FDA grants greater flexibility in using VFD drugs!
The FDA recently sent out a letter that should please most folks involved in aquaculture—veterinarians will now have more flexibility in directing treatment of fish. The staff here at AADAP have condensed and translated some of the more technical jargon in this letter into layman’s terms for ease of understanding.
Although originally prohibited, FDA is now making exceptions for the extralabel use of Veterinary Feed Directive (VFD) drugs in fish and other minor species under certain conditions. This means that a veterinarian will be able to write a prescription for use of a VFD drug for the following:
1. Use in species not listed in the labeling,
2. Use for indications (disease or other conditions) not listed in the labeling,
3. Use at frequencies or routes of administration other than those stated in the labeling, and
4. Deviation from the labeled withdrawal time based on these different uses.
The letter doesn’t state that it is legal to prescribe extralabel use of VFD drugs. Rather, the letter is intended to provide information to FDA field inspectors to let them know that their agency will no longer take enforcement action against the parties involved in extralabel use (aka, enforcement discretion for a veterinarian writing a prescription for extralabel use of a VFD drug).
This is especially timely good news, since all in-feed antibiotics became VFD drugs as of January 1, 2017. For aquaculture, this means products such as Terramycin 200 for Fish (active ingredient, oxytetracycline dihydrate; VFD drug no longer available over-the-counter) and Aquaflor (active ingredient, florfenicol; always a VFD drug). By granting greater flexibility to veterinarians, FDA is helping to make safe and effective treatments more accessible to fish and fish culturists in need. For More Information