Montana § 37-7-610 Rulemaking Authority

Montana Statutes

§ 37-7-610 — Rulemaking Authority

Montana·Title 37 PROFESSIONS AND OCCUPATIONS·Ch. 7 PHARMACY·Part 6 Wholesale Distributors -- Licensing

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:

(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.

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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:
(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.

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