Congress, FDA, and the states, together with a wide mix of other stakeholders, are wrestling with how to define a more viable and coherent model for regulating pharmacy compounding – where the boundaries should be placed between state and federal oversight and what the respective regulatory structures and rules should look like.
There is general agreement that the “traditional” form of compounding by pharmacies, involving the filling of individual prescriptions for specific low-risk formulations that are not otherwise commercially available, should continue to be regulated at the state level.
However beyond that, opinions differ significantly on both what approach would be most effective and what could realistically be implemented.
The US Congress and the states are working separately and together to try to fill the deep gap in regulatory oversight that was placed in prominent relief by the nationwide meningitis outbreak stemming from severely inadequate quality controls in the large-scale injectable operations at the New England Compounding Center (NECC) (see IPQ’s November Special Report and follow-up coverage provided on November 26, November 27, December 26, and February 22).
While the gap is apparent, crafting a viable way of filling it is proving to be a complex puzzle with less than well-defined pieces to work with and significant resource constraints to factor in at both the state and federal levels.
Over the past two decades, the states, FDA, legislators and the courts have all weighed in at various times on the jurisdictional issues between “compounding” and drug “manufacturing,” with its new drug application and GMP requirements. The interpretations and enforcement decisions have not been consistent, and the NECC disaster has added strong fuel to the debate.
[CLICK HERE for the complete story. Included is a review of the discussions among key stakeholders at a recent FDLI forum on the issues that need to be considered in improving the model for regulating pharmacy compounding. Nonsubscribers can purchase the story for $195 by contacting Peter Blachly (peter@IPQpubs.com). For subscription/license information, click here.]
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