FDA rule requests safety, effectiveness data on OTC topical antiseptics

The U.S. Food and Drug Administration (FDA) released a proposed rule on the safety and effectiveness of over-the-counter (OTC) healthcare antiseptics on May 1, in the Federal Register. The rule is being proposed  to “establish conditions under which OTC antiseptic products intended for use by healthcare professionals in a hospital setting or other healthcare situations outside the hospital are generally recognized as safe and effective,” according to the FDA.’

In response to the proposed rule, the Association for Professionals in Infection Control and Epidemiology (APIC) and the Society for Healthcare Epidemiology of America (SHEA) agree that certain ingredients in these products should meet infection control guidelines while additional data is being compiled. The most common active ingredients affected by this rule are alcohol and iodine.

In addition to hand washes and rubs for healthcare personnel, other OTC antiseptic products affected by this rule include surgical hand scrubs and rubs and preoperative skin preparations.

The transmission of multidrug-resistant organisms and healthcare-acquired infections can be controlled through vigilant infection control programs.

Topics: Clinical , Regulatory Compliance , Risk Management