Indiana § 16-42-3-7 - New drugs; federal qualification; testing; application to introduce drug
Full text of Indiana Indiana Code § 16-42-3-7 — New drugs; federal qualification; testing; application to introduce drug, with citation guidance and answers to common questions.
§ 16-42-3-7. New drugs; federal qualification; testing; application to introduce drug
Sec. 7. (a) This section does not apply under the circumstances described in section 9 of this chapter.
(b) A person may not sell, deliver, offer for sale, hold for sale, give away, or introduce into intrastate commerce any new drug unless:
(1) an application to sell, deliver, offer for sale, hold for sale, give away, or introduce into intrastate commerce a new drug has been approved and the approval has not been withdrawn under Section 505 of the Federal Act; or
(2) if not subject to the Federal Act the drug has been tested and has been found to be safe for use and effective in use under the conditions prescribed, recommended, or suggested in the labeling of the drug.
(c) Before selling or offering for sale the new drug, there must be filed with the state department an application setting forth the following:
(1) Full reports of investigations that have been made to show whether or not the drug is safe for use and whether the drug is effective in use.
(2) A full list of the articles used as components of the drug.
(3) A full statement of the composition of the drug.
(4) A full description of the methods used in and the facilities and controls used for the manufacture, processing, and packing of the drug.
(5) Such samples of the drug and of the articles used as components of the drug that the state department requires.
(6) Specimens of the labeling proposed to be used for the drug.
[Pre-1993 Recodification Citations: 16-1-30-16; 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 § 16-42-3-7
What does Indiana Code § 16-42-3-7 cover?
Section 16-42-3-7 ("New drugs; federal qualification; testing; application to introduce drug") 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 § 16-42-3-7?
A common citation format is "Indiana Code § 16-42-3-7" (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 § 16-42-3-7 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.