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Alexander, Senate Committee Direct FDA to Meet With MDs, Patients, Pharmacists on Compounding Law
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Friday, May 23, 2014

The United Voice of Compounders Is Heard!

Dear IACP Member:

A special thanks to all the IACP members who participated either in person at Compounders on Capitol Hill or via our Virtual Hill Day -- your efforts made a HUGE impact. And a fast one as well. One of our key messages to Senators and Congressmen was that the FDA's interpretation of the 2013 Drug Quality & Security Act (DQSA) appears to ignore Congressional intent. Despite repeated invitations from IACP to speak with our conference attendees, everybody at the FDA was "unavailable" to attend and talk to those most impacted by the agency's activities... and that was noticed by Congress.

U.S. Senator Lamar Alexander (R-Tenn.) today announced that, at his request, the Senate Appropriations Committee is directing the Food and Drug Administration (FDA) to meet with doctors, patients, and pharmacists to discuss their concerns about implementation of the compounding legislation passed into law in November 2013.

“The purpose of the compounding law is to end confusion and improve communication so we can help prevent another tragic meningitis outbreak. If FDA isn’t sitting down with doctors, patients and pharmacists and communicating how it is implementing the law, then I will stay on FDA until it does.” – Lamar Alexander

Click here to read today's U.S. Senate HELP Press Release.

IACP and its legislative team have worked tirelessly for the past several months emphasizing that FDA should be implementing DQSA according to congressional intent. This issue was the primary basis of our CCH 2014 Asks. Click here to review these Asks.

As covered in a Pink Sheet article from this week, there currently is an unenviable dilemma for pharmacists: whether to follow FDA regulations or those of their state.

"The International Academy of Compounding Pharmacists argues that FDA is not following the congressional intent of the Drug Quality and Security Act (DQSA), which was that office use regulation should be left to the states. Academy executive VP and CEO David Miller said the group wants FDA and/or Congress to clarify the office use issue as well as write other necessary regulations so pharmacists can operate under DQSA.

“'It is much more cloudy, muddy, messed up, uncertain, unclear, than we had, even from the compounding professionals’ standpoint, originally anticipated,' Miller said May 19 during a media briefing. Guidance may be coming, but it is unclear how the agency would address the office use issue.'"

On behalf of the entire IACP team, thank you to all IACP Members who participated in CCH. Your passion for pharmacy compounding has helped result in today's U.S. Senate HELP announcement. IACP will continue to work with congressional offices, and follow up on the visits our IACP Members made to their respective representatives. We will apprise you of any developments.

Please email with any questions regarding this IACP Member Alert.




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