Importance of Office Use Compounding Part 2

 

Criteria to Demand From Your Sterile Compounding Partner

The compounding pharmacy supplying sterile office use products must place quality above everything else.  For a sterile products compounding pharmacy, this means, at a minimum, that the pharmacy:

  • Maintains a constant state of control in their cleanroom

    • Continuous monitoring of temperature, humidity and pressure differentials

    • Daily, weekly and monthly environmental monitoring

    • Regular certification of all cleanrooms and laminar flow hoods by an accredited third party

  • Meets or exceeds USP <797>  

    • This includes meeting the requirements for sterility, fungal, endotoxin and potency testing

  • Is accredited by the Pharmacy Compounding Accreditation Board

  • Has a robust set of Standard Operating Procedures that have been reviewed by an accrediting body

    • This includes a recall procedure that is regularly tested and allows the pharmacy to track every ingredient and device used to compound a particular product and recall it within hours.

  • Labeling products with labels that meet ISMP (Institute for Safe Medication Practices) guidelines.

    • This includes a barcode that allows health systems to integrate compounded medications into their automated dispensing systems

    • All labels for compounded product will clearly state:

      • This Is A Compounded Product

      • For Office Use Only

      • Not for Resale

Office use compounding saves the healthcare system money by allowing facilities to stock the medications they need based on historical usage.  In addition, it is clearly an efficient way to provide the best possible patient care by giving the physician the ability to choose from multiple medication options based on the patient’s unique needs. JCB supports additional regulation as long as it will  improve patient safety and still allow healthcare providers efficient access to compounded medications in a timely fashion.  Unnecessary restrictions or hurdles (such as requiring patient-specific prescriptions for compounded medications for office use, FDA notification on new compounds or arbitrary Do Not Compound Lists)  do not improve patient safety and will cost our health system substantial dollars due to inefficiencies.

Written by Newport Beach Compounding Center Staff

As one of the most experienced compounding pharmacies in Newport Beach, We provide a valuable service working together with physicians and patients to create medications tailored to specific requirements. We are specialists in the art and science of pharmacy compounding. Our Team of experts can meet all of your unique pharmaceutical needs.

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