Part 113 — Standard Requirements

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• §113.1 Compliance.
• §113.2 Testing aids.
• §113.3 Sampling of biological products.
• §113.4 Exemptions to tests.
• §113.5 General testing.
• §113.6 Animal and Plant Health Inspection Service testing.
• §113.7 Multiple fractions.
• §113.8 In vitro tests for serial release.
• §113.9 New potency test.
• §113.10 Testing of bulk material for export or for further manufacture.
• §113.25 Culture media for detection of bacteria and fungi.
• §113.26 Detection of viable bacteria and fungi except in live vaccine.
• §113.27 Detection of extraneous viable bacteria and fungi in live vaccines.
• §113.28 Detection of mycoplasma contamination.
• §113.29 Determination of moisture content in desiccated biological products.
• §113.30 Detection of Salmonella contamination.
• §113.31 Detection of avian lymphoid leukosis.
• §113.32 Detection of Brucella contamination.
• §113.33 Mouse safety tests.
• §113.34 Detection of hemagglutinating viruses.
• §113.35 Detection of viricidal activity.
• §113.36 Detection of pathogens by the chicken inoculation test.
• §113.37 Detection of pathogens by the chicken embryo inoculation test.
• §113.38 Guinea pig safety test.
• §113.39 Cat safety tests.
• §113.40 Dog safety tests.
• §113.41 Calf safety test.
• §113.42 Detection of lymphocytic choriomeningitis contamination.
• §113.43 Detection of chlamydial agents.
• §113.44 Swine safety test.
• §113.45 Sheep safety test.
• §113.46 Detection of cytopathogenic and/or hemadsorbing agents.
• §113.47 Detection of extraneous viruses by the fluorescent antibody technique.
• §113.50 Ingredients of biological products.
• §113.51 Requirements for primary cells used for production of biologics.
• §113.52 Requirements for cell lines used for production of biologics.
• §113.53 Requirements for ingredients of animal origin used for production of biologics.
• §113.54 Sterile diluent.
• §113.55 Detection of extraneous agents in Master Seed Virus.
• §113.64 General requirements for live bacterial vaccines.
• §113.65 Brucella Abortus Vaccine.
• §113.66 Anthrax Spore Vaccine—Nonencapsulated.
• §113.67 Erysipelothrix Rhusiopathiae Vaccine.
• §113.68 Pasteurella Haemolytica Vaccine, Bovine.
• §113.69 Pasteurella Multocida Vaccine, Bovine.
• §113.70 Pasteurella Multocida Vaccine, Avian Isolate.
• §113.71 Chlamydia Psittaci Vaccine (Feline Pneumonitis), Live Chlamydia.
• §113.100 General requirements for inactivated bacterial products.
• §113.101 Leptospira Pomona Bacterin.
• §113.102 Leptospira Icterohaemorrhagiae Bacterin.
• §113.103 Leptospira Canicola Bacterin.
• §113.104 Leptospira Grippotyphosa Bacterin.
• §113.105 Leptospira Hardjo Bacterin.
• §113.106 Clostridium Chauvoei Bacterin.
• §113.107 Clostridium Haemolyticum Bacterin.
• §113.108 Clostridium Novyi Bacterin-Toxoid.
• §113.109 Clostridium Sordellii Bacterin-Toxoid.
• §113.110 Clostridium Botulinum Type C Bacterin-Toxoid.
• §113.111 Clostridium Perfringens Type C Toxoid and Bacterin-Toxoid.
• §113.112 Clostridium Perfringens Type D Toxoid and Bacterin-Toxoid.
• §113.113 Autogenous biologics.
• §113.114 Tetanus Toxoid.
• §113.115 Staphylococcus Aureus Bacterin-Toxoid.
• §113.116 Pasteurella Multocida Bacterin, Avian Isolate, Type 4.
• §113.117 Pasteurella Multocida Bacterin, Avian Isolate, Type 1.
• §113.118 Pasteurella Multocida Bacterin, Avian Isolate, Type 3.
• §113.119 Erysipelothrix Rhusiopathiae Bacterin.
• §113.120 Salmonella Typhimurium Bacterin.
• §113.121 Pasteurella Multocida Bacterin.
• §113.122 Salmonella Choleraesuis Bacterin.
• §113.123 Salmonella Dublin Bacterin.
• §113.200 General requirements for killed virus vaccines.
• §113.201-113.203 Reserved
• §113.204 Mink Enteritis Vaccine, Killed Virus.
• §113.205 Newcastle Disease Vaccine, Killed Virus.
• §113.206 Wart Vaccine, Killed Virus.
• §113.207 Encephalomyelitis Vaccine, Eastern, Western, and Venezuelan, Killed Virus.
• §113.208 Avian Encephalomyelitis Vaccine, Killed Virus.
• §113.209 Rabies Vaccine, Killed Virus.
• §113.210 Feline Calicivirus Vaccine, Killed Virus.
• §113.211 Reserved
• §113.212 Bursal Disease Vaccine, Killed Virus.
• §113.213-113.214 Reserved
• §113.215 Bovine Virus Diarrhea Vaccine, Killed Virus.
• §113.216 Bovine Rhinotracheitis Vaccine, Killed Virus.
• §113.300 General requirements for live virus vaccines.
• §113.301 Ovine Ecthyma Vaccine.
• §113.302 Distemper Vaccine—Mink.
• §113.303 Bluetongue Vaccine.
• §113.304 Feline Panleukopenia Vaccine.
• §113.305 Canine Hepatitis and Canine Adenovirus Type 2 Vaccine.
• §113.306 Canine Distemper Vaccine.
• §113.308 Encephalomyelitis Vaccine, Venezuelan.
• §113.309 Bovine Parainfluenza 3 Vaccine.
• §113.310 Bovine Rhinotracheitis Vaccine.
• §113.311 Bovine Virus Diarrhea Vaccine.
• §113.312 Rabies Vaccine, Live Virus.
• §113.313 Measles Vaccine.
• §113.314 Feline Calicivirus Vaccine.
• §113.315 Feline Rhinotracheitis Vaccine.
• §113.316 Canine Parainfluenza Vaccine.
• §113.317 Parvovirus Vaccine (Canine).
• §113.318 Pseudorabies Vaccine.
• §113.319-113.324 Reserved
• §113.325 Avian Encephalomyelitis Vaccine.
• §113.326 Avian Pox Vaccine.
• §113.327 Bronchitis Vaccine.
• §113.328 Fowl Laryngotracheitis Vaccine.
• §113.329 Newcastle Disease Vaccine.
• §113.330 Marek's Disease Vaccines.
• §113.331 Bursal Disease Vaccine.
• §113.332 Tenosynovitis Vaccine.
• §113.400-113.405 Reserved
• §113.406 Tuberculin, Intradermic.
• §113.407 Pullorum antigen.
• §113.408 Avian mycoplasma antigen.
• §113.409 Tuberculin—PPD Bovis, Intradermic.
• §113.450 General requirements for antibody products.
• §113.451 Tetanus Antitoxin.
• §113.452 Erysipelothrix Rhusiopathiae Antibody.
• §113.453 Reserved
• §113.454 Clostridium Perfringens Type C Antitoxin.
• §113.455 Clostridium Perfringens Type D Antitoxin.
• §113.456-113.498 Reserved
• §113.499 Products for treatment of failure of passive transfer.