21 CFR 299.5
§ 299.5 Drugs; compendial name.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 299.5, § 299.5 Drugs; compendial name, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86203
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Full text
(a) The name by which a drug is designated shall be clearly distinguishing and differentiating from any name recognized in an official compendium unless such drug complies in identity with the identity prescribed in an official compendium under such recognized name.
(b) The term drug defined in an official compendium means a drug having the identity prescribed for a drug in an official compendium.
(c) A statement that a drug defined in an official compendium differs in strength, quality, or purity from the standard of strength, quality, or purity set forth for such drug in an official compendium shall show all the respects in which such drug so differs, and the extent of each such difference.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.