FDA reminds aquaculture producers of the correct use of florfenicol

Extra label use of florfenicol in or on feed is not permitted
July 16, 2009

FDA reminds aquaculture producers of the correct use of Florfenicol

The Food and Drug Administration (FDA) is reminding aquaculture producers about the appropriate use of the drug, florfenicol, an antibiotic for use in fish. FDA’s Center for Veterinary Medicine (CVM) has received reports indicating that florfenicol is being administered to fish in forms not currently approved by FDA.  Using a form of florfenicol other than the product form approved for use in or on feed is illegal and can result in illegal drug residues in fish, be unsafe for the fish, or be ineffective in treating the specific diseases in catfish and salmonids for which it is approved. 

Florfenicol is approved for use in fish only as a Veterinary Feed Directive (VFD) drug.  VFD drugs are drugs used in or on animal feed under the supervision of a licensed veterinarian.  There are two VFD animal drug florfenicol products approved/conditionally approved by FDA for use in catfish and salmonid feed: Aquaflor® and Aquaflor®-CA1.

CVM has received reports that some aquaculture producers are using florfenicol in an unapproved manner.  The reports indicate that aquaculture producers are adding florfenicol to pelleted fish feed, commonly called, “fish pills.”  The Animal Medicinal Drug Use Clarification Act (AMDUCA) does not permit the extra label use of a drug in or on feed.  Aquaculture producers are producing food for humans and need to comply with FDA regulations pertaining to human food and animal feed.

CVM is reminding veterinarians and aquaculture producers to always read and carefully follow the drug label directions.

Any questions about the use of the VFD for florfenicol in aquaculture may be directed to Fran Pell, CVM, Division of Compliance, 240-276-9211,