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217.055 When drug deemed adulterated.
A drug or device shall be deemed to be adulterated:
(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 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 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 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 below, the standard set forth in such compendium. Such determination as
to strength, quality, or purity shall be made in accordance with the tests or
methods of assay set forth in such compendium, or in the absence of or
inadequacy of such tests or methods of assay, those prescribed under
authority of the federal act. No drug defined in an official compendium shall be
deemed to be adulterated under this subsection because it differs from the
standard of strength, quality, or purity therefor set forth in such compendium, if
its difference in strength, quality, or purity from such standard is plainly stated
on its label. 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 provisions of the Homeopathic Pharmacopoeia 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 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
(b) Substituted wholly or in part therefor.
Effective:
History: Created 1960 Ky. Acts ch. 247, sec. 6.
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