Compounding Pharmacies Sue FDA For Conflating Out-Of-State Dispensing And Distribution In MOU

The US Food and Drug Administration faces a court challenge on its final standard memorandum of understanding with states on interstate compounding from seven pharmacies that say the agency exceeded its statutory authority by setting limits on dispensing activities that are typically under the purview of state pharmacy boards.

The MOU will also have a detrimental business impact on pharmacies in states that do not sign the MOU and deny patients access to compounded medicines. The FDA also violated...