US FDA Must Assess Business Impact Of Final Interstate Compounding MOU, Court Rules
Executive Summary
Summary judgment puts 20-year-old effort to define ‘inordinate’ out-of-state drug compounding back on slow track.
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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.