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General Chapter <797> Pharmaceutical Compounding—Sterile Preparations

Type of Posting: Notice of Intent to Revise

Posting Date: 27–Dec–2013

Targeted Official Date: TBD

Expert Committee: Compounding

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 the clarity of the general chapter. 

The revision process for <797> began in July 2010 with the formation of the 2010–2015 Council of Experts. The Compounding Expert Committee formed the <797> Expert Panel in April 2013 to provide additional expertise in sterile compounding and included members who are compounding practitioners, educators, infection control specialists, industrial hygienists, environmental engineers, nuclear medicine specialists, microbiologists, surveyors, and industry experts.

Revisions will be posted in the Pharmacopeial Forum for public comment pursuant to section 7.02 of the Rules and Procedures.

Should you have any questions, please contact Rick Schnatz, Pharm.D., Manager Compounding and Healthcare Standards (301-816-8526,