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US - FDA clarifies policy guideline on extralabel use of Veterinary Feed Directive Drugs

There has been considerable confusion over extralabel use of VFD drugs as described by the Compliance Policy Guideline (CPG) released in December 2016. What may be of most interest in this document is the Veterinary Feed Directive (VFD) Medicated Feed subsection that covers what a veterinarian must do when authorizing the extralabel use of a VFD medicated feed for a minor species such as fish. 

September 8, 2017


 

 

At the 23rd annual Aquaculture Drug Approval Coordination Workshop held August 1-3, 2017 in Bozeman, MT, a series of presentations and panel discussion on Veterinary Feed Directives (VFDs) was led by Dr. Mike Murphy, CVM Office of the Director, Science Policy Team. 

The VFD-themed session was organized because there has been considerable confusion over extra-label use of VFD drugs as described by the Compliance Policy Guideline (CPG) released in December 2016. Although such use is illegal, Dr. Murphy pointed to the sentence in the Guideline (CPG 615.115; page 5) that states \"In general, the Agency [FDA] will not recommend or initiate enforcement action against the veterinarian, animal producer, feed mill, or other distributor when extralabel use is consistent with this document.\"

Compliance Policy Guideline 611.115 is for Minor Species only. The document contains useful information and veterinarians will probably are probably very familiar with what is described in the (1) General Considerations and (2) Veterinarian Considerations sections. 

What may be of most interest in this document is the Veterinary Feed Directive (VFD) Medicated Feed subsection that covers what a veterinarian must do when authorizing the extralabel use of a VFD medicated feed for a minor species such as fish. 

CPG 615.115 can be rescinded. Therefore, there needs to be a concerted effort to ensure compliance with extralabel use of VFD medicated feeds. In addition, it would be well advised, to let the sponsor, AADAP, and CVM know when extralabel use occurs so we can more strategically coordinate research to expand the approved label accordingly. 

Click here for more information on veterinarian responsibilities when authorizing extralabel use of a VFD medicated feed for fish: FDA Revises CPG on Extralabel Use of Medicated Feeds for Minor Species.

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