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changes are sure to come.
"You can see why the FDA is gong to be coming down on the compounding pharmacies because of this," says Ms. Brownlie. "Patients
will think twice about having steroid injections done."
Not the first time for NECC
Besides finding black specks of fungus in sealed methylprednisolone
acetate vials that had been recalled and returned to NECC,
Massachusetts health officials' preliminary investigation also found
that NECC distributed drugs before the return of tests to check for
sterility. "On 13 occasions, NECC staff shipped orders from the [3]
suspect lots before receiving their own test results confirming that
those lots were sterile" — as many as 11 days before results were
received, says the report.
Inside NECC, inspectors also found dirty floor mats, a leaky boiler
next to the clean room, inadequate sterilization of medications and
improper testing of laboratory equipment.
State boards of pharmacy regulate compounding pharmacies —
meaning rules of production vary and, perhaps more importantly, so
do resources that allow for oversight and inspections. The FDA doesn't directly regulate these pharmacies (though it can and will send
warning letters when issues come to its attention) because they're not
considered "manufacturers" in the strictest sense. And although the
federal body made overtures toward treating compounding pharma2 4
O U T PAT I E N T S U R G E R Y M A G A Z I N E O N L I N E | N O V E M B E R 2012
