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Licensed Veterinary Biological

Product Information

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Currently Licensed Veterinary Biological Products 

(includes imported under permit)

Current Veterinary Biologics Product Catalog (January 10, 2024) 

Currently Licensed Biologics for Aquatic Animals (November 2021) 

Product Licensing Data

This web page provides the public with summaries of safety and effectiveness

(efficacy) studies used to license a particular USDA-regulated veterinary biological

product. Product summaries are published for vaccines, bacterins, and

immunomodulators, but not diagnostic test kits, antibody products, or allergenic

extracts.

Typically a Product Summary will contain an efficacy study summary for each

microbial agent/disease against which the product is claimed to be effective.

Additional studies may be included to support administration to multiple animal

species, multiple routes of administration, or other product features; some of these

studies are conducted after initial licensure of the product. Typically there is also

one field safety study, but there may be additional studies for specialized safety
claims, such as safety in pregnant animals.

Limited product licensing efficacy or safety data are currently available on this

website due to the phased implementation of the supporting regulation.

Implementation will continue through 2021. Product licensing efficacy and safety

data will be available on the website within 30 days of licensure for veterinary

biologics licensed after December 15, 2016.

Precautionary Statements and Disclaimers

Do not attempt to compare studies of similar products. Differences in

study design, animal sources, environmental conditions, and the number of

animals tested can affect study outcomes and preclude meaningful

comparisons. These data summaries are not to be used by manufacturers for

the purposes of comparative marketing. Please consult with a veterinarian for

interpretation of data.

Products are typically shown to be effective in healthy animals. A protective

immune response may not be elicited if animals are incubating an infectious

disease, are malnourished or parasitized, are stressed due to shipment or

environmental conditions, are otherwise immunocompromised, or the vaccine

is not administered in accordance with label directions.

Products may be considered effective without producing 100% protection

against disease. Many products instead reduce the severity of disease. All

products must provide a significant, clinically meaningful effect.

Efficacy studies are conducted with a product batch formulated to the minimum

approved potency (strength).

The studies on this site were conducted over a wide time period. USDA policy

has evolved over the years to address increasing scientific knowledge and

demands for product quality. The data for an individual study were generated in

accordance with applicable regulations and guidelines at the time the study

was conducted.

USDA-APHIS requires published summaries only for studies submitted on, or

after, January 2007. Some older studies may be published voluntarily. Also,

efficacy and safety data for some products licensed many years ago may no

longer be available for various legitimate reasons. The lack of data for those

products does not mean those products are any less efficacious or less safe
than those products for which efficacy and safety data are available.

Search for Product Summaries

More Information

History of the single-tier label claim (14.07 KB)

Common questions about veterinary biologics

USDA regulatory authority for veterinary biological products (16.44 KB)

Federal Regulations regarding veterinary biologics

USDA expectations for:

Efficacy studies (Veterinary Services Memorandum 800.202)

Safety studies (Veterinary Services Memorandum 800.204)

Contact Us

Please email questions about product licensing data or the supporting regulation to

CVB.Single.Tier@usda.gov.