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

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

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

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

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

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

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

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

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)

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

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

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

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.

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.

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

Veterinarian-client-patient-relationship

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

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

Required information for a lawful vfd

Name, Address, phone number Veterinarian and Producers

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

Date issuance The date the veterinarian writes the VFD

“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)

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.

“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

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

Species and production class and approximate numbers

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

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

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).

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.

Combination vfd drug

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!

“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

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.

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

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

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

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

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

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

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

Questions?