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 brought by seven compounding pharmacies after the FDA issued the final version of the standard MOU last fall