FDA looks to reboot nonprescription drug system

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Posted: Feb 21, 2014 8:10 AM by Matthew Parrone
Source: Associated Press

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Topics: FDA, Food and Drug Administration, over-the-counter, non-prescription, drugs

WASHINGTON, D.C. - The Food and Drug Administration is seeking to revamp its 40-year-old 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.

In a federal posting Friday, the agency announced a two-day meeting next month to discuss overhauling the system known as the over-the-counter monograph.

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 the process has proven cumbersome and extremely time-consuming, requiring multiple rounds of scientific review, public hearings and comments before a final monograph can be published. As a result, many common pain relievers and cough medicines are still technically under review.

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