Montana Title 37. Professions and Occupations § 37-7-602. Definitions

(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.

(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).

(a) further sale; or

(b) distribution without a further transaction.

(7)(a) “Wholesale distribution” means distribution of prescription drugs to persons other than a consumer or patient.

(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.