Drugs

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.

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.”

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.

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.

 

Page Last Updated: 11/21/2017
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