Ohio Code 3715.63 – When drug or device is adulterated
(A) A drug or device is adulterated within the meaning of sections 3715.01 and 3715.52 to 3715.72 of the Revised Code, if any of the following apply:
Terms Used In Ohio Code 3715.63
- Cosmetic: means :
(a) Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance;
(b) Articles intended for use as a component of any such article, except that "cosmetic" does not include soap. See Ohio Code 3715.01
- Drug: means :
(a) Articles recognized in the United States pharmacopoeia and national formulary, or any supplement to them;
(b) Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals;
(c) Articles, other than food, intended to affect the structure or any function of the body of humans or other animals;
(d) Articles intended for use as a component of any of the foregoing articles, other than devices or their components, parts, or accessories. See Ohio Code 3715.01
- Food: means :
(a) Articles used for food or drink for humans or animals;
(b) Chewing gum;
(c) Articles used for components of any such articles. See Ohio Code 3715.01
- Label: means a display of written, printed, or graphic matter upon the immediate container, exclusive of package liners, of any article. See Ohio Code 3715.01
- United States: includes all the states. See Ohio Code 1.59
(1) It consists, in whole or in part, of any filthy, putrid, or decomposed substance.
(2) It has been produced, processed, 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) 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.
(4) 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 authority of the “Federal Food, Drug, and Cosmetic Act,” 52 Stat. 1040 (1938), 21 U.S.C.A. 301, as amended.
(5) It purports to be or is represented as a drug the name of which is recognized in the United States pharmacopoeia and national formulary, or any supplement to them, and its strength differs from or its quality or purity falls below the standard set forth in those compendiums. A determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in the compendiums, or in the absence or inadequacy of such tests or methods of assay, those prescribed under the authority of the “Federal Food, Drug, and Cosmetic Act.” A drug recognized in the compendiums is not adulterated under this division because it differs from the standard of strength, quality, or purity set forth for that drug in the compendiums, if the difference in strength, quality, or purity is plainly stated on its label. Whenever a drug is recognized in both the homoeopathic pharmacopoeia of the United States and in the United States pharmacopoeia and national formulary, including their supplements, it shall be subject to the requirements of the United States pharmacopoeia and national formulary 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 and national formulary.
(6) It is not subject to the provisions of division (A)(5) 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) It is a drug and any substance has been:
(a) Mixed or packed with the drug so as to reduce the drug’s quality or strength;
(b) Substituted wholly or in part for the drug.
(B) An expired drug is not adulterated within the meaning of sections 3715.01 and 3715.52 to 3715.72 of the Revised Code if the drug is donated pursuant to sections 3715.88 to 3715.92 of the Revised Code.