Final Rule on Surgical Scrubs, Preps, and Hand Washes for OTC Use – Well, Almost!
FDA published a Final Rule (here), finding that 24 ingredients in the proposed monograph, “Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use,” are not considered, or generally recognized, as safe and effective (GRAS/GRAE) for OTC use. However, as noted in the Rule, the FDA has deferred regulatory action on 6 active ingredients: […]