Beyond-Use Dates for Sterile Preparations and Stability in Compounding Pharmacies

Today Stacey Bruzzese is joined by guest Rick Rhoads to discuss lessons learned in performing stability tests.

Traditionally, compounding pharmacists have relied on professional experience and published data to determine product stability. Based on this knowledge, compounders have extended beyond use dates when deemed safe and effective. With rapidly changing guidelines, these kinds of judgement calls are no longer allowable. Many compounders are forced to conduct expensive and time consuming stability studies to extend the BUDs for compounded sterile preparations.

• Article: Lessons Learned from a Trimix Stability Study in 503A Compounding Pharmacy by Rick Rhoads, PharmD.

• USP Stakeholder Engagement Plan for Beyond Use Dates (795) (797) • USP Review Perspective on Pharmaceutical Quality

• Historical: Beyond use date (BUD) refers to the date or time after which a compounded sterile/non-sterile preparation

• May not be stored and based on the original date of compounding. BUDs help decrease the risks to patients cause by physical or chemical degradation, microbial contamination and proliferation, and impact on the integrity of the product and it’s container. Compounding Pharmacist are faced with several challenges surrounding BUDs including, varying regulations from state to state, lack of stability testing on compounded preparation, lack of prior knowledge or experience with either the components of a compound, or the compounded preparation and many instabilities cannot be detected without the use of analytic equipment.

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