The bigger the impact something has, the more important it is to keep track of it.
The Veterinary Feed Directive (VFD) changes in 2017 had a drastic impact on producers. As such, it is important to evaluate the compliance of affected parties to understand the effects of the reformed regulations. The early waves of some of the Food and Drug Administration’s (FDA’s) evaluations were released Aug. 29.
Recent events
The FDA’s Center for Veterinary Medicine (CVM) transitioned medically important antimicrobial drugs in feed from over-the-counter to VFD status in 2017. VFD drugs require a prescription from a licensed veterinarian for food-producing animals to receive a medicated feed.
After publishing the final rule 2015, CVM developed a plan for inspections of those involved in the VFD process in order to provide education opportunities and evaluate compliance.
During the fiscal years of 2016 and 2017, inspections were focused on educating producers, veterinarians, and medicated feed distributors to begin phasing in the new VFD regulation. Fiscal year 2018 saw a shift from education to compliance inspections and documenting violations.
FDA began a pilot inspection program in fiscal year 2016 that consisted of three parts. First, investigators discussed adherence to regulations with distributors and reviewed a random VFD for compliance. Then the FDA took it one step further and inspected the veterinarian and client named on the VFD.
FDA continued these inspections into 2017 and 2018 and expanded the program to include state feed regulatory partners. Participating state feed regulatory partners began a similar three-part inspection service in fiscal year 2018.
Inspectors are also beginning to conduct VFD inspections as part of the Drug Residue Investigation Program to further understand adherence to VFD requirements.
Inspection results
The results of the first wave of FDA compliance inspections indicate affected parties are generally aware of and in compliance with the VFD regulations. Most inspections took place at the VFD distributors, followed by clients, and then veterinarians. The majority of cases, 91 percent, inspected from fiscal years 2016 to 2018 were classified as no action required regarding compliance.
Only one investigation out of 456 was marked as official action being needed, depending on the impact on public health and the facility’s voluntary corrective action. A warning letter was issued to a feed mill that misbranded VFD feed by distributing the feed to other distributors before approved, as well as misbranded medicated and non-medicated feed for other reasons.
Other details of the compliance evaluations include:
• VFD distributors – Facilities are required to notify the FDA prior to the first time an animal feed containing a VFD drug is distributed. As of August 2019, more than 9,600 facilities across the U.S., Puerto Rico and Canada have notified the FDA of their intent to distribute. This is a sharp increase from the original number of 1,400 facilities at the end of 2015. The majority of VFD feed distributors had notified FDA of their intent to distribute VFD feeds and complied with the terms of the VFD, as well as correctly labeled feed tags.
• Licensed veterinarians – All of the inspected veterinarians were licensed in the state where the VFD feed was being fed and almost all VFDS included signatures. Most VFDs included withdrawal times, special instructions or cautionary statements.
• Producers use of VFD feed – Clients feeding a VFD feed for the most part did not feed beyond the expiration date, but fiscal year 2017 saw a drop in compliance from 92 percent to 75 percent. The majority of producers fed the medicated feed only to authorized animals and for the duration identified.
Although a relatively small number of inspections were conducted during fiscal years 2016 to 2018, CVM will continue to expand compliance strategies. The agency will continue to monitor all parties involved and provide enforcement where compliance is not achieved. — Anna Miller, WLJ editor
