USP General Chapter <797> Pharmaceutical Compounding—Sterile Preparations

USP General Chapter <797> provides standards for compounding sterile preparations to promote patient safety and prevent harm. These standards help ensure patients receive quality preparations that are free from contaminants and are consistent in intended identity, strength and potency. This General Chapter describes a number of requirements, including responsibilities of compounding personnel, training, environmental monitoring, storage and testing of finished preparations.

Important Dates 

The General Chapter was last revised in the Second Supplement to USP 31–NF 26, which became official on June 1, 2008, and is the currently official standard.

A revision to General Chapter <797> was proposed for public comment from Sept. 25, 2015, to Jan. 31, 2016. The USP Compounding Expert Committee is continuing to review the public comments received and is in the process of revising the General Chapter. Based on the nature and significance of the public comments received, the chapter will be republished in the Pharmacopeial Forum for another public comment period. The existing General Chapter <797>, as published in the USP–NF and the Compounding Compendium, is the currently official standard for sterile compounding.

Stakeholder Engagement

  • USP proposed revisions to USP General Chapter <797> and sought public comments from Sept. 25, 2015, to Jan, 31, 2016—during which time over 2,500 stakeholders submitted more than 8,000 comments. The Compounding Expert Committee continues to review and revise the chapter based on the public comments submitted.
  • Based on the nature and significance of the public comments submitted to USP, the chapter is currently being revised and will be published in the Pharmacopeial Forum for another public comment period. Learn more about the second posting for public comment.
  • There is currently no anticipated date for proposal of a revision in the Pharmacopeial Forum for public comment. Sign up for the USP Healthcare Quality Standards Newsletter to receive updates on the chapter revision.
  • USP hosts roundtables to identify opportunities for additional dialogue and collaboration related to specific concerns related by stakeholder groups. Two took place in early February 2017 and focused on the compounding of allergen extracts and radiopharmaceuticals. These USP roundtable activities are supplemental to the public comment process, and the Expert Committee will use the proceedings to assist in its revision process.

Expert Committee

The USP Compounding Expert Committee is responsible for reviewing and revising General Chapter <797>. Review its work plan and past meeting summaries.

Additional Resources