Part 113. PART 113—STANDARD REQUIREMENTS

• Applicability

  • SECTION § 113.1 - Compliance.
  • SECTION § 113.2 - Testing aids.
  • SECTION § 113.3 - Sampling of biological products.
  • SECTION § 113.4 - Exemptions to tests.
  • SECTION § 113.5 - General testing.
  • SECTION § 113.6 - Animal and Plant Health Inspection Service testing.
  • SECTION § 113.7 - Multiple fractions.
  • SECTION § 113.8 - In vitro tests for serial release.
  • SECTION § 113.9 - New potency test.
  • SECTION § 113.10 - Testing of bulk material for export or for further manufacture.

• Standard Procedures

  • SECTION § 113.25 - Culture media for detection of bacteria and fungi.
  • SECTION § 113.26 - Detection of viable bacteria and fungi except in live vaccine.
  • SECTION § 113.27 - Detection of extraneous viable bacteria and fungi in live vaccines.
  • SECTION § 113.28 - Detection of mycoplasma contamination.
  • SECTION § 113.29 - Determination of moisture content in desiccated biological products.
  • SECTION § 113.30 - Detection of Salmonella contamination.
  • SECTION § 113.31 - Detection of avian lymphoid leukosis.
  • SECTION § 113.32 - Detection of Brucella contamination.
  • SECTION § 113.33 - Mouse safety tests.
  • SECTION § 113.34 - Detection of hemagglutinating viruses.
  • SECTION § 113.35 - Detection of viricidal activity.
  • SECTION § 113.36 - Detection of pathogens by the chicken inoculation test.
  • SECTION § 113.37 - Detection of pathogens by the chicken embryo inoculation test.
  • SECTION § 113.38 - Guinea pig safety test.
  • SECTION § 113.39 - Cat safety tests.
  • SECTION § 113.40 - Dog safety tests.
  • SECTION § 113.41 - Calf safety test.
  • SECTION § 113.42 - Detection of lymphocytic choriomeningitis contamination.
  • SECTION § 113.43 - Detection of chlamydial agents.
  • SECTION § 113.44 - Swine safety test.
  • SECTION § 113.45 - Sheep safety test.
  • SECTION § 113.46 - Detection of cytopathogenic and/or hemadsorbing agents.
  • SECTION § 113.47 - Detection of extraneous viruses by the fluorescent antibody technique.

• Ingredient Requirements

  • SECTION § 113.50 - Ingredients of biological products.
  • SECTION § 113.51 - Requirements for primary cells used for production of biologics.
  • SECTION § 113.52 - Requirements for cell lines used for production of biologics.
  • SECTION § 113.53 - Requirements for ingredients of animal origin used for production of biologics.
  • SECTION § 113.54 - Sterile diluent.
  • SECTION § 113.55 - Detection of extraneous agents in Master Seed Virus.

• Live Bacterial Vaccines

  • SECTION § 113.64 - General requirements for live bacterial vaccines.
  • SECTION § 113.65 - Brucella Abortus Vaccine.
  • SECTION § 113.66 - Anthrax Spore Vaccine—Nonencapsulated.
  • SECTION § 113.67 - Erysipelothrix Rhusiopathiae Vaccine.
  • SECTION § 113.68 - Pasteurella Haemolytica Vaccine, Bovine.
  • SECTION § 113.69 - Pasteurella Multocida Vaccine, Bovine.
  • SECTION § 113.70 - Pasteurella Multocida Vaccine, Avian Isolate.
  • SECTION § 113.71 - Chlamydia Psittaci Vaccine (Feline Pneumonitis), Live Chlamydia.

• Inactivated Bacterial Products

  • SECTION § 113.100 - General requirements for inactivated bacterial products.
  • SECTION § 113.101 - Leptospira Pomona Bacterin.
  • SECTION § 113.102 - Leptospira Icterohaemorrhagiae Bacterin.
  • SECTION § 113.103 - Leptospira Canicola Bacterin.
  • SECTION § 113.104 - Leptospira Grippotyphosa Bacterin.
  • SECTION § 113.105 - Leptospira Hardjo Bacterin.
  • SECTION § 113.106 - Clostridium Chauvoei Bacterin.
  • SECTION § 113.107 - Clostridium Haemolyticum Bacterin.
  • SECTION § 113.108 - Clostridium Novyi Bacterin-Toxoid.
  • SECTION § 113.109 - Clostridium Sordellii Bacterin-Toxoid.
  • SECTION § 113.110 - Clostridium Botulinum Type C Bacterin-Toxoid.
  • SECTION § 113.111 - Clostridium Perfringens Type C Toxoid and Bacterin-Toxoid.
  • SECTION § 113.112 - Clostridium Perfringens Type D Toxoid and Bacterin-Toxoid.
  • SECTION § 113.113 - Autogenous biologics.
  • SECTION § 113.114 - Tetanus Toxoid.
  • SECTION § 113.115 - Staphylococcus Aureus Bacterin-Toxoid.
  • SECTION § 113.116 - Pasteurella Multocida Bacterin, Avian Isolate, Type 4.
  • SECTION § 113.117 - Pasteurella Multocida Bacterin, Avian Isolate, Type 1.
  • SECTION § 113.118 - Pasteurella Multocida Bacterin, Avian Isolate, Type 3.
  • SECTION § 113.119 - Erysipelothrix Rhusiopathiae Bacterin.
  • SECTION § 113.120 - Salmonella Typhimurium Bacterin.
  • SECTION § 113.121 - Pasteurella Multocida Bacterin.
  • SECTION § 113.122 - Salmonella Choleraesuis Bacterin.
  • SECTION § 113.123 - Salmonella Dublin Bacterin.

• Killed Virus Vaccines

  • SECTION § 113.200 - General requirements for killed virus vaccines.
  • SECTION §§ 113.201-113.203 - §[Reserved]
  • SECTION § 113.204 - Mink Enteritis Vaccine, Killed Virus.
  • SECTION § 113.205 - Newcastle Disease Vaccine, Killed Virus.
  • SECTION § 113.206 - Wart Vaccine, Killed Virus.
  • SECTION § 113.207 - Encephalomyelitis Vaccine, Eastern, Western, and Venezuelan, Killed Virus.
  • SECTION § 113.208 - Avian Encephalomyelitis Vaccine, Killed Virus.
  • SECTION § 113.209 - Rabies Vaccine, Killed Virus.
  • SECTION § 113.210 - Feline Calicivirus Vaccine, Killed Virus.
  • SECTION § 113.211 - [Reserved]
  • SECTION § 113.212 - Bursal Disease Vaccine, Killed Virus.
  • SECTION §§ 113.213-113.214 - §[Reserved]
  • SECTION § 113.215 - Bovine Virus Diarrhea Vaccine, Killed Virus.
  • SECTION § 113.216 - Bovine Rhinotracheitis Vaccine, Killed Virus.

• Live Virus Vaccines

  • SECTION § 113.315 - Feline Rhinotracheitis Vaccine.
  • SECTION § 113.316 - Canine Parainfluenza Vaccine.
  • SECTION § 113.317 - Parvovirus Vaccine (Canine).
  • SECTION § 113.318 - Pseudorabies Vaccine.
  • SECTION §§ 113.319-113.324 - §[Reserved]
  • SECTION § 113.325 - Avian Encephalomyelitis Vaccine.
  • SECTION § 113.326 - Avian Pox Vaccine.
  • SECTION § 113.327 - Bronchitis Vaccine.
  • SECTION § 113.328 - Fowl Laryngotracheitis Vaccine.
  • SECTION § 113.329 - Newcastle Disease Vaccine.
  • SECTION § 113.330 - Marek's Disease Vaccines.
  • SECTION § 113.331 - Bursal Disease Vaccine.
  • SECTION § 113.332 - Tenosynovitis Vaccine.
  • SECTION § 113.300 - General requirements for live virus vaccines.
  • SECTION § 113.301 - Ovine Ecthyma Vaccine.
  • SECTION § 113.302 - Distemper Vaccine—Mink.
  • SECTION § 113.303 - Bluetongue Vaccine.
  • SECTION § 113.304 - Feline Panleukopenia Vaccine.
  • SECTION § 113.305 - Canine Hepatitis and Canine Adenovirus Type 2 Vaccine.
  • SECTION § 113.306 - Canine Distemper Vaccine.
  • SECTION § 113.308 - Encephalomyelitis Vaccine, Venezuelan.
  • SECTION § 113.309 - Bovine Parainfluenza3 Vaccine.
  • SECTION § 113.310 - Bovine Rhinotracheitis Vaccine.
  • SECTION § 113.311 - Bovine Virus Diarrhea Vaccine.
  • SECTION § 113.312 - Rabies Vaccine, Live Virus.
  • SECTION § 113.313 - Measles Vaccine.
  • SECTION § 113.314 - Feline Calicivirus Vaccine.

• Diagnostics and Reagents

  • SECTION §§ 113.400-113.405 - §[Reserved]
  • SECTION § 113.406 - Tuberculin, Intradermic.
  • SECTION § 113.407 - Pullorum antigen.
  • SECTION § 113.408 - Avian mycoplasma antigen.
  • SECTION § 113.409 - Tuberculin—PPD Bovis, Intradermic.

• Antibody Products

  • SECTION § 113.450 - General requirements for antibody products.
  • SECTION § 113.451 - Tetanus Antitoxin.
  • SECTION § 113.452 - Erysipelothrix Rhusiopathiae Antibody.
  • SECTION § 113.453 - [Reserved]
  • SECTION § 113.454 - Clostridium Perfringens Type C Antitoxin.
  • SECTION § 113.455 - Clostridium Perfringens Type D Antitoxin.
  • SECTION §§ 113.456-113.498 - §[Reserved]
  • SECTION § 113.499 - Products for treatment of failure of passive transfer.