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Stability Reference Document for Pharmaceutical Compounding

Rebecca Lisa Diggs Ashworth, Phil Ayers, Gus Bassani, Brett Cordes, Gigi Davidson, Edmund J. Elder, Jr., Blaine Groat, Kevin N. Hansen, Patricia Kienle, Brenda Jensen, Elizabeth Rebello, Rick Rhoads, Robert Shrewsbury, Connie Sullivan, Vanessa Pinheiro

Correspondence should be addressed to: Blaine Groat, Senior Scientist II, US Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852-1790; email: blaine.groat@usp.org.

This Stimuli article is intended to assist the compounder in understanding the 2023 revisions to USP general chapters:

  • Pharmaceutical Compounding—Nonsterile Preparations 〈795〉

  • Pharmaceutical Compounding—Sterile Preparations 〈797〉

  • Hazardous Drugs—Handling in Healthcare Settings 〈800〉

  • Radiopharmaceuticals—Preparation, Compounding, Dispensing, and Repackaging 〈825〉

This Stimuli article is not part of the referenced chapters, is not a comprehensive overview of the chapters, and is not intended to be used in place of chapters. It is a resource to help compounders further understand and perform stability studies used to establish or extend the Beyond-Use Dates (BUDs). The stability of a compounded preparation has several factors that must be evaluated by compounders utilizing or developing stability studies to determine the BUD. This does not reflect the opinions of the Compounding Expert Committee (CMP EC) on further revisions to the chapters. Please note that this article is not official United States Pharmacopeia (USP) and National Formulary (NF) text and is not intended to be enforceable by regulatory authorities. Users must refer to the USP–NF for official text. Questions may be sent to CompoundingSL@usp.org.

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