§616. Adulterated drugs

A drug is considered adulterated if it has been found to be such by any department of the United States government, or:

(1) If it consists in whole or in part of any filthy, putrid, or decomposed substance.

(2) If it has been 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 its container is composed of any poisonous or deleterious substance which may render it injurious to health.

(4) If it contains, for purposes of coloring only, a coal-tar color other than one from a batch that has been certified in accordance with department regulations.

(5) If its name is recognized in the official compendium, or if it purports to be a drug the name of which is so recognized, and it differs from the standard of strength, quality, or purity as determined by the tests or methods of assay set forth in the official compendium or in the regulations of the department, unless its standard of strength, quality, or purity is plainly stated on its label.

However, no such department regulation shall be adopted unless tests or methods of assay have not been prescribed in the official compendium or the tests or methods of assay prescribed therein are insufficient and, after due notice by the department of that fact, the official body in charge of the revision of the compendium has not corrected the deficiency.

(6) If it is not subject to the provisions of paragraph (5) of this Section and its identity or strength differs from or its purity or quality falls below that which it purports or is represented to possess.

(7) If any substance has been mixed or packed therewith so as to reduce its quality or strength or substituted wholly or in part therefor.

Amended by Acts 1978, No. 786, §5, eff. July 17, 1978.