— So far, 32 people have died of fungal meningitis after they were injected with tainted steroids made at a compounding pharmacy in Massachusetts. Another 438 people in 18 states have fallen ill.
What those patients didn’t know is that the pharmacy that made the steroids and others like it have been largely exempted from Food and Drug Administration oversight.
More FDA oversight in the specialty businesses is needed, but it should be done in a way that does not bring onerous regulation to the many small compounding pharmacies that provide a valuable service for patients and doctors.
Most of the compounding pharmacies are small operations that custom-mix drugs, such as specific compounds to treat children or seniors who can’t easily swallow pills.
The small, specialized industry doesn’t come under the same regulation as large drug makers that must ensure they’re operating sterile facilities in a safe manner.
But some compounding pharmacies have grown into mega-drug manufacturers that are pushing the legal limits.
Continue reading here
What those patients didn’t know is that the pharmacy that made the steroids and others like it have been largely exempted from Food and Drug Administration oversight.
More FDA oversight in the specialty businesses is needed, but it should be done in a way that does not bring onerous regulation to the many small compounding pharmacies that provide a valuable service for patients and doctors.
Most of the compounding pharmacies are small operations that custom-mix drugs, such as specific compounds to treat children or seniors who can’t easily swallow pills.
The small, specialized industry doesn’t come under the same regulation as large drug makers that must ensure they’re operating sterile facilities in a safe manner.
But some compounding pharmacies have grown into mega-drug manufacturers that are pushing the legal limits.
Continue reading here
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