The American Cleaning Institute (ACI) is co-leading a coalition with the Personal Care Products Council (the Council) to engage in the U.S. Food and Drug Administration’s (FDA) process to finalize the 1994 Tentative Final Monograph (TFM) for over-the-counter (OTC) Health-care Antiseptic Drug Products. This regulation prescribes requirements for the use of specific active ingredients, efficacy testing, and product label claims for currently marketed healthcare, food handler, and consumer topical antimicrobial products. ACI and the Council actively work with the coalition member organizations to engage the FDA, the industry, and relevant other stakeholders to ensure that the Final Monograph regulation is scientifically appropriate. These efforts are often associated with the submission of relevant technical information to the FDA.