Deadly Infection Triggers Closer Scrutiny of Compounding

At last count close to 400 people have been infected with fungal meningitis and more than two dozen have died. Others have developed infections in their shoulders, elbows, knees and hips because of steroid injections into such joints. The New England Compounding Center of Massachusetts responsible for the contaminated vials of methylprednisolone has been closed and is now under investigation.
This entire tragic event has led to closer scrutiny of large compounding pharmacies. A sister company of the New England Compounding Center, Ameridose, has also been closed for inspection. In addition, Massachusetts authorities have shut down an unrelated pharmacy called Infusion Resource because of concerns about sterility.
Now Florida regulators have suspended operations at a compounding pharmacy in their state as well because of a number of violations. The Florida health department cited issues regarding cleanliness in the prescription department and rule violations regarding record keeping and compounding. Now that the spotlight has been directed at problems linked to large compounding pharmacies, legislators are calling for more FDA authority to monitor such facilities. The agency and Congress are discussing ways to move forward so that compounding would be more appropriately regulated.