FDA commissioner calls for power to regulate compounding pharmacies

SILVER SPRING, Md. — The commissioner of the Food and Drug Administration is renewing calls for legislation to give the agency more authority to regulate pharmacy compounding.

In a blog post Friday, Margaret Hamburg wrote that while the FDA has inspected more than 30 compounding pharmacies and worked to inspect state-licensed pharmacies that produce sterile drug products, the agency's authority remained limited and was "not the right fit for FDA to provide appropriate and efficient oversight of this growing industry."

In the past week, Hamburg wrote, there were two recalls of sterile compounded and repackaged drug products due to contamination. In one case, five patients were diagnosed with serious eye infections after receiving doses of Genentech's Avastin (ddd) from a compounding pharmacy in Augusta, Ga. In another, fungus was found in bags of magnesium sulfate intravenous solution.

"There is a legitimate role for traditional pharmacy compounding," Hamburg wrote. "Every day, thousands of pharmacists practice traditional pharmacy compounding — mixing a drug in response to a valid prescription for an individual patient's need." These include liquids for patients who can't swallow pills, or medications made for patients allergic to certain ingredients.

But sterile compounding, Hamburg wrote, has evolved and "outgrown the law." Sterile compounding is a much more complex process and requires careful attention to sanitation. It generally involves medications designed for intravenous delivery.

Sterile compounding has received significant attention in recent months following a nationwide outbreak of fungal meningitis among patients who received injected steroids from the New England Compounding Center in Framingham, Mass. An investigation of the NECC found widespread contamination, disregard for safety standards, and former employees of the pharmacy have said that it had essentially become a manufacturer. According to the Centers for Disease Control and Prevention, 722 have become sick with the meningitis, and 50 have died.