NCPA joined the Alliance for Pharmacy Compounding (APC) in submitting comments to an information collection request by the Food and Drug Administration regarding its memorandum of understanding (MOU) for compounding, stating that there is no information collection burden associated with section 503A of the federal Food Drug and Cosmetic Act regarding the MOU if FDA correctly defines and applies the statutory distinction between dispensing and distribution.
NCPA and APC argued that the statutory condition that would trigger MOU-related reporting under section 503A(b)(3) — interstate distribution of compounded drugs by pharmacies — does not occur when pharmacies are operating lawfully under section 503A. Because lawful 503A pharmacy practice does not involve distribution, there is no ongoing state activity requiring entry into MOUs, no reporting obligations triggered by such MOUs, and therefore no associated recordkeeping, reporting, or information collection burden for states or pharmacies.
NCPA submitted comments to HHS in July 2025, calling for the FDA to suspend its MOU with state boards of pharmacy indefinitely, given our multiple concerns.
