Regulatory

USP releases new and revised chapters for compounding

ASHE is developing a new resource to help facilities comply with the revised standards
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The U.S. Pharmacopeia (USP) has published the new and revised USP Compounding General Chapters and made them available for free download. 

The chapters published include: 

The new and revised standards, in addition to General Chapter <800> published in February 2016, go into effect Dec. 1.

They provide a comprehensive set of standards for health care workers to help ensure quality compounded preparations and the safe handling of hazardous drugs. More than 8,000 public commenters, including The Joint Commission, contributed to the new and revised standards. The revisions reflect advancements in science and clinical practice and clarify topics that were frequently misconstrued.

USP has provided a summary of the updates to the chapters, along with frequently asked questions responses.

The American Society for Health Care Engineering (ASHE) is addressing compliance with USP <800> with resources for facilities professionals.

The 56th ASHE Annual Conference & Technical Exhibition in Baltimore July 14-17 will feature a session titled “Compliance with USP <800> Hazardous Drug Compounding.” The session on Mon. July 15, at 3:15-4:15 p.m. will cover:

  • Understanding the design requirements of USP <800> and how it relates to USP <797> design requirements.
  • Reviewing and analyzing strategies to ensure compliance with USP <800>.
  • Identifying key risk components of USP General Chapter <800>.
  • Recognizing the value of partnering with risk management throughout the project to ensure a successful project.

The session will cover key topics in a monograph that ASHE will release in July to accompany a new risk assessment tool being developed by the American Society for Health Care Risk Management (ASHRM).

This resource bundle will help support health care facility professionals and their teams in complying with USP General Chapter <800>. A free digital version will be available to ASHE and ASHRM members.

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