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# Some OTC Antiseptic Ingredients Not GRASE
- URL: https://www.fdaweb.com/some-otc-antiseptic-ingredients-not-grase/
- Published: 2018-01-02T12:00:00.000Z
- Updated: 2026-09-14T23:09:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140376

FDA has issued a final rule establishing that 24 active ingredients in over-the-counter antiseptic products for use by healthcare professionals in a hospital setting or other healthcare situations outside the hospital are not generally recognized as safe and effective. The agency says it issued the [final rule](https://www.federalregister.gov/documents/2017/12/20/2017-27317/safety-and-effectiveness-of-health-care-antiseptics-topical-antimicrobial-drug-products-for?ref=fdaweb.com) after considering recommendations of the Nonprescription Drugs Advisory Committee, public comments from a notice of proposed rulemaking, and all data and information on OTC healthcare antiseptic products that have come to the agency’s attention.

The final rule finalizes the 1994 tentative final monograph for OTC healthcare antiseptic products. Healthcare antiseptic products, the rule says, include healthcare personnel hand washes, healthcare personnel hand rubs, surgical hand rubs, and patient antiseptic preoperative and pre-injection skin preparations.

The rule covers 24 ingredients determined to be not generally recognized as safe and effective. In response to comments to the proposed rule, FDA says it is delaying further rulemaking on six other active ingredients to allow for the development and submission to the record of new safety and effectiveness data for those ingredients.