FDA In Brief: FDA issues guidance to help animal drug manufacturers meet antimicrobial sales data reporting requirements

June 28, 2018

Media Inquiries

“The FDA is committed to working with federal, academic and industry partners to obtain more information about how, when and why animal producers and veterinarians use medically important antimicrobial drugs, and how this use can contribute to antimicrobial resistance,” said Steve Solomon, D.V.M., director of FDA’s Center for Veterinary Medicine. “The guidance released today will help ensure that animal drug sponsors not only understand their responsibilities and can comply with the reporting requirements for the antimicrobial drugs they market for use in livestock, but it also represents an important step in the FDA’s efforts to obtain accurate information about the volume of antimicrobial drugs that enter the marketplace for use in food-producing animals. Sales and distribution information are one piece of the overall picture related to antimicrobial resistance that can help to better our understanding of this critical public health issue.”

Today, the U.S. Food and Drug Administration is releasing Guidance for Industry #252, “Antimicrobial Animal Drug Sales and Distribution Reporting Small Entity Compliance Guide.” The guidance follows publication of the May 2016 Antimicrobial Animal Drug Sales and Distribution final rule, which, among other things, revised the annual reporting requirements for drug sponsors of all antimicrobials sold or distributed for use in food-producing animals in order to obtain estimates of sales broken out by major food-producing species (i.e., cattle, swine, chickens, turkeys). The guidance is intended to help small businesses comply with reporting requirements for antimicrobial drug products sold or distributed for use in food-producing animals.

Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105) requires antimicrobial animal drug sponsors to annually report to the FDA the amount of all antimicrobial drugs they sell and distribute for use in food-producing animals, including those medically important antimicrobials that are used in human and veterinary medicine. For more information, please see the annual ADUFA reports.

Antimicrobial resistance is recognized as a growing global threat, and antimicrobial use in animals can contribute to the emergence of antimicrobial resistance in bacteria that may be transferred to humans, thereby reducing the effectiveness of antimicrobial drugs for treating human disease. The FDA is committed to limiting resistance arising from the use of antibiotics in food-producing animals, while continuing to ensure the availability of safe and effective antibiotics for use in animals and humans. Compliance with the reporting requirements for the sale and distribution of antimicrobials in food-producing animals is important to our overall efforts to understand and combat antimicrobial resistance.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.