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Veterinary Services Memoranda

Number Title Issue Date
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 Retired
800.69 Guidelines for Autogenous Biologics November 22, 2021
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 Superseded by VSM 800.50 --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 Inspection of U.S. Veterinary Biologics Licensed and Permitted Establishments December 8, 2020
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)
800.119 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)
800.124 Guidelines for Potency Specifications of Biological Products Administered to Animals (October 2, 2020)
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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