By David Fairfield, Senior Vice President, Feed
The U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine on Aug. 29 published a summary assessment of the agency’s inspection activities conducted from Oct. 1, 2015 through Sept. 30, 2018 related to its Veterinary Feed Directive (VFD) regulations, which are intended to provide for the judicious use of antimicrobial drugs in food-animal production practices.
The assessment provides results of inspections carried out by FDA’s Office of Regulatory Affairs and participating state feed regulatory programs, and highlights that the agency’s inspectional approach is designed to encompass all entities involved in the manufacture, distribution and use of VFD feed – animal producers, veterinarians, feed mills, and retail distributors.
The assessment states that inspections during the Oct. 1, 2015 through Sept. 30, 2017 time period primarily focused on providing education as part of FDA’s phased-in compliance strategy. Beginning on Oct. 1, 2018, the assessment indicates that FDA transitioned toward an inspectional approach focused on compliance with the VFD requirements and documenting violations when found. The following tables from the assessment summarize major inspectional activities and findings.
Other information included within FDA’s assessment provides additional compliance results for each type of firm inspected. The following are some of the key findings from fiscal year 2018 inspections of VFD feed manufacturers and distributors:
- 94. 8 percent of distributors inspected had notified FDA of their intent to distribute VFD feeds.
- 91.5 percent of distributors inspected distributed a VFD feed in compliance with the terms of the VFD.
- 96.7 percent of distributors who manufacture VFD feed maintained drug inventory or production records to demonstrate the correct amount of drug was added to the VFD feed.
- 91 percent of distributors who manufacture VFD feed had labels and formulas that corresponded to the VFD order reviewed during the inspection.
- 77.2 percent of distributors inspected had VFD feed labels that contained the required VFD caution statement.
FDA concludes within the assessment that affected parties (e.g., producers, veterinarians, feed mills and retail distributors) generally are in compliance with the VFD final rule, but that FDA plans to increase the number of inspections in the coming years as resources allow to ensure compliance.