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:

Terms Used In Indiana Code 16-42-3-10

  • Appeal: A request made after a trial, asking another court (usually the court of appeals) to decide whether the trial was conducted properly. To make such a request is "to appeal" or "to take an appeal." One who appeals is called the appellant.
  • Evidence: Information presented in testimony or in documents that is used to persuade the fact finder (judge or jury) to decide the case for one side or the other.
(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.]

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