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