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What FDA guidance 213 and the veterinary feed directive mean on the farm
Introduction: The FDA has published final Guidance for Industry #213 and a proposed Veterinary Feed Directive (VFD) rule. Guidance for Industry #213 asks sponsors to relinquish their claims for production uses (growth promotion or improvement of nutritional efficiency) for antimicrobials in classes that are used in human medicine. The VFD Rule will require all therapeutic uses of these same antimicrobials in feed or water to be under a veterinary order or prescription
Background: Farmers in the United States are allowed to utilize a range of antimicrobials to improve growth or nutritional efficiency without veterinary oversight. Some of these antimicrobials are also in classes used in human medicine. The fluoroquinolone and cephalosporin classes have never been used for production purposes in the U.S.
Certain feed antimicrobials have required a VFD. The current regulations require that the veterinarian state not only the indication and dose, but also an amount of feed that will be consumed during treatment. These requirements have been problematic.
Antimicrobials administered in feed can only be used as labeled. Since administering an antimicrobial for a different indication is considered extra-label, after the production claims are discontinued it will be illegal to use these antibiotics to promote growth.
Impact on the farm: The implementation of Guidance 213 and the revised VFD rule will change how antimicrobials are used in food animal production. Simplistically, many feel that the success of these changes should be measured by a decrease in pounds of antimicrobials sold. However, it is uncertain how much clinical disease is being prevented by the current uses of antimicrobials that will require treatment following the removal of growth promotion antibiotics.
The requirement for the therapeutic uses of antimicrobials in feed and water to be under veterinary oversight will also impact farmers of all sizes. It is expected that the revisions to the VFD rule will make the process more user friendly. However, it is expected these changes will impose a burden on farmers and veterinarians. Since there are relatively few veterinarians practicing food animal medicine in the U.S. the burden to provide and document the veterinary orders may be substantial.
Conclusion: The FDA Guidance for Industry #213 and the changes to the VFD rule will have substantial impact on antimicrobial use decisions on farm and add to the burden to document judicious use of therapeutic antimicrobials by producers who utilize them on their farms.
Keywords: FDA, antimicrobial use, veterinary feed directive