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A Primer on Compounding Pharmacies and Regulation by Congress

Douglas Graham/CQ Roll Call File Photo
Griffith crafted a proposal aiming to clarify in the Senate bill how the FDA should work with state boards of pharmacy in overseeing compounding pharmacies and allowing compounders to engage in traditional practices.

Yes, although not on the same scale as the NECC outbreak. In May, a pharmacy in Florida recalled its sterile products following an FDA inspection. And in August, the FDA issued a voluntary nationwide recall of all sterile products made by a compounding pharmacy in Texas after reports of bacterial infection affecting 15 patients in two Texas hospitals.

Alexander called the recall “deeply troubling” and said it showed the need for action on his bill. “Senators on the health committee have worked carefully to put together the best possible legislation, because we knew that the lack of accountability over compounding businesses would lead to another crisis like last year’s meningitis outbreak,” he said in a statement in August.

What Will Happen Next?

Aides say that members in both chambers are continuing to work on details of the legislation and are aiming to pass a final version this fall. The drug distribution security provision in particular has strong bipartisan support in both chambers.

But bill sponsors in the Senate say they are committed to trying to pass compounding pharmacy legislation as well, as soon as possible. An aide for Harkin said he is eager to move the bill, especially in light of the compounded drug problems that continue to occur.

The biggest obstacle is for House Republicans and senators to agree on how much authority the FDA should have over compounding pharmacies. If they can work that out, it will go a long way to helping the legislation succeed. And if the two committees can hammer out the details in their own negotiations, that would increase the bills’ chances on the floor of their respective chambers — and make reconciliation much easier.

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