The two revised chapters are USP chapter 795, which regulates nonsterile compounding, and USP chapter 797, which regulates sterile compounding.
The panel made its decision to address “issues raised concerning the beyond-use date provisions.”
Last year, the USP postponed the dates these updated chapters were slated to go into effect because of appeals filed against them. Appeals were also filed against USP chapter 825, which deals with radiopharmaceuticals.
While the panel sent chapter 795 and 797 back for review, it denied the appeal for chapter 825 March 12, asking the appellant to submit a narrower request.
The panel’s decision will delay the date the revised version of chapter 797 will be enforced as well as the date for general chapter 800, which deals with hazardous drugs. Chapter 800 will remain informational pending final revisions to 797, according to a news release from the American Hospital Association.
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