FDA Policies: Antimicrobial Drugs for Animals

Over the past several decades, FDA has implemented policies to help ensure that medically important antimicrobials approved for use in animals are used in a manner that is consistent with principles of antimicrobial stewardship. Through these initiatives, FDA strives to slow the development of antimicrobial resistance by optimizing therapeutic efficacy and minimizing selection of resistant microorganisms.

Defining Duration of Use For Certain Feed-use Antimicrobials

• 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

Transitioning Other Dosage Forms from Over-the-Counter to Prescription Marketing Status

• 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
• 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

Assessing Antimicrobial Resistance Risks as Part of Animal Drug Approval Process

• CVM GFI #152 - Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern
• Questions & Answers: Draft Revised GFI #152
• 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 (November 2020)

Eliminating Growth Promotion Use of Medically Important Antimicrobials and Bringing Feed or Water Products Under Veterinary Oversight

• 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 #209 - The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals
• List of Medically Important Antimicrobial Drugs Affected by GFI #213
• Letters to Sponsors of Affected Products
• Letter to Sponsors Regarding Implementation of GFI 213 (PDF - 197KB)
• Letter to Potential Distributors (Retailers) Regarding Implementation of GFI 213

Additional Documents of Interest

• Veterinary Feed Directive
• Extralabel Use and Antimicrobials
• FDA’s CVM Key Initiatives for Antimicrobial Stewardship
• Timeline of FDA actions on antimicrobial resistance