FDA investigators find safety concerns at 30 drug compounding pharmacies

WASHINGTONSafety and sterility problems have been found at 30 specialty pharmacies, the Food and Drug Administration said Thursday.

The agency has ramped up investigations of compounding pharmacies that mix prescriptions for patients in the wake of a recent outbreak of fungal meningitis caused by contaminated steroid injections.

The FDA said its inspectors targeted 31 compounding pharmacies that produce sterile drugs, which must be prepared under highly sanitary conditions. It issued inspection reports to all but one of the pharmacies citing unsanitary conditions and quality control problems, including: rust and mold in supposedly sterile rooms, inadequate ventilation, and employees wearing non-sterile lab coats.

"These inspectional observations reveal that there continues to be reason for concern about sterility deficiencies and other problems in some compounding pharmacies across the country -- problems that could potentially affect the health of patients," wrote FDA Commissioner Dr. Margaret Hamburg in a blog post on the agency's website.

The agency generally issues such reports before taking formal action against companies. Inspectors visited pharmacies in 18 states, including Florida, Arizona, Colorado, Tennessee and New Jersey.

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

The wave of inspections comes in response to a deadly fungal meningitis outbreak linked to contaminated steroids from the Framingham-based New England Compounding Center, a Massachusetts pharmacy. The company's preservative-free methylprednisolone acetate injections, mainly used to treat back pain, have been linked to 53 deaths and 733 illnesses since last summer. Illnesses include fungal meningitis, abscesses and secondary fungal infections in some patients who had already been diagnosed with meningitis.

• 60 Minutes: Lethal medicine linked to meningitis outbreak
• FDA finds contaminated vials, bacteria, mold at New England Compounding Center
• Compounding pharmacy trouble extends beyond NECC

Compounding pharmacies are supposed to mix customized prescriptions based on individual doctors' instructions. However, some pharmacies like the New England Compounding Center have grown into larger businesses, supplying bulk quantities of injectable drugs to hospitals across the country.

The FDA has stepped up its oversight of the pharmacies since the outbreak was identified in September, but agency officials say they have been slowed by the complex overlap of various 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.

In the Thursday blog post, Hamburg noted that four pharmacies initially refused to admit the agency's inspectors. In two cases the agency had to return with search warrants and U.S. marshals to complete the inspections.

"These challenges and others highlight the need for clearer authorities for FDA to efficiently protect public health," Hamburg stated.

Hamburg has asked Congressto pass new laws giving 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.

But the FDA proposal has faced pushback from some members of Congress, particularly House Republicans, who have been investigating whether the FDA could have prevented the meningitis outbreak using its existing powers.

The House Energy and Commerce Subcommittee for Oversight and Investigations will hold its second hearing on the issue next Tuesday. Hamburg is scheduled to testify, according to committee staffers.