A drug or device shall be deemed to be adulterated:

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

2. If it has been produced, 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 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;

4. If it is a drug and it bears or contains, for purposes of coloring only, a coal tar color other than one from a batch certified under the authority of the Federal Food, Drug and Cosmetic Act, 21 U.S.C., Section 301 et seq.;

5. 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 as to 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 paragraph because it differs from the standard of strength, quality or purity therefor set forth in such compendium, if its 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 and the Homoeopathic Pharmacopoeia of the United States it shall be subject to the requirements of the United States Pharmacopoeia unless it is labeled and offered for sale as a homoeopathic drug, in which case it shall be subject to the provisions of the Homoeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopoeia;

6. If it is not subject to the provisions of paragraph 2 of this section and its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess;

7. If it is a drug and any substance has been:

a.mixed or packed therewith so as to reduce its quality or strength, or

b.substituted wholly or in part therefor; or

8. If it is sold or offered for sale and is not lawfully marketed under the federal act for the purpose for which, and in the form in which, it is sold or offered for sale, unless the drug or device has been exempted from the requirements of this paragraph by the Commissioner of Health, or if the drug is compounded by a registered pharmacist pursuant to a prescription by a licensed practitioner.

Laws 1963, c. 325, art. 14, § 1408, operative July 1, 1963; Laws 1992, c. 52, § 3, eff. Sept. 1, 1992.