FDA bans 24 ingredients from hand soaps, antiseptic washes

The FDA issued new regulations Tuesday banning the use of 24 active ingredients, including the commonly-used triclosan, in over-the-counter hand soaps and antiseptic washes that are often used in healthcare settings,  according to the Regulatory Affairs Professional Society.

 

Under the rule, which was first proposed in 2015, manufacturers will have one year to remove the active ingredients, take the product off the market or file a new drug application.

The FDA determined the 24 banned ingredients are no longer appropriate for over-the-counter use since they are not recognized as safe and effective.

"Ensuring the safety and effectiveness of over-the-counter healthcare antiseptics has been a priority for the FDA, not only because these products are an important component of infection control strategies in healthcare settings, but also because of the role these products may play in contributing to antimicrobial resistance if they're not manufactured or used appropriately," said FDA Commissioner Scott Gottlieb, according to RAPS.

At this time the FDA is deferring its decision on six of the most commonly used antiseptic ingredients — ethanol, isopropyl alcohol, povidone-iodine, benzalkonium chloride, benzethonium chloride, and chloroxylenol — while manufacturers test the safety and efficacy of those ingredients.

More articles on healthcare quality: 
Study: Antiviral drugs may permit the safe transplant of hepatitis C-positive livers  
Flu shot now recommended for people with egg allergies: 3 things to know 
More than 300 sickened with gastro illness on Royal Caribbean cruise ship

© Copyright ASC COMMUNICATIONS 2018. Interested in LINKING to or REPRINTING this content? View our policies by clicking here.

 


IC Database-3

Top 40 Articles from the Past 6 Months