USP General Chapter <795> Pharmaceutical Compounding—Nonsterile Preparations

USP General Chapter <795> provides standards for compounding quality nonsterile preparations. This standard describes requirements for the compounding process, facilities, equipment, components, documentation, quality controls and training. General Chapter <795> also provides general guidelines for assigning beyond-use dates to nonsterile preparations.

Important Dates

The General Chapter was last revised in its entirety in USP 34NF 29, which became official on May 1, 2011. A Revision Bulletin was issued on Nov. 22, 2013, with an official date of Jan. 1, 2014, to clarify that the maximum beyond-use dates in the chapter may be applied only to nonsterile preparations.

Stakeholder Engagement

USP General Chapter <795> is currently under review for revision by the Compounding Expert Committee. There is currently no anticipated date for proposal of a revision in the Pharmacopeial Forum for public comment.

Compounding Experts

The USP Compounding Expert Committee is responsible for General Chapter <795>. Review their work plan and past meeting summaries.

Additional Resources