While Senators Lamar Alexander (R-TN) and Tom Harkin (D-IA) of the HELP Committee have pushed to fast track the Pharmacy Compounding Quality and Accountability Act (S. 959) and there had been discussions of a swift vote, those aspirations will be delayed for additional time, as the U.S. Senate has gone into its August recess without a vote on this measure, or a recently introduced track-and-trace measure. This delay is likely attributable to recent actions of Sen. Tom Coburn (R-OK), who in the recent weeks, had been calling for more review of the measure. 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.
Meanwhile, even if the PCQAA and track-and-trace bills are passed by the Senate, they would still need to be reconciled with several bills pending in the House of Representatives, relating to compounding pharmacies and track-and-trace legislation. There are multiple proposals in the House seeking to regulate compounding facilities, each of which differ from the Senate proposal.
