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# FDA Revises Drug Compounding MOU
- URL: https://www.fdaweb.com/fda-revises-drug-compounding-mou/
- Published: 2018-09-07T12:00:00.000Z
- Updated: 2026-09-15T00:30:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142296

FDA commissioner **Scott Gottlieb** says that as part of efforts under its 2018 Compounding Policy Priorities Plan, it has revised a draft memorandum of understanding ([MOU](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/UCM434233.pdf?ref=fdaweb.com)) between FDA and states. He [says](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm619796.htm?ref=fdaweb.com) the revised MOU addresses patient access concerns previously raised by stakeholders, while retaining critical safety provisions. “Today’s action is also an important step to increase our collaboration with the states to maximize resources and our collective public health impact, and it marks a significant milestone in the agency’s implementation of federal law on compounding,” he writes.

According to Gottlieb, the revised MOU addresses concerns that pharmacies raised with respect to earlier drafts. He says a 2015 draft was revised in consultation with the National Association of Boards of Pharmacy, which provided perspectives from state partners. The public is invited to comment on the revised draft, and especially on the newest revisions.

“When finalized,” Gottlieb concludes, “the revised MOU will provide clarity on state investigations of complaints associated with compounded drug products that have been distributed out of state. States that enter into the MOU will investigate complaints and advise FDA when they receive reports of serious adverse drug experiences or serious product quality issues like drug contamination. We anticipate the MOU will help to facilitate increased collaboration between FDA and the states that sign it….. Our expectation is that the states will continue to have day-to-day oversight over traditional compounding pharmacies and physicians located in their states, and that the information that FDA obtains from the states will enable us to focus our inspection and enforcement resources pertaining to traditional compounder based on risk.”

In his statement he also discusses other actions related to drug compounding that FDA intends to take in the coming months.