The United States Pharmacopeia Appeals Panel today remanded the revised USP General Chapter standards <795> for nonsterile compounding and <797> for sterile compounding to an expert committee “for further engagement on the issues raised concerning the beyond-use date provisions.” USP last year postponed the effective dates for these standards and for the new General Chapter <825> radiopharmaceuticals standard due to pending appeals. The appeals panel today denied the General Chapter <825> appeal, encouraging the appellant to submit a narrower request for revision to the expert committee. AHA had urged USP to delay the <797> standard due to implementation and compliance concerns.
Today’s announcement will delay the effective date of the revised <797> chapter, as well as the effective date of General Chapter <800> on hazardous drug handling in health care settings. While <800> will remain informational pending final revisions to <797>, AHA advises members to contact their state boards of pharmacy regarding state-level effective dates for General Chapter <800>. AHA will update members with additional information as it becomes available.