After a multi-year effort, the long-awaited revision of Chapter 797 Standards for Sterile Compounding (797) of the United States Pharmacopeia (USP) has been released with an expected implementation date of November 1, 2023. Thanks to the joint efforts of the AAOA,…
What you need to comply with the pending USP General Chapter <797> Pharmaceutical Compounding — Sterile Preparations
3 key compliance criteria
While the implementation date of the new USP General Chapter <797> Sterile Compounding has been postponed, it is not too early to start preparing. Below is the list of 3 key compliance criteria all compounding personnel must meet annually:
- Annual personnel trainings and competency must be documented. Personnel must demonstrate proficiency in knowledge of principles and skills for sterile compounding
- AAOA USP <797> Allergen Extract Compounding Learning Module helps you meet this requirement
- Successful completion of the gloved fingertip and thumb sampling on both hands, no fewer than 3 separate times.
- Successful completion of the media fill test to demonstrate sterile technique
For more on the USP General Chapter <797> Sterile Compounding criteria, go to USP.
The AAOA will continue to monitor the USP communications to help keep you informed regarding the postponement and implementation date details
