9Animals and Animal Products12012-01-012012-01-01falseTable Of ContentsAnimals and Animal ProductsANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTUREVIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORSSTANDARD REQUIREMENTSApplicabilitySec.113.1Compliance.113.2Testing aids.113.3Sampling of biological products.113.4Exemptions to tests.113.5General testing.113.6Animal and Plant Health Inspection Service testing.113.7Multiple fractions.113.8In vitro tests for serial release.113.9New potency test.113.10Testing of bulk material for export or for further manufacture.Standard Procedures113.25Culture media for detection of bacteria and fungi.113.26Detection of viable bacteria and fungi except in live vaccine.113.27Detection of extraneous viable bacteria and fungi in live vaccines.113.28Detection of mycoplasma contamination.113.29Determination of moisture content in desiccated biological products.113.30Detection of Salmonella contamination.113.31Detection of avian lymphoid leukosis.113.32Detection of Brucella contamination.113.33Mouse safety tests.113.34Detection of hemagglutinating viruses.113.35Detection of viricidal activity.113.36Detection of pathogens by the chicken inoculation test.113.37Detection of pathogens by the chicken embryo inoculation test.113.38Guinea pig safety test.113.39Cat safety tests.113.40Dog safety tests.113.41Calf safety test.113.42Detection of lymphocytic choriomeningitis contamination.113.43Detection of chlamydial agents.113.44Swine safety test.113.45Sheep safety test.113.46Detection of cytopathogenic and/or hemadsorbing agents.113.47Detection of extraneous viruses by the fluorescent antibody technique.Ingredient Requirements113.50Ingredients of biological products.113.51Requirements for primary cells used for production of biologics.113.52Requirements for cell lines used for production of biologics.113.53Requirements for ingredients of animal origin used for production of biologics.113.54Sterile diluent.113.55Detection of extraneous agents in Master Seed Virus.Live Bacterial Vaccines113.64General requirements for live bacterial vaccines.113.65Brucella Abortus Vaccine.113.66Anthrax Spore Vaccine—Nonencapsulated.113.67Erysipelothrix Rhusiopathiae Vaccine.113.68Pasteurella Haemolytica Vaccine, Bovine.113.69Pasteurella Multocida Vaccine, Bovine.113.70Pasteurella Multocida Vaccine, Avian Isolate.113.71Chlamydia Psittaci Vaccine (Feline Pneumonitis), Live Chlamydia.Inactivated Bacterial Products113.100General requirements for inactivated bacterial products.113.101Leptospira Pomona Bacterin.113.102Leptospira Icterohaemorrhagiae Bacterin.113.103Leptospira Canicola Bacterin.113.104Leptospira Grippotyphosa Bacterin.113.105Leptospira Hardjo Bacterin.113.106Clostridium Chauvoei Bacterin.113.107Clostridium Haemolyticum Bacterin.113.108Clostridium Novyi Bacterin-Toxoid.113.109Clostridium Sordellii Bacterin-Toxoid.113.110Clostridium Botulinum Type C Bacterin-Toxoid.113.111Clostridium Perfringens Type C Toxoid and Bacterin-Toxoid.113.112Clostridium Perfringens Type D Toxoid and Bacterin-Toxoid.113.113Autogenous biologics.113.114Tetanus Toxoid.113.115Staphylococcus Aureus Bacterin-Toxoid.113.116Pasteurella Multocida Bacterin, Avian Isolate, Type 4.113.117Pasteurella Multocida Bacterin, Avian Isolate, Type 1.113.118Pasteurella Multocida Bacterin, Avian Isolate, Type 3.113.119Erysipelothrix Rhusiopathiae Bacterin.113.120Salmonella Typhimurium Bacterin.113.121Pasteurella Multocida Bacterin.113.122Salmonella Choleraesuis Bacterin.113.123Salmonella Dublin Bacterin.Killed Virus Vaccines113.200General requirements for killed virus vaccines.113.201Canine Distemper Vaccine, Killed Virus.113.202Canine Hepatitis and Canine Adenovirus Type 2 Vaccine, Killed Virus.113.203Feline Panleukopenia Vaccine, Killed Virus.113.204Mink Enteritis Vaccine, Killed Virus.113.205Newcastle Disease Vaccine, Killed Virus.113.206Wart Vaccine, Killed Virus.113.207Encephalomyelitis Vaccine, Eastern, Western, and Venezuelan, Killed Virus.113.208Avian Encephalomyelitis Vaccine, Killed Virus.113.209Rabies Vaccine, Killed Virus.113.210Feline Calicivirus Vaccine, Killed Virus.113.211Feline Rhinotracheitis Vaccine, Killed Virus.113.212Bursal Disease Vaccine, Killed Virus.113.213Pseudorabies Vaccine, Killed Virus.113.214Parvovirus Vaccine, Killed Virus (Canine).113.215Bovine Virus Diarrhea Vaccine, Killed Virus.113.216Bovine Rhinotracheitis Vaccine, Killed Virus.Live Virus Vaccines113.300General requirements for live virus vaccines.113.301Ovine Ecthyma Vaccine.113.302Distemper Vaccine—Mink.113.303Bluetongue Vaccine.113.304Feline Panleukopenia Vaccine.113.305Canine Hepatitis and Canine Adenovirus Type 2 Vaccine.113.306Canine Distemper Vaccine.113.308Encephalomyelitis Vaccine, Venezuelan.113.309Bovine Parainfluenza3 Vaccine.113.310Bovine Rhinotracheitis Vaccine.113.311Bovine Virus Diarrhea Vaccine.113.312Rabies Vaccine, Live Virus.113.313Measles Vaccine.113.314Feline Calicivirus Vaccine.113.315Feline Rhinotracheitis Vaccine.113.316Canine Parainfluenza Vaccine.113.317Parvovirus Vaccine (Canine).113.318Pseudorabies Vaccine.113.319-113.324[Reserved]113.325Avian Encephalomyelitis Vaccine.113.326Avian Pox Vaccine.113.327Bronchitis Vaccine.113.328Fowl Laryngotracheitis Vaccine.113.329Newcastle Disease Vaccine.113.330Marek's Disease Vaccines.113.331Bursal Disease Vaccine.113.332Tenosynovitis Vaccine.Diagnostics and Reagents113.400-113.405[Reserved]113.406Tuberculin, Intradermic.113.407Pullorum antigen.113.408Avian mycoplasma antigen.113.409Tuberculin—PPD Bovis, Intradermic.Antibody Products113.450General requirements for antibody products.113.451Tetanus Antitoxin.113.452Erysipelothrix Rhusiopathiae Antibody.113.453[Reserved]113.454Clostridium Perfringens Type C Antitoxin.113.455Clostridium Perfringens Type D Antitoxin.113.456-113.498[Reserved]113.499Products for treatment of failure of passive transfer.Authority: