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United States • Title 21 CFR • Part 299

Part 299 — PART 299—DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES

Part 299 of Title 21 CFR outlines definitions and interpretations related to drug names, specifically focusing on 'official names' and 'established names' as defined by the Federal Food, Drug, and Cosmetic Act (the Act). It details the Commissioner's authority to designate official names for drugs to ensure usefulness and simplicity, and mandates that drug labeling must bear the established name. The part also describes the role of the U.S. Adopted Names Council (USAN) in naming drugs and clarifies when the FDA will or will not routinely designate official names, emphasizing reliance on compendial or USAN names.

What this part covers

  • Defines 'Act' as the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321-392).
  • Defines 'official name' as a name designated under section 508 of the Act.
  • Explains that drug labeling must include the 'established name' as per section 502(e) of the Act.
  • Defines 'established name' as an official name, a compendial official title, or a common/usual name.
  • Recognizes the U.S. Adopted Names Council (USAN) for deriving drug names.
  • States the FDA will generally not routinely designate official names, relying on compendial or USAN names.
  • Outlines specific circumstances under which the FDA may designate an official name (e.g., undue complexity, multiple names for one drug, or no existing name for a medically useful drug).
  • Requires drugs defined in an official compendium to clearly distinguish their name unless they meet the compendium's identity standards.
  • Mandates that any differences in strength, quality, or purity from an official compendium standard must be clearly stated.

Sections in Part 299

§ 299.3

Definitions and interpretations.

act(a) As used in this part 299, means the Federal Food, Drug, and Cosmetic Act, sections 201-902, 52 Stat. 1040 (21 U.S.C. 321-392), with all amendments thereto. (b) The definitions and interpretations contained in section 201 of the act shall be applicable to such terms when used in this part 299. official name(c) The term means, with respect to a drug or ingredient thereof, the name designated in this part 299 under section 508 of the act as the official name.

§ 299.4

Established names for drugs.

(a) Section 508 of the Federal Food, Drug, and Cosmetic Act (added by the Kefauver-Harris Drug Amendments of 1962; Pub. L. 87-781) authorizes the Commissioner of Food and Drugs to designate an official name for any drug if he determines that such action is necessary or desirable in the interest of usefulness and simplicity. Section 502(e) of the act (as amended by said Drug Amendments) prescribes that the labeling of a drug must bear its established name, if there is one, to the exclusion of any other nonproprietary name (except the applicable systematic chemical name or the chemical formula) and, if the drug is fabricated from two or more ingredients, the established name of each active ingredient. established name(b) The term is defined in section 502(e)(3) of the act as (1) an official name designated pursuant to section 508 of the act; (2) if no such official name has been designated for the drug and the drug is an article recognized in an official compendium, then the official title thereof in such compendium; and (3) if neither paragraphs (b) (1) or (2) of this section applies, then the common or usual name of the drug. (c) The Food and Drug Administration recognizes the…

§ 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. drug defined in an official compendium(b) The term 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.

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