FDA Issues Final Rule On Hand Sanitizers

The Food and Drug Administration (FDA) recently issued a final rule on hand sanitizers available over-the-counter. The rule says, according to Infection Control Today reports, certain active ingredients are not allowed to be used. It also sets out guidelines to ensure the agency’s safety and effectiveness evaluations and determinations are consistent, up-to-date and appropriately reflect current scientific knowledge and increasing use patterns.

Three active ingredients — benzalkonium chloride, ethyl alcohol and isopropyl alcohol — are being deferred from further rulemaking to allow for the ongoing study and submission of additional safety and effectiveness data necessary to make a determination regarding whether these active ingredients are generally recognized as safe and effective for use in consumer antiseptic rub products.

In response to the final rule, American Cleaning Institute issued a statement by Richard Sedlak, Executive Vice President, Technical & International Affairs. Sedlak emphasized the effectiveness of sanitizers and its support from the Centers for Disease Control and Prevention. He also said, "...the American Cleaning Institute looks forward to providing additional data to ensure the FDA has complete and up-to-date information on ethanol and benzalkonium chloride used in these beneficial products."

While the regulatory process continues, hand sanitizer products can be used with confidence. In fact, they are still a popular solution for facility managers to curb the spread of germs in the buildings for which they are responsible. The success of these efforts rests largely on where the sanitizer dispensers are located within the building, according to earlier CleanLink reports.

Hand sanitizer dispensers should be located in areas that maximize occupant visibility while adhering to building safety codes. It’s wise to have them in places where there is high traffic — conference rooms or auditoriums are great places to have hand sanitizer dispensers.

Many hospitals are now placing dispensers next to check-in desks, medication carts, nurse’s stations, outside patient rooms, and inside patient rooms next to soap dispensers. Grocery stores and other retailers tend to place them next to carts right as customers walk in.