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<795> Pharmaceutical Compounding—Nonsterile Preparations

Type of Posting: Revision Bulletin

Posting Date: 22–Nov–2013

Official Date: 01–Jan–2014

Expert Committee: Compounding Expert Committee

Reason for Revision: Patient Safety

In accordance with the Rules and Procedures of the 2010-2015 Council of Experts, the Compounding 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., Manager Compounding and Healthcare Standards (301-816-8526,