FDA finds safety issues at specialty pharmacies, pushes for oversight

Posted in Drug & Medical Devices on April 14, 2013

Specialty pharmacies have been in the news several times in recent months. First was the deadly fungal meningitis outbreak last October that was linked to contaminated steroids from the New England Compounding Center. Then last month, a New Jersey compounding pharmacy issued a nationwide recall of all its products due to a mold risk because visible particulate contaminants were seen in intravenous solution received by a Connecticut hospital.

A new report by the U.S. Food and Drug Administration shows these two incidents may just be the tip of the iceberg. The FDA says it has uncovered potential safety problems at 30 specialty pharmacies that were inspected in the wake of last year’s meningitis outbreak, which left 53 dead.

The FDA said Thursday it issued inspection reports citing unsanitary conditions at the 30 pharmacies including rust and mold in supposedly sterile rooms, inadequate ventilation and employees wearing non-sterile lab coats. The FDA usually issues these warnings before taking formal action against a company.

A summary of the inspections can be found on the FDA’s website.

FDA officials say they have stepped up efforts to inspect specialty pharmacies but they have been slowed by the complicated overlap of state and federal laws that govern the industry. Pharmacies are licensed and overseen by state pharmacy boards, though the FDA sometimes intervenes when major safety issues arise.

FDA Commissioner Margaret Hamburg has asked Congress to give the FDA explicit oversight over large compounding pharmacies. Under the proposal, large compounders would have to register with the FDA and undergo regular inspections similar to pharmaceutical manufacturers.

If state governments won’t do enough to monitor these specialty pharmacies, then the FDA must be given the authority to do so. We’ve seen too many times how businesses cannot be counted on to put their customers’ safety first. Someone has to make sure that the prescriptions being made in these facilities are safe.