§ 25-5-414 — Adulterations

(1) A drug or device shall be deemed to be
adulterated:

(a) If it consists in whole or in part of any filthy, putrid, or decomposed
substance;

(b) If it has been produced, prepared, packed, or held under unsanitary
conditions under which it may have been contaminated with filth or rendered
injurious to health;

(c) If it is a drug and the methods used in, or the facilities or controls used
for, its manufacture, processing, packing, or holding do not conform to or are not
operated or administered in conformity with current good manufacturing practice
to assure that such drug meets the requirements of this part 4 as to safety and that
such drug has the identity and strength and meets the quality and purity
characteristics which it purports or is represented to possess;

(d) 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;

(e) If it is a drug and it bears or contains, for purposes of coloring only, a
color additive which is unsafe within the meaning of the federal act or section 25-5-413 (1);

(f) If it is a color additive, the intended use of which in or on drugs is for
purposes of coloring only, and is unsafe within the meaning of the federal act or
section 25-5-413 (1);

(g) 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 case of the absence 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 paragraph (g) 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.

(h) If it is not subject to the provisions of paragraph (g) of this subsection (1)
and its strength differs from, or its purity or quality falls below, that which it
purports or is represented to possess;

(i) If it is a drug and any substance has been mixed or packed therewith so as
to reduce its quality or strength or substituted wholly or in part therefor.

Legislative History

Source: L. 57: p. 434, � 14. CRS 53: � 66-22-14. C.R.S. 1963: � 66-20-14. L. 70: p. 204, � 8.