USP Proposes Revisions to Stability Chapter <1191> for Compounding Practice
Summary
The USP Compounding Expert Committee has issued a Notice of Intent to Revise General Chapter <1191> Stability Considerations in Dispensing Practice, with a targeted official date of December 1, 2028. The revision aims to strengthen guidance for compounders on stability study design and application when establishing or extending beyond-use-dates, address practical formulation development considerations including flavorings and dyes, and potentially restructure the chapter with new subchapters <1191.1> and <1191.2>. A public comment period is expected to open in Pharmacopeial Forum 53(5) in September-October 2027, with comments due November 30, 2027.
“The revision aims to strengthen and clarify guidance for compounders on the design and application of stability studies when establishing or extending beyond-use-dates.”
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What changed
USP has announced plans to revise General Chapter <1191> Stability Considerations in Dispensing Practice, which provides guidance for compounders on stability studies and beyond-use-dates. The proposed revision will incorporate concepts from three stimuli articles on formulation development, stability, and flavoring best practices, and may restructure the chapter into subchapters <1191.1> and <1191.2> for improved clarity and accessibility.
Compounders and pharmacies preparing compounded preparations should monitor the Pharmacopeial Forum 53(5) for the proposed revision, which is expected to open for public comment in September-October 2027 with a November 30, 2027 comment deadline. The revised chapter is anticipated to become official on December 1, 2028.
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Apr 28, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Notice of Intent to Revise: <1191> Stability Considerations in Dispensing Practice
Type of Posting: Notice of Intent to Revise
Posting Date: 24-Apr-2026
Targeted Official Date: 01-Dec-2028
Revision Vehicle: In-Process Revision
Expert Committee: Compounding Expert Committee
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the USP Compounding Expert Committee intends to revise General Chapter <1191> Stability Considerations in Dispensing Practice.
The revision aims to strengthen and clarify guidance for compounders on the design and application of stability studies when establishing or extending beyond-use-dates. As part of the effort, the chapter title may also be updated to better reflect the expanded scope addressed in the revision. The revised chapter will also aim to address practical considerations for formulation development of compounded preparations, including the impact of flavorings and dyes on stability.
The committee intends to incorporate key concepts from the following stimuli articles:
- Formulation Development Reference Document for Pharmaceutical Compounding
- Stability Reference Document for Pharmaceutical Compounding
- Flavoring – Best Practices, Regulatory Considerations, and Innovative Approaches in Pharmaceutical Compounding (is expected to be published for public comment in Pharmacopeial Forum 52(3), with an posting date of May 1, 2026) In addition, the committee is also considering structural enhancement to improve clarity and usability of the chapter. Under this approach, the primary chapter <1191> would be supported by two subchapters <1191.1> and <1191.2> to make the material more accessible and enable more efficient future updates by allowing focused revisions to specific sections.
It is anticipated that the proposed revision will be published for public comment in Pharmacopeial Forum 53(5) [Sep.-Oct. 2027] pursuant to the Rules and Procedures. The comment period for PF 53(5) ends November 30, 2027. In the absence of significant adverse comments, this chapter is expected to become official on December 1, 2028.
Should you have any questions, please contact Nicole Mercogliano, Senior Scientist, to the Compounding Expert Committee (CompoundingSL@usp.org).
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