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Veterinary Biologics

APHIS regulates veterinary biologics (vaccines, bacterins, antisera, diagnostic kits, and other products of biological origin) to ensure that the veterinary biologics available for the diagnosis, prevention, and treatment of animal diseases are pure, safe, potent, and effective. This work is done by APHIS' Center for Veterinary Biologics (CVB) and is centered around enforcement of the Virus Serum Toxin Act (PDF 17KB).

Common Questions about Biologics

Licensed Biologics
This section contains a list of biologics which are currently licensed by APHIS.

Adverse Event Reporting Program
This section contains information on how to report adverse events experienced when using biologics, as well as APHIS' role in these scenarios.

Licensing a Biologic
Where to start? What to read first? New applicants can click here to see how to get started on the regulatory pathway toward licensure.

Biologics Regulations & Guidance
This section contains regulations, guidance documents (including draft guidance for public comment), and standardized assay methods pertaining to the licensure of veterinary biologics.

Import/Export of Biologics
This section provides information on importing biologics for experimental use or distribution/sale. It also describes the services that the Center for Veterinary Biologics provides to facilitate the export of licensed biologicals

Biologics Forms

Biologics Public Meetings
The Center for Veterinary Biologics holds a public meeting every 1-2 years, as well as occasional public meetings on special topics. Learn about past public meetings and/or register to attend future meetings.

Other Biologics Activities
The Center for Veterinary Biologics participates in national and international animal health and regulatory organizations. Read more about CVB activities.

Biologics Links
This section contains links to other sites associated with biologics regulation and international harmonization.

Request Biologics Information via Freedom of Information Act

Other Information:  March 4, 2013 marked 100 years of the Virus-Serum-Toxin Act (VSTA).  Click here for historical information on the veterinary biologics program, abstracts on various program components and the program brochure.

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Additional Information