House Bill Seeks Expansion To Regulation Of Compounding Pharmacies
If you were to look at how things are going in terms of lawmakers passing a budget today, you would probably come away with a negative view of politics. Still, there are some issues that are able to unite members of both parties, and one of those issues is apparently the regulation of compounding pharmacies.
Over the weekend, a bill was passed by the House that expands the regulatory power of the Food and Drug Administration to encompass compounding pharmacies. Previously, these firms existed in a sort of regulatory gray zone due to their designation as a state entity and their ability to ship products across the county, an act that would be more typical of a drug distributor.
The problems inherent with this gray area came to the fore last year when products shipped from the Framingham, Massachusetts-based New England Compounding Center led to an outbreak of fungal meningitis that made people across the country sick and claimed the lives of 64 individuals.
The new bill passed by the House with support from both Democrats and Republicans strives to promote better communication between the FDA and state agencies. Those companies that don’t ship products around the country would still fall within the purview of state regulators, and other compounders could choose to register as outsourcing firms under the scope of the FDA. However, this latter distinction has drawn criticism by those who believe a voluntary effort is not sufficient.