21 CFR Part 299 · Drugs; Official Names and Established Names

§ 299.5 Drugs; compendial name

Subpart A - General Provisions Official text on eCFR Amendment history

(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.

Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.

Warning letters citing § 299.5

1 FDA warning letters since 2017 cite this section :

FDA guidance that cites § 299.5

Amendment history

Federal Register documents that created or amended this section.