Vermont § 4065 - New drugs; sale regulations

§ 4065. New drugs; sale regulations

• (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 become effective under section 505 of the
  federal act; or (2) when not subject to the federal act, unless the drug has been tested and has not been
  found to be unsafe for use under the conditions prescribed, recommended, or suggested
  in the labeling thereof and before selling or offering the drug for sale, there has
  been filed with the Department an application setting forth: (i) full reports of investigations that have been made to show whether or not the drug
  is safe for use; (ii) a full list of the articles used as components of the drug; (iii) a full statement of the composition of the drug; (iv) a full description of the methods used in and the facilities and controls used for
  the manufacture, processing, and packing of the drug; (v) such samples of the drug and of the articles used as components thereof as the Department
  may require; and (vi) specimens of the labeling proposed to be used for the drug. (b) An application provided for in subdivision (a)(2) of this section shall become effective
  on the 60th day after the filing thereof, except that if the Commissioner finds, after
  giving the applicant due notice and an opportunity for a hearing, that the drug is
  not safe for use under the conditions prescribed, recommended, or suggested in the
  proposed labeling thereof, the Commissioner shall, before 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 in drugs, provided the drug is plainly
  labeled “for investigational use only”; (2) to a drug sold in this State at any time before the enactment of this chapter or introduced
  into interstate commerce at any time before the enactment of the federal act; or (3) to any drug that is licensed under the Virus, Serum and Toxin Act of July 1, 1902
  (U.S.C. 1934 ed. title 42, chap. 4). (d) An order refusing to permit an application under this section to become effective
  may be revoked by the Commissioner. (Added 1959, No. 172, § 16, eff. May 12, 1959; amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 2023, No. 53, § 95, eff. June 8, 2023.)