December 19, 2017 | | Comments 0
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FDA bans 24 ingredients in healthcare antiseptics

The FDA has banned two dozen active ingredients used in healthcare products because they weren’t generally recognized as safe and effective for use in over-the-counter (OTC) products. The ban is specifically aimed at OTC products used primarily in medical settings like hospitals, clinics, and doctors’ offices. The ingredients had been used in antiseptic hand washes and rubs, surgical hand scrubs, and patient antiseptic skin preps.

“Ensuring the safety and effectiveness of over-the-counter health care antiseptics has been a priority for the FDA, not only because these products are an important component of infection control strategies in health care settings, but also because of the role these products may play in contributing to antimicrobial resistance if they’re not manufactured or used appropriately,” said FDA Commissioner Scott Gottlieb, MD. “Health care providers are on the front lines of care. They need and deserve to have safe and effective means for preventing the spread of infection.”

With the exception of triclosan, none of the ingredients are currently being used in any marketed health care antiseptic products. And at industry urging, the FDA is deferring their final rulemaking for a year for six ingredients to give manufacturers more time to complete the scientific studies on their safety: alcohol (ethanol), isopropyl alcohol, povidone-iodine, benzalkonium chloride, benzethonium chloride, and chloroxylenol (PCMX).

 

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Filed Under: FDA

About the Author: Brian Ward is an Associate Editor at HCPro working on accreditation, patient safety, and quality news.

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