Final Standards for Allergen Extract Compounding under USP Chapter 797 The long-awaited new USP Chapter 797 standards on sterile compounding were released June 1 and take effect Dec. 1. Read the final approved USP letter here. Have questions? Attend the AAOA…
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