When the Food and Drug Administration (FDA) issued its final veterinary feed directive (VFD) rules back in 2015, they also released a draft guidance for industry (GFI) offering answers to anticipated questions regarding application of the rules in common and unusual circumstances.
The VFD rules, along with GFI 213, which removed performance or production claims for medically important antibiotics used in food animals, began full implementation on Jan. 1, 2017. Not surprisingly, producers, veterinarians and feed distributors have, over the past two years, encountered questions and situations that required more clarity for VFD compliance. In late March, FDA released its draft GFI 120, which aims to address those questions. FDA will accept comments on the draft GFI until May 28.
This week, Global VetLink (GVL) hosted a webinar for veterinarians featuring members of its Expert Council, reviewing some key updates from the draft guidance.
- Tyler Holck, DVM, an independent swine veterinary consultant and owner of Feed His People, LLC, who also serves as leader for the GVL Expert Council.
- Michael Apley, DVM, PhD, Professor of Production Medicine / Clinical Pharmacology in the Department of Veterinary Clinical Sciences at Kansas State University.
- Matt Frederking, Vice President of Regulatory Affairs and Quality at Mid America Pet Food.
- Christopher Rademacher, DVM, Senior Clinician and the ISU Swine Extension Veterinarian in the Veterinary Diagnostic and Production Animal Medicine (VDPAM) department at the Iowa State University College of Veterinary Medicine.
Since VFD implementation in January 2017, Holck says, GVL has processed about 230,000 VFD documents for more than 3,000 veterinarians through its FeedLINK electronic records system. About 68% of those VFD orders were for cattle.
Key questions and answers the group addressed include:
Q: My client will have multiple groups of animals moving through their farm during the time period the VFD covers. Can I write the VFD to include the successive groups of animals that will be on the farm during the time period?
A: Yes, but the veterinarian should include information such as the estimated number of animals in each treatment group and ensure that the treatments fall within the time frame specified in the VFD.
Q: Does the VFD feed authorized by a VFD need to be shipped in one load, or can it be delivered in multiple loads?
A: The VFD can cover multiple loads. The veterinarian should specify the approximate number of animals treated and ensure treatments comply with the VFD expiration date.
Q: Does it matter whether the veterinarian uses a drug’s trade name (generic) or proprietary (pioneer) name in the VFD?
A: If the veterinarian specifies the brand-name pioneer drug on the VFD, the client should use that product. If the veterinarian uses the generic name, the client and feed distributor can choose between proprietary or generic formulations.
Q: What if the label for the VFD drug uses the dosage, such as mg/head/day, instead of the level of the drug, such as g/ton, in the feed? Can I just include the dosage on the VFD?
A: The VFD should specify the level of drug in the feed, such as g/ton, along with the number of animals treated. When the drug label just lists dosage, the veterinarian calculates the level for the VFD order. Also, if the drug level in the feed needs to change over the course of the VFD’s duration, due to changes in the animals’ body weight and feed intake, the veterinarian calculates those levels to ensure the proper dosage.
Q: If a single entity or company manufactures VFD feeds, owns the animals covered by a VFD and employs the veterinarian writing the VFD, do they need to retain three copies of VFD orders?
A: No, the company would need to retain just one copy of each VFD.
Q: If clients manage animals at multiple premises, do they need to keep VFD records at each location?
A: No, the client can keep VFD records at one location, as long each VFD specifies the premises for covered animals and the records are readily accessible for inspection.
Q: If the client decides to switch feed suppliers for a medicated feed under an existing VFD, is a new VFD required?
A: Yes, unless the new supplier is part of the same business as the original supplier, the veterinarian needs to cancel the existing VFD and issue a new one. All parties should document the reason for cancelling the original VFD.
Q: If a veterinarian is licensed in one state, can they write a VFD for animals located in another State?
A: The veterinarian issuing the VFD must be licensed in the state in which the covered animals are located.
Q: If a VFD label has a duration range in which a VFD can be fed, such as 21 to 42 days, and the veterinarian authorizes the use of the VFD for the full 42 days, can the client decide when to stop feeding the VFD feed after the minimum provided in the range?
A: The veterinarian specifies the duration of treatment on the VFD. If the veterinarian specifies 42 days, the producer needs to comply with that duration, If the veterinarian enters a range, such as 21 to 42 days, in compliance with the drug label, the producer and veterinarian have flexibility in deciding duration of treatment.
The comment period for this draft revised guidance is 60 days and will end May 28, 2019. For instructions on submitting comments to the FDA, please see the Federal Register notice.
See the full draft guidance for industry 120.
For more about the VFD rules and compliance, see these articles on BovineVetOnline: