Manufacturers Help Infection Control Experts Make Sense of FDA Rules on Antiseptic Ingredients


The American Cleaning Institute (ACI) will help infection control experts better understand the process and possible results from pending Food and Drug Administration (FDA) decisions on the safety and effectiveness of certain active ingredients used in healthcare antiseptics in early 2018.

Dr. Paul DeLeo, ACI associate vice president of environmental safety, will be part of a team of experts speaking at the 2017 Association for Professionals in Infection Control and Epidemiology (APIC) annual meeting in Portland. Joining DeLeo will be Dr. David Macinga, director of regulatory affairs and clinical science for GOJO Industries, Inc.; Dr. Andrew Maier, associate professor of environmental health at the University of Cincinnati; and William Phillips, vice president of regulatory affairs North America for Ecolab Inc.

The FDA is in a multi-year process of establishing a new Healthcare Antiseptic Monograph, which regulates the use of most antiseptic hand hygiene agents in healthcare settings, including what are commonly known as antibacterial soaps, hand sanitizers and pre-operative scrubs.

While FDA's actions are part of the normal process of finalizing Over-the Counter (OTC) drug monographs, the call for additional safety and efficacy data may be confusing to healthcare personnel who routinely use antibacterial soaps and/or hand sanitizers at work.

The pending decisions may significantly impact product availability, according to ACI.

"Healthcare antiseptics are an important component of infection control strategies and remain a standard of care to prevent illness and infection. We want to help healthcare professionals better understand the FDA process and proposed rules," said DeLeo. "Manufacturers continue to advance the science and are providing the FDA with state-of-the art scientific data and research of the safety and efficacy for specific ingredients used in antibacterial soaps and hand sanitizers as part of the FDA framework."

In an FDA statement announcing the proposed healthcare rules in May 2015, the agency said, "The FDA recommends that health care personnel continue to use these products consistent with infection control guidelines while additional data are gathered."

The presenters' June 15 session at the APIC conference will assist infection control specialists in understanding FDA's rules and related regulatory process, the resulting revisions to the final consumer rinse-off monograph, the proposed revisions to the healthcare products monographs, and the FDA's data needs and timeline for decision-making going forward.

ACI has made extensive submissions to FDA on antibacterial product safety and efficacy for healthcare and consumer settings. To view those comments and other related statements, visit ACI's website,

Source: American Cleaning Institute

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