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Electronic Code of Federal Regulations

e-CFR data is current as of December 4, 2019

Title 9Chapter ISubchapter EPart 113


TITLE 9—Animals and Animal Products

CHAPTER I—ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE

SUBCHAPTER E—VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS

PART 113—STANDARD REQUIREMENTS

rule

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.

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.

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 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.

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.

Killed Virus Vaccines

§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.

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.
§§113.319-113.324
[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.

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.

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.
§§113.456-113.498
[Reserved]
§113.499
Products for treatment of failure of passive transfer.

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