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OTC skin protectants

This article was originally published in The Rose Sheet

Executive Summary

FDA denies Cosmetic, Toiletry and Fragrance Association request to stay enforcement action on OTC skin protectant final monograph in a Feb. 24 letter to the association. Request to stay action is "moot" after FDA granted CTFA's citizen petition request to include the indications "help prevent" and "chafing" in monograph in a technical amendment published Dec. 9 in the Federal Register (1"The Rose Sheet" Dec. 15, 2003, p. 10). Compliance dates for OTC skin protectant drug products are June 6, 2005 for products with annual sales less than $25,000 and June 4, 2004 for all others. FDA released the rule June 4 (2"The Rose Sheet" June 9, 2003, p. 3)...
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