Animal Antimicrobial Marketing Data Rule Finalized by FDA

A rule revising reporting requirements for antimicrobial producers who sell products intended to be used in food animals has been finalized by the Food and Drug Administration (FDA) and published in the Federal Register.

The rule requires a breakdown of sales of antimicrobial products by major species of food animal they are used on. The new change expands previous reporting requirements which did not include the by-species breakdown.

The data collected will be used in conjunction with other data collected by FDA on antimicrobials, as part of the National Strategy for Combating Antibiotic-Resistant Bacteria (CARB), a joint effort between FDA, USDA, and the Centers for Disease Control.

“This information will further enhance FDA’s ongoing activities related to slowing the development of antimicrobial resistance to help ensure that safe and effective antimicrobial new animal drugs will remain available for use in human and animal medicine,” said Dr. William Flynn, deputy director for science policy in the FDA’s Center for Veterinary Medicine.