Eighteen months after full implementation of the new VFD rules for medicated feeds, most veterinarians and other stakeholders have become familiar and comfortable with the process and compliance in routine practices. Questions continue to arise though, as producers move through annual production cycles and encounter situations requiring more detailed understanding of the rules.
During a recent webinar on the VFD audit process hosted by GlobalVetLink, several presenters addressed persistent questions regarding VFD compliance, which becomes increasingly critical as the FDA conducts audits and moves from an educational phase toward more enforcement and penalties for non-compliance. Prior to the webinar, GlobalVetLink (GVL) submitted a list of questions to FDA’s Center for Veterinary Medicine (CVM) to ensure accuracy of the answers.
Kansas State University veterinarian Mike Apley, DVM, PhD, addressed several key questions relating to the VFD process in beef and dairy operations. Apley says most of the questions focus on a short list of issues:
- Free-choice vs. hand fed feeds.
- Concurrent use approvals.
- Differences in indications for different trade names for the same drug.
- Renewals - date of VFD becoming effective.
- Minor species.
Using responses directly from FDA/CVM, Apley addressed some specific VFD-compliance questions.
Q. My producers are looking toward a mineral mix with 5,600 gram per ton chlortetracyline (CTC) as a help in keeping the calves healthy. The label is for pneumonia which is out there but wondered how other veterinarians are addressing the requests for this product. This product is usually provided as a free choice mineral.
A. CTC is approved for use in cattle, including calves, for treatment of bacterial pneumonia caused by P. multocida organisms susceptible to CTC. For this indication, CTC is approved for use at levels of 10 mg/lb BW/day, which could be fed from a feed containing between 500 and 2,000 or 4,000 g/ton, or top dress containing between 4,000 and 20,000 g/ton chlortetracycline. There is no approved free-choice medicated feed containing CTC for treatment of pneumonia in cattle.
Q. When I’m asked to write a VFD for free choice mineral with CTC, a problem usually arises. Very few of the distributors for those products in my area use the bluebird products whose concentrations are used as an options on the GVL website. The options given on the site are 700, 5,000, 7,000 and 8000. The problem with that is that none of the distributors in my area use those concentrations in their free-choice mineral. So that poses this question, which one of us, the veterinarian or the distributor, is going to “adapt” to the alternatives?
A. The veterinarian is responsible for ensuring the VFD is complete and in accordance with the conditions for use in the relevant approval, conditional approval, or index listing. When medicating animals through free-choice mineral supplements, the only legal options are approved free-choice medicated feed formulations. While the agency continues to consider ways to address concerns related to these products, on December 20, 2017, CVM provided Question and Answers: FDA Approved Free-Choice Feeding Options for Anaplasmosis Control in Cattle to clarify the issues and assist with the appropriate selection and use of approved VFD free-choice medicated feed products for the control of active infection of anaplasmosis in cattle.
Q. If a veterinarian writes a VFD for CTC in calves at 8,000 g/ton at the treatment level using the topdress claim. That particular feed facility only handles a 20,000 g/ton aureomycin pellet (also legal to topdress). Can the VFD be filled with the 20,000 g/ton product in place of the 8,000 g/ton product (i.e. Aureo 10 in place of Aureo 4) if appropriate feeding rate adjustments are communicated to the farm?
A. In the situation where the VFD already specifies 8,000 g/ton CTC, the producer has three options.
1. Find a distributor who will issue a feed containing 8,000 g/ton CTC, labeled for the approved use specified on the VFD.
2. Get a 20,000 g/ton CTC feed and dilute it to a level of 8,000 g/ton.
3. Contact the veterinarian to request another VFD with a different CTC level from the approved range of 4,000 and 20,000 g/ton CTC).
For information on the FDA’s audit process for VFD compliance, read VFD Audits: What to Expect.
The recorded webinar is available for on-demand viewing from GlobalVetLink.