Veterinary Services Memorandum 800.121_Autologous Therapeutic Biologics; DT 106580; 

Public Comments Due by March 21, 2024, 12AM CST

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Autologous Therapeutic Biologics

1. Purpose and Background 

This memorandum provides guidance on licensing autologous therapeutic biologics.

Advances in technology have allowed preparation of custom vaccines against individual 

cancers and other diseases in animals. These technologies must make use of consistent 

manufacturing systems to manipulate samples from patients to create individualized 

treatments. Examples include, but are not limited to, autologous cancer therapies.

These are veterinary biological products as defined in title 9, Code of Federal Regulations

(9 CFR), part 101.2. The unique and individualized product characteristics have 

necessitated adaptations to the licensure process.

 

2. Document Status 

 

A. Issue Date: TBD 

 

B. This document replaces Veterinary Services Memorandum 800.121 dated June 21, 

2017, which is cancelled. 

 

 

3. Reason for Reissuance 

 

4. Authority and References 

 

 

A. Authorities 

7 CFR 371.4 

9 CFR 101.2 

9 CFR 102.6 

9 CFR 103.3 

9 CFR 116.9 

 

B. References 

 

VSM 800.50, Basic License Requirements and Guidelines for Submitting Materials 

in Support of Licensure 

VSM 800.67, Shipment of Experimental Veterinary Biological Products 

VSM 800.126, Efficacy and Safety Studies for Cancer Immunotherapeutics 

VSM 800. 206, General Licensing Considerations: Preparing Outlines of 
Veterinary Services Memorandum 800.121_Autologous Therapeutic Biologics; DT 106580; 

Public Comments Due by March 21, 2024, 12AM CST

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Production for Vaccines, Bacterins, Antigens, Toxoids, and 

Diagnostic Test Kits 

 

 

C. Definitions 

 

1) Autologous. Derived from the same individual (i.e., involving one individual as 

both donor and recipient). 

 

2) Autologous therapeutic biologic. A veterinary biological product prepared for 

an individual animal under a prescription written by a licensed veterinary 

practitioner and where a valid veterinarian-client-patient relationship exists. 

The product consists of unique cells, antigens, or genetic sequences derived 

from cells or tissues of the animal, for use as a treatment against individual 

cancers and other diseases. Autologous therapeutic biologics act primarily 

through the immune system or immune response. 

 

3) Consistent manufacturing system. A manufacturing process relying on 

appropriate, controlled, and documented procedures to prepare serials 

differing only with respect to the patient source of cells, tissues, or genetic 

material. 

 

5. Audience 

 

VS employees and members of the biologics industry. 

 

6. Guidance 

The Center for Veterinary Biologics (CVB) will consider applications for licensing 

autologous therapeutic biologics produced by a consistent manufacturing system. 

Initially, the autologous therapeutic biologic may be allowed to be distributed as a not for 

sale, experimental biological product until definitive data to support consistent 

manufacturing, pure, safe, and an expectation of efficacy allow qualification for licensure 

as an Autologous Prescription Product.

A. The initial application should include establishment and product applications listed in 

Veterinary Services (VS) Memorandum No. 800.50 and the following:

1. Scientific theory. Demonstration that the mechanism of action for the 

proposed product is immunologically driven and supported by scientifically 

sound theory and peer-reviewed scientific literature. 
Veterinary Services Memorandum 800.121_Autologous Therapeutic Biologics; DT 106580; 

Public Comments Due by March 21, 2024, 12AM CST

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2. Outline of Production. The manufacturing method must be well controlled, 

detailed, and use an approved CVB template. Refer to 9 CFR 114.8 and VS 

Memorandum No. 800.206 for additional information. 

B. The CVB will determine the acceptability of the product concept. If accepted, the CVB 

will regulate the product and manufacturing procedure as an experimental product 

under 9 CFR 103.3, which includes the requirement that it is “Not for Sale,” until the 

product achieves licensure. 

1. Because these products are immunotherapies, many of the prelicensure 

studies will involve client-owned animals with natural disease. Prior to CVB 

approval of pilot studies in client owned animals, preliminary reports on 

environmental release, user safety, and patient safety are required as 

described in VSM 800.126. 

2. Experimental labels must be consistent with 9 CFR 103.3; however, trade 

names will be allowed both prior to and after licensure. 

3. Marketing and promotional information used to recruit patients for licensure 

studies need to be approved by CVB prior to use. Product advertising and 

marketing should be targeted to licensed veterinarians and must not be false 

or misleading. 

4. Upon satisfactory review of the request to ship the experimental autologous 

biologic, the CVB will issue an authorization to distribute the experimental 

biological product, including any restrictions that may be specific to the 

product, for 1 year. A separate shipping authorization from the CVB is not 

required prior to shipping each serial. Instead, submit quarterly distribution 

reports to the CVB no later than the 21st day of January, April, July, and 

October of each year where shipments occur. Include the serial identification, 

animal species for which the serial was manufactured, the disease treated, 

doses shipped, serial release test results, and any adverse events reported. 

Any additional State authorizations for future shipments may be submitted 

with the quarterly reports. 

5. After 12 months, a progress report describing and summarizing safety and 

efficacy data collected to date must be submitted. The report should contain a

completed list of serials manufactured and distributed similar to the quarterly 

reports. The authorization to distribute experimental product may be 

renewed for another year(s) upon request if adequate progress is being made 

toward licensure. This request should also include any existing or new State 

Veterinarian approval letters needed for future experimental product 

distributions.

6. The CVB may conduct an onsite inspection to evaluate the consistent 

manufacturing system.

7. If a firm does not comply with 9 CFR 103.3 or misrepresents the product, the 

CVB may take any actions deemed necessary, including revocation of the 

authorization to distribute the experimental product.
Veterinary Services Memorandum 800.121_Autologous Therapeutic Biologics; DT 106580; 

Public Comments Due by March 21, 2024, 12AM CST

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C. CVB will issue an Autologous Prescription Product License, Product Code 95A7.XX once all

the necessary licensing studies have been accepted by CVB. The Autologous Prescription 

Product License is a special license with many characteristics of both a conditional and a 

prescription license. Demonstration of a reasonable expectation of efficacy and an 

acceptable safety profile in at least one specific species against a single specific disease, 

such as a specific neoplastic disease, is a requirement for licensure of the Autologous 

Prescription Product. However, because this is a prescription product, licensed 

veterinarians may use this consistent autologous manufacturing system on other species 

and other neoplastic diseases not listed on the label, based on their professional 

judgement. Manufacturers labeling must only state the efficacy and safety data from 

pivotal efficacy and safety studies accepted by the CVB. 

1. In general, the preliminary studies and combined pivotal field efficacy and safety 

studies needed for licensure should follow the guidance in VSM 800.126.

Protocols should be submitted to the CVB for review.

2. Safety studies and efficacy studies will need to meet the standards routinely 

required for conditional licensure of a conventional non-autologous product.

3. Serial release.

a. Purity testing is conducted according to the procedures in 9 CFR 

113.26(b), with modifications available on request for product 

manufactured in limited quantities. Modifications should be specified in 

the Outline of Production. A dilution of preservative study will be required 

early in the licensure process to assure there are appropriate purity 

testing methods for experimental serials used in pilot and pivotal studies.

b. Animal safety testing for serial release is not required for autologous 

therapeutic biologics.

c. A fully validated potency test is not required for Autologous Prescription 

Products, but the active components must be quantified to demonstrate 

batching consistency.

d. The licensee is exempted from furnishing to the CVB representative 

samples of each serial prepared. Reserve samples must be selected and 

maintained by the licensee as required in 9 CFR 113.3(e), with 

modifications available on request for product manufactured in limited 

quantities. 

e. A separate serial release action by the CVB is not required prior to 

shipping each serial. Instead, submit semiannual distribution reports to 

the CVB no later than the 21st day of January and July. Include the serial 

identification, animal species for which the serial was manufactured, 

disease treated, doses shipped, serial release test results, and any adverse 

events reported.

D. Conditions of licensure and licensing restrictions

1. Each Autologous Prescription Product License will be issued for 2 years and is 

renewable if there are no safety or efficacy concerns.
Veterinary Services Memorandum 800.121_Autologous Therapeutic Biologics; DT 106580; 

Public Comments Due by March 21, 2024, 12AM CST

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2. License restrictions

a. Marketing and promotional materials must be reviewed by the CVB prior 

to publication or distribution.

b. For use by, or under the supervision of, a veterinarian.

3. If a manufacturer has more than one manufacturing system, a separate license 

will be issued for each consistent manufacturing system.

7. Implementation/Applicability 

This policy is effective June 30, 2025.