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Veterinary Services Memoranda

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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

December

9, 2021

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
Number Title Issue Date

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 November

25, 2022

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

July 14,

2022

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
Number Title Issue Date

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
Number Title Issue Date

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

February

16, 2022

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
Number Title Issue Date

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

800.127 Guidelines for Conducting Product Stability Studies March 29,

2022

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
Number Title Issue Date

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

Guidance for Master Reference Qualification, Requalification,

Dating, and Monitoring

February 8,

2023

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, NonReplicating, Nonviable ProductsMarch 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

(See CVB Notice 01-11 for additional guidance regarding

application of this VS Memo)

July 26,

2001