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Cattle material in OTCs

This article was originally published in The Tan Sheet

Executive Summary

An FDA proposed rule would prohibit the use of certain cattle materials in drugs and homeopathics to prevent the spread of bovine spongiform encephalopathy, according to a Federal Register notice published Jan. 12. The list of materials prohibited from use includes items such as the brain, skull, eyes and spinal cord from cattle 30 months and older. The notice points out homeopathic preparations and OTCs approved through the monograph process will be required to comply with the rule, even though they have not been approved through a new drug application. "Although FDA's database of these products is incomplete, some of them may contain cattle materials that would be prohibited under this proposed rule. The requirements proposed...apply to all drugs for humans, including those marketed without an approved application," the notice states. Comments on the proposed rule are due by March 13...

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