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Pharmaceuticals / Regulatory Affairs

FDA Publishes Final Rule on OTC Antiseptic Hand Wash Ingredients

Dec. 22, 2017

The FDA issued a final rule on the active ingredients in over-the-counter antiseptic hand washes in medical settings.

The agency conducted a safety assessment for such products in 1994, but numerous scientific developments have occurred in the meantime. Systemic exposure to the active ingredients is higher than previously thought and widespread antiseptic use could promote bacterial resistance, the agency found.

In response to these findings, the FDA proposed additional data requirements to demonstrate product safety. These include human safety studies described in current FDA guidance, nonclinical safety studies, data to characterize possible hormonal effects, and data to assess any antimicrobial resistance.

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