Can a designated representative completely delegate their responsibilities?

A designated representative must personally oversee and ensure compliance with all regulatory requirements. This role involves significant responsibilities, including ensuring that the operations of the facility adhere to state and federal laws governing the handling of prescription drugs. The designated representative acts as a key point of accountability and must remain actively involved in the management processes rather than simply delegating tasks.

The nature of this role requires a comprehensive understanding of regulations and the specific practices of the business, which cannot be fully transferred to another individual, regardless of their qualifications. While assistance may be necessary in performing tasks, the ultimate responsibility for compliance and oversight lies with the designated representative. This ensures that there is a clear chain of accountability and that regulations are followed diligently, which is critical in maintaining the integrity of drug distribution systems.