An Equal Opportunity Provider and Employer

CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 20-13

TO: Biologics Licensees, Permittees, and Applicants

Directors, Center for Veterinary Biologics

Veterinary Services Leadership Team

FROM: Byron Rippke

Director

SUBJECT: Use of Nonproprietary Names from the United States Adopted 

Names (USAN) Council as True Names for Veterinary Biologic 

Immunotherapeutics

I. PURPOSE

The intended purpose of this Notice is to inform licensees, permittees, and applicants 

of a change which will allow the use of nonproprietary names as True Names on 

labeling, product summaries, and other documents for immunotherapeutic veterinary 

biologics.

II. BACKGROUND

The Center for Veterinary Biologics (CVB) assigns a formal True Name for each 

veterinary biologic as the primary method to describe a product per title 9, Code of 

Federal Regulations, part 101.4(d). Additional nomenclature assigning organizations 

such as the United States Adopted Names (USAN) Program1 provide an alternative

nomenclature system which is applicable to immunotherapeutics regulated by CVB. 

Manufacturers can request and be assigned a nonproprietary name from the USAN 

Council; however, nonproprietary names are not currently allowed on CVB 

approved labeling and product summaries because they are not the CVB assigned 

True Name. In contrast to the highly descriptive CVB assigned True Name, the 

USAN nomenclature system assigns a nonproprietary name using a less descriptive 

nomenclature system, which would be useful for naming an immunotherapeutic 

approved for treating two or more different diseases. Allowing the use of 

nonproprietary names assigned by the USAN Council will provide advantages for 

industry in marketing immunotherapeutics, be helpful to the end user in identifying 

and prescribing immunotherapeutics, and be consistent with the nomenclature used 

in scientific publications.

III. ACTION (or POLICY)

CVB will allow the use of a nonproprietary name assigned by the USAN Council for 

a veterinary biologic immunotherapeutic to become the CVB True Name. This will 

allow the manufacturer to use the nonproprietary name on labels and product 

summaries. The use of nonproprietary names will be limited to immunotherapeutics 

Animal and Plant

Health Inspection

Service

Veterinary Services

Center for Veterinary 

Biologics

1920 Dayton Avenue

PO Box 844

Ames, IA 50010

(515) 337-6100
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 20-13

Page 2

 An Equal Opportunity Provider and Employer

such as monoclonal antibodies and does not apply to other classes of products such as 

vaccines, bacterins, toxoids, serum-derived products, and diagnostic test kits. The use of 

USAN nonproprietary names is voluntary, as CVB will continue to create and assign 

product True Names following the existing nomenclature system. 

CVB will assign a True Name during the prelicense process. Firms may request that the 

assigned True Name be replaced with the USAN nonproprietary name anytime during the 

prelicense process once they have obtained USAN approval. The request for the name 

change must include the formal USAN response assigning the USAN nonproprietary 

name. If the request is accepted by CVB, the process of changing the True Name to the 

USAN nonproprietary name would occur at or prior to licensure. The Outline of 

Production and Labels must be changed to be consistent in representing the USAN 

nonproprietary name as the True Name. Preferably, firms should begin the process of 

obtaining a USAN nonproprietary name early in the licensure process, so that the 

transition from the assigned True Name to the USAN nonproprietary name as the new 

True Name can be concluded by the time of licensure.

For products that are initially licensed or permitted with the CVB assigned True Name, 

firms may request that the CVB assigned True Name be replaced with the USAN 

nonproprietary name at any time after licensure/permitting. If the proposal is accepted by 

CVB, the USAN nonproprietary name will become the new True Name for the product.

CVB will reissue the license or permit with the USAN nonproprietary name as the new 

True Name for the product. Firms must update labels, the Outline of Production, and 

other related documents within one year of reissuance of the license. CVB will re-issue 

product summaries upon approval of new labeling. Since these products will have already 

been marketed with the True Name assigned at licensure or permit issuance, firms may 

use both the assigned True Name and the USAN nonproprietary name on labels during 

the one-year transition period. After a maximum of one year, the True Name assigned at 

licensure or permit issuance must be removed from labels, Outline of Production and 

other related documents.

IV. IMPLEMENTATION/ APPLICABILITY

This policy is effective immediately.

References

1. https://www.ama-assn.org/about/united-states-adopted-names