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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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.
Under the US FDA’s final MOU on interstate compounding, states are given more time to decide whether to sign the agreement and investigate complaints of adverse events associated with drugs compounded by 503A pharmacies. Agreement draws mixed reactions from pharmacy groups.