Switching-the Triple Threat from Tylenol® to Ibuprofen

Abstract

Understanding the distinction between OTC and prescription drugs and the legal basis for the distinction requires a knowledge of the statutory and regulatory history of nonprescription medications in the United States. The regulatory mechanisms for switching from prescription to OTC status will increase as a result of the ANDA /Patent Term Restoration Bill. The methods of switching a drug are petition to the FDA, NDA, NDA Supplement; or the OTC review process. There are substantial questions as to how switches are to be accomplished in the future.