Animal and Plant Health Inspection Service
Veterinary Services Memoranda
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| Number | Title (PDF format) |
| 800.50 | Basic License Requirements and Guidelines for Submission of Materials in Support of Licensure (April 2, 2018) |
| 800.51 | Additives in Administered Animal Biological Products (August 17, 2018) |
| 800.52 | Export Certificates and Certificates of Licensing and Inspection for Animal Biological Products (June 27, 2018) |
| 800.53 | Serial Release of Licensed Biological Products (July 15, 2020) |
| 800.54 | Guidelines for the Preparation and Review of Labeling Materials (September 17, 2018) |
| 800.55 | Concurrent and Confirmatory Tests of Market Serials (February 17, 1986) |
| 800.56 | Disposal of Unsatisfactory and Undesirable Materials (March 12, 2008) |
| 800.57 | Market Suspensions and Post Marketing Temperature Deviations (June 11, 2018) |
| 800.58 | Sublicensing of Veterinary Biological Products (October 18, 2007) |
| 800.59 | Veterinary Biological Product Samples (July 20, 2016) |
| 800.60 | Biological Products Returned to Licensed or Permitted Establishments (March 11, 2008) |
| 800.61 | Split Manufacturing of Veterinary Biological Products (October 21, 1999) |
| 800.62 | Relabeling, Rebottling, and Reprocessing Veterinary Biological Products (December 22, 1999) |
| 800.63 | Personnel at Licensed Establishments (December 19, 2016) |
| 800.64 | Preparation of Experimental Products at Licensed Establishments (March 14, 2012) |
| 800.65 | Eggs and Chickens for Production of Veterinary Biological Products (May 03, 2016) |
| 800.66 | Freedom of Information Act Requests Involving Veterinary Biological Products (October 21, 1999) |
| 800.67 | Shipment of Experimental Veterinary Biological Products (October 10, 2018) |
| 800.68 | New Biotechnology for Preparation of Animal Biological Products (December 4, 1984) |
| 800.69 | Guidelines for Autogenous Biologics (September 28, 2016) |
| 800.70 | Rabies Vaccine Immunogenicity Test Protocols (April 27, 2000) |
| 800.73 | Diagnostic Test Kit Validation *title change (September 24, 2019) |
| 800.74 | Preparation and Distribution of Sterile Diluents (November 4, 1999) |
| 800.75 | Reissuance of Product Licenses for Products Under Conditional Licenses (October 27, 1999) |
| 800.77 | Unsatisfactory Product Stability (July 14, 1986) |
| 800.78 | Preparation and Submission of Facilities Documents (September 24, 2019) |
| 800.79 | Submission of Host Animal Serum Samples for In Vitro Potency Tests (March 20, 2013) |
| 800.81 | Chicken Bursa Origin Bursal Disease Vaccines (March 30, 2001) |
| 800.83 | Export of Serials Before Completion of Serial Release Testing (November 14, 2011) |
| 800.84 | Canceled. Superseded by VSM 800.50 |
| 800.85 | Avian Influenza Vaccines (July 13, 2020) |
| 800.86 | Exemption from Mycoplasma Testing in Accordance with Title 9, Code of Federal Regulations, Part 113.200 (c) (3) (November 4, 1999) |
| 800.87 | Guidelines for Licensing Establishments with Separated Premises (May 13, 2005) |
| 800.88 | Testing for Reticuloendotheliosis Virus Contamination (August 23, 1999) |
| 800.89 | Chicken Anemia Virus (December 22, 1999) |
| 800.90 | Retired. Incorporated into VSM 800.112 |
| 800.91 | Categories of Inspection for Licensed Veterinary Biologics Establishments (June 28, 2016) |
| 800.92 | Retired. Incorporated into VSM 800.206 and 800.53 |
| 800.94 | Food and Drug Administration's Export Reform and Enhancement Act of 1996 (May 10, 2011) |
| 800.95 | GB Texas Newcastle Disease Challenge Virus (September 2, 2015) |
| 800.97 | Standard Reference Preparations, Test Reagents, and Seed Cultures for Laboratory Test Reagents (June 12, 2014) |
| 800.98 | Advertising and Promotional Materials (July 25, 2008) |
| 800.99 | Guidelines for Using In Vitro Relative Potency Tests to Determine the Antigen Content of Inactivated Bovine Rhinotracheitis Vaccine (April 26, 2001) |
| 800.100 | Exemption from Using Heat or Ionizing Radiation to Treat Equine Plasma Used in Manufacturing Plasma Products for Oral or Parenteral Administration to Horses Under 9 CFR 113.450(e)(1) and Exemption from the Mouse Safety Test Under 9 CFR 113.450 (i) (July 29, 2002) |
| 800.101 | U.S. Veterinary Biological Product Permits for Distribution and Sale (November 1, 2016) |
| 800.102 | Exemption from Leptospira Bacterin Testing Under 9 CFR 113.101-104 and the Associated References and Studies (December 12, 2013) |
| 800.103 | Reissuance of Product Licenses for Autogenous Products and Guidance Concerning Restrictions on the Production and Use of Veterinary Biologics (July 18, 2018) |
| 800.104 | In Vitro Serial Release Potency Test for Completed Product Containing Clostridium chauvoei (December 13, 2018) |
| 800.106 | Exemption to Sterility Test Requirement for Allergenic Extract Prescription Product (December 9, 2002) |
| 800.107 | Policy for Changing Cells and Cell Substrates of Licensed Vaccines (November 25, 2002) |
| 800.108 | Inventory and Disposition Records (January 15, 2003) |
| 800.109 | Master Seed and Master Cell Stock Testing Report Submission (May 26, 2004) |
| 800.110 | 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 (June 30, 2017) |
| 800.111 | Viral Strain Changes in Equine Influenza and Swine Influenza Vaccines (Killed Virus) (September 19, 2007) |
| 800.112 | Guidelines for Validation of In Vitro Potency Assays (April 10, 2015) |
| 800.113 | Production, Testing and Storage of Master Seed and Master Cell Stocks at Alternate Locations (September 17, 2008) |
| 800.114 | Alternative Test Procedure for Tuberculin, PPD Bovis, Intradermic (April 13, 2012) |
| 800.115 | Potency and Safety Testing by Unlicensed Facilities (April 11, 2019) |
| 800.116 | Target Animal Safety Testing Exemption (August 14, 2017) |
| 800.117 | Guidance for Inactivation Studies (August 12, 2013) |
| 800.118 | Live Master References (December 12, 2013) |
| 800.119 | Exemptions to title 9, Code of Federal Regulations (9 CFR), Part 113.28, Detection of Mycoplasma Contamination (March 19, 2014) |
| 800.120 | Dilution of Preservative Screening for Sterility Testing of Veterinary Biologics (June 27, 2014) |
| 800.121 | Autologous Therapeutic Biologics (June 21, 2017) |
| 800.122 | Electronic Recordkeeping and Compliance with 9 CFR Part 116 (November 3, 2017) |
| 800.123 | Coccidiosis Vaccines (November 8, 2018) |
| 800.125 | Preparation and Submission of Adverse Event Reports for Biological Products by Licensees and Permittees (August 17, 2020) |
| 800.126 | Efficacy and Safety Studies for Cancer Immunotherapeutics (September 2, 2020) |
| 800.200 | General Licensing Considerations: Study Practices and Documentation (June 12, 2014) |
| 800.201 | General Licensing Considerations: Backpassage Studies (January 25, 2018) |
| 800.202 | General Licensing Considerations: Efficacy Studies (October 26, 2016) |
| 800.203 | General Licensing Considerations: Compatibility of Components (January 16, 2007) |
| 800.204 | General Licensing Considerations: Field Safety Studies (January 25, 2018) |
| 800.205 | General Licensing Considerations: Biotechnology-derived Veterinary Biologics Categories I, II, and III (May 28, 2003) |
| 800.206 | General Licensing Considerations: Preparing Outlines of Production for Vaccines, Bacterins, Antigens, and Toxoids and Diagnostic Test Kits (November 13, 2018) |
| 800.207 | General Licensing Considerations: Target Animal Safety (TAS) Studies Prior to Product Licensure - VICH Guideline 44 (July 6, 2010) |
| 800.208 | Special Labels for Product for Export (October 21, 2010) |
| 800.209 | Bovine Corona Virus and Rotavirus Master Reference Qualification by Colostral Antibody Titers (December 8, 2010) |
| 800.210 | Manufacturing Deviations Identified Prior to Marketing Release (May 31, 2018) |
| 800.211 | Guidelines for Master Reference Qualification and Requalification (June 28, 2011) |
| 800.212 | Licensing Considerations: Vaccine Claims for Protection of the Fetus Against Bovine Virus Diarrhea Virus (November 14, 2011) |
| 800.213 | Licensing Guidelines for Production Platform-Based, Non-Replicating, Nonviable Products (March 12, 2018) |
| 800.214 | Prescription Platform Product Biologics (March 12, 2018) |
| 800.215 | Guidelines Regarding the Revision to Animal and Plant Health Inspection Service (APHIS) Implementing Procedures for the National Environmental Policy Act (NEPA) (January 31, 2019) |
| 800.300 | Stability Testing of New Biotechnological/Biological Veterinary Medicinal Products (July 26, 2001) |
| 800.301 | Good Clinical Practices (July 26, 2001) (See CVB Notice 01-11 for additional guidance regarding application of this VS Memo.) |
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