FDA’s MOU: Reining-in the rumor mill
We’ve been hearing several rumors about the FDA’s interstate-shipping MOU. Please help us make sure state boards of pharmacy are clear on the facts.
As a reminder, we believe the MOU has serious flaws. It’s the subject of litigation that could result in its being withdrawn — but that’s far from a certainty. But by taking action now, state boards of pharmacy can avoid severe curtailment of patient access to compounded medications if they don’t sign by the FDA’s October 2021 deadline.
Rumors to correct:
Individual states cannot negotiate their own customized MOU with FDA. There is only one version of the MOU; it’s a take-it-or-leave it document for every state. This is the MOU.
Signing the MOU absolutely does not commit the state board of pharmacy to review every single compounded prescription from a pharmacy. Rather, via NABP’s data collection tool, boards of pharmacy will require compounders to attest to data on out-of-state shipments once annually. Based on that attestation, the state board will report to FDA any compounder shipping more than 50 percent of compounded preparations out-of-state.
It’s NOT a done deal that the FDA will extend the enforcement deadline. A flurry of extension requests, including from APC and members of Congress, is pretty clear — and has been heard by FDA. CDER director Gail Bormel has mentioned publicly that they’re seriously considering an extension, but it’s far from a sure thing. Boards of pharmacy need to continue to act as if the October 2021 deadline is carved in granite.
Our request of boards of pharmacy hasn’t changed:
- Determine now if the board has the authority to sign and comply with the MOU. If state law must be amended, the board should notify FDA immediately and request a delay in enforcement. It should also advise FDA if it has concerns about costs associated with complying with the MOU.
- If the board has authority to sign and comply with the MOU, it should prepare to sign it — but wait until just before the deadline to do so to allow the litigation to run its course, and also to delay for the state having to comply with the MOU before its effective date.
We appreciate any help you can give keeping this high on your pharmacy board’s radar — and correcting any misperceptions!