FDA Public Hearing: Using Innovative Technologies and Other Conditions of Safe Use To Expand Which Drug Products Can Be Considered Nonprescription

The U.S. Food and Drug Administration (FDA or the Agency) is holding a public hearing to obtain public input on a new paradigm they 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. The public hearing will be held on March 22 and 23, 2012, from 9 a.m. to 4 p.m. 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.

See: https://www.federalregister.gov/articles/2012/02/28/2012-4597/using-inno...