General Chapter <797> Pharmaceutical Compounding–Sterile Preparations
In accordance with section 7.05(c) of the 2010–2015 Rules and Procedures of the Council of Experts, this is to provide notice that the Compounding Expert Committee intends to revise General Chapter <797> Pharmaceutical Compounding—Sterile Preparations. The purpose of the revision is to reflect new science, respond to stakeholder input, and improve clarity of the General Chapter. Specifically, the Expert Committee proposes to revise the Storage and Beyond-Use Dating section in General Chapter <797> to eliminate the cross-references to General Chapter <795> Pharmaceutical Compounding—Nonsterile Preparations. The revision will clarify that the beyond-use dates in General Chapter <795> are solely for nonsterile preparations and do not apply to sterile preparations.
- The two proposed revisions are:
- 1. Delete the statement “(see Stability Criteria and Beyond-Use Dating under Pharmaceutical Compounding—Nonsterile Preparations <795>)” in the section Storage and Beyond-Use Dating.
2. Delete the statement “BUDs for CSPs that lack justification from either appropriate literature sources or by direct testing evidence shall be assigned as described in Stability Criteria and Beyond-Use Dating under Pharmaceutical Compounding—Nonsterile Preparations <795>” in the subsection Determining Beyond-Use Dates
This intent to revise is posted along with the Revision Bulletin for General Chapter <795> Pharmaceutical Compounding—Nonsterile Preparations. The Revision Bulletin for General Chapter <795> will remove the reference to sterile preparations in the section General Guidelines for Assigning Beyond-Use Dates to clarify that the beyond-use dates in the chapter is specific only to nonsterile preparations and do not apply to sterile preparations.
Should you have any questions, please contact Rick Schnatz, Pharm. D., Manager Compounding and Healthcare Standards (301-816-8526, rxs@usp.org).
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