Customer Spotlight | Duke University Health System

What Is a 503B Pharmacy? | Olympia Compounding Pharmacy

In the past, ConsortiEX has addressed the many benefits that a central-fill model can offer to health systems; ranging from process improvements to cost savings, and, more importantly, improved patient safety and patient outcomes.

To show the real world impact a central-fill operation can have, we sat down with Matt Brown, PharmD., at Duke University Health System, to discuss how a central-fill operation has impacted the Duke University Health System. Read the full transcript below.

  1. What is the scope of operations at your facility?

  2. Our facility exclusively performs batch compounding for Duke University Hospital. We produce approximately 70,000 units per month, both sterile and non-sterile. All of our sterile batches have USP 71 sterile testing performed so we can extend the beyond-use-dates. In doing so, we are able to significantly reduce the amount of product purchased from 503B pharmacies.

  1. Can you provide a brief background/history behind the journey and decision to create a central fill operation at Duke? What were some challenges the organization faced? Were there any unexpected hurdles?

  2. Originally called “Production and Repackaging”, the compounding facility has existed for decades. Over the last 10-20 years, the facility has really morphed into what it is today. Already having the facility allowed us to identify cost savings for products we could “in-source” from 503Bs.

    When you begin to create (or expand) an operation such as this; patient safety really has to be at the forefront. For us, a challenge was a compounding workflow software that allowed for step by step directions, and custom hard-stops for safety checks. We also wanted a software that allowed for quarantine tracking and incorporation of batch testing results. The biggest hurdle was finding a software designed for the more complex processes involved in in-sourcing compounding. ConsortiEX has worked with us over the years to continually update the software to meet our evolving needs.
"Patient Safety really has to be at the forefront"
  1. How has your facility used the Assure-Trak® Compounding Management System to improve operations and batch processing?

  2. Assure-Trak allows [us] to track our completed product and quarantine inventories more effectively and to use standardized processes across all batches, resulting in more uniform and complete batch records.


  1. Based on your experience, what are some best-practices you’ve been able to implement using Assure-Trak® Compounding Management System?

  2. One that stands out is the ability to standardize the batch size. It eliminates the guess work for the technician and the pharmacist by making the compounding record a set size. If you need two different batch sizes, create 2 separate master formulations. It also reduces the chance that not enough product or drug is pulled for the batch.

    Set batches also allow us to create “Compounding Packs”. Sequestered ingredients and materials needed for a single batch. Reduces prep-time for technicians gather materials for their batch.


  1. Do you feel that the Assure-Trak® Compounding Management System has equipped your team to meet future compliance regulations?

  2. It’s hard to speak for future compliance regulations, as we seem to be stuck in limbo with USP 797. However, I will say that having an electronic batch record and ingredient scanning process is a current best practice and should be incorporated wherever possible to ensure patient safety. Batch compounding can be repetitive and fatiguing; to err is human.
  1. What has your experience been with the ConsortiEX Support Team? Have there been any new features implemented based on your feedback?

  2. Yes, many. We are constantly providing feedback based on our experience and findings. Including increased label design options, and batch record improvements. ConsortiEX actively solicits feedback to continuously improve their system.

ConsortiEX is committed to ensuring compliance today, in order to improve patient outcomes tomorrow, and providing industry best practice solutions moving forward. If you have any concerns about your compliance standing, or are interested in improving your workflow processes, we want to talk to you 


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