General Chapter <797> Pharmaceutical Compounding – Sterile Preparations is revised and finalized

Status and Update

The Sterile Compounding Expert Committee (SCC) has completed the review and revision of chapter <797>. The revised chapter has been posted on USP's Web site  (7.7MB) as a Revision Bulletin to allow practitioners the opportunity to review and assimilate the content of the chapter before it becomes official on June 1, 2008. It will be published in Second Supplement to USP 31 – NF 26, and in the Pharmacists' Pharmacopeia. Once the chapter becomes official in June of 2008, the current version in USP 31 – NF 26 will no longer be the official chapter.

The completely revised chapter contains the following topics:

  • Introduction and Organization of the Chapter
  • CSP Microbial Contamination Risk Levels
  • Single-Dose v. Multiple Dose Containers
  • Hazardous Drugs as CSPs
  • Radiopharmaceuticals as CSPs
  • Allergen Extracts as CSPs
  • Sterilization Methods
  • Environmental Quality and Control
  • Exposure of Critical Sites
  • Placement of Primary Engineering Controls
  • Additional Personnel Requirement
  • Personnel Cleansing and Garbing
  • Disinfectant and Cleaning
  • Appendices

The section on Environmental Monitoring has been deleted. Two subsections and three appendices were developed from the environmental monitoring section. The two subsections are listed under the Environmental Quality and Control section.

The Revision Bulletin was updated on January 28, 2008, to correct several errata in the chapter that were identified after it was posted. Details of the corrections made are available here.

Access to the Revised General Chapter <797>

The revised General Chapter <797> is available online  (7.7MB) without charge. Early in 2008 the revised General Chapter <797> will be available in a newly updated Guidebook.

Access to the Sterile Compounding Committee's Response to Comments

Read the Sterile Compounding Expert Committee's response  (102KB) to the more than 500 comments received from the publication of the proposed revisions to Chapter <797>.

Coming Soon

Guidebook on USP General Chapter <797> Pharmaceutical Compounding – Sterile Preparations

USP General Chapter <797>

Contents include:

  • Introduction: General Chapter <797> and the USP Revision Process
  • Enforceability and Recognition of General Chapter <797>
  • General Chapter <797> Pharmaceutical Compounding— Sterile Preparations (Current Official Text from USP31)
  • Revisions to General Chapter <797> Pharmaceutical Compounding — Sterile Preparations (with Markup)
  • General Chapter <797> Pharmaceutical Compounding — Sterile Preparations (Official Text as of June 1, 2008)
  • Rationale for Major Changes Proposed for the In-Process Revision of USP General Chapter <797> Pharmaceutical Compounding —Sterile Preparations
  • Frequently Asked Questions (FAQ5) Regarding General Chapter <797>