Beyond Use Testing (BUD)

DEFINITION OF DRUG STABILITY
Beyond Use Dating (BUD) is the date determined beyond which medications that have been manipulated and/or repackaged and stored or dispensed in a container other than the original manufacturer’s storage container. (Example – A refrigerated drug that has a dating of nine days moves to a room temperature drug that has a dating of 90 days). This is different than expiration date which is the date beyond which ideally stored medications in the unopened manufacturer’s storage container.

Stability dating can be demonstrated on specific formulas which includes drug, concentration, diluent, container, & storage conditions. Each product (sterile or non-sterile), should be tested from the compounded date and last point. Typically, it is good to track any trends for a particular product throughout the study.

DYNALABS' APPROACH
DYNALABS has developed a “safe harbor” for hospitals and compounding pharmacies as it pertains to beyond use dating of selective drugs. We perform stability indicating tests (three lots to demonstrate consistency of stability) within the USP guidelines via specific storage condition of the drug. Dating is based on historical data that we have gathered on selective drugs with different variables. Our approach not only addresses the dating but also the implementation of the dating within the pharmacy/s workflow.

IMPACT