1. VFD – Trying To Sort It Out
DEC 3, 2016
Bob Ebbesmeyer, D.V.M. (German valley, IL)
Alan Whitman, D,V.M. (piper city, IL)

2. What Is a VFD (Veterinary Feed Directive)?
Written statement provided by a veterinarian (licensed in the state where the animals reside) in the presence of a VCPR (Veterinarian-Client-Patient Relationship) that authorizes a client to use a VFD drug in an animal feed in accordance with approved use
One drug for one group of animals belonging to one producer for a specific disease state for a specified time with feed purchased from one distributor
It is NOT a prescription; it is much more specific than a prescription

3. What Is a VFD?
VFD is not a new concept - we have had several VFD antibiotics for more than 10 years
Most commonly used: Pulmotil in swine and beef feedlot cattle
Others: Tilmovet, Kavault, Aivlosin
What is the new concept for 2017?
Almost all feed grade animal antibiotics will be VFD January 1

4. What Drugs Require a VFD?
January 1, 2017: All Medically Important (MI) drugs used in feed are considered VFD drugs, and any use of them, starting January 1, 2017, requires a valid VFD
Medically Important (MI) is defined as any antibiotic belonging to a class of drugs used commonly in human medicine
Includes: Chlortetracycline, oxytetracycline, tylosin, sulfamethazine, neomycin, lincomycin, penicillin, virginiamycin, avilamycin, florfenicol, tilmicosin, tylvalosin

5. What Drugs Do NOT Require a VFD?
Drugs NOT Considered Medically Important (NCMI):
Ionophores (Bovatec, Rumensin)
Carbadox (Mecadox)
Tiamulin (Denagard)
Bacitracin (BMD)
Bambermycin (Flavomycin)
Anthelmentics (dewormers), Beta agonists, anticoccidials

6. What About Drug Combinations?
Just to make sure we do not make this all too simple: NOT Considered Medically Important (NCMI) drugs must be listed on VFD if given in combination with any drug on VFD list, AND the combination must be an approved combination

7. What is a VCPR?
Veterinarians are only allowed to write a VFD for a client when there is a VCPR Veterinarian-Client-Patient Relationship

8. What is a VCPR?
Defined in Veterinary Medicine and Surgery Practice Act of 2004 (225 ILCS 115/)
(1) The veterinarian has assumed the responsibility for making clinical judgments regarding the health of an animal and the need for medical treatment and the client, owner, or other caretaker has agreed to follow the instructions of the veterinarian;

9. What is a VCPR?
(2) There is sufficient knowledge of an animal by the veterinarian to initiate at least a general or preliminary diagnosis of the medical condition of the animal. This means that the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal by virtue of an examination of the animal or by medically appropriate and timely visits to the premises where the animal is kept, or the veterinarian has access to the animal patient's records and has been designated by the veterinarian with the prior relationship to provide reasonable and appropriate medical care if he or she is unavailable; and

10. What is a VCPR?
(3) The practicing veterinarian is readily available for follow-up in case of adverse reactions or failure of the treatment regimen or, if unavailable, has designated another available veterinarian who has access to the animal patient's records to provide reasonable and appropriate medical care.

11. What is NOT a VCPR?
"Veterinarian-client-patient relationship" does not mean a relationship solely based on telephonic or other electronic communications.

12. Why Did FDA create this regulation?
“To promote the judicious use of antimicrobials in food-producing animals…bring the use of these drugs under veterinary supervision so they are used only when necessary for assuring animal health.” (
Basically, to fight the development of antimicrobial resistance

13. Why Did FDA create this regulation?
Antibiotic resistance leads to estimated 2 million infections and 23,000 deaths annually in U.S. (CDC)
Websites and social media share and spread data very easily:
Human antibiotics sold annually: 8 million pounds
Food animal antibiotics sold annually: 29 million pounds
Indirect pressure: large companies going “Antibiotic Free” (McDonalds, Subway, Tyson)

14. Why Did FDA create this regulation?
29 million pounds of livestock feed:
8 million pounds – ionophores (NCMI: not considered medically important to humans)
21 million pounds of MI (medically important) antibiotics used annually
97% of these MI antibiotics were used OTC (over the counter = no/minimal veterinary oversight)

15. Is the FDA cause valid? Yes…and No…and Maybe…
Perhaps Yes:
There is evidence that bacteria can develop resistance and transfer antibiotic resistance to other bacteria when antibiotics are used

16. Is the FDA cause valid? Yes…and No…and Maybe…
Perhaps No:
Antibiotic use is often reported in pounds; does one gram of chlortetracycline equal one gram of ciprofloxacin? No, not even close.
Variable evidence from countries (i.e., Denmark), even with severely limited use of feed-grade antibiotics, that resistance has significantly decreased

17. Is the FDA cause valid? Yes…and No…and Maybe…
Annually, approximately 262 million prescriptions are written for outpatient antibiotic use (Center for Disease Control, CDC) - 8 million pounds of human antibiotics annually
Estimated 30-50% of these prescriptions inappropriate (CDC, various studies)
Azithromycin (Z-Pack) is the most commonly prescribed antibiotic (ironically, it is most often prescribed for bronchitis, which is usually viral, so antibiotics are innappropriate)

18. Is the FDA cause valid? Yes…and No…and Maybe…
Drug companies are quite reluctant to spend billions to develop new antibiotics:
Cost of drug; use may be limited to specific situations
They are looking to create drugs for chronic conditions that get used much more often
Ultimately, human AND animal medical fields must have a change in mindset about antibiotics use

19. Will Antibiotics Still Be Used on Feed? Yes…But…
Feed grade antibiotics can ONLY be used according to specified and approved label indications:
Specified dose (either dose/animal or concentration to be mixed in feed)
Specified species
Specified disease states, for prevention, control or treatment
Specified treatment length (days)

20. Will Antibiotics Still Be Used on Feed? Yes…But…
Cannot be used for “increased rate of gain”
This has been voluntarily removed from the label of all feed grade antibiotics by the manufacturers
No extra-label use of feed antibiotics
Only for approved species, time, dose, indication, etc

21. What Is Included in a VFD?
Must be written (electronic or paper, which can be faxed if necessary)
Triplicate; veterinarian keeps original, distributor and produce each get copy
Cannot be done via telephone call
Requires a good working relationship between the producer, the veterinarian, and the distributor

22. What Is Included in a VFD?
One veterinarian (not a clinic)
One person responsible for care and feeding of animals
One animal production site, can be more if same owner and a common health plan can be justified
One VFD medication (or approved combination) can be listed on each VFD

23. What Is Listed/Required on a VFD?
1. Client
2. Animal location(s)
3. Species
4. Number of head to be fed (over life of the VFD, maximum six months)
5. VFD medication

24. What Is Listed/Required on a VFD?
6. Production class (specified option are on each drug’s label)
7. Indication (must be specifically listed on drug label)
8. Expiration of VFD – typically can be maximum of six months, but some are less if specified on drug label)
9. Dosage and duration
10. Feed concentration (if not indicated in dosage)

25. What Is Listed/Required on a VFD?
11. Cautionary statements
12. Specific instructions
13. Withdrawal time for slaughter
14. VFD statement
15. Any allowed approved combination drugs

26. VFD Limitations
Very Important: No “Extra-Label Use” of any feed antibiotics is allowed
Only for approved species, dose, time, indication, etc
What about “minor species” sheep and goats????
Cannot be used after expiration – if needed after the six month (or less) expiration, another VFD must be written
Blue Bird Labels: /MedicatedFeed/BlueBirdLabels/default.htm

27. What Is Best: Paper or Electronic?
FDA anticipates 750,000 VFD’s written annually, therefore FDA would prefer electronic records
Advantages of electronic:
Should be readily available anytime/anywhere
Digitally stored so cannot be lost
Electronic forms should allow the VFD to be properly filled out

28. Electronic VFD’s (ie, GlobalVetLINK)
Allows proper VFD creation (species, indication, dose, combinations, etc)
Electronically signed and stored
VFD’s are ed to distributor and producer so they can have access anytime/anywhere
s can be sent to notify veterinarian, distributor, and producer as expiration date is approaching

29. What About Antibiotics in Water?
As of January 1, 2017, all water-based antibiotics are prescription drugs. They do NOT require a VFD.
Cannot be bought without veterinary approval, similar to the purchase of a prescription of an injectable drug
They will not be available from feed distributors unless a pharmacist is on staff

30. What About Injectable Antibiotics?
There has been no change in injectable antibiotic regulations.
Current OTC (over the counter) injectables are still available (penicillin, oxytetracyclene, etc)
Anticipate that injectable antibiotics will become more regulated in future years

31. Will There Be FDA Inspections?
Yes, but unknown level of inspection
2017 anticipated to be a teaching year
Random inspections checking to see that steps are were done appropriately
Veterinarian: valid VCPR, properly filled out VFD
Distributor: filled request properly, appropriate quantities
Producer: fed to proper animals for proper time, dose and duration (best to have a written record of when/where fed)
All records must be kept for two years (paper or electronically)

32. Issues and Concerns Barriers to getting antibiotics
Timeliness of animal treatment
Added paperwork and record keeping
Lack of veterinary availability in some places
Potential audits/inspections
Inaccurate VFD’s causing delays
Extra veterinary costs

33. QUESTIONS??? Final Thought www.ilfb.org/vfd
If we want to protect and preserve the use of antibiotics in food-producing animals, we are going to have to jump through VFD hoops
QUESTIONS???