FDA starts taking real action on compounding
The FDA officially took a stand Friday and said large-scale pharmacies can no longer compound two drugs, vasopressin and nicardipine hydrochloride, using bulk powders. On its face, it seems like a wonky issue, but it has sweeping public health consequences. (Remember, the FDA started regulating these large-scale compounders after contaminated compounded drugs killed 64 people back in 2012.)
It’s also a shockingly politically charged issue. Reps. Trey Gowdy (R-S.C.) and Jim Jordan (R-Ohio) wrote to the FDA back in December questioning the legality of the FDA’s move (which they first announced in draft form back in August). The agency is also locked in a legal battle over its compounding policy for one of these drugs.
It’s also a shockingly politically charged issue. Reps. Trey Gowdy (R-S.C.) and Jim Jordan (R-Ohio) wrote to the FDA back in December questioning the legality of the FDA’s move (which they first announced in draft form back in August). The agency is also locked in a legal battle over its compounding policy for one of these drugs.
No hay comentarios:
Publicar un comentario