Administrative Rules of Montana
Department 24 - LABOR AND INDUSTRY
Chapter 24.174 - BOARD OF PHARMACY
Subchapter 24.174.14 - Dangerous Drug Act
Rule 24.174.1401 - REQUIREMENTS FOR REGISTRATION

Universal Citation: MT Admin Rules 24.174.1401

Current through Register Vol. 6, March 22, 2024

(1) The board shall register a person to manufacture dangerous drugs (as defined in 50-32-101, MCA) included in Schedules I through V upon the following conditions:

(a) applicant is registered for such purposes pursuant to the Federal Controlled Substances Act of 1970;

(b) the applicant has made proper application and has paid the applicable fee; and

(c) the category of manufacturer as above-stated shall include only those applicants who are engaged in the manufacturing of dangerous drugs within the state of Montana.

(2) The board shall register a person or entity to distribute dangerous drugs included in Schedules I through V under the following conditions:

(a) applicant is registered for such purpose pursuant to the Federal Controlled Substances Act of 1970;

(b) the applicant has made proper application and paid the applicable fee;

(c) the category of distributor as above-stated shall include any person or entity who distributes dangerous drugs or samples thereof within the state of Montana and may include a manufacturer not otherwise required to be registered if such manufacturer also distributes dangerous drugs or samples thereof within the state of Montana; and

(d) representatives of drug manufacturers who distribute controlled substance samples to licensed practitioners shall be exempt from the requirement of registration.

(3) The board shall register a person to analyze or conduct research with narcotic dangerous drugs in Schedules II through V upon making proper application and paying the applicable fee.

(4) The board shall register a person to analyze or conduct research with dangerous drugs in Schedule I, if:

(a) the applicant is a practitioner licensed under the laws of this state;

(b) the applicant has furnished the board evidence of registration for such purpose pursuant to the Federal Controlled Substances Act of 1970;

(c) the applicant has furnished the board a complete resume of all research proposed relative to any dangerous drugs. Such resume must be a duplicate of an application submitted to the DEA; and

(d) the applicant has made proper application and paid the applicable fee.

50-32-103, MCA; IMP, 50-32-306, 50-32-308, MCA;

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