FDA Wants to See Two Classes of Compounding

FDA Wants to See Two Classes of Compounding

November 16th, 2012 // 3:25 pm @

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As FDA commish Margaret Hamburg braces herself for questioning from members of Congress during hearings today and tomorrow about the compounding pharmacy controversy, the agency is proposing that two forms of compounding should be created so that higher-risk production can be more closely regulated (watch the hearing at 10 am EST right here).

In her prepared remarks, Hamburg discusses traditional and so-called non-traditional compounding. Traditional compounding, of course, refers to the recognized practice of mixing or altering ingredients for individual patients on an as-needed basis. But non-traditional compounding poses a higher risk that she argues would – and should – require federal government oversight.

The suggestion comes in the wake of an outbreak of fungal meningitis traced to the New England Compounding Center in which 438 cases, including 32 deaths, have been reported in nearly two dozen states. The episode has cast a harsh spotlight on the FDA and state regulators, and the extent to which they properly exercise their available authority.

The FDA has been criticized for failing to pursue enforcement action against the NECC, even though the agency issued a 2006 warning letter and the compounder had regularly shipped large volumes of compounded medicines around the country. The FDA has argued that court rulings have compromised its authority, although the agency has previously declared a willingness to pursue compounders that engage in the equivalent of drug manufacturing (back story).

In an attempt to place responsibility with Congress to clarify lines of authority, Hamburg is, essentially, challenging lawmakers to pass legislation that would dispel what some complain is an unnecessarily confusing situation. But how would non-traditional compounders be defined and what powers ought the FDA have to exercise greater enforcement?

As Hamburg envisions the concept, a statute specifies non-traditional compounding might include the type of product or activity, such as sterile compounding; the amount of product made; whether production takes place before prescriptions are received for a particular patient; whether drugs are shipped interstate; or whether a drug is sent to someone other than the patient when a shipment leaves a facility.

And these riskier products should be subject to a higher degree of oversight, Hamburg maintains, such as good manufacturing practices. But there are instances where compounding should not take place, she insists, such as when a compounded medicine would be a copy of a drug already approved by the FDA, except under certain circumstances, such as a shortage.

What else? Hamburg believes compounding should not be undertaken for complex dosage forms of drugs, such as extended released medications, transdermal patches, liposomal products and most biologics. In her view, producing such drugs would require that applications are submitted to the agency, as well as compliance with GMP practices.

There is more. Hamburg wants the FDA to have complete statutory authority to collect and test product samples, and collect pharmacy records for review. These would include documents pertaining to shipments, sterility and batch testing, prescriptions received, and other operational records.

Finally, she proposes that compounding pharmacies be required to register with the agency, which would presumably make it easier to coordinate efforts with state regulators when necessary. And she suggests that compounders report adverse events and start labeling their products


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