Applying the Science Behind Parenteral Drug Stability for use in Assigning Beyond-Use Dates to Compounded Sterile Preparations - On Demand
Recorded On: 09/20/2023
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When the usage timeframe in the manufacturer product labeling is limited or omitted, published stability studies can potentially support extending the beyond-use date assigned to a compounded sterile preparation. This presentation will focus on the process of evaluating stability studies of parenteral drugs as a critical step in determining an appropriate beyond-use date for a compounded sterile preparation.
Learning Objectives:
- Navigate the literature resources and review drug stability studies for validity.
- Assess the applicability of a drug stability study to assigning a beyond-use date to a compounded sterile preparation.
- Differentiate the changes made in USP <797>, analyze how these impact the beyond-use date.
Michelle Simpson, PharmD, BCSCP, MWC
Clinical Program Manager
National Home Infusion Association
Michelle C. Simpson, PharmD, BCSCP, MWC, is a Board Certified Sterile Compounding Pharmacist with an established career in home infusion. She is the Clinical Program Manager for the National Home Infusion Association (NHIA), where she is responsible for research studies, non-profit foundation initiatives, data benchmarking, and clinical education development. Michelle is Editor in Chief of Infusion Journal, a peer-reviewed scholarly publication that features independent original research on infusion therapies and is published by the National Home Infusion Foundation (NHIF). Michelle is Co-Editor of Extended Stability for Parenteral Drugs, 7th Edition, a publication of the American Society of Health-System Pharmacists (ASHP).
No Disclosures to Report
Christpher Roy, PharmD, BCSCP
Pharmacist Training Specialist
Option Care Health
Chris Roy, PharmD, BCSCP, began his career with Option Care Health in 2018 as a PGY-1 resident. Since that point, he has held roles as a Clinical Pharmacist, Pharmacy Supervisor, and currently is the Pharmacist Training Specialist with Option Care Health. Chris believes that proper training and education are key to the future of the pharmacy profession and necessary to further the home infusion industry.
No Disclosures to Report