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

Indiana § 16-42-3-10

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

Text

(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.]

Legislative History

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