KRS 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 co ntaminated 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 Ph armacopoeia 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 provisio ns 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.