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U.S. Department of Health and Human Services

Animal & Veterinary

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COMPLIANCE POLICY GUIDE IN EFFECT FOR THE EXTRA-LABEL USE OF MEDICATED FEEDS IN MINOR SPECIES

FDA Veterinarian Newsletter July/August 2001 Volume XVI, No IV

by Meg Oeller, D.V.M.

The FDA has published a new Compliance Policy Guide (CPG), effective April 23, 2001, to allow for regulatory discretion for the extra-label use of medicated feeds in minor species (any species other than cattle, horses, pigs, dogs, cats, chickens, or turkeys).

A CPG is FDA's direction to its field inspectors. It describes the actions that they should take when they encounter a given situation. This CPG lets inspectors know that FDA will not ordinarily take regulatory action against producers, veterinarians, or feed mills who use or produce medicated feeds for extra-label use in minor species. This does not make the use legal. It simply means that, at this time, the FDA has chosen not to take action when medicated feeds are used under the conditions described in the CPG.

The full text of the CPG is the version that you should consult. This announcement is only intended to make you aware that this policy is in effect and to point out some of the more significant provisions.

A copy of the full text of the CPG is available on the FDA Home Page . If you prefer a paper copy, you may submit a written request for a copy of CPG number 615.115 to the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855. Please send one self-addressed adhesive label or envelope with your request.

"Extra-label use" refers to the use of an approved medicated feed in a manner that is not in accordance with the approved labeling. Extra-label use includes, but is not limited to use in a species not listed in the labeling, use for indications (diseases or other conditions) not listed in the labeling, and deviation from the labeled withdrawal time.

Some of the most significant provisions of this CPG include:

  • The policy applies only to minor species.
  • The medicated feed must already be approved for use in a major species.
  • The feed must be formulated and labeled at the feed mill according to its approved labeling for the major species.
  • If the medicated feed is to be used for a food-producing minor species, the medicated feed must be one approved for use in another food-producing species.
  • If the medicated feed is to be used in an aquaculture species, the medicated feed must be one approved for use in another aquaculture species.
  • The policy applies to farmed wildlife species, but not to unconfined wildlife.
  • The medicated feed may be used in an extra-label manner only under the written recommendation and oversight of a licensed veterinarian.
  • Only therapeutic extra-label uses of medicated feed are included. This excludes production claims such as increased weight gain or feed efficiency.
  • The specific responsibilities of the animal producer, veterinarian, and the feed mill are all outlined in the text of the CPG.
  • If the conditions of the CPG are not met or if tissue residue violations occur, then regulatory action may be taken against the producer or the veterinarian, or in some cases against the feed mill.

The FDA hopes that this new CPG will enable minor species producers to more easily treat their animals when they are sick. This policy is intended to make many drugs approved for use in other species, available to these producers. This does not lessen the FDA's intent to encourage sponsors to seek full approvals specifically for minor species. A CPG may be withdrawn at any time, so an approval is still the best guarantee for the legal availability of needed medications.

If you have questions about this policy, you may contact: Fran Pell, FDA, Center for Veterinary Medicine, HFV-235, 7500 Standish Place, Rockville, MD 20855, (301) 827-0188.

Dr. Oeller is a Veterinary Medical Officer in CVM's Office of the Director, and the FDA liaison to NRSP-7 (the USDA's minor species program).