Stakeholders in the animal health and feed industries have spent the better part of two years reviewing the proposed changes to the Food & Drug Administration’s (FDA) Veterinary Feed Directive (VFD). While many of their concerns were addressed, there remain a few areas that will complicate its implementation by January 2017.
Of these problem areas, one major point of contention was the required two-year VFD recordkeeping guideline. I spoke to Richard Sellers, AFIA’s senior vice president of regulatory affairs, shortly after the final rule was released in early June. Sellers reports that he was of the belief that the recordkeeping timeline had been reduced to one year and was a bit taken aback when it remained unchanged.“We believed we had convinced FDA the two-year requirement should be reduced to one year to agree with the one-year recordkeeping requirement that appears in the Current Good Manufacturing Practices regulations," he said.
According to Sellers, the two-year requirement poses a challenge because none of the U.S. feed mills are currently utilizing a validated electronic system due to the high cost. Instead, each of the thousands of feed mills using medicated feeds will end up retaining signed and dated hardcopies of each VFD for two years. This may not seem like a huge inconvenience at first, but when you consider the additional 283 drugs gaining VDF status, holding onto paperwork for two years at a time presents a great administrative burden and, frankly, take up a lot of space.To date, it’s unclear if this portion of the rule will amended.
Another prevailing question: Will there be enough veterinarians available to prescribe the VFD drugs?“It will require a lot of veterinary work to authorize the use of what had been over-the-counter drugs,” Sellers explained. “Where are they going to be trained? Where are they going to come from? It’s a major marketplace concern.”
Sellers also mentioned the potential problem of “dual drugs on marketplace.” Specifically, the existence of outstanding products with growth promotion claims that may still be in circulation when the VFD goes into effect.
To gauge the stocks, Sellers mentioned that AFIA plans to send out a survey later this year to learn about more about the label changes its members have made; the estimated quantity of product with growth promotion claims remaining on market; the dollar value of this outstanding stock; and how long they believe it will take to eliminate those supplies.
AFIA will hosting two webinars addressing VFD questions beginning on June 30. For more information, click here.