Veterinary Feed Directive Extralabel Use in Minor Species

By Barry Whitworth

As of Jan. 1, 2017, producers will need a prescription or a Veterinary Feed Directive (VFD) order to use many of the previously available Over-the-Counter (OTC) antimicrobials. All antimicrobials that are administered in water will require a prescription from a veterinarian. Antimicrobials that are mixed in or on feed will require a Veterinary Feed Directive order from a veterinarian. Hopefully, producers consulted with their veterinarian prior to Jan. 1, 2017, and the transition to these requirements has been smooth.

One of the major differences between prescription drugs and VFD drugs is extralabel use. When congress passed the Animal Medicinal Drug Availability Act (AMDUCA) in 1994, it allowed for veterinarians to use drugs in an extralabel manner provided certain conditions were met.

Extralabel use is defined by the Food and Drug Administration (FDA) as: “Actual use or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling. This includes, but is not limited to, use in species not listed in the labeling, use for indications (disease and other conditions) not listed in the labeling, use at dosage levels, frequencies, or routes of administration other than those stated in the labeling, and deviation from labeled withdrawal time based on these different uses.” (21 CFR 530.3(a))

Veterinarians and producers took liberties by using many of OTC antimicrobials in feed in an extralabel manner. This practice was never legal. AMUDUCA expressly prohibited the extralabel use of drugs in feed. With many of the OTC antimicrobials becoming VFD drugs, this practice has stopped.

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