Veterinary Product Regulations

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

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

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)

  1. 1
    Dropdown - 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
  2. 2
    Dropdown - FDA Center for Veterinary Medicine (Veterinary Regulatory Guidance Documents)
    CVM GFI #100 (VICH GL18 (R2)) Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision 2)
    CVM GFI #103 Possible Dioxin/PCB Contamination of Drug and Biological Products
    CVM GFI #104 Content and Format of Effectiveness and Target Animal Safety Technical Sections and Final Study Reports For Submission
    CVM GFI #105 Computerized Systems Used in Clinical Investigations
    CVM GFI #106 The Use of Published Literature in Support of New Animal Drug Approvals
    CVM GFI #108 Registering with CVM’s Electronic Submission System
    CVM GFI #109 (VICH GL15) Effectiveness of Anthelmintics: Specific Recommendations for Equines
    CVM GFI #110 (VICH GL16) Effectiveness of Anthelmintics: Specific Recommendations for Porcines
    CVM GFI #111 (VICH GL19) Effectiveness of Anthelmintics: Specific Recommendations for Canines
    CVM GFI #112 Fumonisin Levels in Human Foods and Animal Feeds; Final Guidance
    CVM GFI #113 (VICH GL20) Effectiveness of Anthelmintics: Specific Recommendations for Felines
    CVM GFI #114 (VICH GL21) Effectiveness of Anthelmintics: Specific Recommendations for Chickens Gallus gallus
    CVM GFI #115 (VICH GL22) Safety Studies for Veterinary Drug Residues in Human Food: Reproduction Toxicity Testing
    CVM GFI #116 (VICH GL23) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing
    CVM GFI #117 (VICH GL24) Management of Adverse Event Reports (AER’s)
    CVM GFI #118 Mass Spectrometry for Confirmation of Identity of Animal Drug Residues
    CVM GFI #119 How CVM Intends to Handle Deficient Submissions Filed During the Investigation of a New Animal Drug
    CVM GFI #120 Veterinary Feed Directive Regulation Questions and Answers
    CVM GFI #122 Manufacture and Labeling of Raw Meat Foods for Companion and Captive Noncompanion Carnivores and Omnivores
    CVM GFI #123 Development of Data Supporting Approval of NSAIDS for Use in Animals
    CVM GFI #126 BACPAC I-Intermediates in Drug Substance Synthesis Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation
    CVM GFI #13 Evaluation of Effectiveness of New Animal Drugs for Use in Free-Choice Feeds-Medicated Block
    CVM GFI #132 Administrative Applications and the Phased Review Process
    CVM GFI #135 Validation of Analytical Procedures for Type C Medicated Feeds
    CVM GFI #136 Protocols for the Conduct of Method Transfer Studies for Type C Medicated Feed Assay Methods
    CVM GFI #137 Analytical Methods Description for Type C Medicated Feeds
    CVM GFI #141 (VICH GL28) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Carcinogenicity Testing
    CVM GFI #142 (VICH GL29) Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSUs)
    CVM GFI #143 (VICH GL30) Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms
    CVM GFI #144 (VICH GL27) Pre-Approval Information for Registration of New Veterinary Medicinal Products for Food-Producing Animals with Respect to Antimicrobial Resistance
    CVM GFI #145 Bioanalytical Method Validation 
    CVM GFI #147 (VICH GL31) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (90 Day) Toxicity Testing
    CVM GFI #148 (VICH GL32) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Developmental Toxicity Testing
    CVM GFI #149 (VICH GL33) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Testing
    CVM GFI #150 Concerns Related to the use of Clove Oil as an Anesthetic for Fish
    CVM GFI #151 FDA Export Certificates
    CVM GFI #152 Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern
    CVM GFI #156 Comparability Protocols – Chemistry, Manufacturing, and Controls Information for New Animal Drugs
    CVM GFI #158 Use of Material from Deer and Elk in Animal Feed
    CVM GFI #159 (VICH GL36) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI
    CVM GFI #160 (VICH GL37) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (Chronic) Toxicity Testing
    CVM GFI #166 (VICH GL38) Environmental Impact Assessments (EIA’s) for Veterinary Medicinal Products (VMP’s) – Phase II
    CVM GFI #169 Drug Substance Chemistry, Manufacturing, and Controls Information
    CVM GFI #170 Animal Drug User Fees and Fee Waivers and Reductions
    CVM GFI #171 – Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Containing Active Pharmaceutical Ingredients Considered to Be Soluble in Aqueous Media
    CVM GFI #173 Animal Drug Sponsor Fees Under the Animal Drug User Fee Act (ADUFA)
    CVM GFI #173 Appendix for the Animal Drug Sponsor Fees Under ADUFA
    CVM GFI #176 (VICH GL39) Specifications: Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances
    CVM GFI #177 (VICH GL40) Test Procedures/Acceptance Criteria for New Biotechnological/Biological Veterinary Medicinal Products
    CVM GFI #178 Recommended Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims
    CVM GFI #179 Use of Animal Clones and Clone Progeny for Human Food and Animal Feed
    CVM GFI #181 Blue Bird Medicated Feed Labels
    CVM GFI #183 Animal Drug User Fees: Fees Exceed Costs Waiver/Reduction
    CVM GFI #185 (VICH GL43) Target Animal Safety for Veterinary Pharmaceutical Products
    CVM GFI #187 Regulation of Intentionally Altered Genomic DNA in Animals
    CVM GFI #188 Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine
    CVM GFI #191 Changes to Approved NADAs – New NADAs vs. Category II Supplemental NADAs
    CVM GFI #192 Anesthetics for Companion Animals
    CVM GFI #195 Small Entities Compliance Guide For Renderers—Substances Prohibited From Use In Animal Food Or Feed
    CVM GFI #196 Process Validation: General Principles and Practices
    CVM GFI #197 Documenting Electronic Data Files and Statistical Analysis Programs
    CVM GFI #198 (VICH GL45) Bracketing and Matrixing Designs For Stability Testing of New Veterinary Drug Substances and Medicinal Products
    CVM GFI #199 Animal Generic Drug User Fees and Fee Waivers and Reductions
    CVM GFI #200 – Small Entities Compliance Guide Designation of New Animal Drugs for Minor Uses or Minor Species
    CVM GFI #201 SECG for The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
    CVM GFI #203 Ensuring Safety of Animal Feed Maintained and Fed On-Farm
    CVM GFI #204 Active Controls in Studies to Demonstrate Effectiveness of a New Animal Drug for use in Companion Animals
    CVM GFI #205 (VICH GL46) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals:  Metabolism Study to Determine the Quantity and Identify the Nature of Residues (MRK)
    CVM GFI #206 (VICH GL47) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Comparative Metabolism Studies in Laboratory Animals
    CVM GFI #207 (VICH GL48) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs In Food-Producing Animals: Marker Residue Depletion Studies to Establish Product Withdrawal Periods
    CVM GFI #208 (VICH GL49) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Validation of Analytical Methods Used in Residue Depletion Studies
    CVM GFI #209 The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals
    CVM GFI #211 Residual Solvents in Animal Drug Products Questions and Answers
    CVM GFI #213 New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209
    CVM GFI #214 (VICH GL35) Pharmacovigilance of Veterinary Medicinal Products Electronic Standards for Transfer of Data
    CVM GFI #215 Target Animal Safety and Effectiveness Protocol Development and Submission
    CVM GFI #216 Chemistry, Manufacturing, and Controls (CMC) Information – Fermentation-Derived Intermediates, Drug Substances, and Related Drug Products for Veterinary Medicinal Use
    CVM GFI #217 Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals
    CVM GFI #218 Cell-Based Products for Animal Use
    CVM GFI #219 (VICH GL51) Statistical Evaluation of Stability Data
    CVM GFI #220 Use of Nanomaterials in Food for Animals
    CVM GFI #221 Recommendations for Preparation and Submission of Animal Food Additive Petitions
    CVM GFI #223 Small Entity Compliance Guide Declaring Color Additives in Animal Foods
    CVM GFI #224 (Supplement to VICH GL52) Supplemental Examples For Illustrating Statistical Concepts Described in the VICH In Vivo Bioequivalence Guidance GL52
    CVM GFI #224 (VICH GL52) Bioequivalence: Blood Level Bioequivalence Study
    CVM GFI #225 (VICH GL53) Electronic Exchange of Documents: File Format Recommendations
    CVM GFI #226 Target Animal Safety Data Presentation and Statistical Analysis
    CVM GFI #227 Two-Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections
    CVM GFI #229 Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing E. coli in Cattle
    CVM GFI #23 Medicated Free Choice Feeds–Manufacturing Control
    CVM GFI #231 Distributor Labeling for New Animal Drugs
    CVM GFI #232 (VICH GL54) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose (ARfD)
    CVM GFI #233 Veterinary Feed Directive Common Format Questions and Answers
    CVM GFI #234 Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section of Animal Drug Applications
    CVM GFI #235 Current Good Manufacturing Practice Requirements for Food for Animals
    CVM GFI #236 Clarification of FDA and EPA Jurisdiction Over Mosquito-Related Products
    CVM GFI #237 Oncology Drugs for Companion Animals
    CVM GFI #238 Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications
    CVM GFI #239 Human Food By-Products For Use As Animal Food
    CVM GFI #24 Drug Combinations for Use in Animals
    CVM GFI #240 Proprietary Names for New Animal Drugs
    CVM GFI #241 Small Entity Compliance Guide – What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 CFR Part 507)
    CVM GFI #242 In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products
    CVM GFI #243 (VICH GL56) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Study Design Recommendations for Residue Studies in Honey for Establishing Maximum Residue Limits and Withdrawal Periods
    CVM GFI #245 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
    CVM GFI #246 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program
    CVM GFI #252 Small Entity Compliance Guide Antimicrobial Animal Drug Sales and Distribution Reporting
    CVM GFI #253 Current Good Manufacturing Practice for Animal Cells, Tissues, and Cell- and Tissue-Based Products
    CVM GFI #254 Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products
    CVM GFI #255 Elemental Impurities in Animal Drug Products Questions and Answers
    CVM GFI #256 Compounding Animal Drugs from Bulk Drug Substances
    CVM GFI #257 (VICH GL57) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies to Establish Product Withdrawal Periods in Aquatic Species
    CVM GFI #258 Use of Tracers in Animal Food, Type A Medicated Articles, and Medicated Feeds
    CVM GFI #259 (VICH GL58) Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV
    CVM GFI #261 Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs
    CVM GFI #262 Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices
    CVM GFI #263 Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter
    CVM GFI #264 Standardized Medicated Feed Assay Limits
    CVM GFI #265 Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs
    CVM GFI #266 Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs
    CVM GFI #267 Biomarkers and Surrogate Endpoints in Clinical Studies to Support Effectiveness of New Animal Drugs
    CVM GFI #268 Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs
    CVM GFI #271 Reporting and Mitigating Animal Drug Shortages
    CVM GFI #272 Practices to Prevent Unsafe Contamination of Animal Feed from Drug Carryover
    CVM GFI #273 Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals
    CVM GFI #276 Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs
    CVM GFI #278 Human User Safety in New and Abbreviated New Animal Drug Applications
    CVM GFI #279 Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered to be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting
    CVM GFI #281 Infectious Otitis Externa Drugs for Topical Use in Dogs
    CVM GFI #282 Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals
    CVM GFI #284 Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food
    CVM GFI #3 General Principles for Evaluating the Human Food Safety of New Animal Drugs Used In Food-Producing Animals
    CVM GFI #35 Bioequivalence Guidance
    CVM GFI #37 Evaluation of Effectiveness of New Animal Drugs for Use in Poultry Feed for Pigmentation
    CVM GFI #38 Guideline for Effectiveness Evaluation of Topical/Otic Animal Drugs
    CVM GFI #45 Guideline for Uniform Labeling of Drugs for Dairy and Beef Cattle
    CVM GFI #49 Target Animal Safety And Drug Effectiveness Studies for Anti-Microbial Bovine Mastitis Products (Lactating and Non-Lactating Cow Products)
    CVM GFI #5 Drug Stability Guidelines
    CVM GFI #50 Target Animal and Human Food Safety, Drug Efficacy, Environmental and Manufacturing Studies for Teat Antiseptic Products
    CVM GFI #53 Evaluation of the Utility of Food Additives in Diet Fed to Aquatic Animals
    CVM GFI #55 Supportive Data for Cat Food Labels Bearing “Reduces Urinary pH Claims”: Protocol Development
    CVM GFI #56 Protocol Development Guideline for Clinical Effectiveness and Target Animal Safety Trials
    CVM GFI #57 Preparation and Submission of Veterinary Master Files
    CVM GFI #61 Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species
    CVM GFI #62 Consumer Directed Broadcast Advertisements
    CVM GFI #63 (VICH GL1) Validation of Analytical Procedures: Definition and Terminology
    CVM GFI #64 (VICH GL2) Validation of Analytical Procedures: Methodology: Final Guidance
    CVM GFI #65 Industry Supported Scientific and Educational Activities
    CVM GFI #67 Small Entities Compliance Guide for Renderers
    CVM GFI #68 Small Entities Compliance Guide for Protein Blenders, Feed Manufacturers, and Distributors
    CVM GFI #69 Small Entities Compliance Guide for Feeders of Ruminant Animals with On-Farm Feed Mixing Operations
    CVM GFI #70 Small Entities Compliance Guide for Feeders of Ruminant Animals Without On-Farm Feed Mixing Operations
    CVM GFI #72 GMP’S For Medicated Feed Manufacturers Not Required to Register and be Licensed with FDA
    CVM GFI #73 (VICH GL3(R)) Stability Testing of New Veterinary Drug Substances and Medicinal Products
    CVM GFI #74 (VICH GL4 ) Stability Testing of New Veterinary Dosage Forms
    CVM GFI #75 (VICH GL5) Stability Testing-Photostability Testing of New Veterinary Drug Substances and Medicinal Products
    CVM GFI #76 Questions and Answers BSE Feed Regulations
    CVM GFI #79 Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by CVM
    CVM GFI #80 Evaluation the Utility of Anti-Salmonella Chemical Food Additives
    CVM GFI #82 Development of Supplemental Applications for Approved New Animal Drugs
    CVM GFI #83 Chemistry, Manufacturing and Controls Changes to Approved NADA/ANADA
    CVM GFI #85 (VICH GL9) Good Clinical Practice
    CVM GFI #89 (VICH GL6) EIAs for Veterinary Medicinal Products – Phase I
    CVM GFI #90 (VICH GL7) Effectiveness of Anthelmintics: General Recommendations
    CVM GFI #91 (VICH GL8) Stability Testing for Medicated Premixes
    CVM GFI #92 (VICH GL10(R)) Impurities In New Veterinary Drug Substances
    CVM GFI #93 (VICH GL11(R)) Impurities in New Veterinary Medicinal Products
    CVM GFI #95 (VICH GL12) Effectiveness of Anthelmintics: Specific Recommendations for Bovines
    CVM GFI #96 (VICH GL13) Effectiveness of Anthelmintics: Specific Recommendations for Ovines
    CVM GFI #97 (VICH GL14) Effectiveness of Anthelmintics: Specific Recommendations for Caprines
    CVM GFI #98 Dioxin In Anti-Caking Agents In Animal Feed And Feed Ingredients
    CVM GFI #99 (VICH GL17) Testing of New Biotechnological/Biological Products
    FDA’s Strategy on Antimicrobial Resistance – Questions and Answers

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.