FDA rule calls for more data on safety of healthcare antiseptics

The Food and Drug Administration is considering a new rule that would require manufacturers of over-the-counter antiseptics used in the healthcare industry to provide additional information about the safety and effectiveness of their ingredients.

The rule would apply only to products that want to continue marketing under the over-the-counter monograph, which is the rulemaking and regulatory framework the agency uses to determine an ingredient is safe.

Healthcare antiseptics include hand washes, rubs, surgical hand scrubs used with or without water and preoperative skin preparation products used on patients. The products are commonplace in hospitals, clinics, doctors’ offices and nursing homes and the active ingredients most common in them are alcohol and iodine.

{mosads}Consumer antiseptics such as hand soaps and sanitizers are not part of the proposed rule and are much different than the products used in the healthcare industry.

Under the new rule, manufacturers would need to submit additional data to the FDA on the long-term safety of daily, repeated exposure to active ingredients like alcohol and iodine and data on how the ingredients could impact healthcare workers who are pregnant or breastfeeding.

The FDA said systemic exposure to some of the active ingredients in these products is higher than previously thought, and data has raised concerns about the effects of daily use.

Because antiseptics are key to controlling infection, FDA said healthcare professions should continue to use the products while additional data is being collected.

“FDA does not believe these ingredients are ineffective or unsafe,” said Dr. Theresa Michele, director of the Division of Nonprescription Drug Products at the agency’s Center for Drug Evaluation and Research.

The public has 180 days to comment on this proposed rule. When finalized, manufacturers would have a year to submit data.