Stand-alone packaging site changes may be made under SUPAC-IR with CBE supplement, FDA advises.
Executive Summary
STAND-ALONE PACKAGING SITE CHANGES MAY BE SUBMITTED AS CHANGE-BEING-EFFECTED supplement under FDA's Scale-up and Post-Approval Changes Guidance for Immediate Release products, FDA said in a Feb. 18 letter to application holders. The agency has reconsidered its previous position that only packaging site changes that were part of a complete manufacturing operation are covered by SUPAC-IR, the letter states.