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In Brief: Anticaries monograph effective date

This article was originally published in The Rose Sheet

Executive Summary

Anticaries monograph effective date: FDA extends the effective date of the October 1995 final monograph for OTC anticaries drug products by six months -- from Oct. 6, 1996 to April 7, 1997 -- in an Oct. 7 Federal Register notice. The extension is intended to allow manufacturers time to comply with a simultaneously published final rule revising the second general warning for the category to clarify that "`accidental ingestion' does not refer to the amount of product swallowed during normal use," but rather to "excessive" intake of the product...

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