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Purpose of Review <p>USP 797 establishes minimum quality and safety standards for compounding sterile preparations and has important implications for otolaryngology practices, including allergen immunotherapy, nasal irrigations, intratympanic injections, and medication reconstitution. The 2022 revision, enforceable November 1, 2023, represents the first major update since 2008. This review summarizes key changes, highlights Section 21 for allergenic extracts, and discusses operational impacts on clinical practices.</p> Recent Findings <p>The revised USP 797 replaces traditional risk groups with a category-based framework, restructures beyond-use dating, expands immediate-use allowances, and introduces more prescriptive requirements for training, environmental monitoring, cleaning, documentation, and quality oversight. Section 21 establishes tailored standards for patient-specific allergenic extracts. These changes substantially increase time, cost, and administrative burden.</p> Summary <p>While the updated USP 797 increases short‑term operational demands, it establishes a stronger foundation for long‑term improvements in patient safety, quality assurance, and consistency in compounding practices.</p>

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Making Sense of the 2022 USP 797 Update

  • 期刊论文

  • 发表日期：

    2026年5月29日

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  • Kathryn M. Hardin,
  • Thomas S. Edwards,
  • Sarah K. Wise

摘要

Purpose of Review

USP 797 establishes minimum quality and safety standards for compounding sterile preparations and has important implications for otolaryngology practices, including allergen immunotherapy, nasal irrigations, intratympanic injections, and medication reconstitution. The 2022 revision, enforceable November 1, 2023, represents the first major update since 2008. This review summarizes key changes, highlights Section 21 for allergenic extracts, and discusses operational impacts on clinical practices.

Recent Findings

The revised USP 797 replaces traditional risk groups with a category-based framework, restructures beyond-use dating, expands immediate-use allowances, and introduces more prescriptive requirements for training, environmental monitoring, cleaning, documentation, and quality oversight. Section 21 establishes tailored standards for patient-specific allergenic extracts. These changes substantially increase time, cost, and administrative burden.

Summary

While the updated USP 797 increases short‑term operational demands, it establishes a stronger foundation for long‑term improvements in patient safety, quality assurance, and consistency in compounding practices.