2023 Revision to USP 797: What Home Infusion Pharmacies Need to Know

On Novemeber 1, 2022 USP released the revised version of General Chapter <797> Pharmaceutical Compounding--Sterile Preparations, which becomes enforceable November 1, 2023. Although revisions were proposed (and subsequently appealed) in previous years, this version will represent a significant change from the 2008 standards which are currently enforceable. Home infusion pharmacies will need to comprehend how the updated standards apply to their sterile compounding operations. This article will cover the significant areas, including: beyond-use dating for categories 1, 2, and 3 CSPs, requirements for clean room personnel qualification and evaluation, the need for a designated person(s) to ensure the sterile environment maintains quality, environmental monitoring changes and the need for increased testing and cleaning.

Learning Objectives:

  1. Review the latest updates to USP General Chapter <797> compared to the 2008 version which remains enforceable until November 1, 2023. 
  2. Understand the difference between Category 1, 2, and 3 compounded sterile preparations (CSPs) and list the specific requirements for each.
  3. Describe the requirements for personnel qualification and evaluation.
  4. Explain the increased frequencies for environmental monitoring and cleaning.

Abby Roth, BS, CMQ/OE

Founder

Pure Microbiology

Abby Roth, founder of Pure Microbiology, has over 18 years of experience in supporting the testing and consulting needs of the pharmaceutical, medical device, and compounding industries. Her background in pharmaceutical microbiology includes extensive knowledge of environmental monitoring. Abby served as a USP Compounding EC member during the 2015-2020 cycle. She is an involved member of the Controlled Environment Testing Association (CETA), serving on the Board of Directors, speaking at its annual meetings, and chairing committees for the revision of four CETA Application Guides. Abby has been invited to speak for state boards of pharmacy and for national organizations.

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2023 Revisions to USP 797: What Home Infusion Pharmacies Need to Know
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