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OTC ORAL ANTISEPTIC TFM CONTAINS NO CATEGORY I INGREDIENTS,

This article was originally published in The Rose Sheet

Executive Summary

OTC ORAL ANTISEPTIC TFM CONTAINS NO CATEGORY I INGREDIENTS, but FDA is encouraging interested parties to design studies to upgrade Category II (not safe and effective) or Category III (data insufficient to permit classification) ingredients to Category I (safe and effective). In the over-the-counter oral antiseptics tentative final monograph, published in the Feb. 9 Federal Register, FDA noted that the OTC Oral Cavity Drug Products Review Panel's "Proposed in vitro and in vivo testing guidelines and its discussion of clinical studies represent a good starting point for the design of studies to upgrade" Category II and Category III ingredients.
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