The VFDs Are Coming! January 1, 2017 Are You Ready? Federal Regulatory Bodies 1
Growing concern over antimicrobial resistance 2
Veterinary Feed Directive (VFD) President Clinton signed the Animal Drug Availability Act into law in October 1996. It created a new category of animal drugs VFD drugs that can be used in feed for animals with a veterinarian's order. VFD is not a prescription under federal or state Law. Extra label use is prohibited. What is a Veterinary Feed Directive (VFD)? A VFD is a written or electronic license, authorizing a veterinary client to obtain and use a VFD drug intended for use in or on feed for the treatment of that client s animals in accordance within the conditions of the VFD. The term VFD refers to the form issued and the drug category to be used in or on animal feed under the professional supervision of a licensed veterinarian. 3
Veterinary Feed Directive (VFD) The VFD category was offered as an alternative to Rx feed. The first VFD drug was approved in 1996 for swine. 5 current VFD drugs Tilmicosin - Pulmotil - swine & cattle Tilmovet - swine Avilamycin - Kavault - swine Florfenicol - Aquaflor, Nuflor - aquaculture FDA developed the Veterinary Feed Directive over the course of a decade Guidance Document #152 October, 2003 Guidance Document #209 April, 2012 Guidance Document #213 April, 2012 VFD codified in CFR June, 2015 Guidance Document #120 June, 2015 Guidance Document #233 December, 2015 4
VFD Changes: #209 Judicious Use Strategy Limit medically important antimicrobials to therapeutic purposes (i.e., purposes considered necessary to ensure animal health). Require veterinary oversight or consultation for such therapeutic uses in food-producing animals (dual-use). VFD Changes: #213 Expanded Detail By January 2017, the use of medically important antibiotics in food and water will: Be limited to therapeutic purposes only (Production/growth uses) Require the authorization of a licensed veterinarian Products used in water OTC -> Rx Prescription Products used in/on feed OTC -> VFD (milk replacers=feed) 5
Antibiotics are divided into two classes Medically Important Used in human medicine Chlortetracycline Neo-Terramycin Oxytetracycline Sulfamethazine Pulmotil Tylan Lincomycin Penicillin Medically Not Important Not used in human medicine Bovatec Corid Deccox Gainpro Rumensin BMD Denagard Mecadox VFD vs. Rx: What is the difference? VFD prescription They are similar in that a veterinarian provides a document that authorizes the drug s use. A prescription needs to be filled by someone authorized within the state (depending on the state, authorized may mean a licensed veterinarian or someone licensed by a pharmacy board). Distributors of VFD drugs need to send an intent to distribute letter to the FDA. 6
What s required on a VFD What about combinations of drugs? Rumensin/Tylan (beef) requires a VFD because of the Tylan Aureomycin /Bovatec allowed with a VFD, but only the Aureomycin brand of CTC is allowed with Bovatec Aureo S-700 allowed with a VFD CTC/Denagard (swine) requires a VFD because of the CTC component 7
What can a producer do to prepare? Establish a veterinarian-client-patient relationship (VCPR) Review all animal health protocols with your veterinarian Put one person in charge of all things VFD-related Take inventory of antibiotics currently used Add a step in your current recordkeeping system for recording and filing VFD documentation Communicate with your feed mill/distributor On January 1, 2017, have a valid VFD for any feed or drugs being fed that fall within the VFD category of drugs Client Name: VFD Use Summary Business Address: Best contact Name & Phone (cell) Number: Animal VFD Date Location Date Withdrawal Description and Feed name or ID Effective Began Description finished date Veterinarian ID - Number of & VFD Drug Durration Calculate Start Date Feeding and/or Premise ID Animals from VFD from VFD from VFD Year: VFD Expiration date Distributor purchased from 8
Water Soluble Medically important-water soluble medications will require a prescription, Rx Veterinarian must issue the prescription Who will fill it depends on the State Discuss with your veterinarian if their office will carry water soluble medications to fill the prescription Disclaimer Some of the small details are still somewhat fluid and may change, be interpreted differently, or have administrative flexibility applied before January 1, 2017. 9