The Food and Drug Administration (FDA) has issued a proposed rule requesting additional scientific data to support the safety and efficacy of certain ingredients in antiseptics used in healthcare and marketed under the over-the-counter drug monograph.

The agency is requesting additional scientific data to demonstrate that healthcare antiseptics in the over-the-counter drug monograph are generally recognized as safe and effective (GRASE) for their intended use to reduce bacteria that potentially can cause disease. This request is based on new scientific information and concerns expressed by outside scientific and medical experts on the FDA Nonprescription Drugs Advisory Committee.

New data also suggest that systemic exposure is greater than previously thought for some of the active ingredients in healthcare antiseptics and that current study results raise potential concerns about the effects of repeated daily human exposure to some antiseptic active ingredients. Data on the long-term safety of daily, repeated exposure to those ingredients in the healthcare setting and use of these products by certain populations (such as pregnant and breastfeeding healthcare workers) is of particular interest to the FDA.

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Healthcare antiseptics used by professionals in hospitals, clinics, doctors’ offices, outpatient settings and nursing homes include hand washes and rubs, surgical hand scrubs and rubs (with or without water), and patient preoperative skin preparations, including pre-injection preparations. Alcohol and iodines are the most common active ingredients in healthcare antiseptics marketed under the over-the-counter drug monograph. Consumer antiseptics such as antibacterial soaps and hand sanitizer rubs are not part of this proposed rule and differ from healthcare antiseptics.

The FDA recommends that healthcare professionals continue to use these products in accordance with infection control guideline while additional data are gathered. This request for additional data for should not be taken to mean that the FDA believes that these products are ineffective or unsafe. The proposed rule will be available for public comment for 180 days and companies will have one year to submit new data and information on their products’ active ingredients’ safety and effectiveness, including data to evaluate absorption, potential hormonal effects, and development of bacterial resistance. This will be followed by a 60-day rebuttal comment period.

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