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FDA Commissioner Margaret Hamburg
Hamburg

FDA pressed for clarity on compounding pharmacies


By Jaimy Lee
Posted: December 19, 2012 - 6:45 pm ET
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Officials from state pharmacy boards repeatedly told members of the Food and Drug Administration that they need clarification on the definition of a nontraditional compounding pharmacy.

The FDA held a hearing Wednesday to help establish a framework for how the federal agency and the states should regulate compounding pharmacies in the wake of the fungal meningitis outbreak that has sickened 620 and led to the deaths of another 39 people.

The outbreak has prompted questions from lawmakers and other authorities about whether the FDA or state boards of pharmacies are responsible for regulating compounding pharmacies.

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Current laws mandate that state pharmacy boards oversee compounding pharmacies, while the FDA is responsible for regulating manufacturing. However, in recent years, some compounding pharmacies have evolved from local compounders to large-scale distributors that ship thousands of drugs into multiple states.

The New England Compounding Center in Framingham, Mass., had been distributing large volumes of drugs to multiple states when it shipped the contaminated vials of methylprednisolone acetate tied to the meningitis outbreak.

As a result of the outbreak, the FDA has said the new category of nontraditional pharmacy compounding is higher-risk and may need additional oversight, while some states have moved forward with plans to tighten their oversight of compounders.

“We have been stunned and horrified by the magnitude of the devastation,” said FDA Commissioner Dr. Margaret Hamburg during the meeting.

More than 100 officials from 50 states and Washington attended the hearing, which was split into an intergovernmental meeting in the morning and a public meeting in the afternoon.

“What's the definition of pharmacy compounding?” said Cody Wiberg, executive director of the Minnesota Board of Pharmacy, who added that it was still unclear whether NECC was operating as a nontraditional compounder or as a nontraditional manufacturer.

While traditional compounders make a drug to fit the needs of an individual patient, defining nontraditional compounding could address factors as wide-ranging as whether the pharmacy is conducting sterile compounding, at what volume do they compound drugs and whether the products are crossing state lines.

“I'm not as concerned with volume,” said Mark Johnston, executive director of the Idaho State Board of Pharmacy. “I'm concerned with distribution versus dispensing.”

Other state board of pharmacy officials pushed the FDA to improve its communication with the states. Jay Campbell, executive director of the North Carolina Board of Pharmacy, said the agency should provide information about regulatory actions, including warning leters, to pharmacy boards in states where the pharmacy has a license, as well as to the National Association of Boards of Pharmacy.

“That communication to state regulators has been sporadic at best,” he said.


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