APPLICABILITY

• § 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 - 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 - 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 - 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 - 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 - 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

• § 113.315 - 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.

• § 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.

DIAGNOSTICS AND REAGENTS

• §§ 113.400–113.405 - §[Reserved]

• § 113.406 - Tuberculin, Intradermic.

• § 113.407 - Pullorum antigen.

• § 113.408 - Avian mycoplasma antigen.

• § 113.409 - Tuberculin—PPD Bovis, Intradermic.

ANTIBODY PRODUCTS

• § 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.