Comply with the rules, keep good records and organize those records for accessibility, and you shouldn’t worry about FDA inspectors scheduling an audit. That general message surfaced repeatedly during a recent webinar on the VFD audit process hosted by GlobalVetLink. The webinar featured several presenters representing different industry segments affected by the expanded VFD rules, implemented in January 2017. They included:
- Tyler Holck, DVM, with Feed His People, LLC.
- Peter Schneider, DVM, with Innovative Agriculture Solutions, LLC, and a swine producer.
- Mike Apley, DVM, PhD, Kansas State University.
- Matt Frederking, VP for Regulatory Affairs, Mid America Pet Food, LLC.
This article summarizes Dr. Schneider’s presentation which focused on his experience with a VFD “educational audit” FDA conducted at his family’s swine operation in 2017. Over the first year since the rules launched, FDA has focused its audits on education rather than penalties for non-compliance, but enforcement will become stricter over time.
Schneider says the typical pathway for an FDA investigation will begin at the feed distributor that sells medicated feeds subject to VFD regulations. These audits are unannounced, and the inspectors likely will review VFD orders from multiple customers.
The audit might end there, or the inspectors might select some VFD orders to follow back to the veterinarians who issued them and to the producers who purchased the medicated feeds. The inspectors will notify veterinarians and producers prior to the audit, but the time will be short, with most follow-up audits conducted within 24 hours of the initial feed-distributor audit.
Schneider notes that FDA relies on state departments of agriculture to assist with the audits. In his case, the inspection team included one representative from the FDA and one from the Iowa Department of Agriculture. The inspection, he says, was relatively painless and took less than one hour to complete.
The process, he says, was relatively simple. The inspectors asked to review the operation’s VFD records and used a standardized VFD inspection tool, essentially a checklist of questions for distributors, veterinarians and producers, to complete the audit. Key points included verification that the veterinarian is licensed to practice in that state and has a valid veterinarian-client-patient relationship (VCPR) with the operation, and that the producer has maintained records for the required two years and has followed the VFD and the product label specifications in administering the medicated feeds.
Schneider lists these take-home points:
- Details are important. Ensure that your VFD forms include pertinent information on animals, rations, dosage and duration of use for VFD products
- Justification is important. Be sure to document the reasons for using a VFD product, based on the veterinarian’s familiarity with the operation and animals, diagnostics and best professional judgement.
- Beware of “double dipping.” Pulse treatments, or repeated treatments with a medicated feed, must be justified and a new VFD is needed for the second or subsequent courses of treatment.
- If a producer and veterinarian determine a treatment is not working during the period covered by a VFD, they can and should switch to a different treatment, with a new VFD.
- Keep good records. The biggest weakness the FDA has noted in VFD compliance has been a lack of documentation, particularly at the producer level. More records and greater detail probably will serve you better than less.
The recorded webinar is available for on-demand viewing from GlobalVetLink.