Department of Health and Human Services February 28, 2012 – Federal Register Recent Federal Regulation Documents

The U.S. Food and Drug Administration (FDA or the Agency) is announcing a public hearing to obtain input on a new paradigm we are considering. Under this paradigm, the Agency would approve certain drugs that would otherwise require a prescription for nonprescription use (also known as over-the-counter or OTC) under conditions of safe use. These conditions of safe use would be specific to the drug product and might require sale in certain pre-defined health care settings, such as a pharmacy. This public hearing is being held to obtain information and comments from the public on the feasibility of this paradigm and its potential benefits and costs.