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Compliance Date Passed for Consumer Antiseptic Wash Final Rule

September 6th, 2017 marked the compliance date for the U.S. Food and Drug Administration’s (FDA) Consumer Antiseptic Wash Final Rule.  As of this date, over-the-counter (OTC) antiseptic washes containing any of nineteen active ingredients deemed by FDA as not “generally recognized as safe and effective” (GRASE) are not permitted to be introduced into interstate commerce without approval of a new drug application (NDA).  The rule applies to antiseptic washes intended to be used with water and does not cover products such as wipes or hand sanitizers.  Soaps, hand washes, and body washes containing these ingredients that are currently in retail establishments do not require removal, but new batches of these products may not enter the market.  You will find the list of affected ingredients below.

Why are these ingredients not GRASE?

Before the September 6 compliance date, products containing the nineteen affected ingredients were able to be marketed without approval of an NDA.  The ingredients were part of a 1994 tentative final monograph for OTC antiseptic drug products.

In 2013, FDA published a proposed rule to amend the 1994 monograph.  The Agency stated that further review of the data revealed the monograph did not sufficiently account for the health risks associated with repeated, long-term exposure to these ingredients and risks were greater than previously thought.  According to FDA, long-term exposure can have hormonal effects and can lead to the development of bacterial resistance.  In terms of effectiveness, FDA determined there was insufficient evidence that using products containing the covered ingredients was more beneficial than using products used for a comparable purpose with lower health risk (i.e. non-antibacterial soap and water).  Due to these findings, FDA deemed these nineteen ingredients “not generally recognized as safe and effective” for this intended use.

FDA has not yet made a determination on three additional active ingredients: benzalkonium chloride, benzethonium chloride, and chloroxylenol.  In March of 2017, FDA granted an additional year for interested parties to conduct studies providing further data that would support the safety and effectiveness of these ingredients.  Products using these ingredients may currently be introduced into the market, and FDA states that it may extend this time period if studies yield adequate progress.

Not sure how this rule affects your products?  Registrar Corp’s Regulatory Specialists can help determine how FDA regulates your specific antiseptic wash products and review your labeling for compliance.  For questions or assistance, call us at +1-757-224-0177. Alternatively you can chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

Ingredients Deemed Not Generally Recognized as Safe and Effective under the Consumer Antiseptic Wash Final Rule:

Cloflucarban
Methylbenzethonium chloride
Fluorosalan
Phenol (greater than 1.5 percent)
Hexachlorophene
Phenol (less than 1.5 percent)
Hexylresorcinol
Secondary amyltricresols
Iodophors (Iodine containing ingredients)
• Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
• Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
• Nonylphenoxypoly (ethyleneoxy) ethanoliodine
• Poloxamer—iodine complex
• Povidone-iodine 5 to 10 percent
• Undecoylium chloride iodine complex
Sodium oxychlorosene
Tribromsalan
Triclocarban
Triclosan
Triple dye

 





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