The FDA’s new Veterinary Feed Directive (VFD) rule has generated a great deal of interest among veterinarians, producers and feed suppliers, as evidenced by over 1,000 participants linking to a live June 17 webinar sponsored by Zoetis.
The full webinar now is available on demand from BovineVetOnline.
The webinar’s lead presentation was from John Hallberg, DVM, PhD, director of Regulatory Affairs for Veterinary Medicine Research and Development at Zoetis.
The new VFD rule, Hallberg says, mandates the rules and responsibilities of licensed veterinarians in prescribing and administering medically important antimicrobials (those important in human and animal health) in feed, and use of medically important antibiotics in water will require a veterinary prescription. Key provisions of the rule include:
- A VFD is comparable to a veterinary prescription for producers to obtain and use medically important antimicrobial for their animals.
- A VFD will be required for all products containing medically important medicated feed additive (MFA) products by December 2016.
- Updates are made in accordance with established procedures in Guidance 213 and aligned with Guidance 209.
The VFD rule works in concert with Guidance 213, which outlines the process to withdraw growth promotion claims for medically important antibiotics and outlines how manufacturers can apply for prevention or therapeutic claims.
Hallberg points out that antimicrobials with performance claims that are not considered medically important, such as ionophores and coccidiostats, are not affected by Guidance 213 or the VFD rule.
As for specifics of the VFD rule, Hallberg stressed these key points:
- It will be illegal to use a VFD in an extra-label manner. You must follow the product label.
- The rule allows issuance of a VFD that may apply for a farm/location for up to six months (unless otherwise noted on the product label).
- The rule allows electronic issuance of a VFD.
- The rule requires maintenance of VFD records for two years. The DVM, feed mill and client must each maintain a copy of the VFD for two years.
- The rule outlines the responsibilities of the DVM, distributor and producer and defines the “script” information that must be on a VFD.
- A veterinarian-client-patient relationship (VCPR) should be established. If the state has a veterinary practice act that defines VCPR, that state regulation will govern a veterinarian’s responsibility in that state.
- Caution statements will be required: “Caution: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.”
Hallberg also stresses there is time for veterinarians and producers to learn about the new VFD requirement and prepare for its December 2016 implementation.
- Review your current list of medicated feed additives to see what might be affected.
- Assign a VFD leader within your operation who can become a go-to resource.
- Consider how you will update/modify record-keeping procedures for recording and filing VFD documentation.
- Stay up to date with any new information from the FDA.
Visit www.ResponsibleAntibioticUse.com/vfd for information and updates.
View the webinar at BovineVetOnline.