How tough should compounding oversight be?
When considering new, stiffer regulations governing the compounding of medicines in the wake of the meningitis outbreak, tread carefully and don’t throw the baby out with the bathwater.
That’s the message chain pharmacy had for Congress as lawmakers mull new restrictions on drug compounding by pharmacists.
Both the House and Senate held hearings last week on a deadly outbreak of a rare strain of fungal meningitis whose origin is tied to several batches of steroids produced by the New England Compounding Center in Massachusetts. Federal investigators found contamination from mold and bacteria at the center, and some congressional lawmakers from both parties are vowing to write new legislation to boost the authority of the Food and Drug Administration over compounding pharmacies.
As of mid-November, the disease had already sickened 438 people in 19 states and killed 32. Members of the U.S. Senate Committee on Health, Education, Labor and Pensions and the U.S. House Committee on Energy and Commerce grilled FDA Commissioner Margaret Hamburg about the FDA’s actions leading up to shipments of the tainted steroids, but Hamburg defended the agency, saying its authority over compounding pharmacies is limited and unclear.
Hamburg told lawmakers the FDA needs the legal power to adopt a tiered approach to overseeing compounding centers that separates them into “traditional” compounders – which fall under the authority of state boards of pharmacy – and “nontraditional” compounding pharmacies. Nontraditional centers like the NECC, she argued, should be treated as manufacturers and required to register with the FDA and forced to subscribe to other guidelines for drug manufacturers.
Chain pharmacy leaders, however, are worried Congress will take a legislative sledgehammer to the problem of poorly regulated compounding pharmacies. In a Nov. 14 letter to the Republican and Democratic heads of both committees, the National Association of Chain Drug Stores reminded lawmakers that compounding is part of pharmacy’s basic DNA and has been a core part of the profession since its earliest days. What’s more, NACDS noted, “Compounding services are the only source of critical medications for millions of patients with unique health needs. For these patients, there are no commercially manufactured preparations available. Through compounding, pursuant to a prescription, pharmacies provide these patients with personalized medications.”
The group also pointed out that “the type of compounding tied to the recent meningitis outbreak — sterile compounding — is a much smaller subset of compounding, and sterile compounding must be performed in very controlled settings. Sterile compounding is not the kind of compounding that is typically available to a patient who walks into a chain pharmacy to fill a prescription.”
Also urging caution at last week’s Senate hearing was David Miller, CEO of the International Academy of Compounding Pharmacists. Miller said he was “very concerned” over calls for a tiered approach to regulation of compounding pharmacies. “The more complex we make this and the more we get into the shuffle between who is accountable…we will not resolve this problem,” he told panelists. “Either you are a pharmacy or you are a manufacturer."
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