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

Sec. 10. (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.