APhA SUPPORTS FDA RULES FOR DUAL STATUS

Pharmacy Times, Volume 0, 0

Organized pharmacy leaders urged theFDA to develop new rules clarifying theagency's power to approve dual statusdrugs—a move that could clear the pathfor the simultaneous marketing of pharmaceuticalsas both prescription andOTC products.

In urging the agency to act on thisissue, officials at the American PharmacistsAssociation (APhA) cited the recentupsurge in prescription to OTC switchesand the likelihood of even more Rx drugsbeing approved for nonprescription salein the near future. "As the number ofswitch applications increases, so will thepotential for active ingredients that maybest be simultaneously classified as botha prescription and an OTC, or placed insome type of in-between or transitioncategory," an APhA official said.