e-CFR Navigation Aids


Simple Search

Advanced Search

 — Boolean

 — Proximity


Search History

Search Tips


Latest Updates

User Info


Agency List

Incorporation By Reference

eCFR logo

Related Resources

Electronic Code of Federal Regulations

We invite you to try out our new beta eCFR site at https://ecfr.federalregister.gov. We have made big changes to make the eCFR easier to use. Be sure to leave feedback using the Feedback button on the bottom right of each page!

e-CFR data is current as of March 2, 2021

Title 9Chapter ISubchapter EPart 113

TITLE 9—Animals and Animal Products






Testing aids.
Sampling of biological products.
Exemptions to tests.
General testing.
Animal and Plant Health Inspection Service testing.
Multiple fractions.
In vitro tests for serial release.
New potency test.
Testing of bulk material for export or for further manufacture.

Standard Procedures

Culture media for detection of bacteria and fungi.
Detection of viable bacteria and fungi except in live vaccine.
Detection of extraneous viable bacteria and fungi in live vaccines.
Detection of mycoplasma contamination.
Determination of moisture content in desiccated biological products.
Detection of Salmonella contamination.
Detection of avian lymphoid leukosis.
Detection of Brucella contamination.
Mouse safety tests.
Detection of hemagglutinating viruses.
Detection of viricidal activity.
Detection of pathogens by the chicken inoculation test.
Detection of pathogens by the chicken embryo inoculation test.
Guinea pig safety test.
Cat safety tests.
Dog safety tests.
Calf safety test.
Detection of lymphocytic choriomeningitis contamination.
Detection of chlamydial agents.
Swine safety test.
Sheep safety test.
Detection of cytopathogenic and/or hemadsorbing agents.
Detection of extraneous viruses by the fluorescent antibody technique.

Ingredient Requirements

Ingredients of biological products.
Requirements for primary cells used for production of biologics.
Requirements for cell lines used for production of biologics.
Requirements for ingredients of animal origin used for production of biologics.
Sterile diluent.
Detection of extraneous agents in Master Seed Virus.

Live Bacterial Vaccines

General requirements for live bacterial vaccines.
Brucella Abortus Vaccine.
Anthrax Spore Vaccine—Nonencapsulated.
Erysipelothrix Rhusiopathiae Vaccine.
Pasteurella Haemolytica Vaccine, Bovine.
Pasteurella Multocida Vaccine, Bovine.
Pasteurella Multocida Vaccine, Avian Isolate.
Chlamydia Psittaci Vaccine (Feline Pneumonitis), Live Chlamydia.

Inactivated Bacterial Products

General requirements for inactivated bacterial products.
Leptospira Pomona Bacterin.
Leptospira Icterohaemorrhagiae Bacterin.
Leptospira Canicola Bacterin.
Leptospira Grippotyphosa Bacterin.
Leptospira Hardjo Bacterin.
Clostridium Chauvoei Bacterin.
Clostridium Haemolyticum Bacterin.
Clostridium Novyi Bacterin-Toxoid.
Clostridium Sordellii Bacterin-Toxoid.
Clostridium Botulinum Type C Bacterin-Toxoid.
Clostridium Perfringens Type C Toxoid and Bacterin-Toxoid.
Clostridium Perfringens Type D Toxoid and Bacterin-Toxoid.
Autogenous biologics.
Tetanus Toxoid.
Staphylococcus Aureus Bacterin-Toxoid.
Pasteurella Multocida Bacterin, Avian Isolate, Type 4.
Pasteurella Multocida Bacterin, Avian Isolate, Type 1.
Pasteurella Multocida Bacterin, Avian Isolate, Type 3.
Erysipelothrix Rhusiopathiae Bacterin.
Salmonella Typhimurium Bacterin.
Pasteurella Multocida Bacterin.
Salmonella Choleraesuis Bacterin.
Salmonella Dublin Bacterin.

Killed Virus Vaccines

General requirements for killed virus vaccines.
Mink Enteritis Vaccine, Killed Virus.
Newcastle Disease Vaccine, Killed Virus.
Wart Vaccine, Killed Virus.
Encephalomyelitis Vaccine, Eastern, Western, and Venezuelan, Killed Virus.
Avian Encephalomyelitis Vaccine, Killed Virus.
Rabies Vaccine, Killed Virus.
Feline Calicivirus Vaccine, Killed Virus.
Bursal Disease Vaccine, Killed Virus.
Bovine Virus Diarrhea Vaccine, Killed Virus.
Bovine Rhinotracheitis Vaccine, Killed Virus.

Live Virus Vaccines

General requirements for live virus vaccines.
Ovine Ecthyma Vaccine.
Distemper Vaccine—Mink.
Bluetongue Vaccine.
Feline Panleukopenia Vaccine.
Canine Hepatitis and Canine Adenovirus Type 2 Vaccine.
Canine Distemper Vaccine.
Encephalomyelitis Vaccine, Venezuelan.
Bovine Parainfluenza3 Vaccine.
Bovine Rhinotracheitis Vaccine.
Bovine Virus Diarrhea Vaccine.
Rabies Vaccine, Live Virus.
Measles Vaccine.
Feline Calicivirus Vaccine.
Feline Rhinotracheitis Vaccine.
Canine Parainfluenza Vaccine.
Parvovirus Vaccine (Canine).
Pseudorabies Vaccine.
Avian Encephalomyelitis Vaccine.
Avian Pox Vaccine.
Bronchitis Vaccine.
Fowl Laryngotracheitis Vaccine.
Newcastle Disease Vaccine.
Marek's Disease Vaccines.
Bursal Disease Vaccine.
Tenosynovitis Vaccine.

Diagnostics and Reagents

Tuberculin, Intradermic.
Pullorum antigen.
Avian mycoplasma antigen.
Tuberculin—PPD Bovis, Intradermic.

Antibody Products

General requirements for antibody products.
Tetanus Antitoxin.
Erysipelothrix Rhusiopathiae Antibody.
Clostridium Perfringens Type C Antitoxin.
Clostridium Perfringens Type D Antitoxin.
Products for treatment of failure of passive transfer.

Need assistance?