In late November 2013, Congress passed the Compounding Bill. This legislation enforces regulation of compounding pharmacies, as a result of injections of contaminated compounded drugs - which caused 64 deaths and many more nonfatal injuries. PLEASE NOTE: The preparation of…
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