Montana Code 50-32-306. Criteria for registration of manufacturers and distributors
50-32-306. Criteria for registration of manufacturers and distributors. (1) The board shall register an applicant to manufacture or distribute dangerous drugs included in 50-32-222, 50-32-224, 50-32-226, 50-32-229, and 50-32-232 unless it determines that the issuance of that registration would be inconsistent with the public interest.
Terms Used In Montana Code 50-32-306
- Board: means the board of pharmacy provided for in 2-15-1733. See Montana Code 50-32-101
- Dangerous drug: means a drug, substance, or immediate precursor in Schedules I through V set forth in Title 50, chapter 32, part 2. See Montana Code 50-32-101
- Dispense: means to deliver a dangerous drug to an ultimate user or research subject by or pursuant to the lawful order of a practitioner, including the prescribing, administering, packaging, labeling, or compounding necessary to prepare the drug for that delivery. See Montana Code 50-32-101
- Distribute: means to deliver other than by administering or dispensing a dangerous drug. See Montana Code 50-32-101
- Manufacture: means the production, preparation, propagation, compounding, conversion, or processing of a dangerous drug either directly or indirectly by extraction from substances of natural origin, independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis and includes the packaging or repackaging of the drug or labeling or relabeling of its container. See Montana Code 50-32-101
- State: when applied to a part of the United States, includes a state, district, commonwealth, territory, insular possession of the United States, and any area subject to the legal authority of the United States of America. See Montana Code 50-32-101
(2)In determining the public interest, the board shall consider the following factors:
(a)maintenance of effective controls against diversion of dangerous drugs into other than legitimate medical, scientific, or industrial channels;
(b)compliance with applicable state and local law;
(c)any convictions of the applicant under any federal and state laws relating to any dangerous drug;
(d)past experience in the manufacture or distribution of dangerous drugs and the existence in the applicant’s establishment of effective controls against diversion;
(e)furnishing by the applicant of false or fraudulent material in any application filed under this chapter;
(f)suspension or revocation of the applicant’s federal registration to manufacture, distribute, or dispense dangerous drugs as authorized by federal law; and
(g)any other factors relevant to and consistent with the public health and safety.
(3)Compliance by manufacturers and distributors with the provisions of the federal law respecting registration (excluding fees) entitles them to be registered under this chapter.