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Last week, the United States Pharmacopeia (USP) appeals panel 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. Last week, the panel denied the General Chapter 825 appeal, encouraging the appellant to submit a narrower request for revision to the expert committee. The American Hospital Association had urged USP to delay the 797 standard due to implementation and compliance concerns.
Last week’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 contacting state boards of pharmacy about state-level effective dates for General Chapter 800.