Antiperspirant Drug Products for Over-the-Counter Human Use; Final Monograph; Partial Stay; Reopening of the Administrative Record

The Food and Drug Administration (FDA) is staying part of the final monograph (FM) for over-the-counter (OTC) antiperspirant drug products that published in the Federal Register on June 9, 2003 (68 FR 34273). The FM established conditions under which OTC antiperspirant drug products are generally recognized as safe and effective (GRASE) and not misbranded. This partial stay applies only to the labeling claims for enhanced duration in Sec. 350.50(b)(3) and (b)(5) (21 CFR 350.50(b)(3) and (b)(5)). In addition, FDA is reopening the administrative record for the rulemaking on OTC antiperspirant drug products to allow for comment and data specifically on the information requested in this document. FDA is taking this action in response to a citizen petition containing data demonstrating that FDA's effectiveness testing guidelines for OTC antiperspirant drug products may support an enhanced duration claim greater than 24 hours. This action is part of FDA's ongoing review of OTC drug products.