                                 CODE OF VIRGINIA

ADULTERATED DRUG OR DEVICE (§ 54.1-3461)

A. A drug or device shall be deemed to be adulterated:

   1. If it consists in whole or in part of any filth, putrid or decomposed
   substance;

   2. If it has been produced, prepared, packed, or held under insanitary
   conditions whereby it has been contaminated with filth, or whereby it has 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;

   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 the federal act or &#xA7;
   54.1-3460; or

   6. 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 &#xA7; 54.1-3460.

B. A drug or device shall be deemed to be adulterated 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 of strength, quality,
or purity shall 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 shall be deemed to be adulterated under this
subsection because it differs from the standard of strength, quality, or purity
set forth in such compendium, if the 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
National Formulary and the Homeopathic Pharmacopoeia of the United States it
shall be subject to the requirements of the United States Pharmacopoeia National
Formulary 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 National Formulary.

C. A drug or device shall be deemed to be adulterated if it is not subject to
the provisions of subsection B of this section and its strength differs from, or
its purity or quality falls below, that which it purports or is represented to
possess.

D. A drug or device shall be deemed to be adulterated 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.

HISTORY: Code 1950, § 54-461; 1970, c. 650, § 54-524.92; 1988, c. 765.