Montana Code 37-7-610. Rulemaking authority
37-7-610. Rulemaking authority. (1) The board shall adopt rules and regulations necessary to carry out the purpose and enforce the provisions of this part, including FDA guidelines and rules pursuant to the Drug Quality and Security Act of 2013, which includes the Drug Supply Chain Security Act, 21 U.S.C. § 301, et seq., to implement:
Terms Used In Montana Code 37-7-610
- Board: means the board of pharmacy provided for in 2-15-1733. 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
- 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
- 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 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
(a)product tracing, reporting, and other requirements compliant with FDA uniform national policy; or
(b)national standards for the licensing of wholesale distributors, third-party logistics providers, manufacturers, and repackagers.
(2)If the rules and regulations conflict with the wholesale distributor, third-party logistics provider, manufacturer, or repackager guidelines or rules promulgated by the FDA, the latter control.