Indiana § 16-42-3-8 New drugs; time for application to take effect

Indiana Statutes

§ 16-42-3-8 — New drugs; time for application to take effect

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

(a)This section does not apply under the circumstances described in section 9 of this chapter.

(b)An application provided for under section 7 of this chapter becomes effective on the one hundred eightieth day after the filing of the application. However, if the state department finds, after due notice to the applicant and giving the applicant an opportunity for a hearing that:

(1)the drug is not safe or not effective for use under the conditions prescribed, recommended, or suggested in the proposed labeling of the drug;

(2)the methods used in and the facilities and controls used for the manufacture, processing, and packing of the drugs are inadequate to preserve the drug's identity, strength, quality, and purity; or

(3)based on a fair evaluation of all material facts, that the labelin

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(a) This section does not apply under the
circumstances described in section 9 of this chapter.
(b) An application provided for under section 7 of this chapter
becomes effective on the one hundred eightieth day after the filing of
the application. However, if the state department finds, after due notice
to the applicant and giving the applicant an opportunity for a hearing
that:
(1) the drug is not safe or not effective for use under the
conditions prescribed, recommended, or suggested in the
proposed labeling of the drug;
(2) the methods used in and the facilities and controls used for the
manufacture, processing, and packing of the drugs are inadequate
to preserve the drug's identity, strength, quality, and purity; or
(3) based on a fair evaluation of all material facts, that the
labeling is false or misleading in any particular;
the state department shall, before the effective date of the application,
issue an order refusing to permit the application to become effective.
[Pre-1993 Recodification Citations: 16-1-30-17; 16-1-30-18
part.]

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