US FDA Must Assess Business Impact Of Final Interstate Compounding MOU, Court Rules
Summary judgment puts 20-year-old effort to define ‘inordinate’ out-of-state drug compounding back on slow track.
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Responding to court ruling, US FDA will explore what it will cost compounding pharmacies to submit to increased state restrictions and oversight of out-of-state compounding quality under a standard MOU that Congress required decades ago.
Seven pharmacies have filed a lawsuit against the FDA claiming the agency exceeded its statutory authority in its final standard memorandum of understanding on interstate compounding and that the MOU will have an adverse impact on compounding pharmacies and patients.
US pharmacy group says that 10 to 12 states have indicated through an informal survey that they do not have the manpower or funding to implement the US FDA’s final MOU on inordinate compounding. They say what is at stake in these states is patient access to compounded medicines.