Dr. Liz Wagstrom - What Will Guidance 213 Mean To Producers For Antibiotic Use

Information about Dr. Liz Wagstrom - What Will Guidance 213 Mean To Producers For...

Published on February 11, 2016

Author: trufflemedia

Source: slideshare.net


1. Guidance 213 – what will it mean for producers? Liz Wagstrom, DVM, MS, DACVPM Chief Veterinarian, NPPC


3. FDA Guidance 213/VFD • Guidance #213 finalized in 2014, VFD final rule on June 2, 2015 • All manufacturers have agreed to comply • Growth Promotion and Nutritional Efficiency Labels will be removed by Dec. 2016 – “Medically Important” • Disease Prevention, Control and Treatment will be VFD in feed, Rx in water

4. FDA medically important • All swine antibiotics will be affected under Guidance 209 except – Bacitracin* – Carbadox – Bambermycin – Ionophores – Tiamulin* *Considered medically important by WHO list These antibiotics will remain available for growth promotion and/or over-the-counter (OTC) in feed and water

5. Industry Efforts - #213/VFD • VFD negotiations with FDA – Barnyard meetings – Veterinarians and producers – Producers to listening sessions – Goal – make the VFD process more workable • Education and outreach to producers and veterinarians – Avoiding out of feed situations – Avoiding enforcement actions

6. VFD Final Rule Previous Rule • 2 year record retention • Original document to mill • No extra-label use • Order for tons of feed • No refills, unless on label • Written for one group of animals on a premise • VCPR required Revised Rule • 2 year record retention • May email or fax document • No extra-label use • Order for number of days • No refills, unless on label, – Standing order? • Attached list of premises – For each mill • State VCPR* required • Max of 6 mo. expiration

7. Producer Impacts • On Farm Feed Manufacturing – Will not need to register as a distributor unless producing feed for commerce – Will need VFD to buy medicated premix (Type B) – Will not be able to have medicated feed in bin after expiration of the VFD

8. Producer Impacts • Likely most impactful to small producers or those without a veterinarian • Floor stock – will be legal but will it be available • Feed mill interpretation of rule – Standing orders will be an issue – Multiple groups during 6 months – Pulse dosing of same group

9. Guidance 213/VFD Summary • Most changes won’t be felt on farm until manufacturers change labels • Current VFD products now under the new rule • Label changes for others are required by Dec, 2016 • Uncertain how many products will change labels versus stop marketing

10. Next steps • The FDA acknowledges the important role medically important antimicrobials play in treating, controlling, and preventing disease in food producing animals

11. • Agency has been actively engaging stakeholders to express our position that medically important antibiotics labeled for continuous or undefined durations of use is not consistent with judicious use principles • In the case of disease prevention, the FDA believes it is important such use is appropriately targeted to animals at risk for a specific disease and the use duration is limited and risk-based

12. Disease Prevention

13. Disease Prevention • NPB, NPPC, AASV Task Force – Identified as major area to protect – Identifying which products are at risk – AASV – defining when prevention uses appropriate (AABP and AAAP) • Working with FDA to reinforce that prevention is appropriate and necessary to protect animal health • USDA ARS research on production practices

14. Conclusion • Implementation of the rule will require a collaborative effort – Veterinarians, producers, feed manufacturers, sponsor companies and FDA • Compliance guidance written by FDA will further clarify specific issues • January 2017 should be really interesting!

15. Discussion?

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