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Antiseptic Meetings

On March 27, 2020, the President signed the Over-the-Counter Monograph Safety, Innovation, and Reform Act into law. This act is intended to modernize the process by which FDA regulates over-the-counter monograph drugs. The FDA is in the process of implementing the changes set forth in the act and will update the public and this webpage as we have additional information.

Consumer hand and body wash antiseptics

March 20, 2015: A meeting with American Cleaning Institute to discuss the safety and effectiveness data gaps for the active ingredients benzethonium and benzalkonium chloride and propose a new and significant set of testing requirements to fill those gaps and establish that those active ingredients are generally recognized as safe and effective when used in consumer antiseptic products intended for use with water.

April 24, 2015: A meeting with American Cleaning Institute to discuss the safety and effectiveness data gaps for the active ingredient chloroxylenol and propose a new and significant set of testing requirements to fill those gaps and establish that those active ingredients are generally recognized as safe and effective when used in consumer antiseptic products intended for use with water.

May 6, 2015: A meeting with Lonza America, Inc. to discuss overall approach for providing a safety database for the active ingredients benzethonium and benzalkonium chloride in consumer antiseptic hand washes.

May 9, 2018: A meeting with Lewis and Harrison on behalf of Lonza, Inc. (Lonza) and Henkel Consumer Good Inc. (Henkel) to discuss additional guidance on final testing parameters for planned Maximal Usage Trials (MUsT) on benzethonium chloride (BZC) and benzalkonium chloride (BAK).

August 6, 2018: A meeting with American Cleaning Institute to discuss an enterotoxigenic E.coli (ETEC) clinical challenge study intended to be responsive to FDA’s request for data from clinical outcome studies.

July 30, 2020: A meeting with Lewis and Harrison to discuss results and obtain FDA feedback on the proposed Maximum Use Trial (MUsT) and in vitro dermal penetration (IVDP) assays conducted with benzalkonium chloride as well as to discuss the draft protocol for the definitive MUsT study.

Health care antiseptics

July 30, 2015: A meeting with GOJO Industries, Inc. to discuss the protocols submitted to health care antiseptic Docket No. FDA-2015-N-0101 regarding Physiologically-Based Pharmacokinetic (PBPK) Modeling, formulation variances, and efficacy for ethyl alcohol.

October 20, 2015: A meeting with American Chemistry Council to discuss the data gaps identified for isopropyl alcohol for use in patient preoperative skin preparations, healthcare personnel hand rubs, and surgical hand rubs.

May 25, 2016: A meeting with Lonza America, Inc. to obtain clarification on the human pharmacokinetic maximal use trial (MUsT) and discuss the process of requesting a time extension for completion of the MUsT and other safety data required to support generally recognized as safe listing for benzethonium chloride and benzalkonium chloride.

August 18, 2016: A written response to American Chemistry Council as follow-up to the October 20, 2015 meeting and in response to FDA’s meeting minutes to further discuss the data gaps identified for isopropyl alcohol for use as in patient preoperative skin preparations, healthcare personnel hand rub, and surgical hand rubs.

March 19, 2019: A meeting with Cardinal Health to discuss the requirements to support a finding of Generally Recognized as Safe for Isopropyl Alcohol (IPA) in health care setting for use as a patient antiseptic skin preparation (pre-injection pads and pre-operative swabs). Discussion focuses on nonclinical safety and toxicology and clinical pharmacology and bioavailability.

Health care antiseptics and consumer antiseptic rubs

March 1, 2018: A meeting with American Cleaning Institute to discuss in vivo clinical simulation hand rub study to evaluate the effectiveness of ethanol as a hand rub for use in health care antiseptic and consumer antiseptic rubs.

September 29, 2020: A written response to American Cleaning Institute to discuss in vivo efficacy studies for benzethonium chloride for use as a health care antiseptic. 

Consumer hand and body wash and consumer antiseptic rubs

July 9, 2019: A meeting with Lewis and Harrison requesting a guidance meeting to discuss formula selection, number of hand washes, and updated protocol for pilot Maximal Usage Trial (MUsT) studies with benzalkonium chloride and benzethonium chloride consumer hand wash products.

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