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.
You may also be interested in...
Senate legislation to reform the US OTC monograph process mirrors the House draft proposed in January, including a two-year market exclusivity provision for some products. The Consumer Healthcare Products Association says it is working with legislators and is encouraged a reform bill will pass this year.
Responding to industry's requests, US FDA's rulemaking on six health care personnel antiseptics remaining in the OTC drug monograph is delayed one year to allow firms to demonstrate the ingredients are GRASE. ACI says the research could impact whether ingredients remain available for consumer hand washes.
FDA’s rule “clarifies the mission” for manufacturers of consumer antibacterial soaps, which have a year to demonstrate that they are safe and effective or risk losing the entire OTC drug category.