{"data":{"id":"us-ky/krs-217.075","jurisdiction":"us-ky","citation":"KRS 217.075","heading":"Restrictions on handling of new drugs.","body":"(1) No person shall sell, deliver, offer for sale, hold for sale, or give away any new drug\nunless:\n(a) An application with respect thereto has become effective under the federal act;\nor\n(b) When not subject to the federal act unless such drug has been tested and has\nnot been found to be unsafe for use under the conditions prescribed,\nrecommended, or suggested in the labeling thereof, and prior to selling or\noffering for sale such drug, there has been filed with the cabinet an application\nsetting forth: full re ports of investigations which have been made to show\nwhether or not such drug is safe for use; a full list of the articles used as\ncomponents of such drug; a full statement of the composition of such drug; a\nfull description of the methods used in, and the facilities and controls used for,\nthe manufacture, processing, and packing of such drug; such samples of such\ndrug and of the articles used as components thereof as the cabinet may\nrequire; and specimens of the labeling proposed to be used for such drug.\n(2) An application provided for in subsection (1)(b) of this section shall become\neffective on the sixtieth day after the filing thereof, except that if the cabinet finds\nafter due notice to the applicant and giving him an opportunity for a hearing,\nconducted in accordance with KRS Chapter 13B, that the drug is not safe for use\nunder the conditions prescribed, recommended, or suggested in the proposed\nlabeling thereof, it shall, prior to the effective date of the application, issue an order\nrefusing to permit the application to become effective.\n(3) This section shall not apply:\n(a) To a drug intended solely for investigational use by experts qualified by\nscientific training and experience to investigate the safety in drugs provided\nthe drug is plainly labeled \"For investigational use only\"; or\n(b) To a drug sold in the state at any time prior to the enactment of KRS 217.005\nto 217.215 or introduced into interstate commerce at any time prior to the\nenactment of the federal act; or\n(c) To any drug which is lic ensed under the Virus, Serum, and Toxin Act of July\n1, 1902, and any amendments thereto. (42 U.S.C. secs. 262 et seq., and\namendments thereto).\n(4) An order refusing to permit an application under this section to become effective\nmay be revoked by the cabinet.","path":["KRS Chapter 217"],"source_url":"https://apps.legislature.ky.gov/law/statutes/statute.aspx?id=9278","current_through":"Includes enactments through the 2026 Regular Session","vintage":"09/05/2026","retrieved_at":"2026-09-05T20:52:24Z","sha256":"3c50dc57e8be0ec386036c3ac5e88d8f270015ce688b189c712336beb6ffb8bb","source_id":"us-ky","stale":false,"prev":"us-ky/krs-217.070","next":"us-ky/krs-217.080"},"notice":"GroundRules: Original legal text. Not legal advice."}