Over-the-Counter Drug Review Process

Over-the-counter (OTC) drugs play an increasingly vital role in America's health care system. Today, six out of every ten medications bought by consumers are OTC drugs. Much of the work of reviewing these products is accomplished in CDER's Division of OTC Drug Products. The information below provides an understanding of how CDER works to assure the safety and effectiveness of OTC drug products.

	Introduction
	OTC Drug Review Process- An interactive chart that provides an overview of CDER's over-the-counter drug review process, and how CDER determines the safety and effectiveness of OTC drug products.
	Division of OTC Drug Products Home Page- For further information about non-prescription drugs, visit the Division of OTC Drug Products home page. This page also contains documents that are frequently requested of the Division.