RX-TO-OTC Switch—The Process and Procedures

Most people know that there are two main categories of drugs: (1) drugs that can be bought only if prescribed by a licensed practitioner, and (2) drugs that can be purchased “over the counter,” without a prescription. Yet most people know very little about the process for determining whether a drug will be prescription or OTC or about the procedures for switching a drug from Rx-to-OTC status. Public attention has been focused on the switch procedures within the last 2 years primarily because of controversies surrounding the OTC availability of metaproterenol as a bronchodilator and of ibuprofen as an analgesic. A discussion of the statutory scheme and the FDA's established procedures may help to remove some of the confusion that seems to surround the essentially uncomplicated switch process.