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News & Press: Breaking News

Press Release: IACP Files Formal Comments on Proposed FDA Memorandum of Understanding

Tuesday, July 21, 2015   (0 Comments)
Posted by: Dagmar Anderson
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In a press release today, July 21st, the International Academy of Compounding Pharmacists (IACP) has raised serious concerns about patient access to vital medications in comments submitted yesterday to the U.S. Food and Drug Administration, as the agency develops a new regulatory framework for pharmacy compounding based upon the Drug Quality and Security Act (DQSA) of 2013.

 

“We believe the FDA’s draft guidance overreaches far beyond the intentions of Congress and contradicts the clear language of the DQSA and previous federal legislation – to the point that, if left intact, it will hinder patient access to compounded medications, limit patient choice of their pharmacist, and disrupt the essential physician-patient-pharmacist triad relationship,” said David G. Miller, RPh, the IACP’s Executive Vice President and Chief Executive Officer.

 

“Our organization, along with a diverse group of stakeholders in the health care industry, has worked cooperatively with the FDA as the agency implements the DQSA, and we urge the FDA to incorporate our feedback,” Miller said. “The fact that more than 3,000 individuals and organizations have commented on the draft guidance underscores that the agency has a great deal of work to do before finalizing this document and ensuring that it does not negatively impact patient access to compounded medications.”

 

IACP Press Release

 

Click here to read the entire IACP press release.

 

IACP Comments to FDA

 

Click here to read IACP's submitted MOU comments to the FDA.


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