FDA issues proposed rule to investigate the safety of active ingredients in healthcare antiseptics

May 13, 2015

The U.S. Food and Drug Administration issued a proposed rule last month, requesting additional scientific data to support the safety and effectiveness of certain active ingredients used in healthcare antiseptics marketed under the over-the-counter drug monograph.

Healthcare antiseptics are primarily used by healthcare professionals and include hand washes and rubs, surgical hand scrubs and rubs (with or without water), and patient preoperative skin preparations. The most common active ingredients in the antiseptics include alcohol and iodine. These are different from consumer antiseptics, such as antibacterial soaps and hand sanitizer rubs, which are not included in this proposed rule.

Based on new scientific information and concerns expressed by outside scientific and medical experts on an FDA advisory committee, the agency is requesting additional scientific data to demonstrate that healthcare antiseptics in the over-the-counter drug monograph are generally recognized as safe and effective for their intended use to reduce bacteria that potentially can cause disease. The request for more safety and effectiveness data for healthcare antiseptic active ingredients should not be taken to mean the FDA believes that these products are ineffective or unsafe.