FDA Final Rule on Safety and Effectiveness of Health Care Antiseptics

PUBLISHED: Dec 21, 2017
Relevant to: Ambulatory Care, Behavioral Health, Clinical Lab, Critical Access Hospitals, Dialysis Facilities, Home Health, Hospice, Hospitals, Long Term Care, Medical Office, Pharmacy

The US Food and Drug Administration (FDA) has issued a final rule establishing that certain active ingredients used in nonprescription/over-the-counter (OTC) antiseptic products intended for use by health care professionals in a hospital setting or other health care situations outside the hospital are not generally recognized as safe and effective. Health care antiseptic products include health care personnel hand washes, health care personnel hand rubs, surgical hand 4 scrubs, surgical hand rubs, and patient antiseptic skin preparations (i.e., patient preoperative and pre-injection skin preparations).

In the final rule the FDA lists triclosan and twenty-three other active ingredients that are not generally recognized as safe because there is no additional safety and effectiveness data provided for these ingredients. According to the FDA, the majority of products currently available do not use these ingredients.

At this time the FDA recommends that health care professionals continue to use these antiseptic products consistent with infection control guidelines while additional data about the products are gathered.

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