Ohio Code 3715.65 – Application for new drug required
(A) No person shall sell, deliver, offer for sale, hold for sale, or give away any new drug unless an application with respect to the drug has become effective under section 505 of the “Federal Food, Drug, and Cosmetic Act,” 52 Stat. 1040 (1938), 21 U.S.C.A. 301, as amended.
Terms Used In Ohio Code 3715.65
- 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
- New drug: means :
(a) Any drug the composition of which is such that the drug is not generally recognized among experts qualified by scientific training and experience to evaluate the safety of drugs, as safe for use under the conditions prescribed, recommended, or suggested in the labeling thereof;
(b) Any drug the composition of which is such that the drug, as a result of investigation to determine its safety for use under such conditions, has become so recognized, but that has not, other than in an investigation, been used to a material extent or for a material time under such conditions. See Ohio Code 3715.01
- Person: means an individual, partnership, corporation, or association. See Ohio Code 3715.01
- state: means the state of Ohio. See Ohio Code 1.59
(B) This section does not apply to the following:
(1) A drug intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety of drugs, provided that the drug is plainly labeled “For investigational use only”;
(2) A drug sold in this state at any time prior to the enactment of sections 3715.01 and 3715.52 to 3715.72 of the Revised Code, or introduced into interstate commerce at any time prior to the enactment of the “Federal Food, Drug, and Cosmetic Act”;
(3) Any drug that is licensed under the “Public Health Service Act,” 58 Stat. 682 (1944), 42 U.S.C.A. 301, as amended, or under the “Virus-Serum-Toxin Act,” 37 Stat. 832 (1913), 21 U.S.C.A. 151, as amended.