2006 Code of Virginia § 54.1-3461 - Adulterated drug or device

54.1-3461. Adulterated drug or device.

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 decomposedsubstance;

2. If it has been produced, prepared, packed, or held under insanitaryconditions whereby it has been contaminated with filth, or whereby it hasbeen rendered injurious to health;

3. If it is a drug and the methods used in, or the facilities or controlsused for, its manufacture, processing, packing, or holding do not conform toor are not operated or administered in conformity with current goodmanufacturing practice to assure that such drug meets the requirements ofthis chapter;

4. If it is a drug and its container is composed, in whole or in part, of anypoisonous or deleterious substance which may render the contents injurious tohealth;

5. If it is a drug and it bears or contains, for purposes of coloring only, acolor additive which is unsafe within the meaning of the federal act or 54.1-3460; or

6. It is a color additive, the intended use of which in or on drugs is forpurposes of coloring only, and is unsafe within the meaning of the federalact or 54.1-3460.

B. A drug or device shall be deemed to be adulterated if it purports to be oris represented as a drug the name of which is recognized in an officialcompendium, and its strength differs from, or its quality or purity fallsbelow, the standard set forth in such compendium. Such determination ofstrength, quality, or purity shall be made in accordance with the tests ormethods of assay set forth in such compendium, or in the absence of orinadequacy of such tests or methods of assay, those prescribed underauthority of the federal act. No drug defined in an official compendium shallbe deemed to be adulterated under this subsection because it differs from thestandard of strength, quality, or purity set forth in such compendium, if thedifference in strength, quality, or purity from such standard is plainlystated on its label.

Whenever a drug is recognized in both the United States PharmacopoeiaNational Formulary and the Homeopathic Pharmacopoeia of the United States itshall be subject to the requirements of the United States PharmacopoeiaNational Formulary unless it is labeled and offered for sale as a homeopathicdrug, in which case it shall be subject to the provisions of the HomeopathicPharmacopoeia of the United States and not to those of the United StatesPharmacopoeia National Formulary.

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

D. A drug or device shall be deemed to be adulterated if it is a drug and anysubstance has been (i) mixed or packed with it so as to reduce its quality orstrength or (ii) substituted wholly or in part for it.

(Code 1950, 54-461; 1970, c. 650, 54-524.92; 1988, c. 765.)