FDA Will Require Veterinary Oversight for All Animal Antibiotics Important to Human Medicine

Editor’s Note: This analysis was updated on July 14, 2021 to more accurately reflect the companies affected by the revised FDA guidance.

The U.S. Food and Drug Administration’s Center for Veterinary Medicine on June 10 finalized guidelines for the agribusiness that put all medically important antibiotics used in food-producing animals under veterinary supervision. Known as Guidance for Industry # 263 (GFI # 263), the new guideline closes an important loophole that allows manufacturers to purchase over-the-counter antibiotics without a prescription and encourages more prudent use of these drugs.

Previously, the FDA only required veterinary oversight for antibiotics used in feed and water; GFI # 263 extends this requirement to drugs that are administered by other routes such as injection. By requiring veterinary oversight of all medically important antibiotics, the agency is taking a critical step to strengthen antibiotic stewardship and protect public health from the growing threat of antibiotic resistance.

The strong public support for the new directive, which will be fully implemented in June 2023, shows the continued interest in the FDA’s efforts to combat the emergence of super bacteria. When the draft version of GFI # 263 was released in 2019, the agency received more than 5,000 positive comments from people urging the requirement to be completed and implemented quickly. As antibiotics become less effective the more frequently, public support for expanded veterinary oversight helps ensure that these life-saving drugs are used wisely in any setting.

With the completion of GFI # 263, the FDA has achieved a key goal in its five-year plan to promote antibiotic stewardship in veterinary facilities. Other elements of the plan still need to be implemented, including steps to address the urgent need to set firm, evidence-based deadlines for all medically important antibiotics and to improve data collection on antibiotic use and resistance. Such measures would be an important step in promoting the more prudent use of antibiotics in animal husbandry.

David Hyun, MD, is the director and Helene Sherburne is a contributor to The Pew Charitable Trusts’ antibiotic resistance project.