Judicious Use of Antimicrobials
Judicious use of therapeutic antimicrobials is an integral part of good veterinary practice. It is an approach to maximize therapeutic efficacy and minimize selection of resistant microorganisms.
Communications
- February 15, 2022 - FDA Requests Public Comments on the Use of Antimicrobials in Companion Animals
- January 21, 2022 - FDA Announces Two Veterinary Antimicrobial Stewardship Funding Opportunities for FY 2022
- January 10, 2021 - FDA Finalizes Guidance to Bring Remaining Approved Over-The-Counter Medically Important Antimicrobial Drugs Used for Animals Under Veterinary Oversight
- January 8, 2021 - FDA Seeks Public Comment on Potential Approach for Defining Durations of Use for Certain Medically Important Antimicrobial Drugs for Food Animals
- October 9, 2020 - FDA Holds Virtual Public Meeting to Discuss Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial Animal Drugs
- January 30, 2020 - FDA Announces 2020 Funding Opportunity to Help Define Durations of Use for Certain Medically Important Antimicrobial Drugs for Food Animals
- September 23, 2019 - FDA Releases Draft Guidance on Bringing Remaining Approved Over-The-Counter Medically Important Antimicrobial Drugs Used for Animals Under Veterinary Oversight
- August 29, 2019 FDA Publishes Assessment of Compliance with Veterinary Feed Directive Final Rule
- April 1, 2019 FDA Announces Funding Opportunity to Help Define Durations of Use for Certain Medically Important Antimicrobial Drugs for Food Animals
- March 27, 2019 FDA Issues Revised Question & Answer Draft Guidance on Veterinary Feed Directive Regulation
- September 14, 2018 FDA Releases Five-Year Plan for Supporting Antimicrobial Stewardship in Veterinary Settings
- December 20, 2017 FDA Clarifies Approved Free-Choice Feeding Options for Anaplasmosis Control in Cattle
- December 18, 2017 FDA Provides Information on the Use of Medically Important Antimicrobials in Bees
- January 03, 2017 FDA Announces Implementation of GFI #213, Outlines Continuing Efforts to Address Antimicrobial Resistance
- December 23, 2016 Update on Implementation of FDA’s Guidance for Industry #213
- November 28, 2016 FDA Seeks Public Input on Next Steps to Help Ensure Judicious Use of Antimicrobials in Animal Agriculture
- June 30, 2016 FDA Fifth Biannual Progress Report on Judicious Use of Antimicrobials in Food-producing Animals
- March 16, 2016 FDA Announces Grant Award Opportunity for Antimicrobial Use and Resistance Data Collection
- January 20, 2016 FDA Biannual Progress Report on Judicious Use of Antimicrobials in Food-producing Animals
- December 11, 2013 FDA's Strategy on Antimicrobial Resistance - Questions and Answers
- Notice of Availability of Guidance for Industry #213: Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals
Documents
- 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 #209 - The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals
- 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 #152 - Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern
- Final Rule: Veterinary Feed Directive
Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine
- Concept Paper: Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs
- FDA Public Meeting on Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial Animal Drugs
Implementing Guidance for Industry #213
- FDA’s CVM Key Initiatives for Antimicrobial Stewardship
- List of Medically Important Antimicrobial Drugs Affected by GFI #213
- Letters to Sponsors of Affected Products
- Drugs with Veterinary Feed Directive (VFD) Marketing Status
- Drugs Transitioning from Over-the-Counter (OTC) to Prescription (Rx) Status
- Drugs Transitioning from Over-the-Counter (OTC) to Veterinary Feed Directive (VFD) Status
- Letter to Sponsors Regarding Implementation of GFI 213 (PDF - 197KB)
- Letter to Potential Distributors (Retailers) Regarding Implementation of GFI 213
- Using Medically Important Antimicrobials in Bees - Questions and Answers
- Questions and Answers: FDA Approved Free-Choice Feeding Options for Anaplasmosis Control in Cattle
Defining Duration of Use
- List of Approved Medically Important Antimicrobial Drugs Administered in the Feed of Food-Producing Animals that Lack a Defined Duration of Use
- Potential Approach for Defining Durations of Use for Medically Important Antimicrobial Drugs Intended for Use In or On Feed: A Concept Paper
Over-the-Counter to Prescription Marketing Status
- List of Approved Medically Important Antimicrobial Drugs Transitioning from Over-the-Counter to Prescription Marketing Status
- GFI #263: Frequently Asked Questions for Farmers and Ranchers
Additional Resources