Failing to formally name a “designated person” (DP) is one of the most frequently cited deficiencies for compounding pharmacies. As of November 1, 2023, USP General Chapter <800> became enforceable, along with updated revisions to USP General Chapters <795> and <797>. A common theme among these three chapters is the requirement to designate a person or persons responsible for maintaining operational quality.

This requirement isn’t just for traditional compounding pharmacies. It applies to any facility engaged in sterile or non-sterile compounding, or in handling hazardous drugs. Read More >