Indiana § 16-42-3-10 New drugs; revocation of order refusing application to take effect;
revocation of approved application

Indiana Statutes

§ 16-42-3-10 — New drugs; revocation of order refusing application to take effect; revocation of approved application

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

(a)An order refusing to permit an application under section 7 or 8 of this chapter to become effective may be revoked by the state department.

(b)The state department may, after affording an opportunity for public hearing and judicial appeal, revoke an application approved under section 7 or 8 of this chapter if the state department finds any of the following:

(1)That the drug, based on evidence acquired after approval, may not be safe or effective for the intended use.

(2)That the facilities or controls used in the manufacture, processing, or labeling of the drug may present a hazard to the public health. [Pre-1993 Recodification Citation: 16-1-30-19.]

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(a) An order refusing to permit an
application under section 7 or 8 of this chapter to become effective may
be revoked by the state department.
(b) The state department may, after affording an opportunity for
public hearing and judicial appeal, revoke an application approved
under section 7 or 8 of this chapter if the state department finds any of
the following:
(1) That the drug, based on evidence acquired after approval, may
not be safe or effective for the intended use.
(2) That the facilities or controls used in the manufacture,
processing, or labeling of the drug may present a hazard to the
public health.
[Pre-1993 Recodification Citation: 16-1-30-19.]

Indiana § 16-42-3-10 (New drugs; revocation of order refusing application to take effect; revocation of approved application) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.