Nov 1, 2023, Deadline to comply with USP 797 revisions made last year
USP 797 revisions were released on November 1st, 2022, with a year grace period for pharmacy spaces to become compliant with new regulations. Many pharmacies’ current sterile compounding space are an unclassified air space with no ante room or buffer room, which is non-compliant with the 2022 revisions. Per the 2022 revisions, all RABs and hoods must be placed in a clean suite with an ante room consisting of ISO 8 air (non-hazardous) and a buffer room consisting of ISO 7 air (non-hazardous). Prior to Nov 1, 2023, pharmacies must have a fully compliant clean suite with a true ante room, buffer room, and appropriate air pressures to comply with the new regulation requirements.




