FDA Issues Proposed Rule to Address Data Gaps for Certain Active Ingredients in Healthcare Antiseptics?

FDA has issued a proposed rule requesting additional scientific data to support the safety and effectiveness of certain active ingredients used in health care antiseptics marketed under the over-the-counter drug monograph.

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

Based on new scientific information and concerns expressed by outside scientific and medical experts on an FDA advisory committee, the agency is requesting additional scientific data to demonstrate that health care 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. The FDA’s request for more safety and effectiveness data for healthcare antiseptic active ingredients should not be taken to mean the FDA believes that these products are ineffective or unsafe.

Since the FDA began review of healthcare antiseptics in the 1970s, many things have changed, including the frequency of use of some of these products, hospital infection control practices, new technology that can detect low levels of antiseptics in the body, the FDA’s safety standards and the scientific knowledge about the impact of widespread antiseptic use.

Emerging science also suggests that for at least some healthcare antiseptic active ingredients, systemic exposure (full body exposure as shown by detection of antiseptic ingredients in the blood or urine) 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 FDA is particularly interested in gathering additional data on the long-term safety of daily, repeated exposure to these ingredients in the healthcare setting and on the use of these products by certain populations, including pregnant and breastfeeding healthcare workers, for which topical absorption of the active ingredients may be important.