February 24, 2023

HHS projects October 2023 MOU release

HHS has released its plan of work for the coming year, including a proposed release date for the latest iteration of the MOU on interstate shipments of compounded medications. The agency’s semiannual regulatory agenda targets October 2023 for that release.

This re-do of the MOU by FDA is the result of successful litigation filed by seven compounding pharmacies against the agency in 2021. In February 2022 a federal judge sent FDA back to the drawing board on the MOU after FDA admitted it had not followed notice-and-comment rulemaking in promulgating the MOU. APC filed an amicus brief in the case in support of the compounder plaintiffs.

APC is developing legislation to eliminate the MOU—and the 5 percent cap on shipments in states that don’t sign the MOU—and replace it with mandatory reporting by states that ship more than 50 percent of their production out-of-state.