Title 9--Animals and Animal Products
CHAPTER I--ANIMAL AND PLANT HEALTH
INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 113--STANDARD REQUIREMENTS
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|
| 113.1 |
Compliance. |
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| 113.2 |
Testing aids. |
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| 113.3 |
Sampling of biological products. |
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| 113.4 |
Exemptions to tests. |
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| 113.5 |
General testing. |
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| 113.6 |
Animal and Plant Health Inspection Service testing. |
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| 113.7 |
Multiple fractions. |
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| 113.8 |
In vitro tests for serial release.
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|
| 113.9 |
New potency test. |
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| 113.10 |
Testing of bulk material for export or for further manufacture. |
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| 113.25 |
Culture media for detection of bacteria and fungi. |
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| 113.26 |
Detection of viable bacteria and fungi except in live vaccine. |
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| 113.27 |
Detection of extraneous viable bacteria and fungi in live vaccines. |
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| 113.28 |
Detection of mycoplasma contamination. |
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| 113.29 |
Determination of moisture content in desiccated biological products. |
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| 113.30 |
Detection of Salmonella contamination. |
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| 113.31 |
Detection of avian lymphoid leukosis. |
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| 113.32 |
Detection of Brucella contamination. |
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| 113.33 |
Mouse safety tests. |
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| 113.34 |
Detection of hemagglutinating viruses. |
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| 113.35 |
Detection of viricidal activity. |
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| 113.36 |
Detection of pathogens by the chicken inoculation test. |
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| 113.37 |
Detection of pathogens by the chicken embryo inoculation test. |
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| 113.38 |
Guinea pig safety test. |
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| 113.39 |
Cat safety tests. |
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| 113.40 |
Dog safety tests. |
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| 113.41 |
Calf safety test. |
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| 113.42 |
Detection of lymphocytic choriomeningitis contamination. |
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| 113.43 |
Detection of chlamydial agents. |
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| 113.44 |
Swine safety test. |
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| 113.45 |
Sheep safety test. |
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| 113.46 |
Detection of cytopathogenic and/or hemadsorbing agents. |
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| 113.47 |
Detection of extraneous viruses by the fluorescent antibody technique. |
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| 113.50 |
Ingredients of biological products. |
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| 113.51 |
Requirements for primary cells used for production of biologics. |
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| 113.52 |
Requirements for cell lines used for production of biologics. |
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| 113.53 |
Requirements for ingredients of animal origin used for production of biologics. |
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| 113.54 |
Sterile diluent. |
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| 113.55 |
Detection of extraneous agents in Master Seed Virus. |
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| 113.64 |
General requirements for live bacterial vaccines. |
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| 113.65 |
Brucella Abortus Vaccine. |
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| 113.66 |
Anthrax Spore Vaccine--Nonencapsulated. |
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| 113.67 |
Erysipelothrix Rhusiopathiae Vaccine. |
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| 113.68 |
Pasteurella Haemolytica Vaccine, Bovine. |
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| 113.69 |
Pasteurella Multocida Vaccine, Bovine. |
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| 113.70 |
Pasteurella Multocida Vaccine, Avian Isolate. |
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| 113.71 |
Chlamydia Psittaci Vaccine (Feline Pneumonitis), Live Chlamydia. |
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| 113.100 |
General requirements for inactivated bacterial products. |
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| 113.101 |
Leptospira Pomona Bacterin. |
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| 113.102 |
Leptospira Icterohaemorrhagiae Bacterin. |
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| 113.103 |
Leptospira Canicola Bacterin. |
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| 113.104 |
Leptospira Grippotyphosa Bacterin. |
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| 113.105 |
Leptospira Hardjo Bacterin. |
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| 113.106 |
Clostridium Chauvoei Bacterin. |
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| 113.107 |
Clostridium Haemolyticum Bacterin. |
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| 113.108 |
Clostridium Novyi Bacterin-Toxoid. |
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| 113.109 |
Clostridium Sordellii Bacterin-Toxoid. |
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| 113.110 |
Clostridium Botulinum Type C Bacterin-Toxoid. |
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| 113.111 |
Clostridium Perfringens Type C Toxoid and Bacterin-Toxoid. |
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| 113.112 |
Clostridium Perfringens Type D Toxoid and Bacterin-Toxoid. |
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| 113.113 |
Autogenous biologics. |
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| 113.114 |
Tetanus Toxoid. |
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| 113.115 |
Staphylococcus Aureus Bacterin-Toxoid. |
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| 113.116 |
Pasteurella Multocida Bacterin, Avian Isolate, Type 4. |
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| 113.117 |
Pasteurella Multocida Bacterin, Avian Isolate, Type 1. |
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| 113.118 |
Pasteurella Multocida Bacterin, Avian Isolate, Type 3. |
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| 113.119 |
Erysipelothrix Rhusiopathiae Bacterin. |
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| 113.120 |
Salmonella Typhimurium Bacterin. |
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| 113.121 |
Pasteurella Multocida Bacterin. |
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| 113.122 |
Salmonella Choleraesuis Bacterin. |
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| 113.123 |
Salmonella Dublin Bacterin. |
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| 113.200 |
General requirements for killed virus vaccines. |
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| 113.201 |
Canine Distemper Vaccine, Killed Virus. |
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| 113.202 |
Canine Hepatitis and Canine Adenovirus Type 2 Vaccine, Killed Virus. |
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| 113.203 |
Feline Panleukopenia Vaccine, Killed Virus. |
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| 113.204 |
Mink Enteritis Vaccine, Killed Virus. |
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| 113.205 |
Newcastle Disease Vaccine, Killed Virus. |
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| 113.206 |
Wart Vaccine, Killed Virus. |
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| 113.207 |
Encephalomyelitis Vaccine, Eastern, Western, and Venezuelan, Killed Virus. |
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| 113.208 |
Avian Encephalomyelitis Vaccine, Killed Virus. |
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| 113.209 |
Rabies Vaccine, Killed Virus. |
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| 113.210 |
Feline Calicivirus Vaccine, Killed Virus. |
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| 113.211 |
Feline Rhinotracheitis Vaccine, Killed Virus. |
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| 113.212 |
Bursal Disease Vaccine, Killed Virus. |
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| 113.213 |
Pseudorabies Vaccine, Killed Virus. |
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| 113.214 |
Parvovirus Vaccine, Killed Virus (Canine). |
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| 113.215 |
Bovine Virus Diarrhea Vaccine, Killed Virus. |
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| 113.216 |
Bovine Rhinotracheitis Vaccine, Killed Virus. |
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| 113.300 |
General requirements for live virus vaccines. |
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| 113.301 |
Ovine Ecthyma Vaccine. |
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| 113.302 |
Distemper Vaccine--Mink. |
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| 113.303 |
Bluetongue Vaccine. |
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| 113.304 |
Feline Panleukopenia Vaccine. |
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| 113.305 |
Canine Hepatitis and Canine Adenovirus Type 2 Vaccine. |
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| 113.306 |
Canine Distemper Vaccine. |
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| 113.308 |
Encephalomyelitis Vaccine, Venezuelan. |
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| 113.309 |
Bovine Parainfluenza3 Vaccine. |
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| 113.310 |
Bovine Rhinotracheitis Vaccine. |
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| 113.311 |
Bovine Virus Diarrhea Vaccine. |
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| 113.312 |
Rabies Vaccine, Live Virus. |
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| 113.313 |
Measles Vaccine. |
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| 113.314 |
Feline Calicivirus Vaccine. |
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| 113.315 |
Feline Rhinotracheitis Vaccine. |
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| 113.316 |
Canine Parainfluenza Vaccine. |
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| 113.317 |
Parvovirus Vaccine (Canine). |
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| 113.318 |
Pseudorabies Vaccine. |
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| 113.325 |
Avian Encephalomyelitis Vaccine. |
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| 113.326 |
Avian Pox Vaccine. |
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| 113.327 |
Bronchitis Vaccine. |
|
| 113.328 |
Fowl Laryngotracheitis Vaccine. |
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| 113.329 |
Newcastle Disease Vaccine. |
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| 113.330 |
Marek's Disease Vaccines. |
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| 113.331 |
Bursal Disease Vaccine. |
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| 113.332 |
Tenosynovitis Vaccine. |
|
| 113.406 |
Tuberculin, Intradermic. |
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| 113.407 |
Pullorum antigen. |
|
| 113.408 |
Avian mycoplasma antigen. |
|
| 113.409 |
Tuberculin--PPD Bovis, Intradermic. |
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| 113.450 |
General requirements for antibody products. |
|
| 113.451 |
Tetanus Antitoxin. |
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| 113.452 |
Erysipelothrix Rhusiopathiae Antibody. |
|
| 113.454 |
Clostridium Perfringens Type C Antitoxin. |
|
| 113.455 |
Clostridium Perfringens Type D Antitoxin. |
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| 113.499 |
Products for treatment of failure of passive transfer. |