FDA’s Final Rule On OTC Antiseptic Rubs Affects Just 3% Of Market; Alcohol Rulemaking Deferred

11 Apr 2019

The majority of over-the-counter hand sanitizers and wipes on the US market rely on ethyl alcohol, one of three active ingredients for which final rulemaking has been deferred to allow industry to generate additional safety and effectiveness data. FDA's final rule, released April 11, completes a series of related actions pertaining to OTC antiseptic drug products.

The US market for OTC consumer antiseptics – including germ-killing soaps, hand sanitizers and wipes – hangs in the balance as industry works to deliver data to FDA demonstrating general recognition of safety and effectiveness for active ingredients of highest priority.

FDA released a final rule April 11 for consumer antiseptic rubs – i.e., hand sanitizers, wipes and other products...