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United States Adopted Names


USAN COUNCIL

UPDATED Jun 25, 2024 . 6 MIN READ
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Contents

 1. 2024 USAN application fee increase notification
 2. About the USAN Council
 3. Meeting minutes
 4. USANC procedures and policies
 5. USAN program address
 6. USAN program staff contacts
 7. USAN Review Board
 8. USAN newsletter


2024 USAN APPLICATION FEE INCREASE NOTIFICATION

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.

--------------------------------------------------------------------------------


ABOUT THE USAN COUNCIL



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).


MEETING MINUTES

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.


USANC PROCEDURES AND POLICIES

Electronic payment for USAN Review. USAN applications and USAN payments must be
sent electronically. Please send all applications to USAN@ama-assn.org or
stephanie.shubat@ama-assn.org. For electronic payment information please
contact AMA.treasury@ama-assn.org. 


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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.


USAN PROGRAM ADDRESS

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


USAN PROGRAM STAFF CONTACTS

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 stephanie.shubat@ama-assn.org.

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 gail.karet@ama-assn.org.

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 brad.wells@ama-assn.org.

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
miki.hewitt@ama-assn.org.

For general information on the USAN program, call (312) 464-4028 or
email USAN@ama-assn.org.


USAN REVIEW BOARD

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.


USAN NEWSLETTER

Read the November 2023 USAN newsletter (PDF).


TABLE OF CONTENTS

 1. 2024 USAN application fee increase notification
 2. About the USAN Council
 3. Meeting minutes
 4. USANC procedures and policies
 5. USAN program address
 6. USAN program staff contacts
 7. USAN Review Board
 8. USAN newsletter

Table of Contents 2024 USAN application fee increase notification About the USAN
Council Meeting minutes USANC procedures and policies USAN program address USAN
program staff contacts USAN Review Board USAN newsletter
Upvote
319
 * United States Adopted Names Council
 * Catalog of Topics




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Targeted Advertising

Third party trackers collect information used for analytics and to personalize
your experience with targeted ads. Under the Colorado Privacy Act, you have the
right to opt out of targeted advertising. You may exercise your right to opt out
of targeted advertising by turning off this toggle. If you opt out, we will not
serve you personalized ads based on your actions on other websites, but you may
still receive personalized ads based on your interactions with us. Please review
our Privacy Policy for additional information. Additionally, you may contact our
legal department for further clarification about your rights as a Colorado
consumer.

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