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217.055 When drug deemed adulterated.

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217.055 When drug deemed adulterated. A drug or device shall be deemed to be adulterated: <br>(1) (a) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or (b) If it has been produced, prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth or whereby it may have <br>been rendered injurious to health; or (c) If it is a drug and its container is composed in whole or in part of any poisonous or deleterious substance which may render the contents injurious to <br>health; or (d) If 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 <br>act; (2) If 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 <br>below, the standard set forth in such compendium. Such determination as to <br>strength, quality, or purity shall be made in accordance with the tests or methods of <br>assay set forth in such compendium, or in the absence of or inadequacy of such tests <br>or methods of assay, those prescribed under authority of the federal act. No drug <br>defined in an official compendium shall be deemed to be adulterated under this <br>subsection because it differs from the standard of strength, quality, or purity therefor <br>set forth in such compendium, if its difference in strength, quality, or purity from <br>such standard is plainly stated on its label. Whenever a drug is recognized in both <br>the United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the <br>United States it shall be subject to the requirements of the United States <br>Pharmacopoeia unless it is labeled and offered for sale as a homeopathic drug, in <br>which case it shall be subject to the provisions of the Homeopathic Pharmacopoeia <br>of the United States and not to those of the United States Pharmacopoeia; (3) If it is not subject to the provisions of subsection (2) of this section and its strength differs from, or its purity or quality falls below, that which it purports or is <br>represented to possess; (4) If it is a drug and any substance has been: (a) Mixed or packed therewith so as to reduce its quality or strength; or <br>(b) Substituted wholly or in part therefor. Effective: <br>History: Created 1960 Ky. Acts ch. 247, sec. 6.