What Will Guidance 213 Mean To Producers For Antibiotic Use - Dr. Liz Wagstrom, Chief Veterinarian, National Pork Producers Council, from the 2015 Allen D. Leman Swine Conference, September 19-22, 2015, St. Paul, Minnesota, USA. More presentations at http://www.swinecast.com/2015-leman-swine-conference-material

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

2. FDA GUIDANCE #213
VFD RULE

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?