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News From the Food and Drug Administration
June 2, 2015

More Scrutiny for Ingredients in Over-the-Counter Antiseptics

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Copyright 2015 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2015;313(21):2115. doi:10.1001/jama.2015.5303

The FDA has issued a proposed rule asking for additional scientific data to support the safety and effectiveness of certain active ingredients used in over-the-counter health care antiseptics.

Such products include hand washes and rubs, surgical hand scrubs and rubs, and patient perioperative skin preparations that contain alcohol and iodine. Consumer antiseptics, such as antibacterial soaps and hand sanitizers, are not part of the proposed rule.

The request stems from new scientific information and concerns raised last September by an FDA advisory committee, the agency said in a statement. New research suggests that for at least some of the active ingredients in health care antiseptics, systemic exposure is higher than previously thought, according to the statement. The FDA said it is particularly interested in gathering data about the long-term safety of daily exposure in health care settings and on the use of these products by pregnant and breastfeeding health care workers.

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