April 26, 2024
APC to regulators: The stability study backlog is real
This week, APC wrote to state boards of pharmacy and FDA to make them aware of delays in completing stability studies as USP 797 is enforced across the country. Sterile compounding pharmacies are required to complete stability studies for category 3 sterile preparations. We’ve heard from some of you that analytical labs are experiencing considerably longer turnaround times — largely due to the increased volume of testing requests that the new 797 standard has prompted — leading to current and significant delays in obtaining results. The letters are FYI, so that boards and FDA are aware of the situation.
