9 CFR Part 113 - PART 113—STANDARD REQUIREMENTS
-
Applicability (§§ 113.1 - 113.10)
- § 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 - 113.47)
- § 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 - 113.55)
- § 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 - 113.71)
- § 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 - 113.123)
- § 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 - 113.216)
- § 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 - 113.332)
- § 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 - 113.409)
-
Antibody Products (§§ 113.450 - 113.499)
- § 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.
Source:
34 FR 18004, Nov. 7, 1969, unless otherwise noted.
Editorial Note:
Nomenclature changes to part 113 appear at 79 FR 55969, Sept. 18, 2014.