little baby cow feeding from milk bottle.

What is the Veterinary Feed Directive (VFD) Rule and What Does It Mean for Me?

Since the 1950’s, the use of medications in feed has served as a convenient and effective method of preventing and treating certain disease conditions in groups of livestock. However, bacteria can become resistant to the antimicrobial drugs used to fight them, and antibiotic use is now considered a public health issue due to growing concerns that low doses of antibiotics in animal feed lead to antibiotic resistance in people who consume the animal products. In light of these concerns, important steps were taken recently by the U.S. Food and Drug Administration (FDA) towards the use of “medically important antibiotics”—antibiotics that are important for treating human diseases—in feed or water for food-production animals. The agency is also moving to eradicate the use of medically important antibiotics as growth promoters or to increase feed efficiency. Moreover, FDA is regulating the use of medically important antibiotics in feed or water to only be used under the supervision of licensed veterinarians.

On June 3, 2015 the FDA published the final Veterinary Feed Directive Rule, which becomes effective January 1, 2017. As of January 1, 2017, animal producers will no longer be able to buy medicated feed over the counter if it contains medically important antibiotics. To ensure the judicious use of these drugs in food-production animals, the marketing status of medically important antimicrobials will change from over-the-counter (OTC) to prescription (Rx) or to veterinary feed directive (VFD) by the end of 2016.

A veterinary feed directive is a written statement issued by a licensed veterinarian in the course of the veterinarian’s professional practice that orders the use of a VFD drug in or on an animal feed. This written statement authorizes the client to obtain and use the VFD drug in or on animal feed to treat the client’s animals only in accordance with the directions for use approved or indexed by the FDA. The FDA requires the veterinarian under its client-patient relationship (VCPR) to only provide VFDs when medically important antibiotics are needed for specific animal health resolutions. As an example, milk replacers with neomycin and oxytetracycline to reduce bacterial enteritis caused by E. coli or tylosin to reduce liver abscesses will need a VFD to be used. The final VFD Rule will require veterinarians to follow state-defined VCPR requirements; in states where the FDA defines that no applicable or appropriate state VCPR requirements exist, veterinarians will need to issue VFDs in compliance with federally defined VCPR requirements. The FDA will work with each state to review their VCPR requirements and define if they are consistent with the federal standards.

Veterinarians will play a main role in animal and human health and their oversight, as an integral part of the VFD process, and will help ensure that medically important antimicrobial drugs will be used in feed only according to label directions. No extra-label use is allowed under the guidelines. However, veterinarians may still prescribe extra-label for water-delivered medication which is regulated by the Animal Medicinal Drug Use Clarification Act (AMDUCA). Veterinarians will only be able to authorize uses of fed antimicrobial products which follow the label (all 25 affected drug sponsors have committed to implementing the label changes as described in Guidance #213 by January 2017). It is important to understand that veterinarians will be responsible for deciding when these medications are needed, the dose, and duration to resolve infection and protect animal health.

Drugs Transitioning From OTC to VFD Status

Established drug nameExamples of proprietary drug name(s)
chlortetracycline (CTC)Aureomycin, CLTC, CTC, Chloratet, Chlorachel, ChlorMax, Chlortetracycline, Deracin, Inchlor, Pennchlor, Pfichlor
chlortetracycline/sulfamethazineAureo S, Aureomix S, Pennchlor S
chlortetracycline/sulfamethazine/penicillinAureomix 500, Chlorachel/Pficlor SP, Pennchlor SP, ChlorMax SP
hygromycin BHygromix
oxytetracycline (OTC)TM, OXTC, Oxytetracycline, Pennox, Terramycin
oxytetracycline/neomycinNeo-Oxy, Neo-Terramycin
penicillinPenicillin, Penicillin G Procaine
sulfadimethoxine/ormetoprimRofenaid, Romet
tylosinTylan, Tylosin, Tylovet
tylosin/sulfamethazineTylan Sulfa G, Tylan Plus Sulfa G, Tylosin Plus Sulfamethazine
virginiamycinStafac, Virginiamycin, V-Max

Current VFD Drugs

Established drug nameProprietary drug name(s)
florfenicolAquaflor, Nuflor
tilmicosinPulmotil, Tilmovet

The complete list of affected applications will continue to be updated as changes are made and can be located here.

Here is a video overview released by the FDA:

For more detailed information, please visit the FDA website pertaining to the Veterinary Feed Directive.