Supporting Evidence for Beyond Use Dates: Evaluating Stability-Indicating Analytical Methods in Primary Literature

NOTE: This session is part of the Live Intensive Studies and Clinical Sessions packages. All attendees may attend these thought-provoking and highly educational sessions. However, if you are board-certified, you must purchase the package(s) for your specialty to receive the recertification assessment and claim the recertification credit.

Many pharmacists falsely believe that the maximum allowable USP dating may be assigned without supporting stability data due to differences between sterile and non-sterile USP compounding standards. In this session, USP <797> requirements for stability by category are discussed as well as how to support master formulation record beyond-use date (BUD) assignments for category 1, 2, and 3 compounded sterile products. Attendees will review the components of a stability-indicating analytical method and study design requirements, apply the most recent stability and compatibility study guidelines published in the American Journal of Health-System Pharmacy, and learn to apply guidelines when critically evaluating the primary literature. Common pitfalls to avoid when assigning BUDs will be reviewed, along with the use of bracketing to assign BUDs across different concentrations.

This activity is approved for Board-Certified Sterile Compounding Pharmacist (BCSCP) recertification credit.