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Autogenous Biologics

Overview

Autogenous biologics are custom vaccines that consist of herd specific (homologous) 

antigens. They are licensed products, produced in a licensed facility, according to an 

approved Outline of Production. Autogenous biologics are approved for use by or under 

the direction of a veterinarian or approved non-veterinarian specialist. Therefore, good 

basic diagnostic work and incorporation of the proper adjuvant, are essential to enhance 

effectiveness of these products. Autogenous products fit well with small companies that 

have a close relationship with veterinarians/fish health specialists who can provide 

personal service to clients. Use of autogenous products is considered when no 

commercially licensed product is available, or when commercially licensed products have 

not provided adequate protection. 

Regulations and guidance regarding autogenous biologics are found in the following 

documents. 

9CFR 113.113

9 CFR 112.7

VSM 800.85

Autogenous Biologics

Labeling Requirements

Avian Influenza Vaccines

VSM 800.69 Guidelines for Autogenous Biologics

VSM 800.103 Guidelines Concerning Restrictions on 

the Production and Use of Veterinary 

Biologics

CVB Notice 02-04

CVB Notice 09-15

Autogenous Vaccine Use in Turkeys

Autogenous Vaccines Containing 

Porcine Circovirus 

Definitions

Herd of Origin: The group of animals from which the disease-causing microorganism 

was originally isolated. The herd of origin includes animals moved into the original herd. 

Movement of the entire original herd to a new location without additional commingling is 

still the same herd. Groups of animals under the same ownership, but at different 

locations are separate herds. Offspring and excess breeding stock moved from the 

original herd have changed herds. 

Adjacent Herd: An adjacent herd is a group of animals that are physically contiguous 

with the herd of origin; no other herds exist between the adjacent herd and the original 

herd. Shipment of an autogenous product to an adjacent herd requires notification of 

State regulatory authorities and CVB. 

Nonadjacent Herd: Nonadjacent herds include all herds other than the herd of origin 

and adjacent herds. Approval for use of autogenous products in nonadjacent herds must 
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be received from appropriate State Veterinarians prior to shipment. CVB must be 

notified. 

Isolate: The isolate used to make the autogenous product must be from the herd of origin 

(although exceptions apply). Isolates must be properly identified to at least the genus and 

species level for bacterial isolates. Viral isolates must be properly identified to at least

the family level. Characterization should be to the strain and/or serotype if the firm’s 

intent is to use the isolate for a year or more. For some viruses (like influenza), this 

information is important and firms should be encouraged to provide this information if 

available.

Non-veterinarian Specialist: 9 CFR 113.113 allows an autogenous biologic to be 

prepared for use by a person of specialized expertise other than a veterinarian in special 

situations approved by the Administrator. An example of a non-veterinarian specialist is

a fish health specialist approved to dispense aquaculture vaccines. To request approval 

to prepare an autogenous biologic for use by a non-veterinarian, a firm needs to provide 

the following information to CVB-IC:

• Identification; name and qualifications of the non-veterinarian

• Justification; description of the special situation

Veterinarian-Client-Patient Relationship (VCP): Autogenous products are only 

prepared for use by or under the direction of a veterinarian or approved non-veterinarian 

specialist under a VCP relationship. A VCP relationship exists when all of the following 

conditions are met: 

• The veterinarian has assumed responsibility for making clinical judgments 

regarding the health of the animal(s) and the need for medical treatment, and the 

client has agreed to follow the veterinarian’s instructions. 

• The veterinarian has sufficient knowledge of the animal(s) by virtue of an 

examination of the animal(s), or by medically appropriate and timely visits to the 

premises where the animal(s) are kept. 

• The veterinarian is readily available, or has arranged for emergency coverage, for 

follow-up evaluation in the event of adverse reactions or failure of the treatment 

regimen.

When a VCP relationship exists, veterinarians must maintain medical records. 

Reviewing Autogenous Product Submissions

1. Types of Autogenous licenses include 

a. Autogenous Vaccine, Killed Virus

b. Autogenous Bacterin

c. Autogenous Vaccine, Killed Virus, Autogenous Bacterin 

d. Autogenous Vaccine, Killed Fungus

2. Outlines of Production (OP)s for Autogenous products 

a. Autogenous OPs follow the same basic format used for all vaccines, 

bacterins, and toxoids, as outlined in 9 CFR 114.9. 

b. Usually generically worded for production flexibility. 

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recommended, or in another animal species whose immunological response has been 

shown to correlate with the response of the species for which the product is 

recommended. An exemption to this requirement may be considered for isolates used 

in zoos. The exemption should be documented in Section V.C of the related Outline 

of Production. 

5. 9 CFR 113.113(2)(iv)(B) requires that each serial of an autogenous biologic from a 

microorganism older than 24 months from the date of isolation must be potency 

tested. An exemption to this requirement may also be considered for isolates used in 

zoos. If this exemption is granted, Section V.C. of the related Outline of Production 

should be updated with the lot number of the isolate and a statement that the 

exemption was granted for this isolate. The mail log number associated with the 

exemption should also be added to the Outline of Production. 

Release of First Serial and Subsequent Serials

1. First Serial (50 containers or less)

a. Permissible to ship after 3 days of incubation on safety and abbreviated 

purity tests and there is no reason to suspect they will be unsatisfactory. 

b. No APHIS Form 2008 or samples to APHIS needed. (Quarterly reports of 

serials released are submitted to APHIS instead.)

c. Serial recalled if final results of purity or safety test are not satisfactory.

2. Second and Subsequent Serials

a. Must be tested as per 9 CFR 113.100 or 113.200 to include purity, safety 

and identification

b. APHIS Forms 2008 submitted to CVB IC for release prior to shipment

c. Samples submitted to APHIS unless serial is ≤ 50 containers. 

Confirmatory testing by APHIS may occur. For serials of ≤ 50 containers, 

2 reserve samples are held and may be requested by APHIS

Required Restrictions for Autogenous Products

Restrictions for autogenous products are listed in Chapter 2.2.1, List of Standard 

License Restrictions, in the Reviewers Manual. The required restrictions are as 

follows: 

1. LSRTIS #50, Trade Names shall not be used with this product. 

2. LSRTIS #55, This license does not authorize production, distribution, or 

shipment of autogenous vaccine/bacterin for Foot and Mouth Disease, 

rindepest, any H5 or H7 subtype of avian influenza, any subtype of avian 

influenza in chickens, swine vesicular disease, Newcastle Diesae, African 

Swine Fever, classical swine fever, Brucella abortus, vesicular stomatitis, 

and rabbit hemorrhagic disease, or any other disease the Administrator 

determines may pose a risk to animal or public health. 

a. To ensure that the use of autogenous veterinary biologics does not 

interfere with animal disease surveillance and/or control and 
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eradication programs and does not post other health risks, the use 

of certain microorganisms is restricted. 

b. Production of autogenous biologics from organisms restricted in 

VS Memorandum 800.103 must be approved by CVB. 

c. APHIS Forms 2008 for each serial (first and subsequent) of 

autogenous biologics produced from restricted microorganisms 

must be submitted to the CVB-IC, and the serial must be released 

before shipment.