§ 21a-110 — (Formerly Sec. 19-229). New drugs.

(a) No person shall sell, deliver, offer for sale, hold for sale or give away any new drug unless (1) an application with respect thereto has been approved under Section 355 of the federal act or (2), when not subject to the federal act, unless such drug has been tested and has been found to be safe for use and effective in use under the conditions prescribed, recommended or suggested in the labeling thereof, and prior to selling or offering for sale such drug, there has been filed with the commissioner an application setting forth (A) full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use; (B) a full list of the articles used as components of such drug; (C) a full statement of the composition of such drug; (D) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing and packing of such drug; (E) such samples of such drug and of the articles used as components thereof as the commissioner may require; and (F) specimens of the labeling proposed to be used for such drug. (b) An application provided for in subdivision (2) of subsection (a) shall become effective on the one hundred eightieth day after the filing thereof, except that, if the commissioner finds, after due notice to the applicant and giving him an opportunity for a hearing, that the drug is not safe or not effective for use under the conditions prescribed, recommended or suggested in the proposed labeling thereof, he shall, prior to the effective date of the application, issue an order refusing to permit the application to become effective. (c) This section shall not apply: (1) To a drug intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs, provided the drug shall be plainly labeled in compliance with regulations issued under Section 355 (i) or 357 (d) of the federal act; or (2) to a drug sold in this state at any time prior to the enactment of this chapter or introduced into interstate commerce at any time prior to the enactment of the federal act; or (3) to any drug which is licensed under Title 42 USC 262; or (4) to any drug subject to subsection (o) of section 21a-106 . (d) An order refusing to permit an application under this section to become effective may be revoked by the commissioner.

Legislative History

(1949 Rev., S. 3946; 1963, P.A. 359, S. 7.) History: 1963 act substituted application which has been approved for one which has become effective in Subsec. (a)(1), changed technical language, added provisions re effectiveness of drugs, lengthened time for application becoming effective from sixtieth to one-hundred-eightieth day after filing, changed provision re label in Subsec. (c)(1), requiring compliance with federal regulations and added Subsec. (c)(4); Sec. 19-229 transferred to Sec. 21a-110 in 1983. Annotation to former section 19-229: Whether a drug is a “new drug” or not is a justiciable issue within the jurisdiction of the court. 15 CS 11.