The Food and Drug Administration is requesting more scientific data on the safety and effectiveness of the active ingredients in antiseptic products used in hospitals, physician’s offices, and other health care settings in a proposed rule issued April 30.

“Today’s proposal 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,” Dr. Theresa Michele, director of the division of nonprescription drug products in the FDA’s Center for Drug Evaluation and Research, said in a statement. The proposed rule “should not be taken to mean” that the agency believes these products are not effective or safe, according to the statement.

Alcohol and iodine are among the most common active ingredients in these products, which include hand washes and rubs, surgical hand scrubs and rubs, and preoperative skin preparations used on patients. These products are marketed under an over-the-counter drug monograph and are different than antibacterial soaps, hand sanitizers, and other consumer antiseptic products, which are not included in this proposed rule. To continue to market these products under the monograph, manufacturers must provide the FDA with more data on the safety and effectiveness of the active ingredients, including absorption, hormonal effects, and bacterial resistance, the statement said.

“Emerging science” suggests that, for at least some active ingredients used in these products, “systemic exposure … is higher than previously thought, and existing data raise potential concerns about the effects of repeated daily human exposure to some antiseptic active ingredients,” the statement said. The agency “is particularly interested in gathering additional data on the long-term safety of daily, repeated exposure to these ingredients in the health care setting and on the use of these products by certain populations, including pregnant and breastfeeding health care workers, for which topical absorption of the active ingredients may be important.”

The proposed rule is available at Public comments can be submitted until Oct. 27.


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