For those facilities compounding drug products and distributing them out of state, the FDA has extended the statutory enforcement date. On the Federal Register prepublication page this morning, the Agency announced that it is “extending the period before FDA intends to begin enforcing the statutory 5 percent limit on distribution of compounded human drug products out of the State in which they are compounded in States that have not entered into a standard memorandum of understanding (MOU) with FDA addressing certain distributions of compounded human drug products.”
FDA says it “is extending the period, which was scheduled to end on October 27, 2022, until the effective date of a final rule regarding certain distributions of compounded human drug products and publication of an updated standard MOU.” There has been much discussion (as well as disagreement) with the 5% rule and, while it is not likely to change the length of time for which the FDA will utilize enforcement discretion, it appears to have been extended indefinitely until the provisions in the above sentence are completed. See full text of the notice here.
