The U.S. Food and Drug Administration (FDA) has announced a proposed rule amending the 1994 tentative final monograph for over-the- counter antiseptic drug products. The 1994 monograph proposed that certain active ingredients in antiseptic consumer rubs should be generally recognized as safe and generally recognized as effective.
Due to changes in use and because of scientific developments, FDA suggests that additional safety data are needed to support recognition of the active ingredients as safe and effective. The agency notes, however, that its request for more data “is intended to help the agency ensure that regular use of these products does not present unknown safety and efficacy concerns, and does not mean the FDA believes these products are ineffective or unsafe.” Currently, the rule does not require any consumer hand sanitizers to be removed from the market.
The consumer antiseptic rubs addressed in this proposed rule refer to rubs, leave-on products, hand sanitizers and wipes that are not rinsed off with water and are intended to be used when soap and water is unavailable. It does not address products used by health care professionals or used in a health care setting.
“Today, consumers are using antiseptic rubs more frequently at home, work, school and in other public settings where the risk of infection is relatively low,” Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock commented. “These products provide a convenient alternative when hand washing with plain soap and water is unavailable, but it’s our responsibility to determine whether these products are safe and effective so that consumers can be confident when using them on themselves and their families multiple times a day. To do that, we must fill the gaps in scientific data on certain active ingredients.”
Beyond increased usage, FDA’s proposal was prompted by an independent advisory committee’s input on scientific data gaps. FDA is requesting data on three active ingredients in consumer antiseptic rubs, including alcohol (ethanol or ethyl alcohol), isopropyl alcohol, and benzalkonium chloride. In addition to the safety data, the proposal suggests obtaining in vitro data about the ingredients’ antimicrobial properties as well as in vivo clinical studies logging reductions in bacteria.
FDA’s proposed rule is open for public comment until December 27, 2016. Companies that plan to continue marketing products must provide data within one year of this proposal. After the data is submitted, comments on the information will be accepted for 60 days. A final monograph will be published following FDA’s evaluation of the data and comments. See FDA Press Release, June 29, 2016, and Federal Register, June 30, 2016.