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News & Press: Breaking News

Seeking Greater Clarity and Direction from FDA, IACP Supports Congressional Funding Restriction

Thursday, June 12, 2014   (1 Comments)
Posted by: Dagmar Anderson
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Implementation of DQSA Not Consistent With Intent of the Law


The International Academy of Compounding Pharmacists (IACP), citing a lack of direction from the U.S. Food and Drug Administration (FDA) regarding the implementation of the federal Drug Quality and Security Act (DQSA), as well as the FDA’s misinterpretation of Congressional intent, supports the efforts of the U.S. House of Representatives to restrict an additional $7 million that the agency has requested for inspections.

“We believe in providing FDA with the tools that it needs to do its job and ensure the quality and safety of all medications,” said IACP Executive Vice President & CEO David G. Miller, R.Ph.  “The fact that the agency, however, has not issued any guidelines or regulations that clearly direct the new outsourcing facility entities created under the law, so that these facilities can ensure compliance with standards, is troublesome to our profession.  Additionally, the FDA is interpreting the law in a manner that is not consistent with Congressional intent, by seeking to prohibit traditional compounding pharmacies from preparing medications for office use or from re-packaging medications, even when both practices are allowed in some instances under state law.”

Click here to read IACP's Press Release.

Comments...

Mike Corrado says...
Posted Thursday, June 12, 2014
By the end of business Monday, I will FAX, email or call each member of the AZ Congressional delegation requesting that they "RESTRICT FUNDING FOR FDA PHARMACY INSPECTIONS" until FDA decides it will follow the Intent of Congress AND their own obligations set forth in the Drug Quality and Security Act. We ALL acknowledge that NECC occurred in-part because of a lack of clarity in jurisdiction over Compounders. FDA's actions, or lack thereof, create additional confusion and a further lack of clarity that will put Patients in harm's way. Sending a clear message to FDA that they've gone rogue is the only way to insure greater Patient Safety, which was the goal of DQSA in the first place.

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