FDA inspects specialty compounding pharmacies in targeted action

In response to pressure from Congress and health-care watchdogs, federal regulators have launched an aggressive surprise inspection campaign of large specialty pharmacies, in the spotlight after a deadly meningitis outbreak last fall that was linked to tainted drugs, officials said Friday.

Inspectors from the U.S. Food and Drug Administration fanned out to 11 states and have so far found dozens of safety lapses at four facilities, including medications with no expiration dates, and drug containers that were “not clean and sterilized,” records show.

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The inspections began Feb. 19 and will continue over the next two months, covering about 30 facilities. Depending on the findings, the specialty pharmacies, known as compounders, could face fines and possible suspension of their licenses. These pharmacies custom-mix medications for individual patients, hospitals and clinics.

The actions are part of a new program aimed at the multibillion-dollar compounding industry that has fallen between the regulatory cracks. The inspections were the first targeted enforcement actions against large compounders since the FDA found filthy conditions at a Massachusetts pharmacy that shipped contaminated steroid shots to 23 states. The shots caused the outbreak that has so far killed 48 people and sickened 666 others, making it the country’s worst drug disaster in several decades.

Those already inspected include two companies identified in a Washington Post investigation in February about manufacturing-style compounding pharmacies.

The Post investigation found that shoddy practices and unsanitary conditions at three large compounding pharmacies have been tied to deaths and illnesses over the past decade. The findings showed that serious safety lapses at the Massachusetts-based New England Compounding Center were not an isolated occurrence.

The Post also reported that state and federal authorities did little to systematically inspect and correct hazards at compounding firms. In the lightly regulated industry, pharmacies were rarely punished, even when their mistakes had lethal consequences.

Howard Sklamberg, director of compliance for the FDA’s Center for Drug Evaluation and Research, said in an interview Friday that inspectors focused on the firms that compound sterile injectable products — such as the steroids that triggered the meningitis outbreak last October.

Inspectors also went into facilities that had a history of problems linked to patient illnesses and deaths.

“Because we have limited resources, we have to target firms that pose the greatest risk,” Sklamberg said.

FDA reports show that inspectors found 39 safety deficiencies at the four firms. Two of the firms are among the largest compounding companies in the nation — and were the major focus of the Post investigation.

At California-based Central Admixture Pharmacy Services’ facility in Illinois, inspectors found that personnel failed to take adequate steps to “prevent microbial contamination of drug products.” In one storage room, a bag of citric acid had a hole, which exposed it to possible contamination. Inspectors also found that personnel had failed to properly investigate leaks in a sterile nutritional supplement and potency problems with another drug.