USP Intends to Revise Pharmaceutical Compounding Quality Assurance Chapter <1163>
Summary
The USP Compounding Expert Committee intends to revise General Chapter <1163> Quality Assurance in Pharmaceutical Compounding, proposing to restructure the chapter into a main chapter <1163> and subchapter <1163.1>. The main chapter title would be updated to Quality Management in Pharmaceutical Compounding, and subchapter <1163.1> titled Special Considerations for Quality Management in Pharmaceutical Compounding, with the revision intended to strengthen QA/QC guidance and assign clear responsibilities to designated personnel. Compounding pharmacies, drug manufacturers, and healthcare organizations involved in pharmaceutical compounding should monitor for the proposed revision publication in Pharmacopeial Forum 53(5) [Sep.-Oct. 2027] and prepare to submit comments by November 30, 2027, with an expected official date of December 1, 2028.
“This revision aims to provide practical and flexible frameworks to support different types of compounding settings.”
Compounding pharmacies and healthcare organizations should use this notice period to audit existing quality assurance programs against anticipated <1163> requirements, particularly regarding formal QA program documentation and designated person responsibilities, before the formal comment window opens in late 2027.
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What changed
The USP Compounding Expert Committee has issued a Notice of Intent to Revise General Chapter <1163>, proposing to restructure the chapter into a main chapter <1163> and subchapter <1163.1> with updated titles to Quality Management in Pharmaceutical Compounding and Special Considerations for Quality Management in Pharmaceutical Compounding. The revision aims to provide clearer guidance on implementing quality assurance and quality control expectations, assign clear responsibilities to designated person(s), and emphasize the need for a formal QA program. Compounding pharmacies, drug manufacturers, and healthcare organizations involved in pharmaceutical compounding should monitor for the proposed revision publication in Pharmacopeial Forum 53(5) and prepare to submit comments by November 30, 2027, ahead of the December 1, 2028 official date.
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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: <1163> Quality Assurance in Pharmaceutical Compounding
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 <1163> Quality Assurance in Pharmaceutical Compounding.
This revision aims to provide practical and flexible frameworks to support different types of compounding settings. The update aims to strengthen the chapter by providing clearer guidance on implementing quality assurance (QA) and quality control (QC) expectations, assigning clear responsibilities to the designated person(s), and emphasizing the need for a formal QA program.
The USP Compounding Expert Committee is also considering structural enhancement by creating a main chapter <1163> supported by a subchapter <1163.1> for detailed content. The title of the main chapter will be updated to <1163> Quality Management in Pharmaceutical Compounding, and the title of subchapter <1163.1> will be Special Considerations for Quality Management in Pharmaceutical Compounding. This approach would make the material more digestible and streamline future updates by allowing focused revisions to specific components.
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 will ben November 30, 2027. In the absence of adverse comments, the 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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