Beyond-Use Dates in USP Chapters <795> and <797>
After prevailing in 2020 in an appeal of the arbitrary beyond-use dates in USP’s revised Chapters <795> and <797>, APC is committed to providing expert input to USP’s Compounding Expert Committee to help assure that new USP <795> and <797> chapters do not unduly restrict science-based beyond-use dating.
Resources and information
- APC Recommendations to USP on BUDs in Chapters <795> (Nonsterile) — (February 2021)
- APC Recommendations to USP on BUDs in Chapters <797> (Sterile) — (May 2021)
- BUDs: An Update — December 4, 2020