New drugs; federal qualification; testing; application to introduce drug
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Indiana Code › Title 16 › Article 42 › Chapter 3 › Section 16-42-3-7
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Sec. 7. (a) This section does not apply under the circumstances described in section 9 of this chapter.
(b) A person may not sell, deliver, offer for sale, hold for sale, give away, or introduce into intrastate commerce any new drug unless:
(1) an application to sell, deliver, offer for sale, hold for sale, give away, or introduce into intrastate commerce a new drug has been approved and the approval has not been withdrawn under Section 505 of the Federal Act; or
(2) if not subject to the Federal Act the drug has been tested and has been found to be safe for use and effective in use under the conditions prescribed, recommended, or suggested in the labeling of the drug.
(c) Before selling or offering for sale the new drug, there must be filed with the state department an application setting forth the following:
(1) Full reports of investigations that have been made to show whether or not the drug is safe for use and whether the drug is effective in use.
(2) A full list of the articles used as components of the drug.
(3) A full statement of the composition of the drug.
(4) A full description of the methods used in and the facilities and controls used for the manufacture, processing, and packing of the drug.
(5) Such samples of the drug and of the articles used as components of the drug that the state department requires.
(6) Specimens of the labeling proposed to be used for the drug.
[Pre-1993 Recodification Citations: 16-1-30-16; 16-1-30-18 part.]
As added by P.L.2-1993, SEC.25.
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