(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.

Terms Used In Tennessee Code 53-1-110

  • Commissioner: means the commissioner of agriculture. See Tennessee Code 53-1-102
  • Drug: means articles, not including devices or their components, parts or accessories, that are:
    (A) Recognized in the official United States Pharmacopoeia, Official Homeopathic Pharmacopoeia of the United States, Official National Formulary, or any supplement to any of them. See Tennessee Code 53-1-102
  • Federal act: means the federal Food, Drug and Cosmetic Act (21 U. See Tennessee Code 53-1-102
  • Person: includes an individual, partnership, corporation and association. See Tennessee Code 53-1-102
  • State: means the state of Tennessee and its political subdivisions. See Tennessee Code 53-1-102
(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.).
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