Recent Updates to USP <795> and <797>



Update: USP is hosting an open forum on revisions to both USP <795> (Jan 12) and <797> (Jan 19). Follow this link to register: 

Nov. 4, 2021 - MILWAUKEE

United States Pharmacopeia (USP) has recently issued revisions to both USP <797> Pharmaceutical Compounding—Sterile Preparations, and USP <795> Pharmaceutical Compounding—Non-Sterile Preparations.

Compounding is a crucial component of patient care, granting access to medications for patients who are unable to use commercially available formulations due to dosing requirements, allergies or rare disease. Meeting requirements set forth by USP can minimize the risk of adverse events or death in patients who use compounded medication.

Find high-level overviews of revised topics or inclusions below. Click here for the full USP <797> Guidance, or here for the full USP <795> Guidance.


Notable Topics of Revision in USP <797> 1

  • Expanded guidance for assigning Beyond-Use-Date (BUD) for Compounded Sterile Preparations (CSPs)
  • Guidance for assigning BUDs to compounded multiple-dose containers, including information on assigning BUDs for non-preserved ophthalmic CSPs
  • Update terminology and rename CSP Microbial Risk Levels
  • Set a maximum batch size of 250 final yield units for all CSPs that require sterility testing
  • Add guidance on the use and storage of entered or punctured conventionally manufactured products
  • Add requirements for maintaining master formulation and compounding records
  • Add guidance on use of isolators
  • Remove specific information related to the handling of hazardous drugs and add cross-references to Hazardous Drugs—Handling in Healthcare Settings ⟨800⟩
  • Remove specific information related to radiopharmaceuticals as CSPs and add cross-references to Radiopharmaceuticals—Preparation, Compounding, Dispensing, and Repackaging ⟨825⟩.

Notable Topics of Revision in USP <795> 2

  • Expand guidance for assigning BUDs for compounded non-sterile preparations (CNSPs) in the absence of stability information.
  • Elaborate on the role of water activity in determining BUD limits for preparations.
  • Add a table of commonly compounded dosage forms and their respective water activity levels to aid compounders in determining BUD limits for CNSPs
  • Clarify the requirements for identifying the need for a recall and related procedures.


Stay tuned to the ConsortiEX Blog for compliance updates and recommendations. As always, if you have any concerns about your compliance or internal practices, let’s talk!

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