A drug or device shall be deemed to be adulterated if:

(1)

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Terms Used In Tennessee Code 53-1-108

  • Agriculture: means :
    (i) The land, buildings and machinery used in the commercial production of farm products and nursery stock. See Tennessee Code 1-3-105
  • Color: includes black, white and intermediate grays. See Tennessee Code 53-1-102
  • Department: means the department 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
  • Label: means a display of written, printed, or graphic matters upon the immediate container of any article, and a requirement made by or under authority of this chapter, that any word, statement, or other information appearing on the label shall not be considered to be complied with unless the word, statement or other information also appears on the outside container. See Tennessee Code 53-1-102
  • Official compendium: means 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
  • United States: includes the District of Columbia and the several territories of the United States. See Tennessee Code 1-3-105
(A) It consists, in whole or in part, of any filthy, putrid or decomposed substance;
(B) It has been produced, prepared, packed or held under unsanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health;
(C) It is a drug and its container is composed, in whole or in part, of any poisonous or deleterious substance that may render the contents injurious to health; or
(D) It is a drug and it bears or contains, for purposes of coloring only, a coal-tar color other than one from a batch certified under the authority of the federal act;
(2)

(A)

(i) It purports to be or is represented as a drug, the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in the compendium;
(ii) The determination as to strength, quality or purity shall be made in accordance with the tests or methods of assay set forth in the compendium, or in the absence or inadequacy of those tests or methods of assay, those prescribed by the United States department of agriculture;
(B) No drug defined in an official compendium shall be deemed to be adulterated under this subdivision (2) because it differs from the standard of strength, quality or purity for the drug set forth in the compendium, if its difference in strength, quality or purity from the standard is plainly stated on its label;
(C) Whenever a drug is recognized in both the United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States, it shall be subject to the requirements of the United States Pharmacopoeia, unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the Homeopathic Pharmacopoeia of the United States;
(3) It is not subject to subdivision (2) and its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess; or
(4) It is a drug and any substance has been:

(A) Mixed or packed with the drug so as to reduce its quality or strength; or
(B) Substituted wholly or in part for the drug.
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