Leading the future of sterile compounding through quality, innovation, & trust
For decades, we’ve set the standard in 503B outsourcing, building trusted provider partnerships and delivering reliable sterile medications with an unwavering commitment to safety, quality, and patient care.
Excellence in 503B compounding
From our founding as JCB Laboratories in 2002 to becoming one of the first FDA-registered 503B outsourcing facilities in 2014, Fagron Sterile Services US has pioneered advancements in sterile compounding.
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1990
Fagron founded in the Netherlands
1990 - 2000
Through a quality focus, Fagron grows to serve more than 30 countries, establishing itself as a global leader in pharmaceutical compounding
2002
JCB Laboratories founded as a small sterile compounding operation on the west side of Wichita, KS, specializing in Ophthalmics
2010
Fagron enters the US market through its nonsterile compounding services and Academy geared toward independent pharmacists
2013
Fagron expands its US operations to include sterile compounding with the acquisition of JCB Laboratories
2014
JCB Laboratories / Fagron become one of the first registered 503B outsourcing facilities in the US
2015
FSS builds a second state-of-the-art 50k+ sq ft 503B Outsourcing facility on the east side of Wichita, KS
2016 - 2019
Product portfolio expansion to support Critical Care medications (OR Syringes); first controlled substance launches (ketamine)
2019
Global rebrand across 70+ sites, JCB and FSS synchronize as Fagron Sterile Services US (FSS)
2020
FSS launches revolutionary repackaged Avastin® syringe and the only Sterile LET Gel (topical anesthetic) through innovative engineering
2021
FSS expands portfolio to include IV bag product presentation and begins strategic partnership with Angels for Change to end drug shortages
2022
FSS acquires Fresenius Kabi's 503B outsourcing business in Boston, MA, adds site in Wichita to support customer needs
2022
FSS introduces RFID embedded OR syringe labels, develops Instant Ship program to support patient care
2022
FSS joins the End Drug Shortages Alliance (EDSA), implements sustainability program reducing annual plastic waste by 2+ tons
2023
FSS grows to support 10s of millions of patient procedures each year
2024
FSS breaks ground on multiple strategic expansion projects to support patient care; a State-of-the-art QC Lab and a project to expand capacity by 40%
2024
FSS acquires Ritedose 503B outsourcing business, expands service to Puerto Rico, and protects Dextrose from shortage with Angels for Change
Why choose FSS
Personalized, cGMP-compliant, 503B outsourcing solutions to meet the unique needs of hospitals, clinics, and ambulatory surgery centers focused on supporting patient care
Globally and vertically integrated
Fagron operates across 30+ countries from 70+ facilities with over 4,000 employees supporting patient care and advancing patient safety including 503B outsourcing services across the US.
Customer focused operations
For 34 years Fagron has offered transparency to customers globally; FSS supports peace of mind through virtual and in-person facility visits, partnerships across 60+ industry organizations and top-tier customer service.
Diverse portfolio across the continuum of care
Robust portfolio to meet your patient care needs from delivery rooms to surgery centers and life’s critical moments in between. Our team works with customers to identify the most in-demand presentations to mitigate staff and drug shortages.
Our guiding principles and business segments
Customer is #1
We always deliver excellent customer service! Our expertise, dedication and passion serve to improve the quality of life of patients around the world.
Speed of execution
We act with urgency, work smart and have the courage to change course when needed.
Entrepreneurship
We take ownership, possess an entrepreneurial spirit and challenge our peers.
Creativity
We are problem solvers, relentlessly pursuing innovation and continuous improvement.
Quality
We aim to deliver excellence — nothing less will do. Quality is our center, ingrained in our work, culture and vision.
Fagron Lab
Our global product line of compounding equipment specially designed and developed by Fagron, for the needs of modern compounding pharmacies.
Compounding
A globally trusted compounding expert with over three decades of experience, pharmaceutical compounding represents the origin and cornerstone of Fagron.
Fagron Tech
Our healthcare and business development solution for the pharmacy and beyond — offering integrated operational, administrative, financial management systems and more.
Fagron Genomics
Our laboratory services company, focused on providing specific pharmacogenetics and diagnostic molecular analysis for healthcare professionals.
Leadership
More than 20 years of commercial leadership experience supporting patient care, Ray drives commercial operations across FSS.
With over 20 years of experience in healthcare and pharmaceuticals, Jason oversees all operations across FSS.
With more than 30 years of experience in pharmaceuticals in both Quality and operations roles, Josh oversees the Quality organization for FSS Wichita.
With over 25 years of Quality experience across diagnostics, biotech/pharmaceuticals, and 503B Outsourcing, Deb oversees the Quality organization for FSS Boston.
Quality is at the center of everything we do
100%
of batches tested for sterility, particulate matter and potency to support patient safety
24/7/365
State-of-the-art environmental monitoring
A global network of affiliates
We offer an outsourced compounding solution that millions of Americans rely on each year, while our affiliates specialize in raw materials, equipment, genomics and more.
Wellness, pain management and nuclear medicine
Continuing education for pharmacists
Advanced quality control laboratory services
Raw materials and lab equipments for pharmacists
Customized genetic testing services
Consumer pharmaceuticals and OTC medications
Frequently asked questions
Fagron Sterile Services US utilizes only FDA approved equipment, containers, and closure devices in the processing and packaging of all compounded sterile preparations.
Fagron Sterile Services US employs pharmacists that can be reached 24/7 to field your drug-specific questions.
Fagron Sterile Services US has FDA registered Outsourcing Facilities. These facilities must meet cGMP standards (21CFR 210 & 211) - USP <797> requirements are not applicable for these facilities.
All Fagron Sterile Services US products are compounded from API obtained from FDA registered manufacturers. All API is tested prior to release and use for compounding to ensure they meet compendial specifications.
Monday: Orders placed before 12:00 PM (CST) will ship the same day.
Tuesday - Friday: Orders placed before 2:00 PM (CST) will ship the same day.
Delivery: Time is dependent on the method of delivery chosen.
Note: Refrigerated products will only ship Monday through Wednesday, unless overnight shipping is requested on Thursday (for an additional charge).
Fagron Sterile Services US primarily uses an internal team for all validation activities and an internal laboratory to complete all final testing of our CSPs. Any external support needed has been qualified and approved by our quality team before acceptance.
The staff at Fagron Sterile Services US (FSS) has been thoroughly trained in sterile product compounding. No operator is allowed to perform sterile compounding activities until they have demonstrated competency for their job requirements and completed the appropriate training.
Still have questions?
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Speak with your personal representative today
Service is in our name and we can’t wait to partner with your patient-focused healthcare facility. Schedule a free consultation today to discuss your 503B outsourcing needs.
Globally and vertically integrated operations
Fagron’s 4k+ employees serve 30+ countries from 70+ facilities
Proactively supporting supply chain resiliency
Fagron’s global team of 100 supply chain experts leverage 3k+ suppliers
Diverse portfolio across the continuum of care
FSS supports patient care from the delivery room to the O.R.
including clinics
