Montana Code Annotated 2023



Part 3. Drugs and Devices

New Drug Application Required

50-31-311. New drug application required. (1) Except as provided in Title 50, chapter 42, a person may not sell, deliver, offer for sale, hold for sale, or give away any new drug unless:

(a) an application with respect to the drug has been approved and the approval has not been withdrawn under section 505 of the federal act (21 U.S.C. 355); or

(b) when not subject to the federal act, the drug has been tested and has been found to be safe for use and effective in use under the conditions prescribed, recommended, or suggested in the labeling of the drug and, prior to selling or offering for sale the drug, there has been filed with the department an application setting forth:

(i) full reports of investigations that have been made to show whether or not the drug is safe for use and whether the drug is effective in use;

(ii) a full list of the articles used as components of the drug;

(iii) a full statement of the composition of the drug;

(iv) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of the drug;

(v) samples of the drug and of the articles used as components of the drug that the department may require; and

(vi) specimens of the labeling proposed to be used for the drug.

(2) An application provided for in subsection (1)(b) becomes effective on the 180th day after the filing of the application. However, if the department finds, after due notice to the applicant and giving the applicant an opportunity for a hearing, that the drug is not safe or not effective for use under the conditions prescribed, recommended, or suggested in the proposed labeling of the drug, the department shall, prior to the effective date of the application, issue an order refusing to permit the application to become effective.

(3) An order refusing to permit an application under this section to become effective may be revoked by the department.

History: En. Sec. 17, Ch. 307, L. 1967; amd. Sec. 107, Ch. 349, L. 1974; R.C.M. 1947, 27-717(a) thru (c); amd. Sec. 1, Ch. 333, L. 1981; amd. Sec. 216, Ch. 42, L. 1997.