21 CFR 201.115
§ 201.115 New drugs or new animal drugs.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 201.115, § 201.115 New drugs or new animal drugs, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/85789
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Full text
A new drug shall be exempt from section 502(f)(1) of the act:
(a) To the extent to which such exemption is claimed in an approved application with respect to such drug under section 505 or 512 of the act or an index listing with respect to such drug under section 572 of the act; or
(b) If no application under section 505 or 512 of the act is approved and no request for addition to the index is granted under section 572 with respect to such drug but it complies with section 505(i), 512(j), or 572(g) of the act and regulations thereunder.
No exemption shall apply to any other drug which would be a new drug if its labeling bore representations for its intended uses.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.