FDA’s Revised Draft For Compounding Pharmacies Opens Door To Compounding For Office Use
FDA’s revised draft guidance on GMPs for outsourcing pharmacy compounding operations responds to calls to allow the compounding of small quantities of drugs presumably for office use. The IACP applauds the move.
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Greater clarity on which drugs outsourcing facilities can compound from bulk ingredients and what good manufacturing practice requirements they will have to meet would go a long way toward enabling them to help prevent and resolve drug shortages, Pew report says. Another factor to consider: whether any loosening of restrictions during the pandemic will continue afterward.
Pharmaceutical manufacturers and compounders are in opposition over the US FDA’s plans to carve out a place for pharmacies that want to keep physicians’ offices stocked with small amounts of product. Who will the agency disappoint this time?
Compounding carryover money runs out, crippling some activities although inspections will continue; countdown to the end of PDUFA fee balance continues.