Both the House and Senate are making progress on bills that would ostensibly clamp down on the big compounding pharmacies that are key vendors to hospitals. However, the Senate bill gives the FDA more authority to regulate these compounders, such as the New England Compounding Center (NECC), whereas the House bill appears to strengthen state inspection programs of all pharmacies without giving the FDA any new tools. It is too soon to know which approach will end up on President Obama's desk for his signature. Betting odds should probably favor the Senate bill, because it originated in the Committee on Health, Education, Labor, and Pensions (HELP) with substantial bipartisan support, which is less likely to be true of the House bill.Whichever bill is passed will have a large impact on hospital pharmacies, because they purchase large quantities of compounded drugs and often perform a lot of compounding themselves. The Senate bill is called the Pharmaceutical Compounding Quality and Accountability Act (S. 959). One of its key provisions exempts hospital pharmacies from a newly established category, called "compounding manufacturers." This term is meant to encompass the "NECCs" of the world, which for the first time would be regulated by the FDA Hospitals would remain regulated as traditional pharmacies (i.e., by the states) even if they ship medications to out-of-state facilities that are part of their own health system.
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