§ 21-31-14. Adulterated drug or device.
A drug or device shall be deemed to be adulterated:
(1) If:
(i)it consists in whole or in part of any filthy, putrid, or decomposed substance;
(ii)it has been produced, prepared, packed, or held under unsanitary conditions by
which it may have been contaminated with filth, or by which it may have been rendered
injurious to health;
(iii)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 (iv) it is a drug and it bears or contains, for purposes of coloring
only, a
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§ 21-31-14. Adulterated drug or device.
A drug or device shall be deemed to be adulterated:
(1) If: (i) it consists in whole or in part of any filthy, putrid, or decomposed substance;
(ii) it has been produced, prepared, packed, or held under unsanitary conditions by
which it may have been contaminated with filth, or by which it may have been rendered
injurious to health; (iii) 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 (iv) 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 the compendium. A determination as to strength, quality,
or purity shall be made in accordance with the tests or methods of assay set forth
in the compendium, or in the absence of or inadequacy of the 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 subdivision because it differs
from the standard of strength, quality, or purity set forth in an official compendium,
if its difference in strength, quality, or purity from the 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 subdivision (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: (i) mixed or packed with it so as to reduce
its quality or strength; or (ii) substituted wholly or in part for it.