32-1966

32-1966. Acts constituting adulteration of a
drug or device

A drug or device shall 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 is not securely protected from dust,
dirt, and, as far as may be necessary by all reasonable means, from all foreign or
injurious contamination, or whereby it may have been rendered injurious to health.

3. If 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 or device
meets the requirements of this chapter as to safety and has the identity and strength,
and meets the quality, which it is represented to possess.

4. If 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:

(a) It bears or contains a color additive which is unsafe within the meaning of the
federal act.

(b) It is a color additive, the intended use of which in or on drugs is for the
purpose of coloring only, and is unsafe within the meaning of the federal act.

6. If it is 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. No drug defined in an official compendium shall be deemed to be
adulterated under this paragraph because it differs from the standard of strength,
quality, or purity set forth in such compendium, if its difference in strength, quality,
or purity from such standard is plainly stated on its label.

7. If it is not subject to the provisions of paragraph 6 of this section 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 or device to which any substance has been mixed or packed
therewith so as to reduce its quality or strength, or to be substituted for it in whole
or in part.