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FDA Revises MOU on Interstate Distribution of Compounded Drugs

October 3, 2018

FDA Commissioner Scott Gottlieb announced a revised agreement between the agency and states on interstate distribution of compounded drugs, responding to concerns that the existing distribution limits are too low.

The revised draft memorandum of understanding (MOU) “addresses patient access concerns previously raised by stakeholders, while retaining critical safety provisions,” Gottlieb said.

Under a 2015 draft MOU, states were expected to take action against a compounder that distributed “inordinate amounts” of compounded drugs interstate, defined at the time as an amount equal or greater to 30 percent of all drug products distributed by the compounder.

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