PharMEDium Registers with FDA as an 'Outsourcing Facility' Under New Drug Quality and Security Act

December 9, 2013

FOR IMMEDIATE RELEASE

LAKE FOREST, Ill., Dec. 9, 2013 /PRNewswire/ -- PharMEDium announced today that it is registered with the U.S. Food and Drug Administration (FDA) as a 503B large-scale sterile compounding "outsourcing facility" under the recently enacted Drug Quality and Security Act (DQSA).

The law, signed by the President on November 27, 2013, calls for large-scale entities engaged in non-prescription anticipatory compounding to voluntarily register with the FDA under the newly created section 503B of the federal Food, Drug, and Cosmetic (FDC) Act.

"Our customers can continue to expect a high level of disclosure and transparency based on this new official outsourcing facility category and clarifying rules that govern it," said David Jonas, Chairman and CEO of PharMEDium Healthcare Corp. "Going forward, there will be more consistent regulations and consistent oversight, which should raise the level of confidence among hospital leaders, providers and their patients."