> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Opens Compounding MOU Study
- URL: https://www.fdaweb.com/fda-opens-compounding-mou-study/
- Published: 2022-02-23T12:00:00.000Z
- Updated: 2026-09-14T17:33:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151221

FDA says it intends to engage in notice-and-comment rulemaking on statutory provisions about certain distributions of compounded human drugs and a standard memorandum of understanding (MOU) between the agency and states. An online [notice](https://content.govdelivery.com/accounts/USFDA/bulletins/30bef02?ref=fdaweb.com) says the need for rulemaking came in 10/2020 when FDA was sued in DC federal court over the MOU and the court remanded the MOU to FDA to either certify that it will not have a significant economic impact on small businesses or prepare a regulatory flexibility analysis.

“The agency intends to engage in notice-and-comment rulemaking to fully undertake this analysis and ensure a robust framework for these important public health protections regarding certain distributions of compounded human drugs,” the notice says.

The agency says it intends to update the MOU based on the content of a final rule and announce a new opportunity for all states to consider and sign the MOU. The 10/2020 MOU is suspended for the duration of the rulemaking process.