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.
- § 113.204— 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.
- § 113.212— Bursal Disease Vaccine, Killed Virus.
- § 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 Parainfluenza<sub>3</sub> 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.