Title 26, Chapter 3, Section 10
( 26-3-10)
(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 such 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 prior to selling or offering such drug for sale, there
has been filed with the State Board of Pharmacy an application
setting forth: (A) Full reports of investigations which have been made to show
whether or not such drug is safe for 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 State Board of Pharmacy may require;
and (F) Specimens of the labeling proposed to be used for such drug. (b) An application provided for in paragraph (2) of subsection (a)
of this Code section shall become effective 60 days after the filing
thereof, except that if the State Board of Pharmacy finds after due
notice to the applicant and after giving him 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, he shall prior to the effective date of the application
issue an order refusing to permit the application to become
effective. (c) This Code 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"; or (2) To a drug sold in the 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 manufactured, labeled, and sold for veterinary
purposes. (d) An order refusing to permit an application under this Code
section to become effective may be revoked by the State Board of
Pharmacy. |