FDA issues proposed healthcare antiseptics rule — 4 notes

The Food and Drug Administration has issued a proposed rule with regard to healthcare antiseptics.

Here are four things to know:

1. The new rule requires manufacturers of healthcare antiseptics to provide additional scientific data to support the safety and effectiveness of certain active ingredients.

2. Healthcare antiseptics are primarily used by healthcare professionals and include hand washes and rubs, surgical hand scrubs and rubs as well as patient preoperative skin preparations.

3. The agency wants to request additional data due to new scientific information and concerns expressed by outside scientific and medical experts on an FDA advisory committee.

4. The proposed rule will be available for public comment for 180 days.

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