US FDA Must Assess Business Impact Of Final Interstate Compounding MOU, Court Rules

23 Sep 2021

Summary judgment puts 20-year-old effort to define ‘inordinate’ out-of-state drug compounding back on slow track.

Compounding pharmacy — an 'inordinate' delay on interstate compounding • Source: Alamy

A federal court has ruled that the US Food and Drug Administration must assess the economic impact on compounding pharmacies of a standard memorandum of understanding that would impose reporting requirements in signatory states while allowing a 5% limit on out-of-state distribution to apply elsewhere.

The 21 September partial summary judgment by US District Court for the District of Columbia came in a case...