US looks to reboot nonprescription drug system

24 March 2014

The U.S. Food and Drug Administration is seeking to revamp its system for regulating hundreds of over-the-counter drugs, saying the decades-old process is not flexible enough to keep pace with modern medical developments.
The system was put in place in 1972 as a way to set dosing, labeling and other standards for hundreds of nonprescription drug ingredients, everything from aspirin to anti-bacterial hand scrubs. But regulators acknowledged that the process has proven extremely time-consuming, requiring multiple rounds of scientific review, public hearings and comments before a final monograph can be published (News Item PMPNews, 21 February 2014).
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