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Code of Federal Regulations (Last Updated: April 5, 2024) |
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Title 9 - Animals and Animal Products |
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Chapter I - Animal and Plant Health Inspection Service, Department of Agriculture |
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SubChapter E - Viruses, Serums, Toxins, and Analogous Products; Organisms and Vectors |
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Part 113 - Standard Requirements |
| Killed Virus Vaccines |
| § 113.200 - General requirements for killed virus vaccines. |
| § 113.201 - Canine Distemper Vaccine, Killed Virus. |
| § 113.202 - Canine Hepatitis and Canine Adenovirus Type 2 Vaccine, Killed Virus. |
| § 113.203 - Feline Panleukopenia Vaccine, Killed Virus. |
| § 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 - Pseudorabies Vaccine, Killed Virus. |
| § 113.214 - Parvovirus Vaccine, Killed Virus (Canine). |
| § 113.215 - Bovine Virus Diarrhea Vaccine, Killed Virus. |
| § 113.216 - Bovine Rhinotracheitis Vaccine, Killed Virus. |
| §§ 113.201--113.203 - [Reserved] |
| §§ 113.213--113.214 - [Reserved] |
| Antibody Products |
| § 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. |
| § 113.499 - Products for treatment of failure of passive transfer. |
| §§ 113.456--113.498 - [Reserved] |
| Inactivated Bacterial Products |
| § 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. |
| Standard Procedures |
| § 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. |
| Diagnostics and Reagents |
| §§ 113.400--113.405 - [Reserved] |
| § 113.406 - Tuberculin, Intradermic. |
| § 113.407 - Pullorum antigen. |
| § 113.408 - Avian mycoplasma antigen. |
| § 113.409 - Tuberculin - PPD Bovis, Intradermic. |
| Applicability |
| § 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. |
| Ingredient Requirements |
| § 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. |
| Live Virus Vaccines |
| § 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 Parainfluenza3 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. |
| § 113.325 - 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. |
| §§ 113.319--113.324 - [Reserved] |
| Live Bacterial Vaccines |
| § 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. |