USP panel remands revised compounding standards for further review

Mar 12, 2020 - 02:33 PM

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
Webinar to provide strategies on protecting hospital leadership
The AHA will host a webinar Dec. 18 at 1 p.m. ET on strategies to better protect senior leaders in hospitals. Attendees will learn ways to reduce…
Headline
JAMA article shows patient safety measures surpass pre-pandemic levels 
A JAMA article co-authored by AHA Chief Physician Executive Chris DeRienzo, M.D., and leaders from Vizient highlights that hospitals and health systems have…
Headline
Report: Nonprofit hospitals’ value to communities more than 11 times federal tax exemption
An EY report prepared for the AHA shows that tax-exempt hospitals and health systems delivered $11 in benefits to their communities for every dollar’s worth of…
Headline
Infant formula recall expands as botulism outbreak cases grow
ByHeart has expanded its voluntary recall to include all Whole Nutrition Infant Formula cans and Anywhere Pack products amid an investigation by the Food and…
Headline
Blog shares insights from hospital leaders at AHA’s inaugural Rural Patient Safety Convening
Rural hospital leaders recently shared strategies and insights on improving safety culture, governance and care reliability at the AHA’s Rural Patient Safety…
Headline
FDA sends warning letter to Philips due to quality issues 
The Food and Drug Administration sent a warning letter to Philips last month due to quality violations found at three of its medical device facilities earlier…