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PharMEDium Registers with FDA as an 'Outsourcing Facility' Under New Drug Quality and Security Act
Date:12/9/2013

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."

FDA urges providers to purchase from registered compounders

During a media briefing last week, FDA Commissioner Margaret Hamburg, MD, said: "Helping to protect Americans from unsafe drugs is among the FDA's highest priorities and is part of our core mission." She explained that the DQSA "represents a step forward by creating a new pathway in which a compounder can register with FDA as an outsourcing facility."

Dr. Hamburg said that the section of the new law pertaining to compounders will give healthcare providers and health networks greater safeguards as related to medication safety if they purchase compounded products from registered outsourcing facilities.

"If compounders register with FDA as outsourcers, hospitals and other healthcare providers will be able to provide their patients with drugs that were compounded in facilities that are subject to increased FDA oversight, including
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SOURCE PharMEDium
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