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United States Adopted Name
United States Adopted Names are unique nonproprietary names assigned to pharmaceuticals marketed in the United States. Each name is assigned by the USAN Council, which is co-sponsored by the American Medical Association (AMA), the United States Pharmacopeial Convention (USP), and the American Pharmacists Association (APhA).
The USAN Program states that its goal is to select simple, informative, and unique nonproprietary names (also called generic names) for drugs by establishing logical nomenclature classifications based on pharmacological and/or chemical relationships.〔(Generic Drugs: Myths and Facts )〕 In addition to drugs, the USAN Council names agents for gene therapy and cell therapy, contact lens polymers, surgical materials, diagnostics, carriers, and substances used as an excipient. The USAN Council works in conjunction with the World Health Organization (WHO) International Nonproprietary Name (INN) Expert Committee and national nomenclature groups to standardize drug nomenclature and establish rules governing the classification of new substances.
== History ==
The USAN Council began in June 1961 after the AMA and the USP jointly formed the AMA-USP Nomenclature Committee.〔(US Adopted Names Council on AMA website )〕 The American Pharmacists Association (APhA) became the third sponsoring organization in 1964, at which point the name of the committee was changed to the USAN Council, and United States Adopted Name became the official term to describe any nonproprietary name negotiated and formally adopted by the Council. In 1967, a liaison representative from the Food and Drug Administration (FDA) was appointed to serve on the USAN Council. The FDA announced in 1984 that it would discontinue adding drug names to its official list and use the USAN as the established name for labeling and advertising new single-entity drugs marketed in the United States.〔( Carmen Drahl. Where Drug Names Come From. Chemical & Engineering News. Volume 90 Issue 3 | pp. 36-37. Issue Date: January 16, 2012 )〕〔(CFR-Code of Federal Regulations Title 21 Sec. 299.4 Established names for drugs )〕 The AMA Council on Drugs no longer exists as a separate entity. FDA now has a representative on the USAN Council, which has moved away from chemically derived names.
Currently, the USAN Council has five members, one from each sponsoring organization, one from the FDA, and a member-at-large. One member is nominated to the USAN Council annually by each sponsoring organization; the FDA nominates one liaison member annually. The member-at-large is selected by the sponsoring organizations from a list of candidates proposed by the AMA, APhA, and the USP. The five nominees to the Council must be approved annually by the board of trustees of the three sponsoring organizations.
抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』
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