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FDA updates extra-label guide for minor speciesFDA updates extra-label guide for minor species

FDA revises guide on extra-label use of medicated feeds for minor species.

December 5, 2016

3 Min Read
FDA updates extra-label guide for minor species

In order to allow for the continued protection of health for minor species, the U.S. Food & Drug Administration has released a revised Compliance Policy Guide (CPG) about the extra-label use of new animal drugs approved for use in or on animal feed (medicated feeds) for these animals.

FDA originally published CPG 615.115 in 2001 to provide guidance to FDA field staff concerning the agency’s use of enforcement discretion for the extra-label use of medicated feeds in minor species. Minor species are defined as animals other than cattle, horses, swine, chickens, turkeys, dogs and cats.


Extra-label use means actual use or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, FDA said, explaining that this includes, but is not limited to, use in species not listed in the labeling, use for indications (disease or other conditions) not listed in the labeling, use at frequencies or routes of administration other than those stated in the labeling and deviation from the labeled withdrawal time based on these different uses.

Extra-label use of medicated feed is not legally permitted and can result in FDA taking enforcement action against the parties involved. However, there are some minor species that cannot practically be medicated in any way other than by using medicated feed, the agency said.

Because of the need to have therapeutic options available for treatment of minor species and to help ensure animal safety and human food safety, FDA issued the new CPG to provide guidance to FDA staff about factors to consider when determining whether to take enforcement action against a veterinarian, animal producer, feed manufacturer and/or feed distributor for the extra-label use of medicated feeds in minor species.

Under the CPG, when there are no approved treatment options available, the health of animals is threatened and failure to treat affected animals would result in suffering or death, the extra-label use of medicated feeds may be considered for treatment of minor species as long as the conditions and procedures described in the CPG are followed.

FDA revised this CPG to provide additional guidance to FDA field personnel on how to address the extra-label use of both over-the-counter (OTC) and Veterinary Feed Directive (VFD) drugs in medicated feed for minor species and to avoid potential confusion and harm to minor species requiring treatment with certain antimicrobial new animal drug products converting from OTC to VFD marketing status as a result of recommendations included in FDA’s Guidance for Industry #213 to promote the judicious use of antimicrobials.

FDA is implementing this revised CPG immediately to ensure that FDA field staff and other parties affected by the CPG will be made aware of the agency’s enforcement policy regarding the extra-label use of VFD feeds in minor species before Jan. 1, 2017, which is the target date for the changes recommended in guidance #213 to be fully implemented.

The agency will still solicit public comment on the CPG, but immediate implementation provides stakeholders with the opportunity to operate under the provisions of the revised CPG before they submit comments.

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