FDA issues final rule on health care antiseptic products

The Food and Drug Administration today finalized a 2015 proposed rule requiring manufacturers to provide additional scientific data to support the safety and effectiveness of certain active ingredients in over-the-counter health care antiseptic products, which include hand washes and rubs for health care personnel, surgical hand scrubs and rubs, and patient preoperative skin preparations. The final rule concludes that triclosan and 23 other active ingredients used in certain over-the-counter health care antiseptic products are not generally recognized as safe and effective because no additional safety and effectiveness data were provided for these ingredients. The agency said it expects little change to currently available products because the majority of them do not use these ingredients. The rule defers for one year rulemaking on six common active ingredients in OTC health care antiseptic products to give manufacturers more time to complete studies needed to determine their safety and efficacy. Meanwhile, FDA recommends that health care personnel continue to use currently available products, consistent with infection control guidelines.