Adulterated drugs and devices: Poisonous or insanitary ingredients. A drug or device shall be deemed to be adulterated if:
1. It consists in whole or in part of any filthy or decomposed substance;
2. It has been produced, prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health;
3. 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; or
4. It is a drug and it bears or contains, for coloring only, a color additive which is unsafe within the meaning of the Federal Act.
Last modified: February 26, 2006