§ 16-42-3-7 — New drugs; federal qualification; testing; application to introduce drug

Indiana § 16-42-3-7

• Jurisdiction: Indiana
• Title 16: HEALTH
• Art. 42: REGULATION OF FOOD, DRUGS, AND
• Ch. 3: Uniform Food, Drug, and Cosmetic Act: Adulteration

Text

(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approved and the approval has not been withdrawn under Section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.]

Legislative History

As added by P.L.2-1993, SEC.25.