US FDA Publishes Consumer Antiseptic Wash Q&A

28/07/17

Event Title

08h00 - 16h30

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On July 25, 2017 the US Food and Drug Administration (FDA) published the Consumer Antiseptic Wash Final Rule Questions & Answers Guidance for Industry (Small Entity Compliance Guide). The guidance document explains why the 19 active ingredients listed in the Final Rule were not considered safe and effective for over-the-counter antiseptic wash products and outlines the FDA’s criteria for testing. The guidance also explains that three of the active ingredients received deferral to provide for additional time to gather safety and efficacy data. On March 24, 2017, the FDA renewed the deferral for the three active ingredients for one more year, subject to renewal. While the deferral may be renewed, it should be noted that if the studies conducted do not appear to be productive, the FDA will proceed to rulemaking for those ingredients after deferral.

 

The Consumer Antiseptic Wash Final Rule is effective September 6, 2017. Products containing one of the 19 listed active ingredients either need to be removed from the market, reformulated to remove the active ingredient, or need to submit safety and efficacy data and obtain New Drug Application approval prior to marketing.

 

Background
On September 6, 2016, the FDA published the Final Rule Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use. In the final rule, they determined that 19 active ingredients for antiseptic wash products were not generally recognized as safe and effective (GRASE) due to insufficient safety and efficacy data. At that time they deferred rulemaking on three active ingredients (benzalkonium chloride, benzethonium chloride, and chloroxylenol) to provide additional time to collect new safety and effectiveness data.

 

Click to view Consumer Antiseptic Wash Final Rule Questions & Answers Guidance for Industry.
https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm568513.pdf

 

Click to view the Final Rule:    https://www.federalregister.gov/d/2016-21337

 

How Does this Impact You? Contact Us to Discuss
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