May 4, 2007
FDA Clarifies Extra-label use of medicated feed in minor species per CPG #615.115
FDA’s Center for Veterinary Medicine (CVM) is clarifying the Compliance Policy Guide (CPG) section 615.115 entitled, "Extra-Label Use of Medicated Feeds for Minor Species'' in order to ensure proper use of medicated feed in minor species. CVM has received a number of inquiries relative to the proper use of the CPG. The inquiries have revealed some common points of confusion regarding the appropriate interpretation of the principles specified in the CPG.
The following conditions, in addition to all other stipulations in the CPG, have to be satisfied in order to ensure proper use of medicated feed in minor species:
Veterinarian involvement. Any extra-label use of medicated feed in minor species per this CPG requires involvement of a licensed veterinarian within the confines of a valid veterinarian-client-patient relationship. The veterinarian is expected to make a written recommendation for the extra-label use of medicated feed based on a recent diagnosis of an active disease for which no other drug treatment is approved.
Treatment only use. Medicated feed may be considered for treatment only when the health of animals is threatened and suffering or death would result from failure to treat the affected animals.
No production use. Extra-label use of medicated feed for production purposes is not allowed.
No feed reformulation or relabeling. Once manufactured and labeled as approved for use in a major species, the feed cannot be either reformulated to meet nutritional needs of the intended minor species or relabeled as such.
Comments on the CPG may be submitted any time to: FDA's Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments should be identified with the full title of the CPG and Docket number 99D-2638.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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