Montana Code 37-7-601. Scope and purpose
37-7-601. Scope and purpose. This part applies to the wholesale distribution, third-party logistics, manufacturing, or repackaging of prescription drugs in this state. The purpose of this part is to implement the federal Prescription Drug Marketing Act of 1987 and the Drug Quality and Security Act of 2013, which includes but is not limited to the Drug Supply Chain Security Act, by providing minimum standards, terms, and conditions for licensing by the department of persons or entities engaged in the wholesale distribution, third-party logistics, manufacturing, or repackaging of prescription drugs.
Terms Used In Montana Code 37-7-601
- Department: means the department of labor and industry provided for in Title 2, chapter 15, part 17. See Montana Code 37-7-101
- 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
- Manufacturing: means the production, preparation, propagation, conversion, or processing of a drug or device, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical or biological synthesis. See Montana Code 37-7-101
- 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 distribution: means distribution of prescription drugs to persons other than a consumer or patient. See Montana Code 37-7-602