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USP Regulatory Updates Delayed on Appeal

10/29/19

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By:

Katrina Harper, PharmD, MBA, BCPS, DPLA, Clinical Pharmacy Director, Center for Pharmacy Practice Excellence

We’ve recently shared communications about updates to existing United States Pharmacopeia Convention (USP) Chapters surrounding pharmaceutical compounding regulations as well as a new regulation for handling hazardous drugs in health care facilities. The new and updated rules were scheduled to go into effect Dec. 1.

USP Chapters <795> and <797> establish best practices for mitigating the risk of compounded nonsterile and sterile preparations, respectively. The new language, announced June 1, required swift preparation and attention to budget considerations to meet the deadline. For many pharmacies, process changes are likely underway, but now there’s more time. The enforcement date for both chapters has been delayed to June 1 or later after an appeal was filed by a group of compounding pharmacists and professional associations. The appeal largely focused on beyond use date (BUD) provisions of Chapters <795> (Pharmaceutical Compounding – Nonsterile Preparations) and <797> (Pharmaceutical Compounding – Sterile Preparations), and included a request for postponement of implementation.

The group also challenged the removal of language allowing the use of alternative technologies and techniques in Chapter <797>, applicability of the standards in veterinary practice, and framework and BUD provisions in Chapter <825> (Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging).

The USP ruling

The USP Compounding Expert Committee published its ruling on the appeal Aug. 16, saying it will maintain the BUD provisions in the chapters and that it will commit to the development of “resources for extending BUDs to include stability, sterility, and monitoring (personnel and environmental) considerations.”

The committee also ruled the “alternative technologies and techniques” statement in Chapter <797> will be reinstated with “clarification that it is not intended to permit BUD extension or to extend the time during which single-dose containers may be used.” A decision to include the chapters’ applicability to veterinary practitioners and to maintain veterinary references was upheld.

Enforcement date still pending

Since the ruling, the compounding pharmacies and professional associations that filed the appeal have requested further review by an appointed panel, in accordance with USP bylaws. This prompted the USP Healthcare Quality and Safety team to announce that it would delay the planned Dec. 1 implementation of USP Chapters <795>, <797> and <825>, while the latest review is pending. If the appeal is denied, the USP chapters may become enforceable on June 1. If the appeal is remanded, enforcement may be delayed until at least Dec. 1, 2021 so that USP can update the chapters and once again open review of the changes for public comment. 

USP <800>

USP Chapter <800> (Hazardous Drugs – Handling in Health Care Settings) is not subject to any pending appeals and will become official on Dec. 1., and USP encourages utilization of the chapter in the interest of advancing public health. Even so, many state boards of pharmacy have voted to delay its enforcement to provide time for the completion of the rulemaking activity.

For questions or more information, please contact the Healthcare Quality & Safety Team at CompoundingSL@usp.org.

About the author. As clinical pharmacy director for Vizient, Katrina Harper uses her more than 19 years of health care experience to provide pharmaceutical and clinical expertise to both internal teams and Vizient member hospitals. Her areas of expertise include safe medication use, process improvement, pharmacy operations optimization and regulatory compliance. As the lead subject matter expert on USP compliance for Vizient, Harper has developed a comprehensive portfolio of self-training modules for member hospitals and has led numerous local, regional and national seminars on USP compliance.

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