form.

(3)The issuance of a license may not affect tax liability imposed by the department of revenue on any out-of-state licensee.

(4)A person acting as principal or agent for an out-of-state licensee may not sell or distribute prescription drugs in this state unless the wholesale distributor, third-party logistics provider, manufacturer, or repackager has obtained a license.