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
Growth promotion label claims for medically important antibiotics will be phased out
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)
Veterinarian assumes responsibility for making clinical judgments regarding patient health
Veterinarian has sufficient knowledge of the patient by virtue of examination and/or timely visits to facility where patient is
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
Regulations that will carry over:
Retain VFD for 2 years (producer, vet, feed mill)
No extra-label use
No refills, unless on label
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

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
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
VFD 3- N3- Neo/OTC
VFD 4- F1- Den/CTC

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

19. 3 flows- 1 feed mill per flow
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
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
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
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
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
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
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
Category II
No withdrawal
Require withdrawal
VFD drugs
Type A
Type B
Type C
Manufacture of Type A, B, or C feeds
Manufacture of Type B or C feeds
Complete feed
Substantial quantity of nutrients

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
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

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
What can producers do to prepare?

36. 1100 pigs weaned per week or 26,400 pigs
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 N4
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
Piggy ranch
1236 fatty rd, St Peter, MN
Feed mill 3

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?