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

Full text of Indiana Indiana Code § 16-42-3-10 — New drugs; revocation of order refusing application to take effect; revocation of approved application, with citation guidance and answers to common questions.

§ 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.

[Pre-1993 Recodification Citation: 16-1-30-19.]

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

Source: official Indiana text · Last verified 2026-08-27

Frequently Asked Questions About Indiana § 16-42-3-10

What does Indiana Code § 16-42-3-10 cover?

Section 16-42-3-10 ("New drugs; revocation of order refusing application to take effect; revocation of approved application") is part of the Indiana Code, the codified statutory law of Indiana. It sets out the legal rule or procedure described in the text above. Statutes are amended regularly, so always verify against the official source.

How do I cite Indiana § 16-42-3-10?

A common citation format is "Indiana Code § 16-42-3-10" (Indiana). Legal writing may require the code abbreviation, section number, and year or edition. Match the style required by your court, professor, or publisher.

Is this the official text of Indiana law?

No. This page is for research and education and may not include the most recent amendments. For official current law, check the Indiana official source linked on this page or consult a licensed Indiana attorney.

How does Indiana § 16-42-3-10 apply to my situation?

Statutes are interpreted in context, and application depends on your specific facts. Only a licensed attorney in Indiana can advise on how this section applies to you. Contact your state or local bar association for a referral.

Sources & Verification

Not legal advice. Verify against the official source and consult a licensed attorney in Indiana.