Montana Code 37-7-602. Definitions
37-7-602. Definitions. As used in this part, the following definitions apply:
Terms Used In Montana Code 37-7-602
- Administer: means the direct application of a drug to the body of a patient by injection, inhalation, ingestion, or any other means. See Montana Code 37-7-101
- 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. See Montana Code 37-7-602
- distribution: means the sale, purchase, trade, delivery, handling, storage, or receipt of a drug or device and does not include administering or dispensing a prescription drug, pursuant to section 353(b)(1), or a new animal drug, pursuant to section 360b(b) of the Federal Food, Drug, and Cosmetic Act, 21 U. See Montana Code 37-7-101
- Drug: means a substance:
(a)recognized as a drug in any official compendium or supplement;
(b)intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals;
(c)other than food, intended to affect the structure or function of the body of humans or animals; and
(d)intended for use as a component of a substance specified in subsection (16)(a), (16)(b), or (16)(c). See Montana Code 37-7-101
- FDA: means the United States food and drug administration. See Montana Code 37-7-101
- Hospital: has the meaning provided in 50-5-101. 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
- Pharmacy: means an established location, either physical or electronic, registered by the board where drugs or devices are dispensed with pharmaceutical care or where pharmaceutical care is provided. 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
- Wholesale: means a sale for the purpose of resale. See Montana Code 37-7-101
- Wholesale distribution: means distribution of prescription drugs to persons other than a consumer or patient. See Montana Code 37-7-602
- 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
(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.
(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 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 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.
(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.