NOTE FROM THE EDITOR
This is an introduction to the work of a group of highly knowledgeable pharmacists led by Rad Dillon to a review of the newly released USP <797>; their review, in Excel format is available as a free for download at: https://CompoundingToday.com/Compliance/SCCG USP 797 changes.xlsx (Excel Spreadsheet .xlsx, 32 KB)
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The Sterile Compounding Consensus Group (SCCG), first convened shortly after the release of the most recent draft of USP <797>, created a Sterile Compounding Consensus Statement (SCCS) reviewing and commenting upon the major changes between this draft and the "current," that is "official," version of the chapter.
With the release of the "final" version of USP <797>, with an effective date of November 1, 2023, the group again convened, and created a similar document comparing the most recent draft with the "final" version.
This updated version of the SCCS can be downloaded at: https://CompoundingToday.com/Compliance/SCCG USP 797 changes.xlsx
The overall assessment is that the number of significant changes from the most recent draft is relatively small but almost universally add clarity or "common sense" interpretations to prior text.
A full comparison of the final version to the "current" version of USP <797> was not attempted at this time due to the complexity of the task and the desire to get a synopsis of revision-to-final changes out to the concerned public.
As the organizer of this initiative, I wish to list the prime contributors to this revised version:
Wendy Hagwood, PharmD
Pharmacy Operations Manager
Triangle Compounding Pharmacy, Inc.
Cary, NC
Bryce A. Jackman, RPh, BCNSP
Director of Pharmacy
CarePro Home Infusion/Care
Pro Compounding
Cedar Rapids, IA
Kathleen Jackson, RPh, PhD (H.C), FAPC
Independent Consultant
Alvin, TX
Kenneth Long, RPh
Director of Clinical Services - Pharmacy
Amerita Specialty Infusion Services
Greenwood Village, CO
Gary McCrory RPh FACA, CCN
Independent Consultant
El Paso, TX
Mike Rigas, PharmD
Chief Clinical Officer Emeritus
KabaFusion
Lexington, MA
Regards,
L. Rad Dillon, RPh
Accreditation Commission for Health Care
Loveland, CO
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