APhA SUPPORTS FDA RULES FOR DUAL STATUS

Published Online: Sunday, January 1, 2006

Organized pharmacy leaders urged the FDA to develop new rules clarifying the agency's power to approve dual status drugs—a move that could clear the path for the simultaneous marketing of pharmaceuticals as both prescription and OTC products.

In urging the agency to act on this issue, officials at the American Pharmacists Association (APhA) cited the recent upsurge in prescription to OTC switches and the likelihood of even more Rx drugs being approved for nonprescription sale in the near future. "As the number of switch applications increases, so will the potential for active ingredients that may best be simultaneously classified as both a prescription and an OTC, or placed in some type of in-between or transition category," an APhA official said.



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