Antimicrobial Hand Sanitizers, Healthcare Products Are On Deck

In the years to come, the FDA may next be targeting antimicrobials in healthcare settings and hand sanitizers. The ACI is already on the offensive, anticipating the new set of rules governing antibacterial healthcare hygiene products that’s slated to be proposed next year. The active ingredients used in antibacterial hygiene products save lives and are recognized as a standard of care for reducing infections in a healthcare setting, the ACI stated in a presentation to the FDA’s Nonprescription Drugs Advisory Committee this past summer.

“A robust body of research supports the safety of active ingredients used in healthcare antiseptic products,” the ACI writes.

The tentative final monograph for Healthcare Antiseptic Products is scheduled for publication in April of 2015, with publication of the final monograph in January of 2018. The FDA is still reviewing information from that advisory committee meeting.

The tentative final monograph for consumer antiseptic hand rub products is scheduled to be published in June of 2016, with the publication of the final monograph in April of 2019.

Anyone in the soap and hygiene products industry needs to be paying attention to these rule proposals, says Sansoni.

“We all need to be aware of this and get engaged with this industry effort, because these products are at risk,” he says.

Lisa Ridgely is a freelance writer based in Milwaukee. She is the former Deputy Editor of Sanitary Maintenance.