Manufacturers, Compounders Clash As FDA Prepares Final Offer On Office Compounding
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?
You may also be interested in...
US FDA is frustrated that few stem cell therapy makers are seeking regulatory approval of their products during the current enforcement grace period.
FDA’s revised draft guidance on GMPs for outsourcing pharmacy compounding operations responds to calls to allow the compounding of small quantities of drugs presumably for office use.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.
Concerns that the US pharmaceutical industry will not have the necessary serialization systems in place to fully comply with DSCSA product package serialization requirement appear to be bearing fruit, according to a recent survey.