21 CFR 207.55
§ 207.55 What additional drug listing information may FDA require?
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 207.55, § 207.55 What additional drug listing information may FDA require?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/85901
- Permanent ID
ys:prov:85901@1- SHA-256
2d5ede00fc54ace0f68ca25c9412ca8c2a8ddfbba864b135609a9eeeb682b42a
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
For a particular listed drug, upon our request, the registrant must briefly state the basis for its belief that the drug is not subject to section 505 or 512 of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.