50-31-312. Exemptions from new drug application requirement. (1) Section 50-31-311 shall not apply to:
     (a) a drug intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs, provided the drug is plainly labeled in compliance with regulations issued by the department or pursuant to section 505(i) or 507(d) of the federal act;
     (b) a drug sold in this state at any time prior to the enactment of this chapter or introduced into interstate commerce at any time prior to the enactment of the federal act;
     (c) any drug which is licensed under the Virus, Serum, and Toxin Act of July 1, 1902 (U.S.C. 1958 ed. Title 42, chapter 6A, sec. 262); or
     (d) any drug which is subject to 50-31-306(1)(n).
     (2) The provisions of 50-31-103(30) shall not apply to any drug, when such drug is intended solely for use under conditions prescribed, recommended, or suggested in labeling with respect to such drug, which on October 9, 1962, or on the date immediately preceding July 1, 1967:
     (a) was commercially sold or used in this state or in the United States;
     (b) was not a new drug as defined by 50-31-103(30) as then in force; and
     (c) was not covered by an effective application under 50-31-311 or under section 505 of the federal act.

     History: En. Sec. 17, Ch. 307, L. 1967; amd. Sec. 107, Ch. 349, L. 1974; R.C.M. 1947, 27-717(d), (e); amd. Sec. 2, Ch. 456, L. 1979; amd. Sec. 7, Ch. 169, L. 1989.