USP has postponed the official dates of the below chapters from December 1, 2019 until further notice:
· <795>: Pharmaceutical Compounding – Nonsterile Preparations
· <797>: Pharmaceutical Compounding – Sterile Preparations
· NEW CHAPTER <825>: Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging
Background
USP General Chapters <795> - Pharmaceutical Compounding – Nonsterile Preparations and <797> - Pharmaceutical Compounding – Sterile Preparations were revised and published June 1, 2019. Revisions were made towards the goal of minimizing risk of patient harm. Formal appeals were submitted to USP following publishing of each chapter, and USP has postponed the official dates of these chapters in order to thoroughly review and revise as required. Beyond-Use Date (BUD) and the applicability of both chapters to veterinary practitioners, and the removal of Alternative Technology in <797>, are the key provisions under current appeal.
Effect for Compounding Pharmacies
USP Chapter <800> - Hazardous Drugs – Handling in Healthcare Settings will become official on December 1, 2019. During the postponement, however, it will be informational and not compendially applicable. USP encourages utilization of <800> in the interest of advancing public health, and state and other regulators may determine <800> as enforceable.
Technical Safety Services remains vigilant in reviewing and understanding the impact of the postponement on requirements for our clients. We encourage you to email techsupport@techsafety.com with any questions.
To contact USP directly, contact Healthcare Quality & Safety Team at compoundingsl@usp.org.
Further Details
Read the official USP announcement HERE.
The Decisions on Appeals announcement can be downloaded HERE.
