Indiana § 16-42-3-8 - New drugs; time for application to take effect
Full text of Indiana Indiana Code § 16-42-3-8 — New drugs; time for application to take effect, with citation guidance and answers to common questions.
§ 16-42-3-8. New drugs; time for application to take effect
Sec. 8. (a) This section does not apply under the circumstances described in section 9 of this chapter.
(b) An application provided for under section 7 of this chapter becomes effective on the one hundred eightieth day after the filing of the application. However, if the state department finds, after due notice to the applicant and giving the applicant an opportunity for a hearing that:
(1) the drug is not safe or not effective for use under the conditions prescribed, recommended, or suggested in the proposed labeling of the drug;
(2) the methods used in and the facilities and controls used for the manufacture, processing, and packing of the drugs are inadequate to preserve the drug's identity, strength, quality, and purity; or
(3) based on a fair evaluation of all material facts, that the labeling is false or misleading in any particular;
the state department shall, before the effective date of the application, issue an order refusing to permit the application to become effective.
[Pre-1993 Recodification Citations: 16-1-30-17; 16-1-30-18 part.]
As added by P.L.2-1993, SEC.25.
Source: official Indiana text · Last verified 2026-08-27
Frequently Asked Questions About Indiana § 16-42-3-8
What does Indiana Code § 16-42-3-8 cover?
Section 16-42-3-8 ("New drugs; time for application to take effect") 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 § 16-42-3-8?
A common citation format is "Indiana Code § 16-42-3-8" (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 § 16-42-3-8 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.