PART 113—STANDARD REQUIREMENTS
- 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—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—Feline Rhinotracheitis Vaccine, Killed Virus.
- 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.
- 113.300—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.
- 113.406—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.
- 113.454—Clostridium Perfringens Type C Antitoxin.
- 113.455—Clostridium Perfringens Type D Antitoxin.
- 113.499—Products for treatment of failure of passive transfer.