ACNU Provides a New FDA Approval Pathway for Prescription-to-OTC Drugs

ACNU Provides a New FDA Approval Pathway for Prescription-to-OTC Drugs

Previous FDA Policy Delineating Prescription and OTC Status  Prior to the Additional Condition for Non-prescription Use (ACNU) final rule, FDA regulations only allowed prescription (Rx) drug products to be either fully (“full Rx-to-over-the-counter [OTC] switch”) or partially (“partial Rx-to-OTC switch”; e.g., only specific strengths or indications) changed to non-prescription marketing status. This meant that a single product could not be simul…