A drug or device shall be deemed to be adulterated:
(a)
(1) If it consists in whole or in part of any filthy, putrid or decomposed substance; or
(2) if 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; or
(3) if it is a drug and the container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or
(4) if it is a drug and it bears or contains a coal-tar color that is not from a batch certified by the United States Department of Agriculture.
(b) If it purports or represents to be 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 specific standard. The 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 test or methods of assay, recourse shall be had to those prescribed by the United States Department of Agriculture. 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 set forth therefor if its difference from such standard is plainly stated on its label. If a homeopathic drug is not labeled and offered for sale as such homeopathic drug, it shall conform to the United States Pharmacopoeia; but if it is clearly labeled and is offered for sale as what it really is, it shall conform to the Homeopathic Pharmacopoeia of the United States.
(c) If it is not subject to the provisions of subsection (b) of this section and its strength differs from, or its purity or quality falls below, that which it purports or represents to be.
(d) If it is a drug and any substance has been:
(1) Mixed or packed therewith so as to reduce its quality or strength, or
(2) substituted wholly or in part therefor.
History —Apr. 26, 1940, No. 72, p. 492, § 14, eff. 90 days after Apr. 26, 1940.