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FDA’s OTC Program Has Changed, But Antiseptic Sector Prepares For More Of The Same

 
• By Ryan Nelson

The future of OTC antiseptic products – including antibacterial soaps and sanitizing hand rubs and wipes – came into serious question under FDA monograph actions taken in recent years. Stakeholders agree that Congress’s recently enacted CARES Act promises to transform OTC drug review, but the data requirements and uncertainty surrounding OTC germ-killing ingredients may be quickly reinstated.

Handsanitizaer and mask

Notwithstanding recent COVID-19 relief legislation overhauling the US Food and Drug Administration’s OTC drug review program, studies go on to support GRASE decision-making for six antiseptic drug ingredients hitherto subject to deferred FDA rulemaking.

“We’re proceeding for the time being,” said the American Cleaning Institute’s James Kim, vice president of science and

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