{"data":{"id":"us-ky/krs-217.055","jurisdiction":"us-ky","citation":"KRS 217.055","heading":"When drug deemed adulterated.","body":"A drug or device shall be deemed to be adulterated:\n(1) (a) If it consists in whole or in part of any filthy, putrid, or decomposed\nsubstance; or\n(b) If it has been produced, prepared, packed, or held under insanitary conditions\nwhereby it may have been co ntaminated with filth or whereby it may have\nbeen rendered injurious to health; or\n(c) If it is a drug and its container is composed in whole or in part of any\npoisonous or deleterious substance which may render the contents injurious to\nhealth; or\n(d) If it is a drug and it bears or contains, for purposes of coloring only, a coal -tar\ncolor other than one from a batch certified under the authority of the federal\nact;\n(2) If it purports to be or is represented as a drug the name of which is recognized in an\nofficial compendium, and its strength differs from, or its quality or purity falls\nbelow, the standard set forth in such compendium. Such determination as to\nstrength, quality, or purity shall be made in accordance with the tests or methods of\nassay set forth in such compendium, or in the absence of or inadequacy of such tests\nor methods of assay, those prescribed under authority of the federal act. No drug\ndefined in an official compendium shall be deemed to be adulterated under this\nsubsection because it differs from the standard of strength, quality, or purity therefor\nset forth in such compendium, if its difference in strength, quality, or purity from\nsuch standard is plainly stated on its label. Whenever a drug is recognized in both\nthe United States Ph armacopoeia and the Homeopathic Pharmacopoeia of the\nUnited States it shall be subject to the requirements of the United States\nPharmacopoeia unless it is labeled and offered for sale as a homeopathic drug, in\nwhich case it shall be subject to the provisio ns of the Homeopathic Pharmacopoeia\nof the United States and not to those of the United States Pharmacopoeia;\n(3) If it is not subject to the provisions of subsection (2) of this section and its strength\ndiffers from, or its purity or quality falls below, that which it purports or is\nrepresented to possess;\n(4) If it is a drug and any substance has been:\n(a) Mixed or packed therewith so as to reduce its quality or strength; or\n(b) Substituted wholly or in part therefor.","path":["KRS Chapter 217"],"source_url":"https://apps.legislature.ky.gov/law/statutes/statute.aspx?id=9274","current_through":"Includes enactments through the 2026 Regular Session","vintage":"09/05/2026","retrieved_at":"2026-09-05T20:52:24Z","sha256":"28b09a169cd75848df791938017b55d6d568587bbaf2b79adf6e52352bdc9322","source_id":"us-ky","stale":false,"prev":"us-ky/krs-217.050","next":"us-ky/krs-217.060"},"notice":"GroundRules: Original legal text. Not legal advice."}