3715.65 Application for new drug required. - Ohio Statutes

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.

(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.

Effective Date: 07-22-1998; 04-15-2005