The U.S. Food and Drug Administration (FDA) recently issued a proposed rule seeking more extensive scientific data demonstrating that certain over-the-counter topical antiseptics used in health care settings are safe and effective. The FDA recommends that use of these products continue, consistent with infection control guidelines, while additional data are gathered.
What is FDA proposing?
FDA is asking manufacturers to provide additional scientific evidence that the ingredients in certain antiseptic products used in health care settings – such as hospitals, clinics, medical offices and nursing homes – are safe and effective. Alcohol and iodines are the most common active ingredients in the health care antiseptics affected by this rule.
What products are affected?
Health care antiseptics include health care personnel hand washes and rubs, surgical hand scrubs and rubs, and patient preoperative skin preparations, including pre-injection preparations. This rule does not affect products containing chlorhexidine gluconate, which are regulated through a different pathway.
Is the FDA concerned that these products are not safe and effective? Should I still use them?
We recommend that health care providers continue to use these health care antiseptics consistent with infection control guidelines while more data are gathered. These products are an important component of infection control strategies in health care settings, and remain a standard of care to prevent illness and the spread of infection.
Will products still be available?
This request for data is a proposed rule, so no products are coming off the market.
Why is the FDA taking this action?
FDA is responsible for ensuring that all drug products, including antiseptics, are safe and effective. Since the FDA began review of health care antiseptics in the 1970s, many things have changed, including the frequency of use of some of these products, hospital infection control practices, new technology that can detect low levels of antiseptics in the body, the FDA’s safety standards and the scientific knowledge about the impact of widespread antiseptic use. The FDA is particularly interested in gathering additional data on the long-term safety of daily, repeated exposure to these ingredients and on the use of these products by certain populations, including pregnant and breastfeeding women, for which topical absorption of the active ingredients may be important.
This a proposed rule, and there is a 180-day period for the public to submit to FDA comments and other information. FDA will analyze the new information before issuing a final rule.