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Kentucky News: Revisions to USP Chapter 797 (Sterile Compounding)
Published in the March 2008 Kentucky Board of Pharmacy Newsletter
After nearly thirty (30) months in revision, United States Pharmacopeia (USP) posted the final update for USP General Chapter 797, “Pharmaceutical Compounding – Sterile Preparations.” Information for obtaining a copy of this revised chapter can be obtained at www.USP.org. It was posted in early 2007 and will take effect June 1, 2008. Under KRS 317.015(31), USP is defined as Kentucky’s official compendium. Therefore, these revisions will affect any pharmacy in Kentucky that compounds sterile products.
Due to the magnitude and length of the revisions, a summary of the changes cannot be addressed in this article. Some of the major changes involve new definitions, new risk categories, hazardous drugs, radiopharmaceuticals, environmental controls, and personnel cleansing and garbing. These changes have tried to address the fact that direct contact is the principal source of contamination of compounded sterile products. Needless to say, these changes are far reaching and will affect all sterile compounding pharmacies.
It is urged that all sterile compounding pharmacists review these changes. The new chapter is over sixty (60) pages in length and not an easy read. The last three (3) pages of the revision are check lists that greatly assist the pharmacy in implementation of some of the environmental requirements. Time and concentration will be necessary to understand what areas will have direct impacts on your pharmacy practice site. The Kentucky Board of Pharmacy has previously appointed a committee to review these changes and assess the impact to Kentucky pharmacies. This committee will report to the Board on its findings and all pharmacists will be notified. If you have any comments regarding the changes in USP Chapter 797, please forward your comments to the Board office. We encourage you to contact your pharmacy inspector with any questions you might have.
