VFD Audits: Start with the Feed Distributor
When state or federal authorities conduct an audit for compliance with veterinary feed directive (VFD) rules, they’ll begin at the feed distributor, working back as needed to the veterinarians who filed VFD orders and the producers who purchased the medicated feeds.
During a recent webinar on the VFD audit process hosted by GlobalVetLink, Matt Frederking, VP for Regulatory Affairs with Mid America Pet Food, LLC, addressed questions related to VFD rules and enforcement at the feed-distributor level. The answers, somewhat paraphrased here, came from the FDA’s Center for Veterinary Medicine (CVM).
Q. Can a distributor sell an entire bag of medicated feed containing a VFD drug to a producer when they only need a portion?
A. FDA expects that feed mills will only distribute VFD feeds in quantities that are commensurate with the approximate number of animals as specified by the veterinarian in the VFD. FDA anticipates that, as part of its inspectional activities, it will consider such factors as whether the amount of feed manufactured is reasonable relative to the approximate number of animals specified in the VFD. In cases where VFD feed is pre-bagged in certain amounts, FDA expects the feed mill to distribute the pre-bagged amount that most closely aligns with the approximate number of animals indicated on the VFD.
Q. Does the manufacturer need to keep a VFD on file if the distributor/sales rep already has one?
A. All involved parties (veterinarian, client, and distributor) must retain a copy of the VFD for 2 years. The federal statute requires that any person involved in the distribution or use of a VFD feed maintain a copy of the VFD for that feed. The only exception in the statute is when a distributor is distributing to another distributor and receives an acknowledgment letter instead of a VFD from that other distributor. However, if the distributor/rep and manufacturer are part of the same company, they are considered one distributor, so as long as one member of the company retains the VFD, the requirement that the distributor maintain the VFD for two years is met.
Q. What are the consequences if the VFD is expired or if it’s for the wrong concentration of the drug?
A. FDA reiterates its intention to use a phased enforcement strategy, initially providing education and training for veterinarians, producers, feed mills and other distributors. Over time, FDA will shift toward risk-based surveillance and for-cause inspection assignments. FDA intends to work closely with state regulatory partners and state boards of veterinary medicine in their enforcement strategy.FDA also points out that If animal feed containing a VFD drug is fed to animals without a lawful VFD, then the VFD drug could be considered unsafe, adulterated or misbranded under the FD&C
Act unless the drug and feed are labeled, distributed, held, and used in compliance with the applicable VFD requirements. FDA can pursue several actions for a violation of these prohibited acts including injunction, seizure, monetary penalties, and criminal charges.
Q. What is the expectation for distributors as it applies to the individual drug quantities for which
VFDs are to be distributed in? Are distributors responsible to limit the quantity distributed or, is the responsibility on livestock producers to purchase and feed only the quantities authorized by the respective VFD?
A. FDA expects that feed mills will only distribute VFD feeds in quantities that are commensurate with the approximate number of animals as specified by the veterinarian in the VFD. Since the VFD specifies the number of animals that will be fed and not the exact amount of feed that can be manufactured, feed distributors can work with the client as batches of feed are shipped under the VFD to adjust the amount of feed as feed consumption rates change among the animals.
Q. Is a veterinarian authorized to purchase VFD feeds on the strength of his/her veterinarian license alone, or, must they also notify the FDA of their intent to distribute, and execute an Acknowledgment of Distribution with their VFD distributor for purchases of VFD feeds?
A. If a veterinarian purchasing a VFD feed to distribute that VFD feed to another person they are acting as a distributor under the VFD final rule. Any distributor must send a distributor notification to FDA and comply with the distributor requirements. The veterinarian would then need to provide an acknowledgement letter to the person from whom they purchase the VFD feed.
Q. When will bodyweights become a required field for drugs with bodyweight dependent dosages? Is it the distributor’s responsibility to use that information in selling the customer an appropriate amount of medicated feed.
A. The rule does not require inclusion of estimated body weights for the VFD to be valid, but also does not preclude the veterinarian from including that information. When information about animal body weights is necessary to determine the appropriate amount of feed, FDA encourages distributors,
Veterinarians and clients to work together to share the necessary information about the animals to determine the appropriate amount of feed for the approximate number of animals authorized by the VFD.
Q. Who is responsible for managing the duration of use, the mill or the producer ordering the
feed?
A. If a feed distributor appropriately fills a lawful VFD within the expiration date for an approximate number of animals based on reasonable consumption information provided by the client, but the client uses the VFD feed in a manner inconsistent with the terms of the VFD as issued by the veterinarian, FDA will conduct a follow-up investigation and potentially pursue enforcement against the individual or individuals responsible for any improper activity.
Q. As a feed distributor what liability do we have in enforcing feeding directions written by a vet that may not be legal?
A. As a distributor, per VFD regulation in 21 CFR 558.6(c)(2), you are “permitted to distribute an animal
feed containing a VFD drug or combination VFD drug only if it complies with the terms of the VFD and is
manufactured and labeled in conformity with the approved, conditionally approved, or indexed conditions of use for such drug.”
For information on the FDA’s audit process for VFD compliance, read VFD Audits: What to Expect and VFD Audits: Bovine FAQ.
The recorded webinar is available for on-demand viewing from GlobalVetLink.
