January 6, 2023

APC appeals USP <797> provisions

APC has notified USP that it will appeal certain provisions of the revised USP Chapter <797> and has requested 30 days to file the substance of that appeal.

In a letter to USP, APC CEO Scott Brunner states that the grounds for the appeal “will be narrowly tailored, process-based, and designed to ensure that the 2022 Revisions do not unintentionally cause harm to the public.”

In question is USP’s procedural failure to document the scientific basis for restrictions on beyond-use dates and batch sizes in the revised chapter or to demonstrate how the restrictions serve to improve patient safety or health.

The APC Board of Directors approved the filing of the appeal at a specially called meeting on December 22. The next step will be for USP to determine whether it will grant the appeal, including APC’s request for the 30 days to submit evidence.