The FDA has issued a proposed rule seeking more extensive scientific data demonstrating that 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 changes is the FDA proposing?
The FDA is asking manufacturers to provide additional scientific evidence that the ingredients in antiseptic products used in health care settings – such as hospitals, clinics, medical offices and nursing homes – are safe and effective for health care providers and patients. Alcohol and iodines are the most common active ingredients in health care antiseptics affected by this rule.
The proposed rule does not apply to antiseptics consumers purchase to use in the home such as antiseptic hand washes (antibacterial soap) or hand sanitizers.
Are these products safe and effective?
Over the years, patterns of use have changed, and the FDA continues to evaluate these products. At this time, the agency is asking for more data. The proposed rule doesn’t mean that these products are ineffective or unsafe, and the agency recommends that health care providers continue to use health care antiseptics consistent with infection control guidelines while more data are gathered.
Who is most affected by this regulation?
Most of the products covered by FDA’s proposed rule are used by health care professionals in health care settings. Only preoperative skin preparations and pre-injection preparations are used on patients, and only the pre-injection preparations are used by patients at home.
However, the proposed rule does not require any products to come off the market. The FDA is advising continued use of these products while more information is obtained. If patients have questions, they should consult their health care provider before making changes to their routine use of these products.
This a proposed rule, and there is a 180-day period for the public to submit comments and other information to the FDA. The FDA will analyze the new information before issuing a final rule.
What if I have questions?
Read additional information at Health Care Antiseptics or contact the FDA directly.
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