April 19, 2021

Associations ask FDA to delay MOU enforcement

APC, APhA, the National Alliance of State Pharmacy Associations, and NCPA, have submitted a joint letter to FDA asking that it delay enforcement of the final MOU until at least October 26, 2023.

We have learned that a number of states — including large ones such as Florida and Texas — are unable able to sign the MOU without their respective state legislatures amending state laws to comply with the final MOU’s requirements … assuming they choose to.

For all the MOU’s flaws (and FDA’s overreach in crafting it), the implications of states not signing it could be catastrophic for patients, compounders — and even local economies.

That’s why we’ve asked for what we consider to be a reasonable postponement.

Enforcement of a five percent cap beginning in October of this year will result in an unnecessary disruption of health care for thousands of patients and will put an enormous strain on the pharmacies that serve them.

Patients who rely on compounded medications from pharmacies in states that cannot, or do not sign the final MOU by the October 26, 2021 deadline will be penalized by disruption of care and inability to receive therapy from their pharmacy of choice.