1. Veterinary feed directive
Barry Whitworth, DVM
Area Food/Animal Quality and
Health Specialist for Eastern Oklahoma

2. FDA Task Force Report “The use of antibiotics in animal feed”
Associated with the development of resistant bacteria
Serve as reservoir of antimicrobial-resistant pathogens
Prohibited for growth promotion
By a veterinarian or on a veterinarian prescription
1970

3. references FDA Website Veterinary Feed Directive
21 Code of Federal Regulation 558 and 530
Guidance for Industry #120, 152, 209, 213
Lecture Doug Hufstedle Elanco
Webinar Elanco
Webinar Zoetis
Stewardship of Antimicrobials Workshop: Amarillo

4. Goal of the presentation
History
Define VFD
What OTC drugs will be affected by the change in status
Time frame of implementation
Producer requirements
Not going to Debate the change in status of the OTC drugs

5. Before 1996, there were two options for dispensing new animal drugs:
Over-The-Counter (OTC)
Prescription (Rx)

7. Why not label the drug a prescription drug?
Did Not Want to Invoke State Pharmacy Laws for Prescription Drugs (Impractical to use the drug)

8. Animal drug availability act 1996
Congress created a new category of drugs call Veterinary Feed Directive (VFD) drugs.
Final rule Federal Register of December 8, 2000 (21CFR 558)
Effective January 1, 2001

9. October 1, 2015
Minor changes to the original VFD rule (21 CFR 558.6) went into effect

10. Guidance for industry #209 April 13, 2012 “The judicious use of Medically Important Antimicrobial Drugs in Food-Producing Animals”
Executive Summary
Limiting medically important antimicrobial drugs (drugs that are important for therapeutic use in humans GFI#152) to uses in food-producing animals that are considered necessary for assuring animal health (use for treatment, prevention, and control of disease and not for growth promotion or improved feed efficiency)
Limiting such drugs to uses in food-producing animals that include veterinary oversight or consultation (this changes OTC drugs to VFD or Prescription drugs)

11. Under the guidance for industry #209
Drugs administered in or on feed will switch from OTC to VFD drugs
Drugs administered in water will switch from OTC to Prescription (Rx) drugs

12. January 1, 2017
The date that the OTC drugs will change status to VFD drugs or Prescription drugs

13. Veterinary feed directive (vfd)
Two Meanings
Document or Order
Drug

14. Veterinary feed directive (vfD) (gfi#120)
A written (nonverbal) statement issued by a licensed veterinarian in the course of the veterinarian’s professional practice that orders the use of a VFD drug or combination VFD drug in or on animal feed.
This written statement authorizes the client (the owner of the animal or animals or other caretaker) to obtain and use animal feed bearing or containing a VFD drug or combination VFD drug to treat the client’s animals only in accordance with the conditions for use approved, conditionally approved, or indexed by the FDA.

15. What is a vfd drug? (gfi#120)
A drug intended for use in or on animal feed that is limited to use under the professional supervision of a licensed veterinarian.

16. What is the “professional supervisions of a licensed veterinarian”?
Licensed in the state of Oklahoma
Working with producers within a Veterinary-Client-Patient-Relationship

17. Veterinarian-client-patient-relationship

18. Animal drugs expected to be vfd drugs
Apramycin
Avilamycin (already VFD)
Chlortetracycline
Erythromycin
Florfenicol (already VFD)
Hygromycin B
Lincomycin
Neomycin
Oleandomycin
Oxytetracycline
Penicillin
Sulfadimethoxine:Ormetoprim
Tilmicosin (already VFD)
Tylosin
Sulfamerazine
Sulfamethazine
Virginiamycin

19. Animal drugs that will remain OTC
Ionophores
Coccidiostats
Bacitracin
Bambermycin
Carbadox
Pleuromutilin

20. Required information for a lawful vfd

21. Name, Address, phone number
Veterinarian and Producers

22. Premises at which the animals are located
Needs to be specific enough for someone to be able to find the animals
May be different than the Client’s address

23. Date issuance
The date the veterinarian writes the VFD

24. “Expiration Date”
“Expiration Date” specifies the last date the VFD feed can be fed (If not specified on the label, the veterinarian sets the date which cannot exceed 6 months)

25. Drug, Drug Level, “Duration of use”
The name of the drug to be used
The amount of drug that is to be added to the feed (grams/ton)
This determines the length of time that the animal feed containing a VFD drug is allowed to be fed to the animals.

26. “expiration date” vs “duration of use”
Example: Tilmicosin “expiration date” is 45 days and “duration of use” is 14 days
This means the producers after the issuance of the VFD has 45 days to obtain the VFD feed and complete the 14 days the therapy

27. May I feed past the expiration date ?
NO! VFD feeds may not be fed after “expiration date”
What should I do if I have not completed the “duration of use” before the “expiration date”?
Obtain a new VFD from your veterinarian

28. Species and production class and approximate numbers

29. Indication What is the reason for using this drug?
The condition must be on the label

30. Withdrawal time Number of days before animal may be slaughtered
Other special instructions
Cautions

31. Reorders (refills)
If the drug approval, conditional approval, index expressly allows a reorder (refill) a veterinarian can authorize up to the permitted number of reorders. If a drug is silent on reorders (refills), then a veterinarian may not authorize a reorder (refill).

32. What is a combination vfd drug ?
An approved combination of new animal drugs intended for use in or on animal feed under the professional supervision of a licensed veterinarian, and at least one of the new animal drugs in the combination is a VFD drug.

33. Combination vfd drug

34. Extra-label use
“Extra-label Use” is defined in FDA’s regulations as actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling.
“Extra-label Use” of VFD feed (or any other medicated feed) is not permitted!

35. “pioneer” and “Generic”
Unless forbidden by the veterinarian a “generic” drug may be substituted for the “pioneer” drug
However, not all “generic” drugs have the same label claims as the “pioneer” drugs

36. records
The veterinarian, distributor, and client copies must be kept for 2 years and may be kept as an electronic copy or hardcopy.
All involved parties must make the VFD available for inspection and copying by FDA upon request.

41. What should producers do?
Make sure that you have a good relationship with a veterinarian

42. What should producers do?
Take an inventory of what drugs you currently using

43. What should producers do?
Take list and go visit your Veterinarian and Feed Store

44. What should producers do?
“If you have to treat a disease with antibiotic you have failed”
Are there alternatives to antibiotics?

45. Producer’s responsibilities
Feed according to the label
Do not feed after expiration date
Provide a copy of the VFD order to the feed distributor if the issuing veterinarian sends the feed distributor’s copy with you
Maintain a copy of the VFD order for 2 years and provide VFD orders for inspections and copying by FDA upon request

46. Distributor’s responsibilities
“One-Time” Distributor Notification to FDA
Only fill a VFD order if it contains all the information
Display label were it is easily seen

47. Distributor’s responsibilities (continued)
Acknowledgement letter between distributors
Keep VFD order and Acknowledgement letters for 2 years
Keep VFD manufacturing label for 1 year

48. Questions?