WASHINGTON — Congress today took the final step
in approving a bill that will put in place new federal standards for pharmaceutical compounders, something drug safety advocates have been calling for since a devastating fungal meningitis outbreak last year claimed at least 64 lives and sickened hundreds of others, at least two in Texas.
in approving a bill that will put in place new federal standards for pharmaceutical compounders, something drug safety advocates have been calling for since a devastating fungal meningitis outbreak last year claimed at least 64 lives and sickened hundreds of others, at least two in Texas.
We wrote about these efforts this summer, when the bills were tied down amid opposition from industry.
The bill, which passed the Senate Monday on a voice vote and will be on its way to the President’s desk, is summarized here. It’s a compromise bill that makes it voluntary for pharmacies that compound drugs on a large scale to register as so-called outsourcing facilities. Those that do registered, will be under greater government oversight and subject to more frequent federal inspections.
that compound drugs on a large scale to register as so-called outsourcing facilities. Those that do registered, will be under greater government oversight and subject to more frequent federal inspections.
Those that do not will remain under the oversight of state regulators, usually as in Texas’s case, the state board of pharmacy.
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