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Margaret A. Winker


Physicians and other health care professionals, patients, researchers, manufacturers, and the public may refer to drugs by several names, including the nonproprietary name (often referred to as the generic name) and at least 1 proprietary (brand) or trademark name selected by the manufacturer of the drug. Other drug identifiers include chemical names, trivial (unofficial) names, and code designations.1(pp12-15) However, only 1 drug name, the nonproprietary name, is regulated internationally to ensure consistent usage and no duplication with other drugs. Once a drug has been assigned a nonproprietary name, the nonproprietary name should always be used to refer to the drug. (See 15.4.2, Nonproprietary Names.)

The nonproprietary name is established through nomenclature agencies, such as the United States Adopted Names (USAN) Council (, which work with the World Health Organization (WHO) to establish a single nonproprietary name. According to the WHO, “the existence of an international nomenclature for pharmaceutical substances, in the form of INN [international nonproprietary name], is important for the clear identification, safe prescription and dispensing of medicines to patients and for communication and exchange of information among health professionals and scientists worldwide.”2 The nonproprietary names of drugs that are to be marketed within the United States must be approved by the USAN Council. The nomenclature rules provided in 15.4.13, Nomenclature for Biological Products, are established by the USAN Council.

The pharmaceutical naming system of the WHO has been in operation since 1953. When a drug is being considered for possible approval, the sponsoring manufacturer must file an INN application with the WHO’s Essential Drugs and Medicines team of Quality Safety and Medicines Policy (QSM), or with one of the drug nomenclature councils such as USAN or Japanese Adopted Names (JAN). The British Approved Names (BAN) and Dénominations Communes Françaises (DCF) Councils have now been supersedes by the European Union, which does not have a separate council but requires that the INN be used for drugs marketed within the European Union. These organizations work in conjunction with the WHO to approve a non-proprietary name identical to the INN.3 Manufacturers in countries without a nomenclature agency can request an INN from the WHO directly or apply in a country that has a nomenclature agency.1(p13)

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