Extralabel Use of A Medicated Feed in a Small Ruminant

The Center for Veterinary Medicine of the FDA issued a revised Compliance Policy Guide (CPG 615.115) in which the extralabel use of approved drugs in medicated feed may be considered for minor species.

Extralabel use of medicated feed may be considered for treatment of minor species when there are no approved treatment options available and the health of animals is threatened, and suffering or death would result from failure to treat the affected animals.

The Following criteria must be met in order for medicated feeds to be used in an extralabel manner.
  1. Have a valid Veterinary Client Patient Relationship (VCPR)
    • Veterinarian has assumed responsibility for making medical judgments and the client has agreed to follow the instructions of the veterinarian
    • Veterinarian has sufficient knowledge of the animals to initiate a diagnosis
    • Practicing veterinarian is readily available for follow-up in the case of adverse reactions and has recently seen or is personally acquainted with the care of the animals by virtue of examination of the animals and/or by timely visits to the premises
  2. Extralabel use is limited to:
    • A minor species not listed in the approved drug labeling or the use indications for that minor species not listed in the labeling
    • A medication approved for use in animal feed
    • Use in a minor species similar to the species for which the medicated feed is approved
      • Mammalian species are limited to medicated feeds approved for use in
        mammalian species
      • Avian species are limited to medicated feeds approved for use in avian species
      • Aquaculture is limited to medicated feeds approved for use in aquatic species
    • Farmed or confined minor species
      • Use in unconfined wildlife is not permitted under this CPG
    • Therapeutic treatment and not production (claim) purposes
    • Non-promotional use (no advertising of the medicated feed for an extralabel use)

Writing and Documenting a VFD for a Minor Species

For drugs requiring a Veterinary Feed Directive (VFD), the veterinarian must:
  1. Complete a separate written recommendation to the client including the medical rationale and the withdrawal period with copies maintained by the veterinarian and client for 2 years
  2. Complete a VFD consistent with the approved labeling for the indication (write for a major species and indication) and in special instructions note:
    • “This VFD is being issued in accordance with CPG 615.115”
    • The actual species for which the medicated feed is intended, and
    • The withdrawal interval associated with the extralabel use if different than the labeled withdrawal time as already reflected on the VFD.

Extralabel Drug Use in Small Ruminants