OTC review agenda
This article was originally published in The Rose Sheet
Executive Summary
FDA expects to release the OTC Sunscreen Drug Products Final Monograph in November, according to the Department of Health & Human Services Semiannual Regulatory Agenda, published June 28 in the Federal Register. Rule previously was slated for release this spring following a delay last year to incorporate testing and labeling requirements for UVA/UVB (1"The Rose Sheet" June 9, 2003, p. 3). Final action on the antiperspirant monograph is expected in September, while the agency anticipates publishing technical amendments to the OTC skin protectant drugs final rule in December that permit optional labeling language to include the indications "helps prevent" and "chafed." Also on the agenda is the release of a notice of proposed rulemaking for labeling on convenience-size packaging in August...