FDA revises draft MOU on interstate distribution of compounded drugs

The Food and Drug Administration today released for public comment a revised draft memorandum of understanding for states regarding interstate distribution of “inordinate amounts” of compounded drugs by licensed pharmacists or physicians. Under the prior draft, issued in 2015 and on which AHA commented, inordinate amounts was defined as equal to or greater than 30 percent of all drug products dispensed or distributed by the compounder. “Some were worried that this provision could impede patients’ access to compounded drugs for which they have a medical need,” said FDA Commissioner Scott Gottlieb, M.D. Under the revised draft, states would agree to identify compounders that distribute more than 50 percent of their total prescription orders for compounded drugs interstate and report certain information to the FDA about those compounders. The draft MOU will be published in the Sept. 10 Federal Register with comments accepted for 90 days.