21 CFR § 299.5 - Drugs; compendial name.

---
identifier: "/us/cfr/t21/s299.5"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 299.5 - Drugs; compendial name."
title_number: 21
title_name: "Food and Drugs"
section_number: "299.5"
section_name: "Drugs; compendial name."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "C"
subchapter_name: "DRUGS: GENERAL"
part_number: "299"
part_name: "DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 331, 351, 352, 355, 358, 360b, 371."
regulatory_source: "40 FR 14041, Mar. 27, 1975, unless otherwise noted."
cfr_part: "299"
---


# 299.5 Drugs; compendial name.

(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.