In a twist that I am sure the FDA did not see coming, the landscape of FDA’s compounding position and the use of the Memorandum of Understanding (MOU) between the FDA and the States took a hit in a court decision back in “October 2020, [when] FDA was sued in the U.S. District Court for the District of Columbia regarding the MOU.”

The District Court “remanded the MOU to FDA to either certify that it will not have a significant economic effect on small businesses or prepare a regulatory flexibility analysis.” Clearly this was a task that was bigger than FDA wanted to engage in on its own, and thus they decided to take the MOU through the comment and rulemaking process “to fully undertake this analysis and ensure a robust framework for these important public health protections regarding certain distributions of compounded human drugs.”

Thus, the FDA will not enter into new MOUs with States and does not expect States that have signed the MOU to carry out the required tasks during the pendency of the comment and rulemaking process.  FDA is also suspending the 5% limit on distribution of compounded products shipped out of state until the rule is finalized. FDA had already extended the enforcement of the 5% rule until October 27, 2022 based on an October 2021 FR notice. Now, of course, that date is meaningless.  See previous posts here and   here for more background on the compounding saga.

We all know that the comment and rulemaking process is long and arduous, sometimes taking years to complete.  The comment and rulemaking for the implementing regulations for the Hatch-Waxman Act took a total of 10 years before all was finalized.  Hopefully we will not need to wait that long for this rulemaking to be completed, especially since there have been some significant public health issues associated with a number of 503A compounding pharmacies. A copy of the standard MOU that has been utilized can be found here.