An Equal Opportunity Provider and Employer

CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 23-07

TO: Biologics Licensees, Permittees, and Applicants

Directors, Center for Veterinary Biologics

Veterinary Services Leadership Team

FROM: Dr. David White

Acting Director

SUBJECT: Sale of Unlicensed Autologous Therapeutic Biologics

I. PURPOSE

This Notice informs applicants that all unlicensed autologous therapeutic biologics, 

regulated under Veterinary Services Memorandum (VSM) 800.121 Autologous 

Therapeutic Biologics, will no longer be allowed for sale as experimental biologic 

products as of June 30, 2025. 

II. BACKGROUND

On June 21, 2017, the Center for Veterinary Biologics (CVB) published VSM 

800.121, which provided a licensure pathway for autologous therapeutic biologics.

Prior to VSM 800.121, CVB viewed autologous therapeutics as manufacturing 

processes, not as licensable products. VSM 800.121 stated that applicants should 

generate sufficient data for licensure within 2 years and extensions beyond 2 years to 

sell the unlicensed experimental product may be allowed by CVB. This 2-year grace 

period allowed time for applicants to come into compliance with CVB guidance by 

allowing the sale of unlicensed products during the prelicense process. CVB has 

provided flexibility and extensions as applicants have generated data for licensure;

however, the flexibility allowing prelicense sales cannot be for an indefinite period. 

After June 30, 2025, all autologous therapeutic biologics will be treated like 

conventional prelicense products and must obtain licensure prior to sale.

Applicants currently selling unlicensed autologous therapeutic biologics have been 

previously informed that June 30, 2023, would be the final date for selling 

unlicensed product. The extended June 30, 2025, deadline provides additional time

to these applicants. The June 30, 2025, deadline provides a total of 8 years to both 

generate data for licensure and sell unlicensed product since the 2017 publication of

VSM 800.121. Any new applicants that make an application to CVB prior to 

June 30, 2023, will still be allowed 2 years of prelicense sales as is currently stated 

in VSM 800.121.

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. 23-07

Page 2

 An Equal Opportunity Provider and Employer

III. ACTION 

All applicants developing products intended for an Autologous Prescription Product

license should make a formal request to CVB for authorization for shipment and sale of 

their unlicensed autologous therapeutic biologics as experimental biologic products by

June 30, 2023. The request should document progress made toward licensure and request 

that shipment and sales of unlicensed product be allowed until June 30, 2025. Approval 

of these requests will be contingent upon CVB receipt of all necessary information

documenting progression toward licensure and compliance with VSM 800.121. Products 

that fail to meet these conditions will only be allowed for sale after licensure. 

VSM 800.121 will be revised to reflect this change.

IV. IMPLEMENTATION/ APPLICABILITY

This policy is effective immediately.