"Adulterated"

Sec. 1.5. As used in this chapter, "adulterated" refers to a legend drug that:

(1) consists in whole or in part of a filthy, putrid, or decomposed substance;

(2) has been produced, prepared, packed, or held under unsanitary conditions and may have been contaminated or rendered injurious to health;

(3) has been subjected to conditions in the manufacture, processing, packing, or holding of the legend drug that do not conform to current standards of manufacturing to ensure that the legend drug is safe for use and possesses the identity, strength, quality, and purity characteristics that the legend drug is represented to possess;

(4) is contained in a container composed of a poisonous or deleterious substance that may render the legend drug injurious to health;

(5) bears or contains, for purposes of coloring only, a color additive that is unsafe;

(6) is of a different strength, quality, or purity from the official compendium standard for the legend drug; or

(7) does not meet the considerations of the federal Food, Drug, and Cosmetic Act.

As added by P.L.212-2005, SEC.24.