Topical Antiseptic Drug Products
The U.S. Food and Drug Administration (FDA) is conducting an ongoing review of active ingredients used in over-the-counter (OTC) topical antiseptic drug products to determine whether they are safe and effective. This review encompasses both Consumer Antiseptic Products and Health Care Antiseptic Products. On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security (CARES) Act was signed into law, which included the Over-the-Counter Monograph Safety, Innovation, and Reform Act (OMSIA). This legislation modernized the process by which FDA regulates OTC monograph drugs, including topical antiseptics. Notably, under the CARES Act, sponsor submissions associated with OTC monograph order proceedings are confidential until FDA issues a final order. As a result, the absence of frequent updates to this webpage reflects this statutory change in the regulatory process rather than a lack of ongoing FDA activity. FDA will continue to update this webpage as new regulatory actions or additional information become available.
The completion of the monograph for over-the-counter (OTC) Consumer and Health Care Antiseptic Products is part of FDA’s larger, ongoing review of antiseptic active ingredients to determine whether these active ingredients are safe and effective for use in antiseptic drug products.
FDA Public Communications
- FDA issues final rule on safety and effectiveness of consumer hand sanitizers, 2019
- If Soap and Water Are Not Available, Hand Sanitizers May Be a Good Alternative, 2019
- FDA issues final rule on safety and effectiveness for certain active ingredients in over-the-counter health care antiseptic hand washes and rubs in the medical setting, 2017
- FDA issues final rule on safety and effectiveness of antibacterial soaps, 2016
- FDA requests additional information to address data gaps for certain active ingredient in consumer hand sanitizers, 2016
- FDA issues proposed rule to address data gaps for certain active ingredients in health care antiseptics, 2015
- FDA Drug Safety Communication: FDA requests label changes and single-use packaging for some over-the-counter topical antiseptic products to decrease risk of infection
FDA Letters
Meetings
Background Information
- September 3, 2014, Non-Prescription Drug Advisory Committee Meeting
- Rulemaking History for OTC Topical Antimicrobial Drug Products
- Past public meetings relevant to consumer and health care antiseptics
- Consumer Information on Consumer and Health Care Antiseptics