USAN Council

Firms waiting for results of the upcoming December 2024 USAN Council meeting can expect to be notified the week of Dec. 9. For your submission to be reviewed at the spring 2025 INN consultation, we will need acceptances and proof of payment (e.g., a PDF of the wire transfer confirmation) by Jan. 3, 2025. If your firm has already received a balloting result from the USAN Council and is still considering whether to accept the name, we recommend letting USAN staff know in the next several weeks.

As of Jan. 1, 2024, USAN application fees will be increased. Find the USAN Fee-for-Service changes that will take effect on Jan. 1, 2024: 2024 USAN Fee Increase Notification (PDF). Please feel free to contact USAN staff to answer any additional questions.

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 one member-at-large and a Food and Drug Administration (FDA) liaison, the council consists of one representative from each of the following: The American Medical Association (AMA), United States Pharmacopeia (USP) and the American Pharmacists Association (APhA).

The 2024 Summer Hybrid Meeting of the USAN Council was held Friday, June 14, 2024, at the US Pharmacopeia (USP) Headquarters in Rockville, Maryland. The topics discussed at this meeting included general USAN activities and policy, issues relating to drug nomenclature, and proposed USAN name reviews and recommendations.

Members of the USAN Council were in attendance, as well as members of the USAN Program staff housed at the AMA. Additional observers were present from the USP, the World Health Organization (WHO) International Nonproprietary Names (INN) Program, and The United States Food and Drug Administration (FDA). 

The following items were discussed:

USAN activities

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

USAN negotiations

• 35 negotiations were discussed: 9 biologics, 2 multiple-round, 16 new negotiations, 6 open-ended negotiations and 2 INN actions.

WHO-INN nomenclature and USAN-sponsored applications

• USAN sponsored 10% of the new INN applications discussed (26 USAN-sponsored applications).
• Revisions were approved for 12 USAN Council names previously recommended.

USAN policy

• New stems: 17 approved by the Council.
• 1 new modifier for radicals and anions was approved by the Council.

USP updates

• USP representative provided information pertaining to USP activities.

Electronic payment for USAN Review. USAN applications and USAN payments must be sent electronically. Please send all applications to [email protected] or [email protected]. For electronic payment information please contact [email protected]. 

Monoclonal antibody names. Effective Jan. 1, 2021, there are changes to the monoclonal antibody nomenclature scheme. Visit the monoclonal antibodies page for additional information.

Objections to pINN names submitted for USAN Council review. USAN/INN applicants should notify the USAN Program if they have received correspondence from the INN stating that there have been comments and/or objections to the proposed INN name. This will help USAN eliminate the possibility of having two non-proprietary names for one compound.

Review of negotiations at USAN Council meetings. Effective for the July 2018 USAN Council meeting, only USAN applications for substances that are not proposed or recommended INNs will be reviewed at the USAN Council meetings.USAN applications for names that have proposed or recommended INNs will be reviewed throughout the year via email by the USAN Council.

Meeting reviews will be reserved for:

• New USAN applications for which no proposed or recommended INNs have been selected
• Multiple round USAN negotiations
• Open-ended (noncompleted) negotiations for which not all USAN Council ballots have been received

Two-Letter stems. The USAN Council discussed coining nonproprietary names with 2-letter stems at the USANC summer meeting in As of July 2017, the USAN Council will not coin nonproprietary names with new 2-letter stems. The Council based its decision on the likelihood of 2-letter stems creating the potential for medication errors and the inconsistencies in accepting or rejecting proprietary names containing 2-letter stems.

Stem and name reviews for third-party consultants. 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.

View the USAN stem list. 

Corrections and updates to USAN adoption statements and publication. 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.

The USAN Council requires that all correspondence regarding USAN submissions be sent electronically via email to the AMA staff supporting the USAN Council. However, the mailing address for the USAN Program is

American Medical Association

USAN Program

330 North Wabash Ave., Suite 39300

Chicago, Illinois 60611-5885

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

Contact Stephanie C. Shubat, director at (312) 464-4045 or [email protected].

For questions regarding:

• General information on stems
• Monoclonal antibodies
• Organic radicals and counterions
• USAN modified applications

Contact Gail Karet, senior scientist at (312) 464-5352 or [email protected].

For questions regarding:

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

Contact Brad Wells, operations manager at (312) 464-4906 or [email protected].

For questions regarding:

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

Contact Miki Hewitt, staff assistant at (312) 464-2492 or [email protected].

For general information on the USAN program, call (312) 464-4028 or email [email protected].

In the rare instances where nomenclature disputes between the USAN Council and applicants cannot be resolved and normal procedures fail, the USAN Review Board is the final arbiter. Each sponsoring organization of the USAN Council nominates two 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.

Read the July 2024 USAN newsletter (PDF).