§ 19-02.1-13 — Drugs and devices - Adulteration defined

North Dakota § 19-02.1-13

• Jurisdiction: North Dakota
• Title 19: Foods, Drugs, Oils, and Compounds
• Ch. 19-02.1: North Dakota Food, Drug, and Cosmetic Act

Text

A drug or device must be deemed to be adulterated:
1. If it consists in whole or in part of any filthy, putrid, or decomposed substance.
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.
3. 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 chapter as to safety and has the identity and
strength, and meets the quality and purity characteristics, which it purports or is
represented to possess.
4. 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.
5. 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 subsection 1 of section 19-02.1-12 or 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 subsection 1 of section 19-02.1-12.
6. 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 must 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 may 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
pharmacopoeia and the homeopathic pharmacopoeia of the United States it is 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 is subject to the provisions of
the homeopathic pharmacopoeia of the United States and not to those of the United
States pharmacopoeia.
7. If it is not subject to the provisions of subsection 6 and its strength differs from, or its
purity or quality falls below, that which it purports or is represented to possess.
8. 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.