Pharmacy Compounding Quality and Accountability Act Unlikely to See Swift Passage

While Senators Lamar Alexander (R-TN) and Tom Harkin (D-IA) of the HELP Committee are pushing to fast track the Pharmacy Compounding Quality and Accountability Act (S. 959) and are hoping for a swift vote, recent actions by Sen. Tom Coburn (R-OK) calling for more review of the measure make it unlikely that the bill will be passed before the August recess. PCQAA is the Senate’s response to the NECC incident, and seeks to impose new oversight of compounding pharmacies, dividing them into two categories: traditional compounders and compound manufacturers. The Bill would require certain compounders to become registered by the FDA, and would impose numerous other conditions on a pharmacy’s ability to compound prescriptions across State lines. Senate Bill 959 was quickly approved by the Senate HELP Committee in May, but has sat in the Senate since. With Senator Coburn’s recent actions, calling for more time to review and obtain input from industry stakeholders, it is unlikely that the Bill will be put to a vote before the August recess.