Title 9

PART 113

Part 113 - Standard Requirements

PART 113 - STANDARD REQUIREMENTS Authority:21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4. Source:34 FR 18004, Nov. 7, 1969, unless otherwise noted. Editorial Note:Nomenclature changes to part 113 appear at 79 FR 55969, Sept. 18, 2014.

9:1.0.1.5.51.0.68SUBJGRP 68
   Applicability
9:1.0.1.5.51.0.68.1SECTION 113.1
   113.1 Compliance.
9:1.0.1.5.51.0.68.2SECTION 113.2
   113.2 Testing aids.
9:1.0.1.5.51.0.68.3SECTION 113.3
   113.3 Sampling of biological products.
9:1.0.1.5.51.0.68.4SECTION 113.4
   113.4 Exemptions to tests.
9:1.0.1.5.51.0.68.5SECTION 113.5
   113.5 General testing.
9:1.0.1.5.51.0.68.6SECTION 113.6
   113.6 Animal and Plant Health Inspection Service testing.
9:1.0.1.5.51.0.68.7SECTION 113.7
   113.7 Multiple fractions.
9:1.0.1.5.51.0.68.8SECTION 113.8
   113.8 In vitro tests for serial release.
9:1.0.1.5.51.0.68.9SECTION 113.9
   113.9 New potency test.
9:1.0.1.5.51.0.68.10SECTION 113.10
   113.10 Testing of bulk material for export or for further manufacture.
9:1.0.1.5.51.0.69SUBJGRP 69
   Standard Procedures
9:1.0.1.5.51.0.69.11SECTION 113.25
   113.25 Culture media for detection of bacteria and fungi.
9:1.0.1.5.51.0.69.12SECTION 113.26
   113.26 Detection of viable bacteria and fungi except in live vaccine.
9:1.0.1.5.51.0.69.13SECTION 113.27
   113.27 Detection of extraneous viable bacteria and fungi in live vaccines.
9:1.0.1.5.51.0.69.14SECTION 113.28
   113.28 Detection of mycoplasma contamination.
9:1.0.1.5.51.0.69.15SECTION 113.29
   113.29 Determination of moisture content in desiccated biological products.
9:1.0.1.5.51.0.69.16SECTION 113.30
   113.30 Detection of Salmonella contamination.
9:1.0.1.5.51.0.69.17SECTION 113.31
   113.31 Detection of avian lymphoid leukosis.
9:1.0.1.5.51.0.69.18SECTION 113.32
   113.32 Detection of Brucella contamination.
9:1.0.1.5.51.0.69.19SECTION 113.33
   113.33 Mouse safety tests.
9:1.0.1.5.51.0.69.20SECTION 113.34
   113.34 Detection of hemagglutinating viruses.
9:1.0.1.5.51.0.69.21SECTION 113.35
   113.35 Detection of viricidal activity.
9:1.0.1.5.51.0.69.22SECTION 113.36
   113.36 Detection of pathogens by the chicken inoculation test.
9:1.0.1.5.51.0.69.23SECTION 113.37
   113.37 Detection of pathogens by the chicken embryo inoculation test.
9:1.0.1.5.51.0.69.24SECTION 113.38
   113.38 Guinea pig safety test.
9:1.0.1.5.51.0.69.25SECTION 113.39
   113.39 Cat safety tests.
9:1.0.1.5.51.0.69.26SECTION 113.40
   113.40 Dog safety tests.
9:1.0.1.5.51.0.69.27SECTION 113.41
   113.41 Calf safety test.
9:1.0.1.5.51.0.69.28SECTION 113.42
   113.42 Detection of lymphocytic choriomeningitis contamination.
9:1.0.1.5.51.0.69.29SECTION 113.43
   113.43 Detection of chlamydial agents.
9:1.0.1.5.51.0.69.30SECTION 113.44
   113.44 Swine safety test.
9:1.0.1.5.51.0.69.31SECTION 113.45
   113.45 Sheep safety test.
9:1.0.1.5.51.0.69.32SECTION 113.46
   113.46 Detection of cytopathogenic and/or hemadsorbing agents.
9:1.0.1.5.51.0.69.33SECTION 113.47
   113.47 Detection of extraneous viruses by the fluorescent antibody technique.
9:1.0.1.5.51.0.70SUBJGRP 70
   Ingredient Requirements
9:1.0.1.5.51.0.70.34SECTION 113.50
   113.50 Ingredients of biological products.
9:1.0.1.5.51.0.70.35SECTION 113.51
   113.51 Requirements for primary cells used for production of biologics.
9:1.0.1.5.51.0.70.36SECTION 113.52
   113.52 Requirements for cell lines used for production of biologics.
9:1.0.1.5.51.0.70.37SECTION 113.53
   113.53 Requirements for ingredients of animal origin used for production of biologics.
9:1.0.1.5.51.0.70.38SECTION 113.54
   113.54 Sterile diluent.
9:1.0.1.5.51.0.70.39SECTION 113.55
   113.55 Detection of extraneous agents in Master Seed Virus.
9:1.0.1.5.51.0.71SUBJGRP 71
   Live Bacterial Vaccines
9:1.0.1.5.51.0.71.40SECTION 113.64
   113.64 General requirements for live bacterial vaccines.
9:1.0.1.5.51.0.71.41SECTION 113.65
   113.65 Brucella Abortus Vaccine.
9:1.0.1.5.51.0.71.42SECTION 113.66
   113.66 Anthrax Spore Vaccine - Nonencapsulated.
9:1.0.1.5.51.0.71.43SECTION 113.67
   113.67 Erysipelothrix Rhusiopathiae Vaccine.
9:1.0.1.5.51.0.71.44SECTION 113.68
   113.68 Pasteurella Haemolytica Vaccine, Bovine.
9:1.0.1.5.51.0.71.45SECTION 113.69
   113.69 Pasteurella Multocida Vaccine, Bovine.
9:1.0.1.5.51.0.71.46SECTION 113.70
   113.70 Pasteurella Multocida Vaccine, Avian Isolate.
9:1.0.1.5.51.0.71.47SECTION 113.71
   113.71 Chlamydia Psittaci Vaccine (Feline Pneumonitis), Live Chlamydia.
9:1.0.1.5.51.0.72SUBJGRP 72
   Inactivated Bacterial Products
9:1.0.1.5.51.0.72.48SECTION 113.100
   113.100 General requirements for inactivated bacterial products.
9:1.0.1.5.51.0.72.49SECTION 113.101
   113.101 Leptospira Pomona Bacterin.
9:1.0.1.5.51.0.72.50SECTION 113.102
   113.102 Leptospira Icterohaemorrhagiae Bacterin.
9:1.0.1.5.51.0.72.51SECTION 113.103
   113.103 Leptospira Canicola Bacterin.
9:1.0.1.5.51.0.72.52SECTION 113.104
   113.104 Leptospira Grippotyphosa Bacterin.
9:1.0.1.5.51.0.72.53SECTION 113.105
   113.105 Leptospira Hardjo Bacterin.
9:1.0.1.5.51.0.72.54SECTION 113.106
   113.106 Clostridium Chauvoei Bacterin.
9:1.0.1.5.51.0.72.55SECTION 113.107
   113.107 Clostridium Haemolyticum Bacterin.
9:1.0.1.5.51.0.72.56SECTION 113.108
   113.108 Clostridium Novyi Bacterin-Toxoid.
9:1.0.1.5.51.0.72.57SECTION 113.109
   113.109 Clostridium Sordellii Bacterin-Toxoid.
9:1.0.1.5.51.0.72.58SECTION 113.110
   113.110 Clostridium Botulinum Type C Bacterin-Toxoid.
9:1.0.1.5.51.0.72.59SECTION 113.111
   113.111 Clostridium Perfringens Type C Toxoid and Bacterin-Toxoid.
9:1.0.1.5.51.0.72.60SECTION 113.112
   113.112 Clostridium Perfringens Type D Toxoid and Bacterin-Toxoid.
9:1.0.1.5.51.0.72.61SECTION 113.113
   113.113 Autogenous biologics.
9:1.0.1.5.51.0.72.62SECTION 113.114
   113.114 Tetanus Toxoid.
9:1.0.1.5.51.0.72.63SECTION 113.115
   113.115 Staphylococcus Aureus Bacterin-Toxoid.
9:1.0.1.5.51.0.72.64SECTION 113.116
   113.116 Pasteurella Multocida Bacterin, Avian Isolate, Type 4.
9:1.0.1.5.51.0.72.65SECTION 113.117
   113.117 Pasteurella Multocida Bacterin, Avian Isolate, Type 1.
9:1.0.1.5.51.0.72.66SECTION 113.118
   113.118 Pasteurella Multocida Bacterin, Avian Isolate, Type 3.
9:1.0.1.5.51.0.72.67SECTION 113.119
   113.119 Erysipelothrix Rhusiopathiae Bacterin.
9:1.0.1.5.51.0.72.68SECTION 113.120
   113.120 Salmonella Typhimurium Bacterin.
9:1.0.1.5.51.0.72.69SECTION 113.121
   113.121 Pasteurella Multocida Bacterin.
9:1.0.1.5.51.0.72.70SECTION 113.122
   113.122 Salmonella Choleraesuis Bacterin.
9:1.0.1.5.51.0.72.71SECTION 113.123
   113.123 Salmonella Dublin Bacterin.
9:1.0.1.5.51.0.73SUBJGRP 73
   Killed Virus Vaccines
9:1.0.1.5.51.0.73.72SECTION 113.200
   113.200 General requirements for killed virus vaccines.
9:1.0.1.5.51.0.73.73SECTION 113.201-113.203
   113.201-113.203 [Reserved]
9:1.0.1.5.51.0.73.74SECTION 113.204
   113.204 Mink Enteritis Vaccine, Killed Virus.
9:1.0.1.5.51.0.73.75SECTION 113.205
   113.205 Newcastle Disease Vaccine, Killed Virus.
9:1.0.1.5.51.0.73.76SECTION 113.206
   113.206 Wart Vaccine, Killed Virus.
9:1.0.1.5.51.0.73.77SECTION 113.207
   113.207 Encephalomyelitis Vaccine, Eastern, Western, and Venezuelan, Killed Virus.
9:1.0.1.5.51.0.73.78SECTION 113.208
   113.208 Avian Encephalomyelitis Vaccine, Killed Virus.
9:1.0.1.5.51.0.73.79SECTION 113.209
   113.209 Rabies Vaccine, Killed Virus.
9:1.0.1.5.51.0.73.80SECTION 113.210
   113.210 Feline Calicivirus Vaccine, Killed Virus.
9:1.0.1.5.51.0.73.81SECTION 113.211
   113.211 [Reserved]
9:1.0.1.5.51.0.73.82SECTION 113.212
   113.212 Bursal Disease Vaccine, Killed Virus.
9:1.0.1.5.51.0.73.83SECTION 113.213-113.214
   113.213-113.214 [Reserved]
9:1.0.1.5.51.0.73.84SECTION 113.215
   113.215 Bovine Virus Diarrhea Vaccine, Killed Virus.
9:1.0.1.5.51.0.73.85SECTION 113.216
   113.216 Bovine Rhinotracheitis Vaccine, Killed Virus.
9:1.0.1.5.51.0.74SUBJGRP 74
   Live Virus Vaccines
9:1.0.1.5.51.0.74.86SECTION 113.300
   113.300 General requirements for live virus vaccines.
9:1.0.1.5.51.0.74.87SECTION 113.301
   113.301 Ovine Ecthyma Vaccine.
9:1.0.1.5.51.0.74.88SECTION 113.302
   113.302 Distemper Vaccine - Mink.
9:1.0.1.5.51.0.74.89SECTION 113.303
   113.303 Bluetongue Vaccine.
9:1.0.1.5.51.0.74.90SECTION 113.304
   113.304 Feline Panleukopenia Vaccine.
9:1.0.1.5.51.0.74.91SECTION 113.305
   113.305 Canine Hepatitis and Canine Adenovirus Type 2 Vaccine.
9:1.0.1.5.51.0.74.92SECTION 113.306
   113.306 Canine Distemper Vaccine.
9:1.0.1.5.51.0.74.93SECTION 113.308
   113.308 Encephalomyelitis Vaccine, Venezuelan.
9:1.0.1.5.51.0.74.94SECTION 113.309
   113.309 Bovine Parainfluenza3 Vaccine.
9:1.0.1.5.51.0.74.95SECTION 113.310
   113.310 Bovine Rhinotracheitis Vaccine.
9:1.0.1.5.51.0.74.96SECTION 113.311
   113.311 Bovine Virus Diarrhea Vaccine.
9:1.0.1.5.51.0.74.97SECTION 113.312
   113.312 Rabies Vaccine, Live Virus.
9:1.0.1.5.51.0.74.98SECTION 113.313
   113.313 Measles Vaccine.
9:1.0.1.5.51.0.74.99SECTION 113.314
   113.314 Feline Calicivirus Vaccine.
9:1.0.1.5.51.0.74.100SECTION 113.315
   113.315 Feline Rhinotracheitis Vaccine.
9:1.0.1.5.51.0.74.101SECTION 113.316
   113.316 Canine Parainfluenza Vaccine.
9:1.0.1.5.51.0.74.102SECTION 113.317
   113.317 Parvovirus Vaccine (Canine).
9:1.0.1.5.51.0.74.103SECTION 113.318
   113.318 Pseudorabies Vaccine.
9:1.0.1.5.51.0.74.104SECTION 113.319-113.324
   113.319-113.324 [Reserved]
9:1.0.1.5.51.0.74.105SECTION 113.325
   113.325 Avian Encephalomyelitis Vaccine.
9:1.0.1.5.51.0.74.106SECTION 113.326
   113.326 Avian Pox Vaccine.
9:1.0.1.5.51.0.74.107SECTION 113.327
   113.327 Bronchitis Vaccine.
9:1.0.1.5.51.0.74.108SECTION 113.328
   113.328 Fowl Laryngotracheitis Vaccine.
9:1.0.1.5.51.0.74.109SECTION 113.329
   113.329 Newcastle Disease Vaccine.
9:1.0.1.5.51.0.74.110SECTION 113.330
   113.330 Marek's Disease Vaccines.
9:1.0.1.5.51.0.74.111SECTION 113.331
   113.331 Bursal Disease Vaccine.
9:1.0.1.5.51.0.74.112SECTION 113.332
   113.332 Tenosynovitis Vaccine.
9:1.0.1.5.51.0.75SUBJGRP 75
   Diagnostics and Reagents
9:1.0.1.5.51.0.75.113SECTION 113.400-113.405
   113.400-113.405 [Reserved]
9:1.0.1.5.51.0.75.114SECTION 113.406
   113.406 Tuberculin, Intradermic.
9:1.0.1.5.51.0.75.115SECTION 113.407
   113.407 Pullorum antigen.
9:1.0.1.5.51.0.75.116SECTION 113.408
   113.408 Avian mycoplasma antigen.
9:1.0.1.5.51.0.75.117SECTION 113.409
   113.409 Tuberculin - PPD Bovis, Intradermic.
9:1.0.1.5.51.0.76SUBJGRP 76
   Antibody Products
9:1.0.1.5.51.0.76.118SECTION 113.450
   113.450 General requirements for antibody products.
9:1.0.1.5.51.0.76.119SECTION 113.451
   113.451 Tetanus Antitoxin.
9:1.0.1.5.51.0.76.120SECTION 113.452
   113.452 Erysipelothrix Rhusiopathiae Antibody.
9:1.0.1.5.51.0.76.121SECTION 113.453
   113.453 [Reserved]
9:1.0.1.5.51.0.76.122SECTION 113.454
   113.454 Clostridium Perfringens Type C Antitoxin.
9:1.0.1.5.51.0.76.123SECTION 113.455
   113.455 Clostridium Perfringens Type D Antitoxin.
9:1.0.1.5.51.0.76.124SECTION 113.456-113.498
   113.456-113.498 [Reserved]
9:1.0.1.5.51.0.76.125SECTION 113.499
   113.499 Products for treatment of failure of passive transfer.