ACI is leading multi-year multi-million-dollar efforts to address FDA’s safety and efficacy data requirements in the final OTC Topical Antiseptic Monographs for Health Care, Consumer Wash and Consumer Rub products, in order to preserve and protect the marketplace for these products.
ACI leads Interested Party Groups (IPGs) who fund, plan and direct the testing of antiseptic active ingredients to fill FDA’s Monograph data requirements. ACI also serves as the point-of-contact for the IPGs in discussions with FDA to develop and approve study designs and protocols.
FDA OTC Monograph Requirements for Active Ingredients
Active Ingredients & Their Eligible Uses
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FDA Assessment of Safety Data Gaps
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FDA Assessment of Effectiveness Data Gaps
Consumer Hand Wash Antiseptics
FDA: requires data from clinical outcome studies and surrogate endpoint studies (in vitro – Time Kill)
Consumer Hand Rub & Healthcare Antiseptics
FDA: requires data from surrogate endpoints (in vivo – bacterial log reduction; in vitro – Time Kill and MIC-MBC)
Research
Impact of benzalkonium chloride, benzethonium chloride and chloroxylenol on bacterial antimicrobial resistance
Journal of Applied Microbiology | December 2022
The use of products containing benzalkonium chloride (BKC), benzethonium chloride (BZT) and chloroxylenol (CHO) has been viewed as a concern for potential development of decreased bacterial susceptibility to biocides and/or chemotherapeutic antibiotics. Findings indicate that most literature does not show a decreased susceptibility, or efficacy when using these three active ingredients.
Ecological Risk Analysis for Benzalkonium Chloride, Benzethonium Chloride, and Chloroxylenol in US Disinfecting and Sanitizing Products
Environmental Toxicology and Chemistry | November 2022
The use of three topical antiseptic compounds – benzalkonium chloride (BAC), benzethonium chloride (BZT) and chloroxylenol (PCMX) – has increased due to the phase-out of other antimicrobial ingredients in soaps and other disinfecting and sanitizing products. The study finds that those compounds are unlikely to have adverse impacts in the environment, under the triclosan replacement scenarios that were evaluated.
Environmental Risk Assessments for Topical Antiseptic Ingredients: Chloroxylenol
Society of Environmental Toxicology and Chemistry North America Annual Meeting | November 2019
Environmental Risk Assessments for Topical Antiseptic Ingredients: Benzalkonium Chloride
Society of Environmental Toxicology and Chemistry North America Annual Meeting | November 2019
Environmental Risk Assessments for Topical Antiseptic Ingredients: Benzethonium Chloride
Society of Environmental Toxicology and Chemistry North America Annual Meeting | November 2019