June 23, 2023

APC advises BOPs on USP <797> restrictions

This week, APC sent an advisory memo to state boards of pharmacy raising concerns about adopting without careful consideration the new USP Chapter <797> restrictions on beyond-use dates and batch sizes.

“We think it’s important that state boards have context and perspective as they contemplate implementation of this new USP chapter ahead of the upcoming enforcement date of November 1, 2023,” said APC’s Savannah Cunningham.

From the memo:

“While the CEC can demonstrate that many of the changes instituted under the new chapters will enhance compounding quality and patient safety, that is not true for all of the changes – most notably a couple of restrictions for which the CEC has not enunciated the scientific basis for the restriction or how those restrictions keep patients safer. That not only represents a striking departure from the norm for an independent organization like USP, whose credibility is rooted in its laser-like focus on hard data to document the standards it issues. It also will almost certainly create impediments to patient access to certain compounded sterile preparations.”