While we stare at the January 1
implementation of the FDA’s new veterinary feed directive (VFD) rules,
it is important to note that the VFD itself is not new. The FDA has
required VFDs for certain medicated feeds for years. Most of those have
applied to other livestock species, but for cattle, Elanco’s Pulmotil
(tilmicosin) product for BRD control has required a VFD since it was
introduced in 1996.
During the recent Academy of Veterinary Consultants (AVC) conference, Elanco Animal Health technical services specialist Guy Hufstedler, PhD, outlined some of his company’s experiences and lessons learned through marketing a VFD drug.
First, he says, teamwork is critical for animal-health management and for ensuring compliance with the VFD rules. Producers need to work closely with their veterinarians, nutritionists and feed suppliers, and also look to the companies that market VFD products for information and advice. All parties involved need to make their best efforts to comply with the law, and not look for loopholes or “work-arounds.” For more on action steps for VFD compliance, read VFD plan from BovineVetOnline.com.
FDA will conduct VFD-related inspections at feed distributors, veterinary clinics and cattle operations. At that point, each party must demonstrate they have the required VFD forms on file and the forms contain all the required information. When a producer can quickly access and provide the requested records, it inspires confidence on the part of the FDA inspector and probably results in a positive outcome. In contrast, Hufstedler says if a producer cannot find the requested VFD records, the inspection is off to a bad start.
As for the VFD forms, veterinarians and producers need to work together to ensure the proper information is included, and that all the information about the drug, dosage, intended use, duration of use and withdrawal times conform with the product label. Note that VFD forms specifically state that “Use of feed containing this Veterinary Feed Directive drug in a manner other than directed on the label (extra-label use) is not permitted.”
Animal-health companies provide VFD forms specifically for their products, which can help simplify the process. The form for tilmicosin, for example, states the indication for use as “Control of BRD,” which is the only indication on the product label for cattle. For duration of use, the form specifies 14 days, which is the approved duration listed on the label.
Another of Elanco’s popular products, Tylan (tylosin) Premix, will require a VFD beginning on January 1. Tylosin is approved for continuous use for reducing the incidence and severity of liver abscesses in cattle. Hufstedler notes the “continuous use” application remains valid. Cattle feeders have expressed some concern that as cattle feed intakes change over the feeding period, intake of tylosin could vary from the grams per ton entered on the VFD form. Hufstedler says the FDA understands the variation inherent to biological systems, and he suggests entering a dosage range of eight to 10 grams per ton (on a 90% dry-matter basis), as specified on the product label.
During a panel discussion at the AVC conference, Kansas State University veterinarian Mike Apley, DVM, PhD, outlined some issues FDA is likely to evaluate in the coming months and years. These include:
· Continuous feeding of a medically important antimicrobial with no defined duration. FDA recently issued a Federal Register notice outlining it plans to reexamine indications for VFD drugs that currently have undefined durations of use. For more on this issue, read “Antibiotic Rules: Knowledge Gap Remains” from BovineVetOnline.com.
· “Pulsing” in the use of medicated feeds.
· Action on the remaining OTC antimicrobials.
· Distribution of Type A medicated articles. Type A medicated articles are the most concentrated form of feed-grade antibiotics, which are mixed with other ingredients to create Type B or C medicated feeds
For more information on the VFD rule and related regulations, visit the FDA’s Veterinary Feed Directive website.
For more information on AVC, and access to recordings of entire presentations at AVC conferences, visit AVC-beef.org.
During the recent Academy of Veterinary Consultants (AVC) conference, Elanco Animal Health technical services specialist Guy Hufstedler, PhD, outlined some of his company’s experiences and lessons learned through marketing a VFD drug.
First, he says, teamwork is critical for animal-health management and for ensuring compliance with the VFD rules. Producers need to work closely with their veterinarians, nutritionists and feed suppliers, and also look to the companies that market VFD products for information and advice. All parties involved need to make their best efforts to comply with the law, and not look for loopholes or “work-arounds.” For more on action steps for VFD compliance, read VFD plan from BovineVetOnline.com.
FDA will conduct VFD-related inspections at feed distributors, veterinary clinics and cattle operations. At that point, each party must demonstrate they have the required VFD forms on file and the forms contain all the required information. When a producer can quickly access and provide the requested records, it inspires confidence on the part of the FDA inspector and probably results in a positive outcome. In contrast, Hufstedler says if a producer cannot find the requested VFD records, the inspection is off to a bad start.
As for the VFD forms, veterinarians and producers need to work together to ensure the proper information is included, and that all the information about the drug, dosage, intended use, duration of use and withdrawal times conform with the product label. Note that VFD forms specifically state that “Use of feed containing this Veterinary Feed Directive drug in a manner other than directed on the label (extra-label use) is not permitted.”
Animal-health companies provide VFD forms specifically for their products, which can help simplify the process. The form for tilmicosin, for example, states the indication for use as “Control of BRD,” which is the only indication on the product label for cattle. For duration of use, the form specifies 14 days, which is the approved duration listed on the label.
Another of Elanco’s popular products, Tylan (tylosin) Premix, will require a VFD beginning on January 1. Tylosin is approved for continuous use for reducing the incidence and severity of liver abscesses in cattle. Hufstedler notes the “continuous use” application remains valid. Cattle feeders have expressed some concern that as cattle feed intakes change over the feeding period, intake of tylosin could vary from the grams per ton entered on the VFD form. Hufstedler says the FDA understands the variation inherent to biological systems, and he suggests entering a dosage range of eight to 10 grams per ton (on a 90% dry-matter basis), as specified on the product label.
Next steps?
The upcoming changes to antibiotic regulations in animal agriculture do not represent the end of the process. Veterinarians believe the FDA will continue to assess management practices, monitor antibiotic-resistance trends and make additional changes toward a goal of improving stewardship.During a panel discussion at the AVC conference, Kansas State University veterinarian Mike Apley, DVM, PhD, outlined some issues FDA is likely to evaluate in the coming months and years. These include:
· Continuous feeding of a medically important antimicrobial with no defined duration. FDA recently issued a Federal Register notice outlining it plans to reexamine indications for VFD drugs that currently have undefined durations of use. For more on this issue, read “Antibiotic Rules: Knowledge Gap Remains” from BovineVetOnline.com.
· “Pulsing” in the use of medicated feeds.
· Action on the remaining OTC antimicrobials.
· Distribution of Type A medicated articles. Type A medicated articles are the most concentrated form of feed-grade antibiotics, which are mixed with other ingredients to create Type B or C medicated feeds
For more information on the VFD rule and related regulations, visit the FDA’s Veterinary Feed Directive website.
For more information on AVC, and access to recordings of entire presentations at AVC conferences, visit AVC-beef.org.
