The FDA has proposed cutting three ingredients from its approved list for bulk compounding manufacturing. The agency said that the ingredients — bumetanide, nicardipine hydrochloride and vasopressin — have no clinical need.
It’s the first time the FDA has proposed limiting ingredients for compounded drugs made in bulk, but the agency signaled that more restrictions are on the way.
The push to reconsider approved ingredients for bulk compounding came after a 2012 fungal meningitis outbreak triggered by contaminated injectable steroids made at a state-licensed compounding pharmacy.
Traditionally, compounding pharmacies were used for custom-made medications for specific patients. But the practice has grown to the point where some compounded medications have begun to compete with approved drugs on the market. After the 2012 outbreak, however, Congress passed the Drug Quality and Security Act to bring compounding facilities under federal oversight.
The FDA will now also offer sanitation and GMP guidance for compounding facilities.
Read the full Reuters report.
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