The covered ingredients were initially part of a 1994 tentative final monograph for OTC antiseptic drug products. A 2015 proposed rule called for additional data to support the safety and effectiveness of these ingredients for use in health care antiseptic products. FDA did not receive any additional data, and the available scientific evidence surrounding the ingredients was insufficient to support a determination that they are generally recognized as safe and effective (GRASE).
FDA is delaying final rulemaking for at least one year on benzalkonium chloride, benzethonium chloride, chloroxylenol, alcohol (also known as ethanol or ethyl alcohol), isopropyl alcohol, and povidone-iodine. The Agency has stated that a determination for these ingredients will be dependent upon whether ongoing studies are eventually completed, and if so, when they are completed.
