Monday, February 20, 2017

Medicated Feed

As of January 1, 2017, animal producers will not be able to purchase feeds over the counter that contain antimicrobials deemed important for human health. Instead, to buy and use feeds containing those antimicrobials, animal producers must be authorized by a licensed veterinarian who is operating under the Food and Drug Administration’s revised Veterinary Feed Directive, or VFD, rule. The VFD rule has been in effect for 20 years, but it affected only a small number of producers and just a few antimicrobials. As of January 1, changes to the rule will mean that it will impact most animal producers and apply to many more antimicrobials. The antimicrobials that will be covered by the VFD rule are considered “medically important,” because they are important for human health. A list of medically important antimicrobials is in Appendix A of FDA’s Guidance for Industry #152: http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052519.pdf. And, information on drugs transitioning from over-the-counter status to VFD status is available here: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm482107.htm.) Also, after January 1, animal drug sponsors will have removed the claims of “growth promotion” and “feed efficiency” from the labels of medically important antimicrobials. Animal drug sponsors, in cooperation with CVM, are currently changing the labels for their products so that production claims such as “growth promotion” or “feed efficiency” will be gone from labels, thus those uses will no longer be permitted. These changes will have a significant effect on the animal production industry. We believe that you, in your role as a County Agricultural Agent, can help animal producers learn about the changes and how to comply. Animal producers must have a VFD order – issued by a licensed veterinarian, operating under a veterinarian-client-patient relationship – to use a feed with a medically important antimicrobial. (To find out more about veterinary-client-patient relationships, see Guidance for Industry #120, which you can get to from the VFD page listed below.) The feed distributor that the producer works with must receive the order before releasing the VFD feed to the animal producer. The veterinarian can, for example, give the producer a second copy of the order (one for the producer to keep, and one for the producer to give to the feed distributor), or the veterinarian could send the order directly to the feed distributor. The animal producer must use VFD feeds only in accordance with the VFD order. In other words, the producer can feed only those animals identified by the order, and only during the time period specified in the order. Feeding animals other than those specified in the VFD order or feeding them beyond the expiration date of the VFD order is considered an “extra-label” use of feed. That’s an illegal use. Once the order expires, if continued treatment is required, the animal producer must get a new VFD order from the veterinarian. We understand that there are some questions concerning the use of antimicrobials in feed for show animals, including animals used in FFA and 4-H shows. If you or the animal producers you work with have specific questions about the VFD rule and show animals, please send those questions to this e-mail address: AskCVM@fda.hhs.gov. Your questions will be promptly answered. The changes in the VFD rule will help FDA address the issue of antimicrobial resistance. In principle, giving antimicrobial drugs to food-producing animals at low levels for long periods of time and giving the antimicrobial drugs to large numbers of animals may contribute to the development of antibiotic resistance, which makes diseases caused by resistant bacteria more difficult to treat. Finding antimicrobials to treat a disease is far more difficult when the disease is caused by resistant bacteria. A veterinarian’s involvement is important because veterinarians have the medical training necessary to diagnose the disease and to identify the appropriate antimicrobial for the specific situation. The veterinarian’s involvement will help to ensure judicious use of antimicrobials. Here’s how you can find out more about the VFD rule. More information, including brochures in both English and Spanish for producers, veterinarians, retailers, and distributors, is available on FDA’s VFD page: http://www.fda.gov/animalveterinary/developmentapprovalprocess/ucm071807.htm. (Information about the reasons for the change is in Food and Drug Administration Guidance for Industry #213, which you can find here http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM299624.pdf.) Should you have additional questions, please contact AskCVM@fda.hhs.gov. And, for other information about safe feed, please come to www.FDA.Gov/SafeFeed, a site maintained by CVM’s Animal Feed Safety System Team. Sincerely, The FDA CVM Animal Feed Safety System Team

No comments:

Post a Comment