FDA issues proposed rule for health care antiseptics

The Food and Drug Administration today issued a proposed rule that would require manufacturers to provide additional scientific data to support the safety and effectiveness of certain active ingredients in over-the-counter health care antiseptic products. These include hand washes and rubs for health care personnel, surgical hand scrubs and rubs, and patient preoperative skin preparations, FDA said. The proposal “does not mean that we believe that health care antiseptic products containing these ingredients are ineffective or unsafe, or that their use should be discontinued,” the rule states. Theresa Michele, M.D., who directs the Division of Nonprescription Drug Products at the FDA’s Center for Drug Evaluation and Research, said the rule “seeks to ensure the FDA’s evaluations and determinations for all health care antiseptic active ingredients are consistent, up-to-date and appropriately reflect current scientific knowledge and patterns of use by health care professionals.” Consumer antiseptics such as antibacterial soaps and hand sanitizer rubs are not part of the proposed rule, which will be available for public comment for 180 days.