High-Risk Compounding Pharmacies Targeted for FDA Review

About 30 “high risk” compounding pharmacies are being targeted by U.S. regulators for inspections over the next two months as part of intensified enforcement efforts after last year’s deadly meningitis outbreak.

The companies primarily make sterile drugs and distribute products to health-care providers nationwide, Erica Jefferson, a spokeswoman for the Food and Drug Administration, said today in a phone interview. The visits, which began Feb. 19 and will continue about two months, are the first proactive inspections the agency has conducted of compounding pharmacies, she said.

Facilities in Florida, Chicago, Arkansas and Mississippi were found with conditions that put their drugs at risk of microbiological contamination, the FDA said in four inspection reports today on its website. Drug compounders were thrust into the spotlight when New England Compounding Pharmacy Inc. shut down in October after its contaminated steroid shots were linked to a fungal meningitis outbreak that has killed 48 people.

“The recent tragic fungal meningitis outbreak has shed a harsh and important light on this area for us,” Jefferson said.

Compounding pharmacies traditionally prepare personalized prescriptions and are regulated by state health authorities. The meningitis outbreak revealed some companies go beyond that task by producing larger amounts of medicines, acting more like a drug manufacturer overseen by the FDA.

Typically the FDA waits for complaints against these pharmacies before doing inspections. Jefferson wouldn’t say how many of the businesses targeted have been inspected as of today.

Pharmacy Selection

The agency chose the pharmacies to inspect based on a potential for risk using adverse event reports turned in to the FDA, historical inspection data, reports of quality problems and public information. The FDA is working with state regulators to conduct the inspections.

Republican lawmakers on the House Energy and Commerce Committee said at a November hearing that the FDA should have shut down Framingham, Massachusetts-based New England Compounding years before the outbreak when evidence of contamination first emerged. FDA Commissioner Margaret Hamburg said a patchwork of regulations restrained the agency from acting.

The FDA now plans to test drugs at compounding pharmacies where initial inspections raise flags, Jefferson said.

The agency may not be able to shut down certain pharmacies that are operating within traditional compounding law, which requires firms to make drugs only in response to patient prescriptions. Those cases will be referred to state regulators and the FDA plans to continue to publicly post the inspection observations, Jefferson said.