U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS Memorandum (VSM) 800.75 

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Reissuance of Product Licenses for Products Under Conditional Licenses 

1. Purpose and Background 

This memorandum provides guidelines for reissuing licenses for products under 

conditional U.S. Veterinary Biological Product Licenses upon approach of the termination 

date of the conditional license according to title 9, Code of Federal Regulations (CFR), 

part 102.6(a). 

To meet an emergency condition, limited market, local situation, or other special 

circumstance, APHIS may issue a conditional United States Veterinary Biological Product 

License for a veterinary biological product under expedited procedures that ensure 

purity, safety, and a reasonable expectation of efficacy. APHIS may require 

establishments issued a conditional product license to do additional efficacy studies on 

the product or to develop additional data to support the validity of a proposed potency 

test for the product or both.

Each conditional product license carries a termination date. Conditional licenses are 

typically issued for 1 or 2 years. During the period the conditional license is in effect, the 

Center for Veterinary Biologics (CVB) expects the licensee either to make satisfactory 

progress toward completing the requirements for a regular product license or to fully 

complete the requirements for a regular product license. 

2. Document Status 

A. Issue Date: 07/14/2022 

B. This document replaces Veterinary Services Memorandum 800.75 dated October 

27, 1999, which is cancelled. 

3. Reason for Reissuance 

This document is reissued to be consistent with current guidance.

4. Authority and References 

A. Authorities 

• 9 CFR 102.6

B. References 

• Veterinary Services Memorandum 800.126 Efficacy and Safety Studies for 

Cancer Immunotherapeutics 
U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS Memorandum (VSM) 800.75 

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• Veterinary Services Memorandum 800.213 Licensing Guidelines for 

Production Platform-Based, Non-Replicating, Nonviable Products 

5. Audience 

VS employees and members of the biologics industry. 

6. Guidance 

At the approach of a conditional product license termination date, CVB may reissue the 

product license as a conditional product license or as a regular product license or allow 

the product license to terminate. This depends on the degree to which the licensee has 

demonstrated progress toward completing the requirements for a regular license.

A. Requests for Reissuance of a Product License 

Before the date the conditional product license is to terminate, the licensee must send 

CVB a request to reissue the product license. The request should include all available data 

and information demonstrating progress the licensee has made toward completing the 

requirements for a regular license for the product. The request should be submitted 90 

days prior to the date of the conditional license termination to allow time for processing.

B. CVB Actions 

CVB will respond to a request to reissue the product license for a product under a 

conditional license by doing one of the following:

1. Reissue the Product License as a Regular Product License – If the licensee satisfies all 

the requirements for a regular product license, CVB will issue a regular product 

license for the product.

2. Reissue the Product License as a Conditional Product License – CVB will reissue a 

conditional product license in the following situations:

a) If the licensee makes satisfactory progress toward completing the requirements 

for a regular product license but does not complete all the requirements for a 

regular product license, CVB will reissue a conditional product license for the 

product. 

b) If minimal progress has been made toward completing requirements for a regular 

product license but CVB determines there is still a need for the conditionally 

licensed product, CVB will reissue a conditional license.

3. Allow the Product License to Terminate – CVB will allow a conditional product license 

to terminate in the following situations:
U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS Memorandum (VSM) 800.75 

3 | Page

a) If the licensee does not demonstrate satisfactory progress toward completing the 

requirements for a regular product license, CVB will allow the product license to 

terminate.

b) If the product has qualified for a regular product license by another manufacturer 

since the conditional product license was last issued, CVB may consider the 

reissuance of a conditional product license only if assured that the licensee can 

satisfy all requirements for issuance of a regular product license within that 6-

month period. If the licensee cannot provide such assurance, CVB may allow the 

product license to terminate. 

4. Actively Terminate the Product License – CVB may proactively terminate a conditional 

license in cases of safety or efficacy concerns.

5. Conditional Licenses for Cancer Immunotherapies – CVB will generally allow initial 

conditional licensure and reissuance regardless of the availability of a fully licensed 

similar product due to the heterogenicity within tumor types and variable patient 

responses to seemingly similar cancer immunotherapies. Additional guidance 

regarding the requirements for the reissuance of conditionally licensed cancer 

immunotherapies are found in VSM 800.126 Section 5.E.

6. Conditional Licenses for Platform and Prescription Platform Products – Refer to VSM 

800.213 Section V.A for guidance regarding reissuance of conditionally licensed 

platform products. 

7. Implementation/Applicability 

Updated policy in this memorandum is effective immediately.