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FEDERAL · 9 CFR

Part 113 — Standard Requirements

125 sections · Title 9: Animals and Animal Products

§ 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.
§ 113.25Culture 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.
§ 113.50Ingredients 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.
§ 113.64General 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.
§ 113.100General 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.
§ 113.200General requirements for killed virus vaccines.
§ 113.201-113.203§§ 113.201-113.203 [Reserved]
§ 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.
§ 113.211§ 113.211 [Reserved]
§ 113.212Bursal Disease Vaccine, Killed Virus.
§ 113.213-113.214§§ 113.213-113.214 [Reserved]
§ 113.215Bovine Virus Diarrhea Vaccine, Killed Virus.
§ 113.216Bovine Rhinotracheitis Vaccine, Killed Virus.
§ 113.300General 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 Parainfluenza<sub>3</sub> 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§§ 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.
§ 113.400-113.405§§ 113.400-113.405 [Reserved]
§ 113.406Tuberculin, Intradermic.
§ 113.407Pullorum antigen.
§ 113.408Avian mycoplasma antigen.
§ 113.409Tuberculin—PPD Bovis, Intradermic.
§ 113.450General requirements for antibody products.
§ 113.451Tetanus Antitoxin.
§ 113.452Erysipelothrix Rhusiopathiae Antibody.
§ 113.453§ 113.453 [Reserved]
§ 113.454Clostridium Perfringens Type C Antitoxin.
§ 113.455Clostridium Perfringens Type D Antitoxin.
§ 113.456-113.498§§ 113.456-113.498 [Reserved]
§ 113.499Products for treatment of failure of passive transfer.