From American Medical Association (AMA) On December 20th the House and Senate avoided a government shut down and passed a continuing resolution to keep federal agencies and programs operating until March 14. Most of earlier proposed health care package, including…
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
