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Antiseptic FDA Letters

Consumer hand rub antiseptics granted deferral letter

October 31, 2017: FDA issued deferral grant letters requesting that ethyl alcohol, isopropyl alcohol, and benzalkonium chloride be deferred from the final rulemaking in order to fill safety and efficacy data gaps and establish that those active ingredients are generally recognized as safe and effective when used in consumer hand rub antiseptics intended for use without water.

Consumer hand and body wash antiseptics granted deferral letters

March 10, 2016: FDA issued deferral grant letters requesting that benzalkonium chloride, benzethonium chloride, and chloroxylenol be deferred from the final rulemaking in order to fill safety and efficacy data 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.

Health care antiseptics granted deferral letters

January 19, 2017: FDA issued deferral grant letters requesting that ethyl alcohol, isopropyl alcohol, povidone iodine, benzalkonium chloride, benzethonium chloride, and chloroxylenol be deferred from the final rulemaking in order to fill safety and efficacy data gaps and establish that those active ingredients are generally recognized as safe and effective when used in health care settings.

Health care, consumer hand and body wash, and consumer hand rub antiseptics advice letter

March 24, 2017: FDA issued an advice letter in response to American Cleaning Institute request for an extension to defer final rulemaking on benzalkonium chloride, benzethonium chloride, and chloroxylenol under the OTC consumer antiseptic wash monograph (FDA-1975-N-0012) and to combine into a single Work Plan and reporting cycle the deferrals for those active ingredients plus ethanol under consumer hand rub antiseptic and health care antiseptic (FDA-2015-N-0101) rulemaking proceedings.

July 5, 2018: FDA issued an advice letter in response to American Cleaning Institute submission of the final report for a time-kill study titled: “An In Vitro Time-Kill Evaluation of Four Test Materials When Challenged with Various Bacterial and Yeast Species.” The four test materials evaluated include benzalkonium chloride (BAC), benzethonium chloride (BZC), Dettol (chloroxylenol, PCMX), and ethanol (EtOH).

July 2, 2019: FDA issued an advice letter in response to American Cleaning Institute submission of a completed in vitro study report providing a time-kill evaluation of four antiseptic active ingredients – benzalkonium chloride, benzethonium chloride, chloroxylenol, and ethanol.

August 29, 2019:  FDA issued an advice letter in response to American Cleaning Institute submission of a final study report for the Minimum Inhibitory Concentration (MIC)/Minimum Bactericidal Concentration (MBC) evaluation of five antiseptic active ingredients – benzalkonium chloride, benzethonium chloride, chloroxylenol, ethanol, and povidone iodine.

November 20, 2020: FDA issued an additional advice letter in response to FDA’s Advice Letter dated November 18, 2020 in response to ACI’s July 14, 2020 communication regarding the deferral on benzalkonium chloride, benzethonium chloride, chloroxylenol, ethanol, and povidone-iodine

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Consumer hand and body wash antiseptics advice letter

April 3, 2017: FDA issued an advice letter to American Cleaning Institute in response to November 22, 2016 submission which contained a draft protocol titled: “Incidence of clinical illness and bacterial colonization after ingestion of enterotoxigenic Escherichia coli: effect of hand washing with either plain soap or an antibacterial hand soap.” This is also in response to December 9, 2016 submission which contained a draft protocol titled: “Household use of antimicrobial soap for prevention of recurrent Staphylococcal infection.”

September 8, 2017: FDA issued an advice letter in response to American Cleaning Institute submission of a draft study protocols for assessment of absorption, distribution, metabolism, and excretion (ADME) in rats following oral and dermal administration of PCMX.

Health care and consumer hand and body wash antiseptics advice letter

September 8, 2017: FDA issued an advice letter to American Cleaning Institute in response to Agency letters, dated 10 March 2016 and 19 January 2017, granting initial deferral of chloroxylenol from proposed rulemaking under the OTC drug review on consumer antiseptic washes (78 FR 76444) and on health care antiseptic products (80 FR 25166), respectively, pending receipt of additional data.

August 8, 2019: FDA issued an advice letter to American Cleaning Institute as follow-up to the following: 1) October 12, 2018 submission in reference to the March 1, 2018 meeting (ethanol) and 2) July 5, 2018 FDA advice letter on the time-kill study (ethanol, chloroxylenol, benzalkonium chloride, and benzethonium chloride). 

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Health care antiseptics advice letters

March 8, 2016: FDA issued an advice letter to the American Cleaning Institute as follow-up to the January 5, 2016 protocol submission entitled: An In Vitro Time-Kill Evaluation of Six Test Materials When Challenged With Twenty-Eight Bacterial and Yeast Species.

June 17, 2016: FDA issued an advice letter to the American Cleaning Institute as follow-up to the March 21, 2016 submission which contained a draft in vitro efficacy protocol entitled: Determination of the Minimum Inhibitory Concentration (MIC) and Minimum Bacterial Concentration (MBC) of Six Test Materials.

August 10, 2016: FDA issued an advice letter to the American Cleaning Institute as follow-up to the April 28, 2016 submission which contained a draft pilot in vivo efficacy protocol entitled: Pilot Evaluation of the Antimicrobial Efficacy of Three Test Materials with an Active Control and Inactive Control Based on the ASTM E1174 Standardized Test Method Performed with a Randomized Parallel Design.

September 28, 2016: FDA issued an advice letter to the American Cleaning Institute as follow-up to the July 20, 2016 submission which included a list of organisms that would be tested as part of a proposed single time-kill and a single minimum inhibitory concentration (MIC) and minimum bactericidal concentration (MBC) study for potential pathogens that may be encountered in consumer and health care settings.

December 30, 2016: FDA issued an advice letter to the American Chemistry Council as follow-up to the October 17, 2016 submission discussing the possibility of performing a shared study that will fill data gaps for isopropyl alcohol in both the Health Care Antiseptic and Consumer Rub Antiseptic monographs.

January 4, 2017: FDA issued an advice letter to GOJO Industries as follow-up to the September 6, 2016 submission containing a protocol entitled: Approach and Plan to Address Key Elements for Maximal Use PK trial (MUsT) Design.

July 25, 2018: FDA issued an advice letter in response to American Chemistry Council inquiry regarding inhalation studies to address the data gaps for Isopropyl Alcohol for carcinogenicity assessment and the potential for hormonal effects.

August 6, 2018: FDA issued an advice letter in response to American Cleaning Institute submission of a draft protocol for a pilot human pharmacokinetic maximal use trial (MUsT) for ethyl alcohol as an active ingredient in health care antiseptic rub products and an In Vitro Permeation report.

October 10, 2019: FDA issued an advice letter in response to Cardinal Health submission submitted on November 19, 2018 of the following: 1) An in vitro time-kill evaluation of two test materials when challenged with various bacterial and yeast species (Report #1712509-201.01) with six addenda, 2) Final Report #1712509-201 Amendment, and 3) Test Isopropyl Alcohol Solutions-certificates of Analysis and Post-Efficacy Potency.

October 10, 2019: FDA issued an advice letter in response to Cardinal Health submission submitted on June 13, 2019 of a draft protocol (#1712510-202): Determination of the Minimum Bactericidal Concentrations of Isopropyl Alcohol.

November 18, 2020: FDA issued an advice letter in response to American Cleaning Institute in response to FDA’s Advice Letter regarding the status and milestones for some of the in vivo efficacy studies for the active ingredients povidone iodine and benzethonium chloride for certain health care antiseptic indications.

 

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