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FDA Week - 05/22/2020

Compounders ‘Gravely Concerned’ By MOU's 5% Out-Of-State Sales Cap

By Kelly Lienhard / May 15, 2020 at 3:26 PM
FDA on Thursday (May 14) unveiled a final Memorandum of Understanding (MOU) on interstate distribution of drugs by pharmacy compounders that gives state pharmacy boards a key monitoring role and gives states a year to decide whether to sign the pact, which requires FDA be notified when more than 50% of a compounded drug is sold out-of-state. But the MOU maintains a 5% cap on out-of-state sales in states that don't sign the MOU -- which 503A compounders say raises...


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