"USP Releases Chapter 797 Revision", (c) Cheryl Thompson, Health-System Pharmacy News, 3/12/07

LAS VEGAS, NV, 03 December 2007 — The new version of United States Pharmacopeia (USP) chapter 797, "Pharmaceutical Compounding—Sterile Preparations," became publicly available today and goes into effect June 1, 2008.

For a limited time, U.S. Pharmacopeia stated, the new version of the chapter on compounded sterile preparations (CSPs) is accessible for no fee at www.usp.org/USPNF/pf/generalChapter797.html. This free offering ends January 1 when USP <797> Guidebook to Pharmaceutical Compounding—Sterile Preparations goes on sale.

The standards-setting organization said the current version of chapter 797, as it appears in The United States Pharmacopeia, 31st Revision, and The National Formulary, 26th Edition, remains the official text until publication of the edition's second supplement, scheduled for June 1, 2008.

The text of the new version is not entirely identical to the proposed revision published in May 2006. For example, the proposed section "Environmental Monitoring" was deleted and the content incorporated elsewhere. The new version has the subsection "Depyrogenation by Dry Heat," whereas the proposed revision did not.

In revising USP chapter 797 from the original text, the organization's Sterile Compounding Expert Committee added the following sections:

• Definitions,
• Intermediate-Use CSPs,
• Single-Dose and Multiple-Dose Containers,
• Hazardous Drugs as CSPs,
• Radiopharmaceuticals as CSPs,
• Allergen Extracts as CSPs,
• Personnel Training and Competency Evaluation of Garbing, Aseptic Work Practices, and Cleaning/Disinfection Procedures,
• Elements of Quality Control, and
• Abbreviations and Acronyms.

The committee also created the section "Maintaining Sterility, Purity and Stability of Dispensed and Distributed CSPs" from the former "Maintaining Product Quality and Control after the CSP Leaves the Pharmacy" and added four appendixes.

"ASHP is pleased," said Cynthia Reilly, ASHP's director of clinical standards and quality, "that USP has released the much-anticipated revisions to chapter 797 to give practitioners time to prepare for when that document becomes official in June.

"The timing also provides ASHP an excellent opportunity to provide valuable information to our members—both here at MCM, at the Midyear Clinical Meeting, via educational sessions taught by experts who were involved in the revision and also on an ongoing basis through our practice standard, Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products.

"We'll be reviewing the new USP document carefully with an eye towards creating tools and resources that will help our members comply with state board of pharmacy regulations and accreditation standards that might be impacted by the USP changes," Reilly said.