Saturday, November 23, 2013

USP 795 Nonsterile preparations revisions

<795> Pharmaceutical Compounding—Nonsterile Preparations

Type of Posting
Revision Bulletin
Official Date
Expert Committee
Compounding Expert Committee
Reason for Revision
Patient Safety
In accordance with the Rules and Procedures of the 2010-2015 Council of Experts, theCompounding Expert Committee has revised the General Chapter <795> Pharmaceutical Compounding—Nonsterile Preparations. The purpose for the revision is to remove the reference to sterile preparations in the section General Guidelines for Assigning Beyond-Use Dates. The revision will clarify that the beyond-use date (BUD) in the table “BUD by Type of Formulation” is specific for nonsterile preparations and users should refer to General Chapter <797> Pharmaceutical Compounding—Sterile Preparation for standards on sterile compounding.
The General Chapter <795> Pharmaceutical Compounding—Nonsterile Preparations Revision Bulletin supersedes the currently official General Chapter.  The Revision Bulletin will be incorporated in the Second Supplement to USP 37–NF 32.
Should you have any questions, please contact Rick Schnatz, Pharm. D., ManagerCompounding and Healthcare Standards (301-816-8526,

quoted from here

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