History
Fagron Sterile Services US (FSS) has a rich history in pharmaceutical compounding and was one of the first organizations to register with the FDA in 2014, as a 503B outsourced compounder, then known as JCB Laboratories (est. 2002).
30 Years of Compounding to Serve You Better
Founded in 1990, Fagron is the world’s leading pharmaceutical company dedicated to supporting safe, quality pharmaceutical compounding and personalized medicine. Fagron's purpose statement reflects this:
Together, we create the future of personalizing medicine.
An unwavering dedication to quality and providing superior products has fueled growth for three decades. Today, Fagron provides compounding solutions in over 30 countries to more than 300,000 customers.
In 2010, Fagron entered the North American market. As part of the only vertically integrated pharmaceutical company dedicated to sterile compounding, our 503B facilities drive outsourcing solutions on a comprehensive level across the continuum of care.
As a forward-thinking pharmaceutical supplier, Fagron recognized the opportunity to serve you and your patients better by acquiring JCB Laboratories. JCB was at the forefront of shaping industry standards in sterile preparations for nearly two decades and was one of the first 503Bs in the country to register with the FDA.
In 2019, JCB Laboratories and Fagron Sterile Services synchronized branding to serve customers better and became Fagron Sterile Services US (FSS).
Fagron Sterile Services US
FSS offers specialized solutions to acute care hospitals, ambulatory surgery centers, and physician offices to provide the highest quality service across the continuum of care – putting you and your patients first. FSS shares a belief in the need to improve safety and efficiency for DEA and FDA-Registered 503B Outsourcing Facilities compounding sterile preparations (CSPs).
- Top-tier DEA and FDA-registered 503B Outsourcing Provider, producing reliable supply of high-quality sterile medications with cGMP compliant operations, for patient-focused healthcare facilities across North America
- Employs expertise in legal and regulatory compliance, pharmaceutical manufacturing, and repackaging, leveraging industry leading automation, advanced environmental monitoring, and sophisticated in-house quality testing labs
- Validates all batches to support Beyond Use Dating (BUD) and only releases medications for sale to customers after successful sterility, particulate matter and potency testing are complete
FSS offers a broad product portfolio across Operating Room Anesthesia (OR Syringes & IV Bags), Ophthalmics, Pain Management, and other Specialty Presentations, while holding Integrated Delivery Network (IDN) agreements within all major GPOs.
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