Tenn. Code Ann. § 53-1-110 (2026)

• (a) No person shall sell, deliver, offer for sale, hold for sale or give away any new drug unless an application with respect to the drug has become effective under § 505 of the federal act.

• (b) This section shall not apply to:
  • (1) A drug intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety in drugs; provided, that the drug is plainly labeled "For Investigational Use Only"; and provided, further, that all reports of investigations that are being made and that have been made to show whether or not the drug is safe for use, and whether the drug is effective in use are furnished upon request to the commissioner;
  • (2) A drug sold in this state at any time prior to February 15, 1941, or introduced into interstate commerce at any time prior to the enactment of the federal act; or
  • (3) Any drug that is licensed under the Virus-Serum-Toxin Act (21 U.S.C. § 151 et seq.).

Acts 1941, ch. 120, § 17; C. Supp. 1950, § 6580.17; Acts 1963, ch. 226, § 2; T.C.A. (orig. ed.), § 52-117; Acts 1986, ch. 485, § 1.