(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 th
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(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.)