Montana § 37-7-602 - Definitions

§ 37-7-602. Definitions

Definitions. As used in this part, the following definitions apply: (1) (a) "Dispenser" means a retail pharmacy, a hospital pharmacy, a group of chain pharmacies under common ownership and control that do not act as a wholesale distributor, or any other person authorized by law to dispense or administer prescription drugs, and the affiliated warehouses or distribution centers of the entities listed in this subsection (1)(a), if they are under common ownership and control and do not act as a wholesale distributor. (b) The term does not include a person who dispenses only products used in animals in accordance with FDA laws and regulations, except for persons engaged in animal prescription drug dispensing authorized in Title 37, chapter 18. (2) "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.S.C. 301, et seq., or a biologic pursuant to 42 U.S.C. 262; (b) a person who manufactures a product as defined in section 360eee of the Drug Supply Chain Security Act, 21 U.S.C. 301, et seq., or a biologic pursuant to 42 U.S.C. 262 that is not the subject of an approved application or license by the FDA; (c) a colicensed partner of a person described in subsection (2)(a) or (2)(b) that obtains the product directly from a person described in subsection (2)(a), (2)(b), or (2)(d); or (d) an affiliate of a person described in subsection (2)(a), (2)(b), or (2)(c) that receives the product directly from a person described in subsection (2)(a), (2)(b), or (2)(c). (3) "Prescription drug" has the same meaning as provided in 37-7-101 . (4) "Repackager" means a person who owns or operates an establishment that repacks and relabels a product or a package in accordance with the requirements of the FDA for: (a) further sale; or (b) distribution without a further transaction. (5) "Third-party logistics provider" or "3PL" means an entity that provides or coordinates warehousing or other logistics services of a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of a product but does not take ownership of the product or have responsibility to direct the sale or disposition of the product. (6) "Transaction" has the same meaning as provided in section 360eee of the Drug Supply Chain Security Act, 21 U.S.C. 301, et seq. (7) (a) "Wholesale distribution" means distribution of prescription drugs or devices to persons other than a consumer or patient, including the distribution of prescription drugs or devices to persons or entities authorized to purchase, administer, or dispense prescription drugs or devices. (b) The term does not include the exclusions listed in section 353(e)(4) of the Drug Supply Chain Security Act, 21 U.S.C. 301, et seq. (8) "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 or devices, including entities registered with the FDA.