August 6, 2021
THIS JUST IN: FDA grants MOU extension
We learned this morning that FDA has indicated its intention, via a posting in the Federal Register, to extend by one year – to October 27, 2022 – the date on which it will begin enforcement of the Memorandum of Understanding with states regarding interstate shipments of compounded medications.
FDA’s move comes after requests for an extension from APC and its association partners, as well as from NABP and individual state boards of pharmacy.
We’re sincerely grateful to FDA for recognizing that numerous states will be unable to sign the MOU by the original October 2021 deadline and granting this extension.
APC will turn its attention now to helping state boards of pharmacy navigate any needed changes to their state laws so that can sign the MOU by the new 2022 deadline. We also await action by the Federal District Court on litigation challenging the process FDA followed (or failed to follow) in promulgating the MOU, as well as certain provisions of the MOU itself.
For now, we consider this extension a very positive reprieve, and APC is proud of our work in helping bring it about.