Code of Federal Regulations (alpha)

CFR /  Title 9  /  Part 113: Standard Requirements

Section No. Description
Section 113.1 Testing aids
Section 113.2 Sampling of biological products
Section 113.3 Exemptions to tests
Section 113.4 General testing
Section 113.5 Animal and Plant Health Inspection Service testing
Section 113.6 Multiple fractions
Section 113.7 In vitro tests for serial release
Section 113.8 New potency test
Section 113.9 Testing of bulk material for export or for further manufacture
Section 113.10 Culture media for detection of bacteria and fungi
Section 113.25 Detection of viable bacteria and fungi except in live vaccine
Section 113.26 Detection of extraneous viable bacteria and fungi in live vaccines
Section 113.27 Detection of mycoplasma contamination
Section 113.28 Determination of moisture content in desiccated biological products
Section 113.29 Detection of Salmonella contamination
Section 113.30 Detection of avian lymphoid leukosis
Section 113.31 Detection of Brucella contamination
Section 113.32 Mouse safety tests
Section 113.33 Detection of hemagglutinating viruses
Section 113.34 Detection of viricidal activity
Section 113.35 Detection of pathogens by the chicken inoculation test
Section 113.36 Detection of pathogens by the chicken embryo inoculation test
Section 113.37 Guinea pig safety test
Section 113.38 Cat safety tests
Section 113.39 Dog safety tests
Section 113.40 Calf safety test
Section 113.41 Detection of lymphocytic choriomeningitis contamination
Section 113.42 Detection of chlamydial agents
Section 113.43 Swine safety test
Section 113.44 Sheep safety test
Section 113.45 Detection of cytopathogenic and/or hemadsorbing agents
Section 113.46 Detection of extraneous viruses by the fluorescent antibody technique
Section 113.47 Ingredients of biological products
Section 113.50 Requirements for primary cells used for production of biologics
Section 113.51 Requirements for cell lines used for production of biologics
Section 113.52 Requirements for ingredients of animal origin used for production of biologics
Section 113.53 Sterile diluent
Section 113.54 Detection of extraneous agents in Master Seed Virus
Section 113.55 General requirements for live bacterial vaccines
Section 113.64 Brucella Abortus Vaccine
Section 113.65 Anthrax Spore Vaccine--Nonencapsulated
Section 113.66 Erysipelothrix Rhusiopathiae Vaccine
Section 113.67 Pasteurella Haemolytica Vaccine, Bovine
Section 113.68 Pasteurella Multocida Vaccine, Bovine
Section 113.69 Pasteurella Multocida Vaccine, Avian Isolate
Section 113.70 Chlamydia Psittaci Vaccine (Feline Pneumonitis), Live Chlamydia
Section 113.71 General requirements for inactivated bacterial products
Section 113.100 Leptospira Pomona Bacterin
Section 113.101 Leptospira Icterohaemorrhagiae Bacterin
Section 113.102 Leptospira Canicola Bacterin
Section 113.103 Leptospira Grippotyphosa Bacterin
Section 113.104 Leptospira Hardjo Bacterin
Section 113.105 Clostridium Chauvoei Bacterin
Section 113.106 Clostridium Haemolyticum Bacterin
Section 113.107 Clostridium Novyi Bacterin-Toxoid
Section 113.108 Clostridium Sordellii Bacterin-Toxoid
Section 113.109 Clostridium Botulinum Type C Bacterin-Toxoid
Section 113.110 Clostridium Perfringens Type C Toxoid and Bacterin-Toxoid
Section 113.111 Clostridium Perfringens Type D Toxoid and Bacterin-Toxoid
Section 113.112 Autogenous biologics
Section 113.113 Tetanus Toxoid
Section 113.114 Staphylococcus Aureus Bacterin-Toxoid
Section 113.115 Pasteurella Multocida Bacterin, Avian Isolate, Type 4
Section 113.116 Pasteurella Multocida Bacterin, Avian Isolate, Type 1
Section 113.117 Pasteurella Multocida Bacterin, Avian Isolate, Type 3
Section 113.118 Erysipelothrix Rhusiopathiae Bacterin
Section 113.119 Salmonella Typhimurium Bacterin
Section 113.120 Pasteurella Multocida Bacterin
Section 113.121 Salmonella Choleraesuis Bacterin
Section 113.122 Salmonella Dublin Bacterin
Section 113.123 General requirements for killed virus vaccines
Section 113.200 Mink Enteritis Vaccine, Killed Virus
Section 113.204 Newcastle Disease Vaccine, Killed Virus
Section 113.205 Wart Vaccine, Killed Virus
Section 113.206 Encephalomyelitis Vaccine, Eastern, Western, and Venezuelan, Killed Virus
Section 113.207 Avian Encephalomyelitis Vaccine, Killed Virus
Section 113.208 Rabies Vaccine, Killed Virus
Section 113.209 Feline Calicivirus Vaccine, Killed Virus
Section 113.210 Bursal Disease Vaccine, Killed Virus
Section 113.212 Bovine Virus Diarrhea Vaccine, Killed Virus
Section 113.215 Bovine Rhinotracheitis Vaccine, Killed Virus
Section 113.216 General requirements for live virus vaccines
Section 113.300 Ovine Ecthyma Vaccine
Section 113.301 Distemper Vaccine--Mink
Section 113.302 Bluetongue Vaccine
Section 113.303 Feline Panleukopenia Vaccine
Section 113.304 Canine Hepatitis and Canine Adenovirus Type 2 Vaccine
Section 113.305 Canine Distemper Vaccine
Section 113.306 Encephalomyelitis Vaccine, Venezuelan
Section 113.308 Bovine Parainfluenza [bdi3] Vaccine
Section 113.309 Bovine Rhinotracheitis Vaccine
Section 113.310 Bovine Virus Diarrhea Vaccine
Section 113.311 Rabies Vaccine, Live Virus
Section 113.312 Measles Vaccine
Section 113.313 Feline Calicivirus Vaccine
Section 113.314 Feline Rhinotracheitis Vaccine
Section 113.315 Canine Parainfluenza Vaccine
Section 113.316 Parvovirus Vaccine (Canine)
Section 113.317 Pseudorabies Vaccine
Section 113.318 Avian Encephalomyelitis Vaccine
Section 113.325 Avian Pox Vaccine
Section 113.326 Bronchitis Vaccine
Section 113.327 Fowl Laryngotracheitis Vaccine
Section 113.328 Newcastle Disease Vaccine
Section 113.329 Marek's Disease Vaccines
Section 113.330 Bursal Disease Vaccine
Section 113.331 Tenosynovitis Vaccine
Section 113.332 Tuberculin, Intradermic
Section 113.406 Pullorum antigen
Section 113.407 Avian mycoplasma antigen
Section 113.408 Tuberculin--PPD Bovis, Intradermic
Section 113.409 General requirements for antibody products
Section 113.450 Tetanus Antitoxin
Section 113.451 Erysipelothrix Rhusiopathiae Antibody
Section 113.452 Clostridium Perfringens Type C Antitoxin
Section 113.454 Clostridium Perfringens Type D Antitoxin
Section 113.455 Products for treatment of failure of passive transfer
Section 113.499 Applicability