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FDA Cannot Force an Over-the-Counter Drug Switch

Does the Food and Drug Administration have authority to force manufacturers of prescription drug products to switch those products to over-the-counter (OTC) distribution against their will? The FDA is currently grappling with this issue, a dispute that has generated substantial controversy, including statements by FDA officials and coverage in leading newspapers.

25 minute read February 09, 2004 at 10:00 AM
By
Andrew S. Krulwich
FDA Cannot Force an Over-the-Counter Drug Switch

Does the Food and Drug Administration have authority to force manufacturers of prescription drug products to switch those products to over-the-counter (OTC) distribution against their will?

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