e-CFR data is current as of August 7, 2020
TITLE 9—Animals and Animal Products
CHAPTER I—ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE SUBCHAPTER E—VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PART 113—STANDARD REQUIREMENTS
Applicability
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| Sampling of biological products. |
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| Animal and Plant Health Inspection Service testing. |
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| In vitro tests for serial release. |
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| Testing of bulk material for export or for further manufacture. |
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Standard Procedures
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| Culture media for detection of bacteria and fungi. |
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| Detection of viable bacteria and fungi except in live vaccine. |
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| Detection of extraneous viable bacteria and fungi in live vaccines. |
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| Detection of mycoplasma contamination. |
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| Determination of moisture content in desiccated biological products. |
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| Detection of Salmonella contamination. |
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| Detection of avian lymphoid leukosis. |
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| Detection of Brucella contamination. |
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| Detection of hemagglutinating viruses. |
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| Detection of viricidal activity. |
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| Detection of pathogens by the chicken inoculation test. |
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| Detection of pathogens by the chicken embryo inoculation test. |
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| Detection of lymphocytic choriomeningitis contamination. |
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| Detection of chlamydial agents. |
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| Detection of cytopathogenic and/or hemadsorbing agents. |
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| Detection of extraneous viruses by the fluorescent antibody technique. |
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Ingredient Requirements
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| Ingredients of biological products. |
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| Requirements for primary cells used for production of biologics. |
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| Requirements for cell lines used for production of biologics. |
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| Requirements for ingredients of animal origin used for production of biologics. |
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| Detection of extraneous agents in Master Seed Virus. |
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Live Bacterial Vaccines
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| General requirements for live bacterial vaccines. |
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| Brucella Abortus Vaccine. |
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| Anthrax Spore Vaccine—Nonencapsulated. |
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| Erysipelothrix Rhusiopathiae Vaccine. |
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| Pasteurella Haemolytica Vaccine, Bovine. |
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| Pasteurella Multocida Vaccine, Bovine. |
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| Pasteurella Multocida Vaccine, Avian Isolate. |
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| Chlamydia Psittaci Vaccine (Feline Pneumonitis), Live Chlamydia. |
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Inactivated Bacterial Products
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| General requirements for inactivated bacterial products. |
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| Leptospira Pomona Bacterin. |
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| Leptospira Icterohaemorrhagiae Bacterin. |
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| Leptospira Canicola Bacterin. |
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| Leptospira Grippotyphosa Bacterin. |
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| Leptospira Hardjo Bacterin. |
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| Clostridium Chauvoei Bacterin. |
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| Clostridium Haemolyticum Bacterin. |
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| Clostridium Novyi Bacterin-Toxoid. |
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| Clostridium Sordellii Bacterin-Toxoid. |
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| Clostridium Botulinum Type C Bacterin-Toxoid. |
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| Clostridium Perfringens Type C Toxoid and Bacterin-Toxoid. |
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| Clostridium Perfringens Type D Toxoid and Bacterin-Toxoid. |
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| Staphylococcus Aureus Bacterin-Toxoid. |
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| Pasteurella Multocida Bacterin, Avian Isolate, Type 4. |
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| Pasteurella Multocida Bacterin, Avian Isolate, Type 1. |
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| Pasteurella Multocida Bacterin, Avian Isolate, Type 3. |
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| Erysipelothrix Rhusiopathiae Bacterin. |
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| Salmonella Typhimurium Bacterin. |
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| Pasteurella Multocida Bacterin. |
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| Salmonella Choleraesuis Bacterin. |
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| Salmonella Dublin Bacterin. |
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Killed Virus Vaccines
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| General requirements for killed virus vaccines. |
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| Mink Enteritis Vaccine, Killed Virus. |
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| Newcastle Disease Vaccine, Killed Virus. |
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| Wart Vaccine, Killed Virus. |
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| Encephalomyelitis Vaccine, Eastern, Western, and Venezuelan, Killed Virus. |
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| Avian Encephalomyelitis Vaccine, Killed Virus. |
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| Rabies Vaccine, Killed Virus. |
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| Feline Calicivirus Vaccine, Killed Virus. |
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| Bursal Disease Vaccine, Killed Virus. |
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| Bovine Virus Diarrhea Vaccine, Killed Virus. |
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| Bovine Rhinotracheitis Vaccine, Killed Virus. |
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Live Virus Vaccines
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| General requirements for live virus vaccines. |
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| Feline Panleukopenia Vaccine. |
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| Canine Hepatitis and Canine Adenovirus Type 2 Vaccine. |
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| Canine Distemper Vaccine. |
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| Encephalomyelitis Vaccine, Venezuelan. |
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| Bovine Parainfluenza3 Vaccine. |
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| Bovine Rhinotracheitis Vaccine. |
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| Bovine Virus Diarrhea Vaccine. |
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| Rabies Vaccine, Live Virus. |
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| Feline Calicivirus Vaccine. |
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| Feline Rhinotracheitis Vaccine. |
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| Canine Parainfluenza Vaccine. |
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| Parvovirus Vaccine (Canine). |
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| Avian Encephalomyelitis Vaccine. |
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| Fowl Laryngotracheitis Vaccine. |
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| Newcastle Disease Vaccine. |
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| Marek's Disease Vaccines. |
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Diagnostics and Reagents
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| Avian mycoplasma antigen. |
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| Tuberculin—PPD Bovis, Intradermic. |
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Antibody Products
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| General requirements for antibody products. |
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| Erysipelothrix Rhusiopathiae Antibody. |
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| Clostridium Perfringens Type C Antitoxin. |
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| Clostridium Perfringens Type D Antitoxin. |
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| Products for treatment of failure of passive transfer. |
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