More GRASE Time For 6 OTC Antiseptic Ingredients But 24 Flushed In Final Rule

An FDA final rule rejects generally regarded as safe and effective status for 24 OTC monograph antiseptic ingredients regarding products intended for use by health care professionals in hospitals or similar venues. However, six ingredients on which FDA deferred its decision also are used in consumer antiseptic washes, which GRASE decisions pending in separate rulemakings.

OTC antiseptic product firms are making the most of a recent FDA rulemaking that removes 24 ingredients from approval for use under a monograph by focusing on six substances that remain available but face potential exclusion.

A final rule FDA published in December 2017 applies only the generally regarded as safe and effective (GRASE) status...