FDA Law Blog

Surprise! Fifth Circuit Rejects DEA’s Longstanding Interpretation of a Pharmacist’s “Corresponding Responsibility” And “Usual Course of Professional Practice” Regulations

The Fifth Circuit rejected the DEA’s long‑standing reading of the pharmacist’s “corresponding responsibility” and “usual course of professional practice” regulations, ruling that liability requires proof a prescription was invalid when issued and that the pharmacist actually knew it was invalid. The court clarified that the “usual course” refers to bona‑fide pharmacy practice, not a state‑law standard of care. This decision overturns decades of DEA enforcement precedent and creates a circuit split with the Sixth Circuit. The case is now remanded for the DEA to reassess Neumann Pharmacy’s registration revocation.