§ 21-31-16 - Sale of new drugs – Regulations and procedure – Exceptions.
SECTION 21-31-16
§ 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 awayany new drug unless: (1) an application with respect to the new drug has becomeeffective 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 notbeen 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 salethe drug, there has been filed with the director of health an applicationsetting forth: (i) full reports of investigations which have been made to showwhether or not the drug is safe for use; (ii) a full list of the articles usedas components of the drug; (iii) a full statement of the composition of thedrug; (iv) a full description of the methods used in, and the facilities andcontrols 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 thedirector of health may require; and (vi) specimens of the labeling proposed tobe used for the drug.
(b) An application provided for in subdivision (a)(2) of thissection shall become effective on the sixtieth (60th) day after the filing ofit, except that if the director of health finds after due notice to theapplicant and giving the applicant an opportunity for a hearing that the drugis not safe for use under the conditions prescribed, recommended, or suggestedin its proposed labeling, the director shall, prior to the effective date ofthe application, issue an order refusing to permit the application to becomeeffective.
(c) This section shall not apply:
(1) To a drug intended solely for investigational use byexperts qualified by scientific training and experience to investigate thesafety in drugs provided the drug is plainly labeled "For investigational useonly";
(2) To a drug sold in this state at any time prior to theenactment of this chapter or introduced into interstate commerce at any timeprior 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 thissection to become effective may be revoked by the director of health.