There are distinct differences between the regulations as they apply to veterinary pharmaceuticals, medical devices, and veterinary biologics. Veterinary product regulations in the United States are primarily regulated through three agencies, the FDA-CVM, USDA-CVB or EPA depending on how they are categorized. This page contains links to some of the veterinary product regulations including the Code of Federal Regulations (CFRs) and guidance documents concerning veterinary product regulations & development requirements for veterinary pharmaceuticals (FDA) and veterinary biologics (USDA).
Veterinary Product Regulations
Code of Federal Regulations (CRFs)
Veterinary pharmaceuticals, including feeds, devices, and supplements are regulated under and/or subject to regulations per the Food and Drug Administration – Center for Veterinary Medicine (FDA-CVM).
Code of Federal Regulations: Title 21 CFR Subchapter E: Animal Drugs, Feeds, and Related Products
Veterinary biologics, which include vaccines, diagnostic kits, and immune modulators are regulated by the United States Department of Agriculture – Center for Veterinary Biologics (USDA-CVB).
Code of Federal Regulations: Title 9 Animal and Animal Products; Subchapter E: Viruses, Serums, Toxins, and Analogous Products; Organisms and Vectors
Additional Information on Pet Food: US feed regulations are enforced at the state and federal level. The Association of American Feed Control Officials (AAFCO) is a collaboration of experts and regulatory officials to create guidance on the regulation of animal feeds.
Veterinary Regulatory Documents – hyperlinks
Dropdown accordians contain hyperlinks to veterinary regulatory guidance documents (FDA Guidance for Industry and USDA Veterinary Service Memorandums)
- 1Dropdown - USDA Center for Veterinary Biologics (Veterinary Regulatory Guidance Documents)
Number Title Issue Date 800.211 Guidance for Master Reference Qualification, Requalification, Dating, and Monitoring 8-Feb-23 800.67 Shipment of Experimental Veterinary Biological Products 25-Nov-22 800.75 Reissuance of Product Licenses for Products Under Conditional Licenses 14-Jul-22 800.127 Guidelines for Conducting Product Stability Studies 29-Mar-22 800.106 Exemption to Sterility Test Requirement for Allergenic Extract Prescription Product 16-Feb-22 800.69 Guidelines for Autogenous Biologics 22-Nov-21 800.91 Inspection of U.S. Veterinary Biologics Licensed and Permitted Establishments 8-Dec-20 800.124 Guidelines for Potency Specifications of Biological Products Administered to Animals 2-Oct-20 800.126 Efficacy and Safety Studies for Cancer Immunotherapeutics 2-Sep-20 800.125 Preparation and Submission of Adverse Event Reports for Biological Products 17-Aug-20 800.53 Serial Release of Licensed Biological Products 15-Jul-20 800.85 Avian Influenza Vaccines 13-Jul-20 800.78 Preparation and Submission of Facilities Documents 24-Sep-19 800.115 Potency and Safety Testing by Unlicensed Facilities 11-Apr-19 800.104 In Vitro Serial Release Potency Test for Completed Product Containing Clostridium chauvoei 13-Dec-18 800.206 General Licensing Considerations: Preparing Outlines of Production for Vaccines, Bacterins, Antigens, and Toxoids and Diagnostic Test Kits 13-Nov-18 800.54 Guidelines for the Preparation and Review of Labeling Materials 17-Sep-18 800.103 Reissuance of Product Licenses for Autogenous Products and Guidance Concerning Restrictions on the Production and Use of Veterinary Biologics 18-Jul-18 800.57 Market Suspensions and Post Marketing Temperature Deviations 11-Jun-18 800.5 Basic License Requirements and Guidelines for Submission of Materials in Support of Licensure 2-Apr-18 800.213 Licensing Guidelines for Production Platform-Based, Non-Replicating, Nonviable Products 12-Mar-18 800.214 Prescription Platform Product Biologics 12-Mar-18 800.201 General Licensing Considerations: Backpassage Studies 25-Jan-18 800.204 General Licensing Considerations: Field Safety Studies 25-Jan-18 800.122 Electronic Recordkeeping and Compliance with 9 CFR Part 116 3-Nov-17 800.116 Target Animal Safety Testing Exemption 14-Aug-17 800.11 Label Warnings Concerning Bovine Rhinotracheitis Vaccine, Modified Live Virus, and Bovine Virus Diarrhea Vaccine, Modified Live Virus, for Pregnant Cows or Calves Nursing Pregnant Cows 30-Jun-17 800.121 Autologous Therapeutic Biologics 21-Jun-17 800.63 Personnel at Licensed Establishments 19-Dec-16 800.101 U.S. Veterinary Biological Product Permits for Distribution and Sale 1-Nov-16 800.202 General Licensing Considerations: Efficacy Studies 26-Oct-16 800.59 Veterinary Biological Product Samples 20-Jul-16 800.112 Guidelines for Validation of In Vitro Potency Assays 10-Apr-15 800.2 General Licensing Considerations: Study Practices and Documentation 12-Jun-14 800.117 Guidance for Inactivation Studies 12-Aug-13 800.79 Submission of Host Animal Serum Samples for In Vitro Potency Tests 20-Mar-13 800.114 Alternative Test Procedure for Tuberculin, PPD Bovis, Intradermic 13-Apr-12 800.64 Preparation of Experimental Products at Licensed Establishments 14-Mar-12 800.83 Export of Serials Before Completion of Serial Release Testing 14-Nov-11 800.208 Special Labels for Product for Export 21-Oct-10 800.207 General Licensing Considerations: Target Animal Safety (TAS) Studies Prior to Product Licensure – VICH Guideline 44 6-Jul-10 800.113 Production, Testing and Storage of Master Seed and Master Cell Stocks at Alternate Locations 17-Sep-08 800.98 Advertising and Promotional Materials 25-Jul-08 800.56 Disposal of Unsatisfactory and Undesirable Materials 12-Mar-08 800.58 Sublicensing of Veterinary Biological Products 18-Oct-07 800.111 Viral Strain Changes in Equine Influenza and Swine Influenza Vaccines (Killed Virus) 19-Sep-07 800.203 General Licensing Considerations: Compatibility of Components 16-Jan-07 800.87 Guidelines for Licensing Establishments with Separated Premises 13-May-05 800.109 Master Seed and Master Cell Stock Testing Report Submission 26-May-04 800.205 General Licensing Considerations: Biotechnology-derived Veterinary Biologics Categories I, II, and III 28-May-03 800.108 Inventory and Disposition Records 15-Jan-03 800.107 Policy for Changing Cells and Cell Substrates of Licensed Vaccines 25-Nov-02 800.3 Stability Testing of New Biotechnological/Biological Veterinary Medicinal Products 26-Jul-01 800.301 Good Clinical Practices 26-Jul-01 800.62 Relabeling, Rebottling, and Reprocessing Veterinary Biological Products 22-Dec-99 800.86 Exemption from Mycoplasma Testing in Accordance with Title 9, Code of Federal Regulations, Part 113.200 (c) (3) 4-Nov-99 800.61 Split Manufacturing of Veterinary Biological Products 21-Oct-99 800.55 Concurrent and Confirmatory Tests of Market Serials 17-Feb-86
- 2Dropdown - FDA Center for Veterinary Medicine (Veterinary Regulatory Guidance Documents)
Animal Health Consultants Webpage – quick links
Hyperlinks contained on this page are associated with publicly accessible veterinary pharmaceutical and veterinary biologic documents. Documents may be subject to copyright of the FDA-CVM or USDA-CVB. Woods Consulting, LLC does not represent or warrant the accuracy of these documents.