Title 9, Part 113 — Standard Requirements
125 sections
Section 113.1
Compliance.
Section 113.2
Testing aids.
Section 113.3
Sampling of biological products.
Section 113.4
Exemptions to tests.
Section 113.5
General testing.
Section 113.6
Animal and Plant Health Inspection Service testing.
Section 113.7
Multiple fractions.
Section 113.8
In vitro tests for serial release.
Section 113.9
New potency test.
Section 113.10
Testing of bulk material for export or for further manufacture.
Section 113.25
Culture media for detection of bacteria and fungi.
Section 113.26
Detection of viable bacteria and fungi except in live vaccine.
Section 113.27
Detection of extraneous viable bacteria and fungi in live vaccines.
Section 113.28
Detection of mycoplasma contamination.
Section 113.29
Determination of moisture content in desiccated biological products.
Section 113.30
Detection of Salmonella contamination.
Section 113.31
Detection of avian lymphoid leukosis.
Section 113.32
Detection of Brucella contamination.
Section 113.33
Mouse safety tests.
Section 113.34
Detection of hemagglutinating viruses.
Section 113.35
Detection of viricidal activity.
Section 113.36
Detection of pathogens by the chicken inoculation test.
Section 113.37
Detection of pathogens by the chicken embryo inoculation test.
Section 113.38
Guinea pig safety test.
Section 113.39
Cat safety tests.
Section 113.40
Dog safety tests.
Section 113.41
Calf safety test.
Section 113.42
Detection of lymphocytic choriomeningitis contamination.
Section 113.43
Detection of chlamydial agents.
Section 113.44
Swine safety test.
Section 113.45
Sheep safety test.
Section 113.46
Detection of cytopathogenic and/or hemadsorbing agents.
Section 113.47
Detection of extraneous viruses by the fluorescent antibody technique.
Section 113.50
Ingredients of biological products.
Section 113.51
Requirements for primary cells used for production of biologics.
Section 113.52
Requirements for cell lines used for production of biologics.
Section 113.53
Requirements for ingredients of animal origin used for production of biologics.
Section 113.54
Sterile diluent.
Section 113.55
Detection of extraneous agents in Master Seed Virus.
Section 113.64
General requirements for live bacterial vaccines.
Section 113.65
Brucella Abortus Vaccine.
Section 113.66
Anthrax Spore Vaccine—Nonencapsulated.
Section 113.67
Erysipelothrix Rhusiopathiae Vaccine.
Section 113.68
Pasteurella Haemolytica Vaccine, Bovine.
Section 113.69
Pasteurella Multocida Vaccine, Bovine.
Section 113.70
Pasteurella Multocida Vaccine, Avian Isolate.
Section 113.71
Chlamydia Psittaci Vaccine (Feline Pneumonitis), Live Chlamydia.
Section 113.100
General requirements for inactivated bacterial products.
Section 113.101
Leptospira Pomona Bacterin.
Section 113.102
Leptospira Icterohaemorrhagiae Bacterin.
Section 113.103
Leptospira Canicola Bacterin.
Section 113.104
Leptospira Grippotyphosa Bacterin.
Section 113.105
Leptospira Hardjo Bacterin.
Section 113.106
Clostridium Chauvoei Bacterin.
Section 113.107
Clostridium Haemolyticum Bacterin.
Section 113.108
Clostridium Novyi Bacterin-Toxoid.
Section 113.109
Clostridium Sordellii Bacterin-Toxoid.
Section 113.110
Clostridium Botulinum Type C Bacterin-Toxoid.
Section 113.111
Clostridium Perfringens Type C Toxoid and Bacterin-Toxoid.
Section 113.112
Clostridium Perfringens Type D Toxoid and Bacterin-Toxoid.
Section 113.113
Autogenous biologics.
Section 113.114
Tetanus Toxoid.
Section 113.115
Staphylococcus Aureus Bacterin-Toxoid.
Section 113.116
Pasteurella Multocida Bacterin, Avian Isolate, Type 4.
Section 113.117
Pasteurella Multocida Bacterin, Avian Isolate, Type 1.
Section 113.118
Pasteurella Multocida Bacterin, Avian Isolate, Type 3.
Section 113.119
Erysipelothrix Rhusiopathiae Bacterin.
Section 113.120
Salmonella Typhimurium Bacterin.
Section 113.121
Pasteurella Multocida Bacterin.
Section 113.122
Salmonella Choleraesuis Bacterin.
Section 113.123
Salmonella Dublin Bacterin.
Section 113.200
General requirements for killed virus vaccines.
Section 113.201-113.203
§§ 113.201-113.203 [Reserved]
Section 113.204
Mink Enteritis Vaccine, Killed Virus.
Section 113.205
Newcastle Disease Vaccine, Killed Virus.
Section 113.206
Wart Vaccine, Killed Virus.
Section 113.207
Encephalomyelitis Vaccine, Eastern, Western, and Venezuelan, Killed Virus.
Section 113.208
Avian Encephalomyelitis Vaccine, Killed Virus.
Section 113.209
Rabies Vaccine, Killed Virus.
Section 113.210
Feline Calicivirus Vaccine, Killed Virus.
Section 113.211
[Reserved]
Section 113.212
Bursal Disease Vaccine, Killed Virus.
Section 113.213-113.214
§§ 113.213-113.214 [Reserved]
Section 113.215
Bovine Virus Diarrhea Vaccine, Killed Virus.
Section 113.216
Bovine Rhinotracheitis Vaccine, Killed Virus.
Section 113.300
General requirements for live virus vaccines.
Section 113.301
Ovine Ecthyma Vaccine.
Section 113.302
Distemper Vaccine—Mink.
Section 113.303
Bluetongue Vaccine.
Section 113.304
Feline Panleukopenia Vaccine.
Section 113.305
Canine Hepatitis and Canine Adenovirus Type 2 Vaccine.
Section 113.306
Canine Distemper Vaccine.
Section 113.308
Encephalomyelitis Vaccine, Venezuelan.
Section 113.309
Bovine Parainfluenza Vaccine.
Section 113.310
Bovine Rhinotracheitis Vaccine.
Section 113.311
Bovine Virus Diarrhea Vaccine.
Section 113.312
Rabies Vaccine, Live Virus.
Section 113.313
Measles Vaccine.
Section 113.314
Feline Calicivirus Vaccine.
Section 113.315
Feline Rhinotracheitis Vaccine.
Section 113.316
Canine Parainfluenza Vaccine.
Section 113.317
Parvovirus Vaccine (Canine).
Section 113.318
Pseudorabies Vaccine.
Section 113.319-113.324
§§ 113.319-113.324 [Reserved]
Section 113.325
Avian Encephalomyelitis Vaccine.
Section 113.326
Avian Pox Vaccine.
Section 113.327
Bronchitis Vaccine.
Section 113.328
Fowl Laryngotracheitis Vaccine.
Section 113.329
Newcastle Disease Vaccine.
Section 113.330
Marek's Disease Vaccines.
Section 113.331
Bursal Disease Vaccine.
Section 113.332
Tenosynovitis Vaccine.
Section 113.400-113.405
§§ 113.400-113.405 [Reserved]
Section 113.406
Tuberculin, Intradermic.
Section 113.407
Pullorum antigen.
Section 113.408
Avian mycoplasma antigen.
Section 113.409
Tuberculin—PPD Bovis, Intradermic.
Section 113.450
General requirements for antibody products.
Section 113.451
Tetanus Antitoxin.
Section 113.452
Erysipelothrix Rhusiopathiae Antibody.
Section 113.453
[Reserved]
Section 113.454
Clostridium Perfringens Type C Antitoxin.
Section 113.455
Clostridium Perfringens Type D Antitoxin.
Section 113.456-113.498
§§ 113.456-113.498 [Reserved]
Section 113.499
Products for treatment of failure of passive transfer.