In June 2015, the Food & Drug Administration (“FDA”) promulgated the second Veterinary Feed Directive (“VFD”) affecting livestock producers that use medicated feed and water. The final rule became effective in October 2015 transitioning Over-the-Counter (“OTC”) drugs to be VFD through January 1, 2017. This requires veterinarians to have a Veterinary-Client-Patient Relationship (“VCPR”) and use a VFD to prescribe the use of a VFD drug pursuant to CFR. What should livestock producers know about this law? Here are a few pointers:
1. VFD. So what exactly is this VFD thing? It’s a law. It’s a drug. And it’s a piece of paper. Pursuant to the VFD, livestock producers need a VFD from a veterinarian in order to use a VFD drug on the livestock. Clear as mud? Put simply, livestock producers can no longer use medicated feed and water without getting a document from his/her veterinarian saying that’s a-okay. This document should specify what animals can have the medicated feed/water, for how long, and any special instructions concerning the medicated feed.
2. Record-Keeping. There is a 2 year record keeping requirement for livestock producers. Livestock producers should keep the records in the form that they receive it. For example, if the veterinarian emails the VFD then the farmer or rancher should keep a electronic copy available. Alternatively, if the veterinarian hands over a hard copy of the VFD, then the livestock producer should keep a hard copy for 2 years. Because the FDA can come knocking and asking to see the records, producers should consider keeping records safe from an Act of God (i.e., fire, flood, tornado), such as storing electronic data in the Cloud so it can be accessed from a different location.
3. Expiration Date. Livestock producers should pay special attention to the expiration date on the VFD. If the expiration date is silent then the “default” expiration date is 6 months. The expiration date of the VFD is different than the duration. If the duration on the VFD is longer than the expiration date then the livestock producer should go back to the veterinarian and ask for another VFD.
4. VCPR. The veterinarian is required to work within the parameters of the VCPR in your state. If your state has not yet promulgated a VCPR, then the veterinarian must adhere to the federal VCPR requirements which require that the veterinarian have an established relationship with the livestock producer and have the ability to follow-up with patient-animal. It is important that livestock producers build a relationship and rapport with his or her veterinarian. The VCPR requirements create a need for the veterinarian to be more hands-on and face-to-face with the livestock and its owner.
5. Extra-labeling Use. Livestock producers should strictly follow the instructions of the VFD and steer clear from extra-labeling use such as using the VFD drug in another species, in a different dosage, for a different duration, or for some other therapeutic use other than that is on the label. If the veterinarian prescribes an extra-labeling use judiciously, then carefully follow those instructions.
Rincker Law, PLLC can assist livestock producers, veterinarians and feed distributors to help each segment stay in compliant with the new VFD rule. Cari Rincker will be giving a Lawline presentation on November 3, 2016 on this topic. The recording will be available via Lawline if you cannot make the webinar. The presentation is open to lawyers, law students, and nonlawyers (e.g., farmers, ranchers, veterinarians).