21 CFR 299.5
Drugs; compendial name
21 CFR 299.5 is the regulation titled “Drugs; compendial name” in 21 CFR Part 299, Drugs; Official Names and Established Names. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 201.1, in 1 letter
- Closed out
- 100% of these letters have a published close-out
Letters citing it, by year issued
It is a drug letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 12021
- 02022
- 02023
- 02024
- 02025
- 02026
The regulation
Read the text of 21 CFR 299.5 (eCFR, as of Sep 1, 2026)
(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.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 299.5.
Latest letters citing it
The letter citing 21 CFR 299.5 that FDA posted most recently.
See the letter citing 21 CFR 299.5 →Put this kind of reading to
work on your own records.
Botable builds and runs a custom AI layer around the software you already use, so your team can do the job you hired them for.
Counts include every citation in a letter, as the Letters filter does. How this database is built.