Back to top

USAN Council

Back to top

The United States Adopted Names (USAN) Council is responsible for selecting simple, informative and unique nonproprietary (generic) drug names. The council and staff meet twice a year to discuss outstanding negotiations, new items of interest and policy issues.

The USAN Council establishes logical nomenclature classifications based on pharmacological and/or chemical relationships. In addition to 1 member-at-large and a Food and Drug Administration (FDA) liaison, the council consists of 1 representative from each of the following: The AMA, United States Pharmacopeia (USP) and the American Pharmacists Association (APhA).

Meeting Minutes

The 2016 Winter Meeting of the USAN Council was held Friday, Jan. 8, 2016 in Lake Buena Vista, Florida. All members of the USAN Council were in attendance, along with members of the USAN Program staff housed at the AMA. Additional observers from the USP and WHO–INN Program were present. The following topics were discussed:

USAN activities include:

  • Negotiation statistics showed a steady flow in adoptions, with a slight increase in new submissions.
  • USAN Program activities discussed included statistical reports on active negotiations, cumulative adopted names and USAN participation in the INN Program.

USAN negotiations included 37 negotiations that were discussed: 2 revisions, 12 biologics, 11 multiple round and 12 new negotiations.

WHO–INN Nomenclature and USAN-sponsored applications included:

  • USAN sponsored 22% of the new INN applications discussed (29 USAN-sponsored applications).
  • There were minor changes to 12 USAN Council recommended names.

USAN policy changes included:

  • New stems: 12 approved by the council
  • Revised stems: 2 approved by the council

USAN website statistics were discussed, which included average site views per month, year-to-date totals and average time viewed as well as demographic information of USAN website visitors.

Institute for Safe Medication Practices Medication Errors Reporting Program covering May 1–Oct. 31, 2015 and cumulative data since May 1, 2002 were discussed.

USP representative provided information pertaining to USP activities.

Additional Recent Updates

USAN Program and Biosimilar Nomenclature (PDF)

New Monoclonal Antibody Nomenclature Rules (PDF)

Policy Change: Due to an increase in third-party (non-applicant) requests for stem determinations and the resulting increased demand of USAN staff time, the USAN Program will no longer provide potential stem reviews for third-party nonproprietary naming consultants who bill their clients for "USAN staff provided" information. USAN Program staff will continue to advise USAN applicants directly.

Newly Revised USAN Stem List (PDF)

AMA Headquarters Address

Please send all USAN applications, with checks to:

American Medical Association
USAN Program
330 North Wabash Ave., Suite 39300
Chicago, Illinois 60611-5885

Important Note to Manufacturers: From the date of receiving the adoption notice, a manufacturer has 60 days to review the statement for accuracy, initial and return to the USAN office. After the 60 days expires, with or without an initialed adoption statement, the manufacturer’s adopted USAN will be published on the USAN website after the first of the following month. Any changes, edits or modifications made on the manufacturer’s behalf after the 60-day period will result in a Revision/Modification Fee of $5,000.

Information for USAN Applicants

The USAN Council primarily negotiates a USAN through rounds of balloting via correspondence. Plus, The council and staff meet twice a year to discuss outstanding negotiations, new items of interest and policy issues.

When nomenclature disputes between the USAN Council and applicants occur and normal procedures fail, the USAN Review Board is the final arbiter. Each sponsoring organization nominates 2 members, with the boards of trustees of the other sponsoring organizations approving all nominees. Members have no term limits and all Review Board decisions are final and not subject to appeal.

USAN Program Information

Please use the following contact information to ask general questions about the USAN process.

For questions regarding:

  • Cell therapy and gene therapy applications
  • Correct application of stems
  • Scope of USAN
  • INN review procedure
  • Name-selection process

Stephanie C. Shubat, director
secretary to the USAN Council
(312) 464-4045
[email protected]

For questions regarding:

  • Contact lens applications
  • General information on stems
  • Monoclonal antibodies
  • Organic radicals, counterions and solvent molecules
  • USAN modified applications

Gail Karet, scientist
associate secretary to the USAN Council
(312) 464-5352
[email protected]

For questions regarding:

  • Publications
  • Publication deferments
  • USAN procedural inquiries
  • USAN revised applications
  • USAN website inquiries

Brad Wells, research associate
assistant secretary to the USAN Council
(312) 464-4906
[email protected]

For questions regarding:

  • Electronic application submissions
  • Electronic fund transfers
  • General administrative inquiries
  • General status of applications
  • Payment and application address

Mary Haynes, staff assistant
administrative secretary to the USAN Council
(312) 464-4046
[email protected]

USAN Program general email address: [email protected]
USAN Program main fax number: (312) 464-4028

Email this page