On November 2, 2021, FDA posted an update to the Memorandum of Understanding (MOU) Addressing Certain Distributions of Compounded Drugs (here). FDA notes that it was sued by seven compounding pharmacies (503A compounders) in US District Court regarding the 5% limitation on the out of state distribution of compounded products by pharmacies in states that do not sign the MOU. The Court ordered FDA to either certify that the 5% limit “will not have a significant economic effect on small businesses or prepare a regulatory flexibility analysis. The Agency is evaluating the court’s decision.”
The FDA had extended the enforcement window to October 27, 2022, prior to the issuance of the court’s decision. The Agency indicates it will provide further updates as appropriate. Currently, pharmacies that operate in states that have signed the MOU must report to FDA on pharmacies that distribute greater than 50% of their compounded drugs interstate; however, there is no limit on the percentages of compounded drugs that may be distributed under the MOU. FDA’s concern in receiving this information has to do primarily with the ability to recognize adverse events that may occur once the compounded product leaves the MOU state to “facilitate the reporting of serious issues that have the potential to affect patients in multiple states. For states that have not signed the MOU, the 5% limit is based on a percentage of the pharmacy’s total prescription orders dispensed or distributed”.
We will keep you updated on the progress of the FDA’s evaluation as soon as they provide further updates.