September 3, 2021

More about those USP proposed revisions

USP has just released its proposed revisions to beyond-use dates in chapters <795> and <797> — revisions that the Compounding Expert Committee was directed to reconsider as a result of a 2019 appeal by APC and its partners.

We’ve only had a short time to review them, but we’ve found several notable changes. The Compounding Expert Committee:

  1. …expanded its guidance for assigning BUDs for compounded nonsterile preparations (CNSPs) in the absence of stability information.
  2. …elaborated on the role of water activity in determining BUD limits for preparations.
  3. …added a table of commonly compounded dosage forms and their respective aw values to aid compounders in determining BUD limits for CNSPs.
  4. …clarified the requirements for identifying the need for a recall and related procedures.
  5. …created of a Category 3 for CSPs that allows for “extended” BUDs with requirements above and beyond what is required for Categories 1 and 2

“Earlier this year, APC made recommendations to USP’s <795> and <797> CEC subcommittees, and we’re glad to see that some of our recommendations have been incorporated in these new proposals,” said APC President Michael Blaire. “Still, we’re concerned that the proposed revised chapters continue to place unnecessary limits on BUDs, even when sterility testing, increased environmental monitoring, increased personnel qualification, and stability studies are conducted.”

USP has also announced several open forums at which it will receive feedback on the proposed revisions. APC is reviewing the proposed revisions, and we will be participating in USP’s stakeholder process. We’ll have more details to share soon.