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VETERINARY

BIOLOGICS

United States

Department of

Agriculture

Animal and

Plant Health

Inspection

Service

Program Aid No. 1713

Use and Regulation
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VETERINARY BIOLOGICS

Veterinary biologics are products derived 

from living organisms and biological 

processes. They are used to prevent, 

diagnose, or treat animal diseases and 

function through an immunological 

process. Immunity is a biological 

defense mechanism to avoid 

infection or disease 

that involves innate 

and adaptive 

components. 

Innate immunity is a nonspecific first line of 

defense against disease-causing organisms 

that includes physical, chemical, and cellular 

functions. Adaptive immunity is a specific 

cellular response that provides long-lasting 

protective immunity. Biologics generally 

function through the adaptive immune 

response, which is further differentiated 

into two types: active immunity and passive 

immunity. Active immunity is acquired 

when the body is exposed by natural 

infection or vaccination to a disease-causing 

agent or its derivatives, while passive

immunity involves the transfer of protective 

antibodies from an immune animal to a 

susceptible or nonimmune animal.
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VETERINARY HEALTH—

SAFETY AND OVERSIGHT

The U.S. Government regulates biologics, 

pharmaceuticals, and pesticides for use in 

animals. Three Federal agencies work to 

ensure that these products are pure, safe, 

potent, and effective to protect the health 

and enhance the well-being of animals in 

the United States. 

•	 The Center for Veterinary Biologics 

(CVB) of the U.S. Department of 

Agriculture’s (USDA) Animal and Plant

Health Inspection Service (APHIS) 

regulates the manufacturing and 

distribution of veterinary biological 

products to prevent, diagnose, and treat

animal diseases. 

•	 The U.S. Food and Drug Administration’s

Center for Veterinary Medicine

regulates the manufacturing and 

distribution of animal feed additives, 

drugs, and pharmaceuticals.

•	 The U.S. Environmental 

Protection Agency registers and 

licenses pesticides and ensures that

all pesticides sold in the United

States do not cause unreasonable 

risk when used according to label 

directions and precautions. 
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TYPES OF VETERINARY 

BIOLOGICS

Veterinary biologics are used in a variety 

of animals, including livestock, pets, fish, 

birds, and wildlife. There are many types 

of biologics available, each 

with a different function and 

purpose.

Vaccines, bacterins, 

bacterial extracts, and

toxoids are made from viruses, 

bacteria, spores, or other 

disease-causing organisms. 

These products may contain 

whole organisms or selected 

portions of an organism to 

elicit active immunity. Whole 

organisms in vaccines may be 

live or killed. Living organisms in products 

are modified by cell culture, natural selection, or other processes so that they do not 

cause disease in animals.

Antiserums and antitoxins are products 

containing protective antibodies against 

a particular organism or a toxic substance 

that the organism produces. Administering 

an antibody product to an animal provides 

passive immunity.
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Diagnostics are products used to determine the health status of an animal.

Immunomodulators are products used to 

stimulate or suppress the immune system 

and to treat certain types of tumors or 

infections. 

Allergenic extracts are used to diagnose or 

treat animal allergies to substances like 

pollen, dust, fleas, and feed ingredients. 

About 70 years ago, there were perhaps 

a half-dozen products available. Today, 

there are nearly 2,000 licensed veterinary 

biological products designed to prevent, 

diagnose, or treat more than 200 different 

diseases in over 35 animal species. This 

ever-expanding array of veterinary biologics 

leads to better animal health care and 

reinforces the need for strict regulation 

so that animal and human health and our 

environment are protected. 
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ORIGINS OF VETERINARY 

BIOLOGICS REGULATION

The regulation of veterinary biologics began 

soon after the turn of the 20th century 

because farmers and animal health officials 

did not have reliable 

biologics to treat hog cholera, 

a devastating disease. Many 

products were ineffective

or contaminated with 

disease-causing organisms. 

A costly example was an 

outbreak of foot-and-mouth 

disease in 1909, caused by a 

contaminated vaccinia virus 

imported into the United States to produce a 

smallpox vaccine. 

In response to these problems, Congress 

passed the Virus-Serum-Toxin Act (VSTA) in

1913. VSTA gave the Secretary of Agriculture

authority to license and regulate the 

production and trade of veterinary biologics. 

After seven decades, Congress amended VSTA 

in the Food Security Act of 1985, broadening 

the Secretary’s authority to issue regulations, 

enhancing the Secretary’s enforcement 

powers, and allowing USDA-APHIS to 

regulate all movement of veterinary biological 

products within or imported into the United 

States. In an effort to enhance security at our 

Nation’s borders, the Homeland Security Act 

of 2002 transferred some import duties to the 

U.S. Department of Homeland Security. However, USDA continues to have jurisdiction over 

VSTA regulations and policies. Regulatory activity mandated by these acts is accomplished 

by CVB in Ames, IA, and Riverdale, MD.
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REGULATORY REQUIREMENTS

Federal law prohibits the distribution of 

veterinary biologics unless they are manufactured in compliance with the regulations. 

Veterinary biologics for commercial use 

must be produced at a USDA-approved 

establishment and proven to be pure, safe, 

potent, and efficacious. APHIS issues an 

establishment license to acceptable manufacturing facilities and an individual product 

license for each veterinary biologic that the 

establishment markets. In addition, APHIS 

issues permits for importing veterinary 

biologics for research, transit shipment, or 

distribution and sale in the United States. 

APHIS inspects all licensed and permitted 

manufacturers’ facilities to be sure that they 

are adequate and properly maintained. 

Agency officials examine production 

methods and records to ensure that each 

biological product is made in a consistent 

manner according to approved methods. 

Manufacturers test each batch of a biologic, 

commonly referred to as a serial, to ensure 

that quality is maintained. APHIS may elect 

to test selected serials as an independent 

verification of the test results obtained by 

the manufacturer. All required quality 

control tests must 

be satisfactorily 

concluded prior 

to any licensed or 

permitted 

veterinary 

biological 

product being 
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released to the market. In addition, APHIS 

works with industry to 

develop reference standards 

and validate test methods to 

improve product evaluation 

and quality control, and it 

participates in international 

efforts to align U.S. regulatory 

testing requirements with 

other countries’ requirements 

to facilitate exports.

VETERINARY BIOLOGICS 

INNOVATIONS

1913 First U.S. veterinary biologics license 

issued 

1916 First license for an avian product issued 

1941 First licenses issued for inactivated hog 

cholera vaccines

1943 First modified live veterinary 

vaccine licensed 

1954 First viral combination product licensed 

1976 First aquaculture vaccine licensed 

1977 First pseudorabies vaccine licensed

1979 First use of a monoclonal antibody in a 

 diagnostic test kit 

1986 First gene-deleted viral vaccine licensed 

1990 First recombinant viral product licensed 

1994 First live-vectored product licensed 

2004 First needle-free transdermal-delivered 

product licensed 

2005 First deoxyribonucleic acid (DNA)- 

mediated product licensed 

2005 First invertebrate virus-vectored 

product licensed 

2006 First plant cell-derived product licensed

2006 First live-vectored chimera vaccine 

licensed 

2007 First veterinary cancer vaccine licensed 
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2009 First collaborative effort between USDA

and industry to expedite vaccine 

manufacturing for an emerging 

disease outbreak (pandemic H1N1 

influenza)

2012 First veterinary ribonucleic acid (RNA) 

vaccine licensed

YOUR ROLE IN KEEPING 

VETERINARY BIOLOGICS 

SAFE AND EFFECTIVE

Look for the U.S. establishment 

number on the product 

label when selecting 

veterinary biologics. This 

assures that the product 

has been manufactured 

and tested under Federal 

standards and that the 

information on the label 

and in accompanying 

literature is approved by 

APHIS. Product labeling 

includes the product’s name, the serial 

number, the name and address of the manufacturer, the license or permit number, complete directions for use, the number of doses 

and the quantity of contents, storage instructions, precautions, and the expiration date.

Wholesalers and retailers must carefully 

handle biological products to ensure product 

potency and effectiveness, so only purchase

veterinary biologics from a reputable 

outlet. In addition, buy as much product 

as needed for a specific job; an oversupply 

kept beyond the expiration date can lose 

potency and become worthless. Never use 
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a biological product after the expiration 

date on the label. Also, use care in storing 

veterinary biologics. Most products must be 

kept chilled throughout shipment and stored 

in a refrigerated area between 35 degrees 

and 45 degrees Fahrenheit.

Consult with your veterinarian before 

beginning an immunization program. Only 

someone with specialized 

training, knowledge of 

animal disease, and 

experience using 

veterinary biologics 

should provide advice on 

which products to use. 

In addition, make sure 

animals are healthy before 

vaccinating them; stress, 

exposure to inclement 

weather, and lack of proper feed and water 

may interfere with an animal’s ability to 

develop protective immunity.

GENERAL GUIDELINES FOR 

ADMINISTERING VETERINARY 

BIOLOGICS

•	 	Read and follow product label directions.

•	 	Follow your veterinarian’srecommendations.

•	 	Use sanitary procedures when adminis-	 	

 tering a biological product to an animal. 

 Clean and disinfect the injection site and 

 use sterile instruments for dispensing all 

 biological products.

•	 	Administer the full recommended dose.
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• Mix veterinary biologics only if the 

 product instructions specify to do so.

• Observe withholding times when 

 administering products to meat- and 

 milk-producing animals.

• Do not save unused contents of multiple-

 dose containers. 

• An unexpected, unfavorable reaction 

 associated with the use of a veterinary 

 biologic is called an adverse event. Report

 adverse events directly to the manufac- 

 turer. When reporting an adverse event, 

 have vaccination information available, 

 including the date it was administered,

 the name and serial number of the 

 product, a description of the adverse

 event, and details about the animal(s)

 involved. 

FOR MORE INFORMATION

For more information about APHIS’ role in 

regulating veterinary biologics, please visit 

CVB’s Web site at www.aphis.usda.gov/

animal_health/vet_biologics or contact CVB 

directly using the following information: 

Center for Veterinary Biologics

USDA-APHIS-Veterinary Services

1920 Dayton Avenue

P.O. Box 844

Ames, IA 50010

Telephone: (515) 337-6100

Toll-free telephone: (800) 752-6255

Fax: (515) 337-6120

Email: cvb@aphis.usda.gov
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The U.S. Department of Agriculture (USDA) prohibits 

discrimination in all its programs and activities on the basis 

of race, color, national origin, age, disability, and where applicable, sex, marital status, familial status, parental status, 

religion, sexual orientation, genetic information, political 

beliefs, reprisal, or because all or part of an individual’s 

income is derived from any public assistance program. (Not 

all prohibited bases apply to all programs.) Persons with 

disabilities who require alternative means for communication 

of program information (Braille, large print, audiotape, etc.) 

should contact USDA’s TARGET Center at (202) 720-2600 

(voice and TDD). To file a complaint of discrimination, write 

to USDA, Director, Office of Civil Rights, 1400 Independence 

Avenue, S.W., Washington, D.C. 20250-9410, or call 

(800) 795-3272 (voice) or (202) 720-6382 (TDD). USDA is an 

equal opportunity provider and employer.

Revised February 2013