Usp 797 beyond use dating
Omnicell IVX Workflow is an all-in-one device designed for easy placement within laminar airflow (LAF) hoods or isolators.
It supports best practices in aseptic technique by providing step-by-step instructions to guide technicians in preparing IV doses according to set protocols—safely, accurately, and repeatedly.
It describes the CSP requirements (guidelines, USP 797 procedures and compliance) for CSPs and sets the standards that apply to all settings in which sterile preparations are compounded.
Adherence to 797 will reduce the potential for contamination caused by unclean environment, pharmacist error, lack of quality control, incorrect beyond-use dating and other factors.
The manufacturer’s expiration date refers to the date after which an unopened multi-dose vial should not be used.
The guideline requires environmental controls to include a separate area for compounding that meets a definite level of cleanliness, and monitoring to guarantee that control is maintained.
Important to all preparers and places where CSPs are prepared is that the Joint Commission requires a gap analysis and action plan for USP 797 compliance, and is enforcing USP Chapter 797 within their standards.
The beyond-use-date refers to the date after which an opened multi-dose vial should not be used.
The beyond-use-date should never exceed the manufacturer’s original expiration date.
It is the responsibility of personnel to determine the correct level.