United States Adopted Name
Encyclopedia
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. 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.
(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.
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 nonminates 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.
rights but are entirely in the public domain. This distinguishes them from the trademarked names that have been registered for private use.
USANs assigned today reflect both present nomenclature practices and older methods used to name drug entities. Early drug nomenclature was based on the chemical structure
. As newer drugs became chemically more complex and numerous, nonproprietary names based on chemistry became long and difficult to spell, pronounce, or remember. Additionally, chemically derived names provided little useful information to non-chemist health practitioners. Considering the needs of health professionals led to a system in which USANs reflect relationships between new entities and older drugs, and avoid names that might suggest non-existent relationships.
Current nomenclature practices involve the adoption of standardized syllables called "stems" that relate new chemical entities to existing drug families. Stems may be prefixes, suffixes, or infixes in the nonproprietary name. Each stem can emphasize a specific chemical structure
type, a pharmacologic property, or a combination of these attributes. The recommended list of USAN stemshttp://www.ama-assn.org/ama1/pub/upload/mm/365/stem-list-cumulative.pdf is updated regularly to keep pace to accommodate drugs with new chemical and pharmacologic properties.
As a general rule, the application for a USAN should be forwarded to the USAN Council after the Investigational New Drug
(IND) has been approved by the FDA and clinical trials have begun.
Many drug manufacturers seeking a USAN are multinational companies with subsidiaries in various parts of the world or contractual agreements with drug firms outside the United States
. Therefore, it is highly desirable to the pharmaceutical company
, the various nomenclature committees, and the medical community in general that a global name be established for each new single-entity compound introduced. Assigning a USAN and standardizing names internationally can take anywhere from several months to a few years.
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
. Each name is assigned by the USAN Council, which is co-sponsored by the American Medical Association
American Medical Association
The American Medical Association , founded in 1847 and incorporated in 1897, is the largest association of medical doctors and medical students in the United States.-Scope and operations:...
(AMA), the United States Pharmacopeial Convention (USP), and the American Pharmacists Association
American Pharmacists Association
The American Pharmacists Association , founded in 1852, is the first-established professional society of pharmacists within the United States....
(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. In addition to drugs, the USAN Council names agents for gene therapy
Gene therapy
Gene therapy is the insertion, alteration, or removal of genes within an individual's cells and biological tissues to treat disease. It is a technique for correcting defective genes that are responsible for disease development...
and cell therapy, contact lens
Contact lens
A contact lens, or simply contact, is a lens placed on the eye. They are considered medical devices and can be worn to correct vision, for cosmetic or therapeutic reasons. In 2004, it was estimated that 125 million people use contact lenses worldwide, including 28 to 38 million in the United...
polymers, surgical materials, diagnostics, carriers, and substances used as an excipient
Excipient
An excipient is generally a pharmacologically inactive substance used as a carrier for the active ingredients of a medication. In many cases, an "active" substance may not be easily administered and absorbed by the human body; in such cases the substance in question may be dissolved into or...
. The USAN Council works in conjunction with the World Health Organization
World Health Organization
The World Health Organization is a specialized agency of the United Nations that acts as a coordinating authority on international public health. Established on 7 April 1948, with headquarters in Geneva, Switzerland, the agency inherited the mandate and resources of its predecessor, the Health...
(WHO) International Nonproprietary Name
International Nonproprietary Name
An International Nonproprietary Name is the official nonproprietary or generic name given to a pharmaceutical substance, as designated by the World Health Organization...
(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. 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 AdministrationFood and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(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
DRUGS
Destroy Rebuild Until God Shows are an American post-hardcore band formed in 2010. They released their debut self-titled album on February 22, 2011.- Formation :...
marketed in the United States.
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 nonminates 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.
USAN Council Members
- Anthony Palmieri, Chair
- John Bergen
- Kent Johnson
- David Lewis
- Peter RheinsteinPeter RheinsteinPeter Howard Rheinstein is an American physician, lawyer, author, and administrator . He was an official of the Food and Drug Administration 1974-1999.-Education:...
Use
By definition, nonproprietary names are not subject to proprietary trademarkTrademark
A trademark, trade mark, or trade-mark is a distinctive sign or indicator used by an individual, business organization, or other legal entity to identify that the products or services to consumers with which the trademark appears originate from a unique source, and to distinguish its products or...
rights but are entirely in the public domain. This distinguishes them from the trademarked names that have been registered for private use.
Name assignment
Assignment of a USAN takes into account practical considerations, such as the existence of trademarks, international harmonization of drug nomenclature, the development of new classes of drugs, and the fact that the intended uses of substances for which names are being selected may change.USANs assigned today reflect both present nomenclature practices and older methods used to name drug entities. Early drug nomenclature was based on the chemical structure
Chemical structure
A chemical structure includes molecular geometry, electronic structure and crystal structure of molecules. Molecular geometry refers to the spatial arrangement of atoms in a molecule and the chemical bonds that hold the atoms together. Molecular geometry can range from the very simple, such as...
. As newer drugs became chemically more complex and numerous, nonproprietary names based on chemistry became long and difficult to spell, pronounce, or remember. Additionally, chemically derived names provided little useful information to non-chemist health practitioners. Considering the needs of health professionals led to a system in which USANs reflect relationships between new entities and older drugs, and avoid names that might suggest non-existent relationships.
Current nomenclature practices involve the adoption of standardized syllables called "stems" that relate new chemical entities to existing drug families. Stems may be prefixes, suffixes, or infixes in the nonproprietary name. Each stem can emphasize a specific chemical structure
Chemical structure
A chemical structure includes molecular geometry, electronic structure and crystal structure of molecules. Molecular geometry refers to the spatial arrangement of atoms in a molecule and the chemical bonds that hold the atoms together. Molecular geometry can range from the very simple, such as...
type, a pharmacologic property, or a combination of these attributes. The recommended list of USAN stemshttp://www.ama-assn.org/ama1/pub/upload/mm/365/stem-list-cumulative.pdf is updated regularly to keep pace to accommodate drugs with new chemical and pharmacologic properties.
As a general rule, the application for a USAN should be forwarded to the USAN Council after the Investigational New Drug
Investigational New Drug
The United States Food and Drug Administration's Investigational New Drug program is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines before a marketing application for the drug has been approved...
(IND) has been approved by the FDA and clinical trials have begun.
Many drug manufacturers seeking a USAN are multinational companies with subsidiaries in various parts of the world or contractual agreements with drug firms outside the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
. Therefore, it is highly desirable to the pharmaceutical company
Pharmaceutical company
The pharmaceutical industry develops, produces, and markets drugs licensed for use as medications. Pharmaceutical companies are allowed to deal in generic and/or brand medications and medical devices...
, the various nomenclature committees, and the medical community in general that a global name be established for each new single-entity compound introduced. Assigning a USAN and standardizing names internationally can take anywhere from several months to a few years.
See also
- British Approved NameBritish Approved NameA British Approved Name is the official non-proprietary or generic name given to a pharmaceutical substance, as defined in the British Pharmacopoeia...
- International Nonproprietary NameInternational Nonproprietary NameAn International Nonproprietary Name is the official nonproprietary or generic name given to a pharmaceutical substance, as designated by the World Health Organization...
- Nomenclature of monoclonal antibodiesNomenclature of monoclonal antibodiesThe nomenclature of monoclonal antibodies is a naming scheme for assigning generic, or nonproprietary, names to monoclonal antibodies. An antibody is a protein that is produced in B cells and used by the immune system of humans and other vertebrate animals to identify a specific foreign object like...