USP Chapter 797- Pharmaceutical Compounding Sterile Solution's latest proposed revisions were released in September 2021 for public comment. This release may have slipped right by you and your team in light of the pandemic. There are many proposed revisions including changes to the Beyond Use Dating of Sterile Compounds, additional competency assessment expectations and more robust quality control processes. It is anticipated that there will be minimal modifications made to the proposed requirements when the public comment period is over.
https://go.usp.org/Proposed_2021_Revisions_795_797
Have questions about this information or need assistance? Reach out to C&A to learn how we can help.