Astringent rule
This article was originally published in The Rose Sheet
Executive Summary
Effective date for direct final rule for astringents marketed under the OTC Skin Protectant Monograph is June 13, 2004, FDA says in a Jan. 22 Federal Register notice correcting an earlier published effective date of Oct. 27, 2003. FDA published an amended final rule for skin protectant astringent drug products in June and included small packaging exemptions and minor labeling changes along with the incorrect effective date (1"The Rose Sheet" June 16, 2003, p. 10)...