Changes on Antibiotic Usage - Preparing for Changes to Antibiotic Use - Dr. Sam Holst, Swine Vet Center, from the 2016 World Pork Expo, June 8 - 10, 2016, Des Moines, IA, USA. More presentations at http://www.swinecast.com/2016-world-pork-expo

1. Preparing for Changes to
Antibiotic Use
Sam Holst, DVM
Swine Vet Center
World Pork Expo
June 8-9, 2016

3. Overview of antibiotic use changes
1. Growth promotion label claims for medically important
antibiotics will be phased out
2. Increased veterinary oversight for therapeutic uses:
– Medically important feed grade antibiotics will require a veterinary
feed directive (VFD)
– Medically important antibiotics administered via the drinking water
will require a veterinary prescription

4. Not classified medically important
• Bacitracin (BMD)*
• Carbadox (Mecadox)
• Narasin (Skycis)
• Bambermycin (Flavomycin)
• Tiamulin (Denagard)*
* Considered medically important by WHO
Will remain available for
growth promotion and/or
over-the-counter (OTC) in
feed and water

5. Veterinary oversight of
antibiotic use

6. Veterinary oversight
• Producers will need to work with licensed veterinarian to use:
– Feed medications requiring VFD
– Rx water soluble antibiotics
– Rx injectable antibiotics

7. Veterinary oversight
• Veterinarian-client-patient relationship (VCPR)
1. Veterinarian assumes responsibility for making clinical judgments
regarding patient health
2. Veterinarian has sufficient knowledge of the patient by virtue of
examination and/or timely visits to facility where patient is
3. Veterinarian provides any necessary follow-up evaluation/care

8. Veterinary oversight
• Regular veterinary visits
– “Medically appropriate and timely visits to the premises where the
animal is kept”
– Prescriptions and VFDs = 6 month expiration (at most)
• Additional components to prove sufficient knowledge:
– Necropsies and diagnostic testing
– Treatment protocols
– Production records
– Service team reports

9. Veterinary Feed Directive

10. Veterinary feed directive
• VFD
– written statement from licensed veterinarian
– Authorizes client to obtain and use VFD antibiotic
– In or on animal feed
– According to label directions
– FDA does not allow extra-label use of feed grade antibiotics

11. Changes to existing VFD format
Previous Revised
Original document to mill Electronic copy ok
Approx. tons of feed to be fed Approx. # pigs to be fed
Written for one group on a premise
Attach list of premises
(same mill, same owner)
VCPR required Satisfy state-specific VCPR
6 month expiration max
Regulations that will carry over:
• Retain VFD for 2 years (producer, vet, feed mill)
• No extra-label use
• No refills, unless on label

12. Issuing VFDs: electronic VFDs

13. Issuing VFDs: In-house VFD

14. How will we get VFDs
implemented?
Frequently Asked Questions

15. Frequently Asked Questions
1. Does every group of pigs need its own VFD?
Will my veterinarian need to visit every site to do a VFD?
 Answer: Not necessarily

16. VFD example
• 1 producer, 1 flow, 12 sites, 1 feed mill

17. 2000 Farrow to Finish
VFD 1- N1- Pulmotil
site 1, site 2, site 3, etc
VFD 2- N2- Den/CTC
site 1, site 2, site 3, etc
VFD 3- N3- Neo/OTC
site 1, site 2, site 3, etc
VFD 4- F1- Den/CTC
site 1, site 2, site 3, etc

18. VFD example
• 1 producer, 3 flows, 30 sites, 3 feed mills
Client Flow Sites
Feed
mills Diets w/ Abx VFDs
Bacon Eater A 10 1 4 4
B 10 1 4 4
C 10 1 4 4
Total 3 30 3 12

19. 3 flows- 1 feed mill per flow
Feed Mill 1
VFD 1- N1- Pulmotil
VFD 2- N2- Den/CTC
VFD 3- N3- Neo/OTC
VFD 4- F1- Den/CTC
Feed Mill 2
VFD 1- N1- Pulmotil
VFD 2- N2- Den/CTC
VFD 3- N3- Neo/OTC
VFD 4- F1- Den/CTC
Feed Mill 3
VFD 1- N1- Pulmotil
VFD 2- N2- Den/CTC
VFD 3- N3- Neo/OTC
VFD 4- F1- Den/CTC

20. Frequently Asked Question
2. Can video/photos count as “sufficient knowledge” with an
operation to establish a VCPR?
– Answer: A VCPR cannot be established by video/photos
– “have sufficient knowledge of the patient by virtue of patient
examination and/or visits to facility where patient is managed”

21. Frequently Asked Question
3. My VFD expires tomorrow but have 4 days worth of feed
left, can I feed it?
Answer: Need to have a valid VFD issued in order to feed it
Solution: Timely vet visits to establish VCPR and oversight will
allow vets to have little to no delay in re-issuing VFDs

22. Frequently Asked Question
4. My pigs are sick, am I going to have to wait to medicate
them?
Answer: There will be no delays on water medications if
VCPR/oversight is established
Solution: Water medications can be a good choice until feed can
get delivered
Talk through the problem with your veterinarian and in the event
of an emergency should be able to get VFD generated in a timely
matter

23. Frequently Asked Question
5. Do I have to remember when my VFD or VCPR will expire?
• Answer: Responsibility lies on the producer and veterinarian
• Solution: Most VFD software, such as GVL, will have a
reminder that will alert when VFD will expire

24. Frequently Asked Question
6. What records am I required to keep as a producer?
– Answer: Producer, veterinarian, and distributor required to retain
VFD for 2 years (veterinarian retains original)

25. Treatment records
• Required treatment information to record:

26. Frequently Asked Question
7. If a producer conducts on farm mixing of medicated feed, do
they need a medicated feed mill license?
– Answer: Depends on the category and article used to produce the
medicated feed

27. Medicated feed definitions
Category I
 No withdrawal
Category II
 Require withdrawal
 VFD drugs
Type A
 Manufacture of
Type A, B, or C feeds
Type B
 Manufacture of
Type B or C feeds
 Substantial quantity
of nutrients
Type C
 Complete feed

28. Medicated feed mill license
• Feed manufacturing facility must have license to
manufacture Type B or Type C medicated feed from a
Category II, Type A medicated article

29. Exemptions…
• Manufacture of the following types of feed are exempt from the
required license:
– Type B or C medicated feed using Category II, Type B or C articles
– Type B or C medicated feed using Category I, Type A, B, or C articles

30. Category II, Type A Category II, Type B

31. Frequently Asked Question
8. For a producer who mills their own feed, do they need a
VFD to purchase medicated product?
– Answer: Depends if the producer is also a distributor or not
– If the producer IS NOT a distributor, need to have a VFD to purchase
VFD medicated product
– If the producer IS a distributor, can provide VFD or acknowledgement
letter to purchase VFD medicated feed

32. Distributor classification
• Distributor = any person who distributes a medicated feed
containing a VFD drug to another person
• Producer delivers feed to producer-owned sites…
– NOT considered to be a distributor
• Producer delivers feed to contract production sites…
– IS considered to be a distributor

33. Distributors’ responsibilities
• “One-time” distributor notification to FDA
– Distributor’s complete name and business address
– Distributor’s signature
– Date notification signed
• Notify FDA within 30 days of change in:
– Ownership
– Business name
– Business address
• http://www.fda.gov/downloads/AnimalVeterinary/Developme
ntApprovalProcess/UCM455479.pdf

34. Acknowledgement letter
• Written communication between distributors
• Includes following statements:
– Distributor will not ship VFD feed to site that does not have a VFD
– Distributor will not ship VFD feed to another distributor without
receiving acknowledgement letter
– Distributor has complied with notification requirements
• VFD still required to feed VFD medicated feed

35. Frequently Asked Question
9. What can producers do to prepare?

36. Producer name Bacon Maker
Address 12345 Piggy Rd.
Diet Name Medication Level # pigs on VFD
(approx. # in 6 mo period)
N1 CTC + Denagard 400g/T + 35g/T
1100 pigs weaned per week or
26,400 pigs
N2 Non Medicated
N3 Pulmotil 181g/T
1100 pigs weaned per week or
26,400 pigs
N4 Non Medicated
Site Name Address, City, State Feed mill Name Feed Mill location
I love Bacon 1234 fatty rd, St Peter, MN Feed mill 1 St Peter, MN
Bacon loves me 1235 fatty rd, St Peter, MN Feed mill 2 St Peter, MN
Piggy ranch 1236 fatty rd, St Peter, MN Feed mill 3 St Peter, MN

37. Summary
• Antibiotic use isn’t going away, but it is changing
• Countdown to January 1, 2017 is on
– All VFD feed in bins on Jan 1, 2017 will need VFDs in place
• Communication will be key to
smooth transition
• Preparation will help prevent
gap or delay in treatment

38. Questions?