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General Chapter <797> Pharmaceutical Compounding—Sterile Preparations

Type of Posting: Notice of Intent to Revise
Posting Date: 01–Sep–2021
Targeted Official Date: TBD
Expert Committee: Compounding Expert Committee
In accordance with the 2020–2025 Rules and Procedures of the Council of Experts, this is to provide notice that the Compounding Expert Committee intends to revise General Chapter <797> Pharmaceutical Compounding—Sterile Preparations. The revisions proposed are based on numerous stakeholder engagement activities and intended to improve clarity.  

Major revisions of the General Chapter include:

  • Reorganized the chapter to group similar topics and clarified requirements. Included section and subsection numbers and place procedural information in boxes.
  • Expanded guidance for assigning beyond-use dates (BUD) for compounded sterile preparations (CSPs).
  • Revised CSP microbial risk levels to more neutral categorization. Category 1 and 2 CSPs are distinguished primarily by the facility in which they are made and the length of time within which they must be used.   Category 3 CSPs are those that may be assigned longer BUDs than the limits for Category 1 or Category 2 CSPs, up to 180 days, if additional requirements are met.
  • Added a maximum batch size of 250 final yield units for all CSPs requiring sterility testing.
  • Added information on assigning BUDs to compounded multiple-dose containers, including information on assigning BUDs for non-preserved ophthalmic CSPs.
  • Added information on the use and storage of entered or punctured conventionally manufactured products.
  • Added information on notification and recall of CSPs with out-of-specification results.
  • Clarified requirements for compounding allergenic extract prescription sets.
  • Added requirements for maintaining master formulation and compounding records.
  • Provided information on the 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〉
  • Removed specific information related to radiopharmaceuticals as CSPs and add cross-references to Radiopharmaceuticals—Preparation, Compounding, Dispensing, and Repackaging 〈825〉. 

The proposed revision will be published in Pharmacopeial Forum 47(6) [Nov.–Dec. 2021] pursuant to  the Rules and Procedures. The comment period for this revision ends on March 17, 2022. To allow additional time for public review and comment, the proposed revisions are included below in advance of their publication in PF 47(6):

Please use the electronic form to submit your comments. Comments should include corresponding section to the proposed revisions to the General Chapter. 

Should you have any questions, please contact USP staff at (