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.  
 

Related News Articles

Headline
The National Institutes of Health has awarded about $45 million to expand the research network for its Rapid Acceleration of Diagnostics Underserved…
Headline
The National Institutes of Health will fund six research projects to examine disparities in pregnancy-related complications and deaths among disproportionately…
Headline
Kaufman Hall recently held a virtual health care leadership conference in which Wright Lassiter III, president and CEO of Henry Ford Health System, Eugene…
Headline
Join AHA and AVIA this week for a Health Equity and Diversity Week discussion about addressing health care disparities. To join the conversation, AHA members…
Headline
The Drug Enforcement Administration last week published an interim final rule expanding access to medication-assisted treatment under the SUPPORT for Patients…
Headline
Join AHA and AVIA Nov. 9-13 for a Health Equity and Diversity Week discussion about addressing health care disparities. To join the conversation, AHA members…