2005 Rhode Island Code - § 21-31-16 — Sale of new drugs – Regulations and procedure – Exceptions.

    (a) No person shall sell, deliver, offer for sale, hold for sale, or give away any new drug unless: (1) an application with respect to the new drug has become effective under § 505 of the Federal Act, 21 U.S.C. § 355; 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 of it, and prior to selling or offering for sale the drug, there has been filed with the director of health an application setting forth: (i) full reports of investigations which 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) any samples of the drug and of the articles used as components of it that the director of health 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 sixtieth (60th) day after the filing of it, except that if the director of health finds after due notice to the applicant and giving the applicant an opportunity for a hearing that the drug is not safe for use under the conditions prescribed, recommended, or suggested in its proposed labeling, the director 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 in drugs provided the drug is plainly labeled "For investigational use only";

   (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 licensed under 42 U.S.C. § 262.

   (d) An order refusing to permit an application under this section to become effective may be revoked by the director of health.