Has COVID Changed US FDA’s Thinking About OTC Antiseptics?
The public health emergency has shown that the US needs more hand sanitizers on store shelves, not less, right?
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The American Cleaning Institute is preparing to submit a healthcare personnel hand wash study to the US FDA pending confidentiality discussions, along with results from a literature review on the topic of antimicrobial resistance. A progress report is due to the agency in October, which could stave off an administrative order under the reformed OTC drug review system.
Natural Adventure and PYRLess Group are latest firms to learn FDA, FTC continue monitoring the market for claims promoting supplements as COVID-19 treatments. Hi-Tech Pharmaceuticals recalls APS Nutrition Isomorph 28 and iForce Nutrition Mass Gainz due to undeclared allergens.
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.