APhA SUPPORTS FDA RULES FOR DUAL STATUS

JANUARY 01, 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.



SHARE THIS SHARE THIS
0
 

In Seniors: Consider CMV Serostatus
When Recommending Flu Vaccine

Older people who have cytomegalovirus seem to have less robust responses to the trivalent influenza vaccine than those who do not have CMV.


 

 

Conference Coverage
News from the year's biggest meetings


Pharmacist Education
Clinical features with downloadable PDFs


 

SIGN UP FOR THE PHARMACY TIMES NEWSLETTER
Personalize the information you receive by selecting targeted content and special offers.