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Regulation of compounding pharmacies will be included in the new Drug Quality and Security Act
Confirming that, indeed, Congressional committees have been working hard behind the scenes to complete a compromise draft legislation that will encompass both the longstanding effort for national rules on tracking pharmaceutical shipments, and the more recent effort to give FDA more authority to regulate compounding pharmacies, several Congressmen issued news releases on Sept. 25 announcing their success. The actual bill remains to be revealed, at least as of early on Sept. 26.
Senator Tom Harkin (D-IA), chairman of the Senate Health, Education, Labor and Pensions Committee, issued a statement that commended “the bipartisan spirit that brought this compromise proposal together” in the form of what will now be called the Drug Quality and Security Act. “Today we are taking a notable step toward completing the important work of improving the security of our pharmaceutical supply chain and clarifying the regulation of drug compounding,” said a statement from Fred Upton (R-MI), chairman of the House Energy and Commerce committee. “This step will help us protect the health and safety of the American people,” said Energy and Commerce Committee Chairman Fred Upton (R-MI).
Interestingly, the issue of drug compounding seems to have superseded that of track-and-trace legislation in the discussions. The Senate bill put forward earlier this year included regulation of compounding; the House bill did not. Given that track-and-trace legislation has been debated and wrestled with since around 2006, while the compounding topic only appeared within the past year, there was a risk that the ongoing legislative efforts for track and trace could have been derailed by the compounding issue.