FDA Finds Safety Issues at Specialty Pharmacies

The Food and Drug Administration says it has uncovered potential safety problems at 30 specialty pharmacies that were inspected in the wake of a recent outbreak of meningitis caused by contaminated drugs.

The agency said its inspectors targeted 31 compounding pharmacies that produce sterile drugs, which must be prepared under highly sanitary conditions. The FDA said Thursday 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.

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.

The wave of inspections comes in response to a deadly fungal meningitis outbreak linked to contaminated steroids from the New England Compounding Center, a Massachusetts pharmacy. The company’s injections, mainly used to treat back pain, have been linked to 53 deaths and 733 illnesses since last summer.

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 a blog post to the FDA’s website Thursday, FDA Commissioner Margaret 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 Congress to 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.