The Development and Adoption of Nonproprietary, Established, and Proprietary Names for Pharmaceuticals
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Copyright 0 1997 Drug Information Association Inc.
THE DEVELOPMENT AND ADOPTION OF NONPROPRIETARY, ESTABLISHED, AND PROPRIETARY NAMES FOR PHARMACEUTICALS DANBORING, W H , PI-&) Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Rockville, Maryland, and Chair, CDER Labeling and Nomenclature Committee
Many types of names are used to describe a pharmaceutical substance andproduct. Each of these names has a specific meaning and is developed by detailed methodr. The general health practitioner is unaware of the effort involved with generating nonproprietary, established, and proprietary names for pharmaceuticals. The methodr of the International Nonproprietary Name program of the World Health Organisation, the United States Adopted Names Council, the United States Pharmacopeia, various industry naming programs, the United States Patent and Trademark OfJice, and the Food and Drug Administration are outlined in the following sections. Key Work: Nonproprietary names, Established names; Proprietary names; Trademark
NAMES, NAMES, NAMES
Chemical Name
THE PHARMACEUTICAL INDUSTRY is filled with names-technical, proprietary, nonproprietary, official, and unofficial. These names serve many purposes from identifying drug substances to promoting the reputation of a company. While these many names may seem to be describing the same item, they are not synonyms and have arisen from the varied legal and scientific nomenclature needs of the different segments of the pharmaceutical industry. The following is a short list of commonly used names with a brief definition.
Reprint address: Dan Boring, RPh, PhD, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Sciences, Office of New Drug Chemistry 3, Division of Anti-Viral Drug Products, HF'D-530,5600 Fishers Lane, Rockville, h4D 20857.
The chemical name is applied to a specific chemical structure using the nomenclature rules of the International Union of Pure and Applied Chemistry (IUPAC). These names provide much information to the practicing chemist, but are often long and complex, providing little information to health care professionals.
Nonproprietary Name The nonproprietary name is entirely in the public domain and may be used freely by anyone. Also known as the generic or common name, the official nonproprietary names are provided by national and international nomenclature bodies. In the United States, the United States Adopted Names (USAN) Council is the officially recognized group for selecting nonproprietary names. The USAN
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Dan Boring
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Council works in conjunction with the World Health Organisation (WHO) International Nonproprietary Name (INN) Committee and other national nomenclature groups to standardize drug nomenclature.
fore official nomenclature is developed and can hamper the timely adoption of official nomenclature.
Pharmacy Equivalent Name (PEN)
The United State Pharm
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