FDA mulls expanded universe of nonprescription drugs

Abstract

Some drugs that are now available only with a prescription may one day be obtained after consulting with a pharmacist or answering a series of questions on a computer terminal, under a new system that FDA is considering for nonprescription drug use. Described in the February 28 Federal Register, the new system would establish “conditions of safe use” for nonprescription sales of specific drugs that would, absent these conditions, require a prescription. FDA calls its outline for the expanded availability of nonprescription drugs a new paradigm for medication use. “I would like for us to have additional flexibility for nonprescription use and the ability to use circumstances and technology and incorporate those into practices,” said Janet Woodcock, chief of FDA’s Center for Drug Evaluation and Research, during a March 22–23 public hearing on the new paradigm. The federal Food, Drug, and Cosmetic Act requires FDA-approved drugs to be available by prescription if they cannot be used safely without a prescriber’s supervision.