U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS Memorandum (VSM) 800.67 

___________________________________________________________________ 

1 | Page

An Equal Opportunity Provider and Employer

Shipment of Experimental Veterinary Biological Products

1. Purpose and Background 

This memorandum establishes procedures to comply with title 9, Code of Federal 

Regulations (9 CFR), part 103.3, concerning shipment of all experimental veterinary 

biological products. 

The shipment of experimental veterinary biological products, including unlicensed 

products intended for licensure, within or from the United States for use in animals, is 

prohibited by the Virus-Serum-Toxin Act unless authorized under 9 CFR 103.3. To permit 

and encourage research and to allow required licensing activities, the Animal and Plant 

Health Inspection Service (APHIS) may authorize shipment of such products under certain 

conditions. For reference, 9 CFR 103.3 lists information APHIS requires to support 

requests to ship experimental veterinary biological products. 

Experimental products being shipped between different sites owned by the same firm

and listed on their Establishment License do not require permission from the Center for 

Veterinary Biologics (CVB). Shipment of materials to be used for hybridoma development 

in laboratory rodents does not require permission from CVB.

2. Document Status 

A. Issue Date: 11/25/2022. 

B. This document replaces Veterinary Services Memorandum (VSM) 800.67, dated 

October 10, 2018, which is cancelled. 

3. Reason for Reissuance 

This update provides clarity on when safety testing is required and guidance on the sale 

and distribution of experimental products. Additionally, this document revises the term 

“test kits” to “diagnostic products”, adds the definition of “experimental product", and 

updates CVB’s address.

4. Definitions 

Experimental Veterinary Biological Product

A. CVB considers experimental product to include any prelicense product up to and 

including those derived from Master Seeds and Master Cells, and any product or 

intermediate derived from them (excluding licensed product), if it will be used in 

animals. 

B. Unlicensed diagnostic products that fall under APHIS’ authority are considered 

experimental product. 
U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS Memorandum (VSM) 800.67 

___________________________________________________________________ 

2 | Page

An Equal Opportunity Provider and Employer

C. Shipment of licensed product with license restrictions for off-label use in animals is 

also considered to be experimental use of a product and is subject to CVB’s approval. 

5. Authority and References 

A. Authorities 

 

1) 9 CFR 103.3 

2) 9 CFR 104.4 

3) 9 CFR part 113 

4) 9 CFR 114.9 

B. References 

1) VSM 800.50, Basic License Requirements and Guidelines for Submission of 

Materials in Support of Licensure 

 

6. Audience 

VS employees and members of the biologics industry. 

7. Guidance 

A. Requests for Authorization

Submit a request for authorization to ship experimental veterinary biological 

products, using an APHIS Form 2071, to:

The Center for Veterinary Biologics

Policy, Evaluation, and Licensing

The National Centers for Animal Health

1920 Dayton Avenue

P.O. Box 844

Ames, IA 50010

Authorized National Centers for Animal Health (NCAH) Portal users should submit 

requests via the NCAH Portal. There are also links available on the CVB NCAH Portal 

Guidance webpage. Please follow the NCAH Portal User guidelines and training videos 

for the submission of requests to ship experimental veterinary biological products. 

B. Information Required in Requests

All pertinent information specified in 9 CFR 103.3 (subsections a-h), except the 

summary report of results, must accompany a request for authorization to ship 

experimental products for evaluation. See VSM 800.50, section IV.D, for guidance. To 

import experimental products, apply for a U.S. Veterinary Biological Product Permit 
U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS Memorandum (VSM) 800.67 

___________________________________________________________________ 

3 | Page

An Equal Opportunity Provider and Employer

for Research and Evaluation, and provide all pertinent information specified in 9 CFR 

104.4. You can find guidance regarding this CVB import permit in the Import-Export 

section of the CVB website.

C. Letter of Permission from the Proper State or Foreign Animal Health Authorities

Include an identified address and study participant for each site using experimental 

product. Submit to CVB a copy of the permit or letter of permission from the proper 

State or foreign animal health authorities of each State or foreign country to which 

you will ship the product. Multi-site studies require permission from each 

participating State/country. The proper State animal health authority is usually the 

State veterinarian. Occasionally the State animal health authority is not a veterinarian 

but a designated commissioner. Some State or foreign authorities do not issue 

authorization letters, responding instead that they have no statutory authority to 

approve or disapprove the studies. When the regulatory authority involved received 

the opportunity to take a position but provided a neutral response, submit the 

neutral response to verify you requested authorization to ship experimental product. 

In the absence of State or foreign response, CVB may grant authorization to ship 

experimental product if it receives acceptable other documentation required for 9 

CFR 103.3 shipments. 

D. Description of the Product

1) Products Pending Licensure. If data from the study are to be used in support of a 

U.S. Veterinary Biological Product License, specify and describe the product 

according to the appropriate Outline of Production guidelines in 9 CFR 114.9 and 

identify the serial of product to be shipped.

2) Products Not Intended for Licensure. If data from the study are not intended to 

support licensure, provide the following information concerning the product:

a. The method of preparation.

b. The methods of testing and results.

c. The identity of the serial or serials.

E. Testing Experimental Serials

For each serial of experimental product, perform the following tests and submit a 

summary of the results on an APHIS Form 2008, the Veterinary Biologics Production 

and Test Report, or in another format acceptable to APHIS.

1) Purity Tests. All serials of experimental product must be tested for purity. Test 

results must be completed and found satisfactory for purity prior to shipment. On 

rare occasions, CVB may authorize shipments at risk prior to completion of purity 

testing, with the understanding that the results will be completed and satisfactory 
U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS Memorandum (VSM) 800.67 

___________________________________________________________________ 

4 | Page

An Equal Opportunity Provider and Employer

prior to use of the experimental product in animals. Conduct this testing as 

specified in pertinent parts of 9 CFR 113 and/or filed Outline of Production for 

studies conducted in client-owned animals and studies intended to support 

licensure, where applicable, or as required by CVB. This testing is not required for 

diagnostic products. 

2) Safety Tests. All serials of experimental product administered to client-owned 

animals in uncontained studies must have satisfactory safety test results. Conduct 

testing as specified in the pertinent parts of the 9 CFR, where applicable, or as 

required by CVB. For products administered to animals in contained studies 

where animals are housed in containment caging, laboratories, or facilities and 

are not client-owned, satisfactory safety testing results are recommended but not 

required. This will allow firms, at their discretion, to assess and address any safety 

issues in products with new or unique components. Safety testing is not required 

for diagnostic products. CVB may consider requests to waive safety testing of 

experimental veterinary biological products with acceptable justification.

3) Additional Tests. CVB may require additional testing, as needed. 

F. Experimental Labels

1) 9 CFR 103.3 lists required elements of experimental labels. Include the following 

on the experimental labels:

a. The name, identification, or description of the product must clearly identify 

the agent, and whether it is live or killed. 

i. The label must be clearly understandable to those who may come into 

contact with the product.

ii. Do not use trade names, internal jargon, or other identifiers that do not 

disclose the composition and nature of the product.

b. Prominently display the required warning: “Notice! For experimental use only 

– Not for Sale”.

2) Additional information such as serial number, date of manufacture, storage 

conditions, or other pertinent information can also be included on the 

experimental label. The experimental label should not be styled as for a product 

to be distributed and sold; that is, it should be clear that the product is 

experimental. For diagnostic products, place the experimental label on the carton. 

G. APHIS Authorization

If APHIS authorizes shipment of the experimental product, CVB issues a letter or an 

APHIS Form 2071. Authorizations identify the name of the product, the serial number 
U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS Memorandum (VSM) 800.67 

___________________________________________________________________ 

5 | Page

An Equal Opportunity Provider and Employer

or numbers, the recipient’s name and address, describe all restrictions, and specify 

the State or States granting permission. APHIS returns date-stamped copies of the 

experimental labels. Authorizations usually have an expiration date of 1 year past the 

date of CVB approval unless the expiration date of the State authorization falls before 

that time. If extended authorization periods are needed, CVB will consider those 

requests.

If the product is compromised during shipment or prior to use, one repeat shipment 

for the specified purpose may be made under the same CVB authorization. Submit a 

summary report of results after the end of the experimental study. Full study reports 

are not generally required unless the study is intended to support licensure or 

additional information is needed by CVB to fully assess the study results. 

H. Sale and Distribution of Experimental Products 

Unique situations may arise when an unlicensed biologic is needed to protect against 

or diagnose new and/or emerging animal diseases. Contact the CVB reviewer 

assigned to the firm to discuss the viability of using the experimental product in an

animal health event. 

8. Implementation/Applicability 

This update is effective immediately. Find additional guidance regarding the need for 

permission to ship experimental product under 9 CFR 103.3 on CVB's website.