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 <795> Pharmaceutical Compounding—Nonsterile Preparations. The revisions proposed are based on numerous stakeholder engagement activities and intended to improve clarity.
Major revisions of the General Chapter include:
- Expanded guidance for assigning beyond-use dates (BUDs) for compounded nonsterile preparations (CNSPs) in the absence of stability information.
- Removed information on handling of hazardous drugs and added references to General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings.
- Elaborate on the role of water activity (aw) in determining default BUDs for CNSPs.
- Added table of commonly compounded dosage forms and their respective aw to aid compounders in determining default BUDs for CNSPs.
- Clarified requirements for identifying the need for a recall and related procedures.
- Reorganized existing chapter to improve clarity and to place key procedural information in boxes.
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 January 31, 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 (CompoundingSL@usp.org).