USP's Role
In the United States, unless FDA has designated an official nonproprietary name for a drug (including biologics) by notice and comment rulemaking under FD&C Act section 508, then the compendial/USP name will apply. If no USP monograph has yet been established, the interim official nonproprietary name is that provided in the FDA marketing license (the "established" name in FD&C NDAs or "proper" name in PHS Act BLAs). FDA generally defers to USP to create official nonproprietary names for drugs, and recognizes as well the role of the United States Adopted Names Council (USAN). USAN works to determine names for drug and biological substances, and both USP and FDA are members of USAN. In most but not all cases, the USP Nomenclature Expert Committee accepts the nonproprietary names adopted by USAN. USP's authority to develop official nonproprietary names for drugs and biologics is contained in the adulteration and misbranding provisions of the FD&C Act. As provided in FD&C Act sections 501(b) and 502(e)(3)(B), any drug with a name recognized in USP–NF must comply with compendial identity standards or be deemed adulterated, misbranded, or both. USP's role in naming, drug identity, and quality standards, is also reflected in FDA regulations (see 21 CFR Part 299, and in particular section 299.5). While USP has a key role in designating nonproprietary names, oversight of proprietary (brand) names is solely the responsibility of FDA, working with applicants.
The USP Nomenclature Expert Committee was formed in 1986 to create appropriate compendial (nonproprietary) names for dosage forms and combination drug products, and to develop naming policies. The Nomenclature Expert Committee (termed the Nomenclature, Safety, and Labeling Expert Committee in the 2010–2015 cycle) issued a revised policy for monograph naming in 2007, scheduled to become official on May 1, 2013.
USAN began in 1961 by providing ingredient names for drugs prior to their marketing. USP participates in this activity, together with the American Medical Association, the American Pharmacists Association, and FDA. USAN's output is incorporated, along with other names for drugs (including generic, proprietary, and chemical names and code designations), in the USP Dictionary of USAN and International Drug Names. Since 1988, this publication has been recognized by federal regulation as the source of established names for drug substances in the United States.
- USP Nomenclature Guidelines
- Guideline for Assigning Titles to USP Dietary Supplement Monographs
- Guidance for Implementation and Exceptions: The Monograph Naming Policy for Salt Drug Substances in Drug Products and Compounded Preparations in General Chapter <1121> Nomenclature
- USP Excipient Nomenclature Guidelines
Nomenclature and Labeling
- Recent Nomenclature Decisions (February 2023)
- Cumulative List of Nomenclature Decisions (August 2010-February 2023)
- USP General Chapter <1121> Nomenclature
For questions or comments please contact: nomenclatureSL@usp.org