The US Food and Drug Administration (FDA) has issued a proposed rule requesting additional scientific data to support certain active ingredients used in health care antiseptics marketed under the over-the-counter drug monograph are generally recognized as safe and effective (GRASE) for their intended use to reduce bacteria that potentially cause disease.
The proposed rule also aims to require manufacturers to continue marketing health care antiseptic products under the monograph to provide the FDA with additional data on the active ingredients’ safety and effectiveness, including data to evaluate absorption, potential hormonal effects and development of bacterial resistance.
FDA defines health care antiseptics as primarily used by health care professionals in hospitals, clinics, doctors’ offices, out-patient settings and nursing homes. Health care antiseptics include the following:
- Hand washes and rubs
- Surgical hand scrubs and rubs (with or without water)
- Patient preoperative skin preparations, including pre-injection preparations
Once the proposed rule is finalized, a public consultation will be open for 180 days.