Proposed Revisions to USP Compounding General Chapters <795> and <797>

• September 1, 2021: Proposed Revisions to <795> Pharmaceutical Compounding – Nonsterile Preparations
• September 1, 2021: Proposed Revisions to <797> Pharmaceutical Compounding – Sterile Preparations

Supplemental Documents: 

Stability Study Reference Document for the 2021 Proposed Revisions to <795> and <797>

• June 13, 2023 (Updated): Formulation and Stability Reference Document for Pharmaceutical Compounding

USP General Chapter <795> Informational Documents

• September 1, 2021: BUD Scientific Rationale for the 2021 Proposed Revisions to <795>
• September 1, 2021: BUD Reference for the 2021 Proposed Revisions to <795>
• September 1, 2021: Compounding Expert Committee Responses to Stakeholder Engagement Themes for the 2021 Proposed Revisions to <795>

USP General Chapter <797> Informational Documents

• September 1, 2021: BUD Scientific Rationale for the 2021 Proposed Revisions to <797>
• September 1, 2021: BUD Reference for the 2021 Proposed Revisions to <797>
• September 1, 2021: Compounding Expert Committee Responses to Stakeholder Engagement Themes for the 2021 Proposed Revisions to <797>