§ 16-42-3-3 — Adulterated drug or device

Indiana § 16-42-3-3

• Jurisdiction: Indiana
• Title 16: HEALTH
• Art. 42: REGULATION OF FOOD, DRUGS, AND
• Ch. 3: Uniform Food, Drug, and Cosmetic Act: Adulteration

Text

A drug or device is considered to be
adulterated under the following conditions:
(1) If the drug or device consists in whole or in part of any filthy,
putrid, or decomposed substance.
(2) If the drug or device has been produced, prepared, packed, or
held under unsanitary conditions under which the drug or device
may have been contaminated with filth or made injurious to
health.
(3) If the methods used in or the facilities or controls used for a
drug's 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:
(A) the drug meets the requirements of this article as to safety;
and
(B) the drug:
(i) has the identity and strength; and
(ii) meets the quality and purity characteristics;
that the drug purports or is represented to possess.
(4) If a drug's container is composed in whole or in part of any
poisonous or deleterious substance that may make the contents
injurious to health.
(5) If:
(A) a drug bears or contains, for purposes of coloring only, a
color additive that is unsafe within the meaning of IC 16-42-2-5; or
(B) a color additive, the intended use of which in or on drugs is
for purposes of coloring only, is unsafe under IC 16-42-2-5.
(6) If:
(A) the drug or device purports to be or is represented as a drug,
the name of which is recognized in an official compendium;
and
(B) the strength of the drug differs from or the drug's quality or
purity falls below the standard set forth in that compendium;
the 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 or inadequacy of such tests or
methods of assay, those tests or methods prescribed by the federal
security administrator in regulations promulgated under the
Federal Act. A drug defined in an official compendium is not
considered to be adulterated under this subdivision because the
drug differs from the standard of strength, quality, or purity set
forth in the compendium if the drug's difference in strength,
quality, or purity from the standard is plainly stated on the drug's
label. If a drug is recognized in both the United States
Pharmacopoeia and the Homeopathic Pharmacopoeia of the
United States, the drug is subject to the requirements of the
United States Pharmacopoeia unless the drug is labeled and
offered for sale as a homeopathic drug. In the latter case, the drug
is subject to the provisions of the Homeopathic Pharmacopoeia of
the United States and not to those of the United States
Pharmacopoeia.
(7) If:
(A) the drug or device is not subject to the provisions of
subdivision (6); and
(B) the drug's or device's strength differs from or the drug's or
device's purity or quality falls below that which the drug or
device purports or is represented to possess.
(8) If the drug or device is a drug and any substance has been:
(A) mixed or packed with the drug or device so as to reduce the
drug's or device's quality or strength; or
(B) substituted wholly or in part for the drug.
[Pre-1993 Recodification Citations: 16-1-30-1; 16-1-30-2;
16-1-30-3; 16-1-30-4.]

Legislative History

As added by P.L.2-1993, SEC.25.