Section 4063 - Adulterated drug or device definedA drug or device shall be deemed to be adulterated:
(1)(A) If it consists in whole or in part of any filthy, putrid, or decomposed substance;(B) if it has been produced, prepared, packed, or held under unsanitary conditions in which it may have been contaminated with filth or in which it may have been rendered injurious to health;(C) if it is a drug and its container is composed, in whole or in part, of any poisonous or deleterious substance that may render the contents injurious to health; or(D) 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 act.(2) 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 the compendium. The determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in the compendium, or in the absence of or inadequacy of the 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 subdivision because it differs from the standard of strength, quality, or purity set forth in the compendium, if its difference in strength, quality, or purity from the standard is plainly stated on its label. Whenever a drug is recognized in both the U.S. Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States, it shall be subject to the requirements of the U.S. Pharmacopoeia unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the provisions of the Homeopathic Pharmacopoeia of the United States and not to those of the U.S. Pharmacopoeia.(3) If it is not subject to the provisions of subdivision (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.(4) 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.Amended by 2023 , No. 6, § 142, eff. 7/1/2023.Added 1959, No. 172, § 14, eff. 5/12/1959.