Iowa Cattleman January 2016 : Page 21

VET’S VIEW Grant Dewell , Iowa State University VFD Countdown ne year from now we will be operating under the full imple-mentation of the Veterinary Feed Directive (VFD) rule. I plan on writing an informational article every 2-3 months over the next year to help you prepare for the full implementation of this rule. Over the next few articles I will help you see how the VFD will affect you and what you will want to do to comply, however this article will lay the foundation of how we got to where we are today. The first thing to recognize is that the VFD rule is just the vehicle that the FDA is using to implement policy. The main goal for the FDA is to decrease the threat of antimicrobial resistance in human health. Since 1999 the FDA has been under fire from consumer activists, pro-fessional organizations, and lawmakers to limit usage of antibiotics in livestock feed (especially non-therapeutic). In 2012 the FDA released Guidance #209, The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals. This document highlights the two principals that the FDA is implementing and restricts those principals to Medically Important (human medicine). According to the FDA, medically important antibiotics are all antibi-otics except for ionophores, (Rumensin, Bovatec, Catalyst), bam-bermycins (Gainpro), bacitracin, and tiamulin (Denegard for swine). The two principals in Guidance 209 were that medically important antibiotics should be limited to uses necessary for animal health and that medically important antibiotics require veterinary oversight. However, Guidance 209 did not specify how the many antibiotics for use in feed and water available Over the Counter (OTC) would be han-dled. In December of 2013 the FDA published Guidance 213 which provided recommendations for drug sponsors for voluntarily aligning product use conditions with GFI 209. This document provided a framework for how drug companies could voluntarily revise their label to remove growth promotion from the label and stipulate need for vet-erinary oversight either as a prescription or a VFD by the end of December 2016. Water medications will now require a veterinary pre-scription (Rx) just like Baytril and Draxin do and medically important feed antibiotics will require a VFD beginning January 1, 2017. Note that according to federal regulations it does not matter if you have a stockpile of these products on hand in 2017 you cannot legally use them without a VFD or Rx. The last step was to revise the VFD. The VFD has been around since 1996 but only one antibiotic has ever been approved for use in cattle. Pulmotil was approved for cattle in 2012 but has seen very lim-ited use because the VFD regulations were prohibitive to easy use. Therefore in June 2015 the FDA published a revised VFD rule to streamline the VFD process and make the process more user friendly. In future columns I will provide more information on how VFDs will be handled starting in January 2017. O www.iacattlemen.org 21

Vet’s View

Grant Dewell

VFD Countdown

One year from now we will be operating under the full implementation of the Veterinary Feed Directive (VFD) rule. I plan on writing an informational article every 2-3 months over the next year to help you prepare for the full implementation of this rule. Over the next few articles I will help you see how the VFD will affect you and what you will want to do to comply, however this article will lay the foundation of how we got to where we are today.

The first thing to recognize is that the VFD rule is just the vehicle that the FDA is using to implement policy. The main goal for the FDA is to decrease the threat of antimicrobial resistance in human health. Since 1999 the FDA has been under fire from consumer activists, professional organizations, and lawmakers to limit usage of antibiotics in livestock feed (especially non-therapeutic). In 2012 the FDA released Guidance #209, The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals. This document highlights the two principals that the FDA is implementing and restricts those principals to Medically Important (human medicine). According to the FDA, medically important antibiotics are all antibiotics except for ionophores, (Rumensin, Bovatec, Catalyst), bambermycins (Gainpro), bacitracin, and tiamulin (Denegard for swine).

The two principals in Guidance 209 were that medically important antibiotics should be limited to uses necessary for animal health and that medically important antibiotics require veterinary oversight. However, Guidance 209 did not specify how the many antibiotics for use in feed and water available Over the Counter (OTC) would be handled.

In December of 2013 the FDA published Guidance 213 which provided recommendations for drug sponsors for voluntarily aligning product use conditions with GFI 209. This document provided a framework for how drug companies could voluntarily revise their label to remove growth promotion from the label and stipulate need for veterinary oversight either as a prescription or a VFD by the end of December 2016. Water medications will now require a veterinary prescription (Rx) just like Baytril and Draxin do and medically important feed antibiotics will require a VFD beginning January 1, 2017. Note that according to federal regulations it does not matter if you have a stockpile of these products on hand in 2017 you cannot legally use them without a VFD or Rx.

The last step was to revise the VFD. The VFD has been around since 1996 but only one antibiotic has ever been approved for use in cattle. Pulmotil was approved for cattle in 2012 but has seen very limited use because the VFD regulations were prohibitive to easy use. Therefore in June 2015 the FDA published a revised VFD rule to streamline the VFD process and make the process more user friendly. In future columns I will provide more information on how VFDs will be handled starting in January 2017.

Read the full article at http://digitalmag.iacattlemen.org/article/Vet%E2%80%99s+View/2359454/286410/article.html.

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