AMA Update Tuesday, Congressional leaders released a health care package to accompany the FY 2025 Continuing Resolution that is supposed to be voted on by December 20. Here is a document that highlights the key provisions of interest to medicine. In…
What you need to comply with the pending USP General Chapter <797> Pharmaceutical Compounding — Sterile Preparations
3 key compliance criteria
The new USP General Chapter <797> Sterile Compounding went into effect November 1 2023. Now is a great time to review your in-office procedures to assure compliance. 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
