A United States Adopted Name (USAN) is a unique nonproprietary name assigned to a

medication A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy ( pharmacotherapy) is an important part of the medical field and ...

marketed in the

United States The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 states, a federal district, five major unincorporated territori ...

. Each name is assigned by the USAN Council, which is co-sponsored by the

American Medical Association The American Medical Association (AMA) is a professional association and lobbying group of physicians and medical students. Founded in 1847, it is headquartered in Chicago, Illinois. Membership was approximately 240,000 in 2016. The AMA's sta ...

(AMA), the United States Pharmacopeial Convention (USP), and the

American Pharmacists Association The American Pharmacists Association (APhA, previously known as the American Pharmaceutical Association), founded in 1852, is the first-established professional society of pharmacists in the United States. The association consists of more th ...

(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 or chemical relationships. In addition to drugs, the USAN Council names agents for

gene therapy Gene therapy is a medical field which focuses on the genetic modification of cells to produce a therapeutic effect or the treatment of disease by repairing or reconstructing defective genetic material. The first attempt at modifying human DN ...

and cell therapy, contact lens polymers, surgical materials, diagnostics, carriers, and substances used as an

excipient An excipient is a substance formulated alongside the active ingredient of a medication, included for the purpose of long-term stabilization, bulking up solid formulations that contain potent active ingredients in small amounts (thus often referred ...

. The USAN Council works in conjunction with the

World Health Organization The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level of ...

(WHO) international nonproprietary name (INN) Expert Committee and national nomenclature groups to standardize

drug nomenclature Drug nomenclature is the systematic naming of drugs, especially pharmaceutical drugs. In the majority of circumstances, drugs have 3 types of names: chemical names, the most important of which is the IUPAC name; generic or nonproprietary names, ...

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 Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...

(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. The AMA Council on Drugs no longer exists as a separate entity. The 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.

USAN Council members

*Gerry McEvoy, Pharm.D. (Member-at-Large) *Thomas P. Reinders *David Lewis *

Peter Rheinstein Peter Howard Rheinstein (born September 7, 1943) is an American physician, lawyer, author, and administrator (both private and governmental). He was an official of the Food and Drug Administration (FDA) 1974-1999. Education Rheinstein, a General ...

, Chair (since 2012) *Armen Melikian

Use

By definition, nonproprietary names are not subject to proprietary

trademark A trademark (also written trade mark or trade-mark) is a type of intellectual property consisting of a recognizable sign, design, or expression that identifies products or services from a particular source and distinguishes them from othe ...

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 A trademark (also written trade mark or trade-mark) is a type of intellectual property consisting of a recognizable sign, design, or expression that identifies products or services from a particular source and distinguishes them from othe ...

, 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 A chemical structure determination includes a chemist's specifying the molecular geometry and, when feasible and necessary, the electronic structure of the target molecule or other solid. Molecular geometry refers to the spatial arrangement of ...

. 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 A prefix is an affix which is placed before the stem of a word. Adding it to the beginning of one word changes it into another word. For example, when the prefix ''un-'' is added to the word ''happy'', it creates the word ''unhappy''. Particu ...

suffixes In linguistics, a suffix is an affix which is placed after the stem of a word. Common examples are case endings, which indicate the grammatical case of nouns, adjectives, and verb endings, which form the conjugation of verbs. Suffixes can carry g ...

, or

infixes An infix is an affix inserted inside a word stem (an existing word or the core of a family of words). It contrasts with ''adfix,'' a rare term for an affix attached to the outside of a stem, such as a prefix or suffix. When marking text for ...

in the nonproprietary name. Each stem can emphasize a specific

type, a pharmacologic property, or a combination of these attributes. The recommended list of USAN stems is updated regularly to keep pace to accommodate drugs with new

chemical A chemical substance is a form of matter having constant chemical composition and characteristic properties. Some references add that chemical substance cannot be separated into its constituent elements by physical separation methods, i.e., w ...

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) is active 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

. Therefore, it is highly desirable to the

pharmaceutical company The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, vaccinate them, or alleviate sympto ...

, 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.

Differences between USAN and INN

Examples of drugs for which the USAN differs from the INN include:

References

{{reflist

External links

US Adopted Names Program
Pharmacological classification systems Names