Initiatives

Drug Nomenclature

On June 15, 1961, the American Medical Association-United States Pharmacopeia Nomenclature Committee was formed. This committee evolved into the United States Adopted Names (USAN) Council in January 1964, through the sponsorship of the United States Pharmacopeia, the American Medical Association, and the American Pharmaceutical Association. Its purpose was to institute an orderly and effective system for selecting nonproprietary names for new drug substances and certain other related agents. In 1967, FDA joined the USAN Council as a means of consolidating the work of selecting suitable nonproprietary names for drugs on behalf of the federal government with the work of the council. Currently, FDA generally defers to the USP to create nonproprietary names for drug products and to determine proper names for biologics; oversight of proprietary names remains the responsibility of FDA, working with applicants.

The USP Nomenclature Expert Committee was established in 1985 to work closely with the USAN Council to determine established names for drug products. During the 2010-2015 USP Convention cycle the Nomenclature, Safety and Labeling Expert Committee, which includes FDA liaisons from many areas within FDA, is expected to address mutual topics of interest to both USP and FDA.