News from our Microbiology Team

“The US Food and Drug Administration issued a proposed rule requesting additional scientific data to support the safety and effectiveness of certain active ingredients used in health care antiseptics marketed under the over-the-counter drug monograph.” This rule will require manufacturers of antiseptic products under the monograph to provide additional data on the active ingredients, for example, data on potential hormonal effects and development of bacterial resistance. Once this rule is finalized manufacturers will have to provide the necessary data to allow the product to remain available.

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