§ 39-23-70 — Intrastate commerce, introduction of new drugs.

(a) No person shall introduce or deliver for introduction into intrastate commerce any new drug unless an application filed pursuant to subsection (b) is effective with respect to such drug, or an application with respect thereto has been approved and such approval has not been withdrawn under Section 505 of the Federal act. (b) Any person may file with the Director of Health and Environmental Control an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Director of Health and Environmental Control as a part of the application (1) full reports of investigations which have been made to show whether or not such drug is safe for use; (2) a full list of the articles used as components of such drug; (3) a full statement of the composition of such drug; (4) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (5) such samples of such drug and of the articles used as components thereof as the Director of Health and Environmental Control may require; and (6) specimens of the labeling proposed to be used for such drug. (c) An application provided for in subsection (b) shall become effective on the one hundred eightieth day after the filing thereof, except that if the Director of Health and Environmental Control finds, after due notice to the applicant and giving him an opportunity for a hearing, (1), that the drug is not safe or not effective for use under the conditions prescribed, recommended or suggested in the proposed labeling thereof; or (2) the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drugs are inadequate to preserve its identity, strength, quality, and purity; or (3) based on a fair evaluation of all material facts, such labeling is false or misleading in any particular; he shall, prior to the effective date of the application, issue an order refusing to permit the application to become effective. (d) If the Director of Health and Environmental Control finds, after due notice to the applicant and giving him an opportunity for a hearing, that (1) the investigations, reports of which are required to be submitted to the Director pursuant to subsection (b), do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof; (2) the results of such tests show that such drug is unsafe for use under such conditions or do not show that such drug is safe for use under such conditions; (3) the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug are inadequate to preserve its identity, strength, quality, and purity; or (4) upon the basis of the information submitted to him as part of the application or upon the basis of any other information before him with respect to such drug, he has insufficient information to determine whether such drug is safe for use under such conditions, he shall, prior to the effective date of the application, issue an order refusing to permit the application to become effective. (e) The effectiveness of an application with respect to any drug shall, after due notice and opportunity for hearing to the applicant, by order of the Director of Health and Environmental Control be suspended if the Director finds (1) that clinical experience, tests by new methods, or tests by methods not deemed reasonably applicable when such application became effective show that such drug is unsafe for use under conditions of use upon the basis of which the application became effective, or (2) that the application contains any untrue statement of a material fact. The order shall state the findings upon which it is based. (f) An order refusing to permit an application with respect to any drug to become effective shall be revoked whenever the Director of Health and Environmental Control finds that the facts so require. (g) Orders of the Director of Health and Environmental Control issued under this section shall be served (1) in person by an officer or employee of the Department of Health and Environmental Control designated by the Director or (2) by mailing the order by registered mail addressed to the applicant or respondent at his last known address in the records of the Director. (h) An appeal may be taken by the applicant from an order of the Director of Health and Environmental Control refusing to permit the application to become effective, or suspending the effectiveness of the application. Such appeal shall be taken by filing in the circuit court within any circuit wherein such applicant resides or has his principal place of business, within sixty days after the entry of such order, a written petition praying that the order of the Director be set aside. A copy of such petition shall be forthwith served upon the Director or upon any officer designated by him for that purpose, and thereupon the Director shall certify and file in the court a transcript of the record upon which the order complained of was entered. Upon the filing of such transcript such court shall have exclusive jurisdiction to affirm or set aside such order. No objection to the order of the Director shall be considered by the court unless such objection shall have been argued before the Director or unless there were reasonable grounds for failure so to do. The findings of the Director as to the facts, if supported by substantial evidence, shall be conclusive. If any person shall apply to the court for leave to adduce additional evidence, and shall show to the satisfaction of the court that such additional evidence is material and that there were reasonable grounds for failure to adduce such evidence in the proceeding before the Director, the court may order such additional evidence to be taken before the Director and to be adduced upon the hearing in such manner and upon such terms and conditions as the court may deem proper. The Director may modify his findings as to the facts by reason of the additional evidence so taken, and he shall file with the court such modified findings which, if supported by substantial evidence, shall be conclusive, and his recommendation, if any, for the setting aside of the original order. The judgment and decree of the court affirming or setting aside any such order of the Director shall be final, subject to review as provided by statute. The commencement of proceedings under this subsection shall not, unless specifically ordered by the court to the contrary, operate as a stay of the Director's orders. (i) The Director of Health and Environmental Control shall promulgate regulations for exempting from the operation of this section drugs intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety of drugs.

Legislative History

HISTORY: 1962 Code SECTION 32-1510.107; 1972 (57) 3046.