chapter  16
12 Pages

New Developments in the Approval and Marketing of Nonprescription or OTC Drugs

WithWilliam J. Mead

INTRODUCTION “OTC” refers to an over-the-counter or nonprescription medicine. The term is now somewhat anachronistic since most drug products are easily available to consumers on a self-serve basis from in-store shelves as opposed to being handed over a counter as was the usual way years ago. The basic concept of OTCs, however, is that they are available without the necessity of obtaining a prescription from a healthcare professional. This is advantageous to consumers since it yields ready access, convenience, and usually a cost saving, although OTCs tend not to be covered by health insurance plans.