Veterinary Services Memoranda

Last Modified: May 03, 2024
NumberTitleIssue Date
800.50Basic License Requirements and Guidelines for Submission of Materials in Support of LicensureApril 2, 2018
800.51Additives in Administered Animal Biological ProductsAugust 17, 2018
800.52Export Certificates and Certificates of Licensing and Inspection for Animal Biological ProductsDecember 9, 2021
800.53Serial Release of Licensed Biological ProductsJuly 15, 2020
800.54Guidelines for the Preparation and Review of Labeling MaterialsSeptember 17, 2018
800.55Concurrent and Confirmatory Tests of Market SerialsFebruary 17, 1986
800.56Disposal of Unsatisfactory and Undesirable MaterialsMarch 12, 2008
800.57Market Suspensions and Post Marketing Temperature DeviationsJune 11, 2018
800.58Sublicensing of Veterinary Biological ProductsOctober 18, 2007
800.59Veterinary Biological Product SamplesJuly 20, 2016
800.60Biological Products Returned to Licensed or Permitted EstablishmentsMarch 11, 2008
800.61Split Manufacturing of Veterinary Biological ProductsOctober 21, 1999
800.62Relabeling, Rebottling, and Reprocessing Veterinary Biological ProductsDecember 22, 1999
800.63Personnel at Licensed EstablishmentsDecember 19, 2016
800.64Preparation of Experimental Products at Licensed EstablishmentsMarch 14, 2012
800.65Eggs and Chickens for Production of Veterinary Biological ProductsMay 03, 2016
800.66Freedom of Information Act Requests Involving Veterinary Biological ProductsOctober 21, 1999
800.67Shipment of Experimental Veterinary Biological ProductsNovember 25, 2022
800.69Guidelines for Autogenous BiologicsNovember 22, 2021
800.70Rabies Vaccine Immunogenicity Test ProtocolsApril 27, 2000
800.73Basic Licensing Requirements and Guidelines for Diagnostic ProductsMay 1, 2024
800.74Preparation and Distribution of Sterile DiluentsNovember 4, 1999
800.75Reissuance of Product Licenses for Products Under Conditional LicensesJuly 14, 2022
800.77Unsatisfactory Product StabilityJuly 14, 1986
800.78Preparation and Submission of Facilities DocumentsSeptember 24, 2019
800.79Submission of Host Animal Serum Samples for In Vitro Potency TestsMarch 20, 2013
800.81Chicken Bursa Origin Bursal Disease VaccinesMarch 30, 2001
800.83Export of Serials Before Completion of Serial Release TestingNovember 14, 2011
800.84Canceled. Superseded by VSM 800.50--
800.85Avian Influenza VaccinesJuly 13, 2020
800.86Exemption from Mycoplasma Testing in Accordance with Title 9, Code of Federal Regulations, Part 113.200 (c) (3)November 4, 1999
800.87Guidelines for Licensing Establishments with Separated PremisesMay 13, 2005
800.88Testing for Reticuloendotheliosis Virus ContaminationAugust 23, 1999
800.89Chicken Anemia VirusDecember 22, 1999
800.90Retired. Incorporated into VSM 800.112--
800.91Inspection of U.S. Veterinary Biologics Licensed and Permitted EstablishmentsDecember 8, 2020
800.92Retired. Incorporated into VSM 800.206 and 800.53--
800.94Food and Drug Administration's Export Reform and Enhancement Act of 1996May 10, 2011
800.95GB Texas Newcastle Disease Challenge VirusSeptember 2, 2015
800.97Standard Reference Preparations, Test Reagents, and Seed Cultures for Laboratory Test ReagentsJune 12, 2014
800.98Advertising and Promotional MaterialsJuly 25, 2008
800.99Guidelines for Using In Vitro Relative Potency Tests to Determine the Antigen Content of Inactivated Bovine Rhinotracheitis VaccineApril 26, 2001
800.100Exemption 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
800.101U.S. Veterinary Biological Product Permits for Distribution and SaleNovember 1, 2016
800.102Exemption from Leptospira Bacterin Testing Under 9 CFR 113.101-104 and the Associated References and StudiesDecember 12, 2013
800.103Reissuance of Product Licenses for Autogenous Products and Guidance Concerning Restrictions on the Production and Use of Veterinary BiologicsJuly 18, 2018
800.104In Vitro Serial Release Potency Test for Completed Product Containing Clostridium chauvoeiDecember 13, 2018
800.106Exemption to Sterility Test Requirement for Allergenic Extract Prescription ProductFebruary 16, 2022
800.107Policy for Changing Cells and Cell Substrates of Licensed VaccinesNovember 25, 2002
800.108Inventory and Disposition RecordsJanuary 15, 2003
800.109Master Seed and Master Cell Stock Testing Report SubmissionMay 26, 2004
800.110Label Warnings Concerning Bovine Rhinotracheitis Vaccine, Modified Live Virus, and Bovine Virus Diarrhea Vaccine, Modified Live Virus, for Pregnant Cows or Calves Nursing Pregnant CowsJune 30, 2017
800.111Viral Strain Changes in Equine Influenza and Swine Influenza Vaccines (Killed Virus)September 19, 2007
800.112Guidelines for Validation of In Vitro Potency AssaysApril 10, 2015
800.113Production, Testing and Storage of Master Seed and Master Cell Stocks at Alternate LocationsSeptember 17, 2008
800.114Alternative Test Procedure for Tuberculin, PPD Bovis, IntradermicApril 13, 2012
800.115Potency and Safety Testing by Unlicensed FacilitiesApril 11, 2019
800.116Target Animal Safety Testing ExemptionAugust 14, 2017
800.117Guidance for Inactivation StudiesAugust 12, 2013
800.119Exemptions to title 9, Code of Federal Regulations (9 CFR), Part 113.28, Detection of Mycoplasma ContaminationMarch 19, 2014
800.120Dilution of Preservative Screening for Sterility Testing of Veterinary BiologicsJune 27, 2014
800.121Autologous Therapeutic BiologicsJune 21, 2017
800.122Electronic Recordkeeping and Compliance with 9 CFR Part 116November 3, 2017
800.123Coccidiosis VaccinesNovember 8, 2018
800.124Guidelines for Potency Specifications of Biological Products Administered to AnimalsOctober 2, 2020
800.125Preparation and Submission of Adverse Event Reports for Biological Products by Licensees and PermitteesAugust 17, 2020
800.126Efficacy and Safety Studies for Cancer ImmunotherapeuticsSeptember 2, 2020
800.127Guidelines for Conducting Product Stability StudiesMarch 29, 2022
800.200General Licensing Considerations: Study Practices and DocumentationJune 12, 2014
800.201General Licensing Considerations: Backpassage StudiesJanuary 25, 2018
800.202General Licensing Considerations: Efficacy StudiesOctober 26, 2016
800.203General Licensing Considerations: Compatibility of ComponentsJanuary 16, 2007
800.204General Licensing Considerations: Field Safety StudiesJanuary 25, 2018
800.205General Licensing Considerations: Biotechnology-derived Veterinary Biologics Categories I, II, and IIIMay 28, 2003
800.206General Licensing Considerations: Preparing Outlines of Production for Vaccines, Bacterins, Antigens, and Toxoids and Diagnostic Test KitsNovember 13, 2018
800.207General Licensing Considerations: Target Animal Safety (TAS) Studies Prior to Product Licensure - VICH Guideline 44July 6, 2010
800.208Special Labels for Product for ExportOctober 21, 2010
800.209Bovine Corona Virus and Rotavirus Master Reference Qualification by Colostral Antibody TitersDecember 8, 2010
800.210Manufacturing Deviations Identified Prior to Marketing ReleaseMay 31, 2018
800.211Guidance for Master Reference Qualification, Requalification, Dating, and MonitoringFebruary 8, 2023
800.212Licensing Considerations: Vaccine Claims for Protection of the Fetus Against Bovine Virus Diarrhea VirusNovember 14, 2011
800.213Licensing Guidelines for Production Platform-Based, Non-Replicating, Nonviable ProductsMarch 12, 2018
800.214Prescription Platform Product BiologicsMarch 12, 2018
800.215Guidelines Regarding the Revision to Animal and Plant Health Inspection Service (APHIS) Implementing Procedures for the National Environmental Policy Act (NEPA)January 31, 2019
800.300Stability Testing of New Biotechnological/Biological Veterinary Medicinal ProductsJuly 26, 2001
800.301Good Clinical Practices
(See CVB Notice 01-11 for additional guidance regarding application of this VS Memo)
July 26, 2001