503B Outsourcing Facility
FDA-inspected, in-house quality assurance testing
Your patient's safety is important to us, quality is our priority. All lots are stringently tested and no product is released before all testing is documented and complete. We strive to achieve the highest quality standards in the outsourcing industry and comply with all FDA and DEA regulations, cGMP, GDP and cGLP.
16+ ISO 5 classified aseptic
processing environments
We leverage two DEA and FDA-registered and inspected 503B outsourcing facilities located in Wichita, KS and Boston, MA. Our 503B compounding facilities contain over 14,000 ft2 of space, dedicated to cleanrooms supporting cGMP 21 CFR 210 and 211 compliant operations. Each cleanroom is equipped with independent HVAC systems, state-of-the-art environmental monitoring systems and is fitted with cutting-edge automation and depyrogenation technology.
Industry leading automation
We continue to invest in and implement leading automated solutions in our compounding, filling, visual inspection and labeling processes. This automation expands our production capabilities; allowing us to offer diverse compounded sterile preparations to hospitals, ambulatory surgery centers and physician offices looking for a dependable 503B outsourcing partner.
Efficient systems to deliver superior speed of execution
We offer a variety of shipping options to fit your needs, but two-day delivery comes standard on most orders (expedited options available). More importantly, we hold a >95% same-day fill rate on orders placed before cut-off times! Low fill rates can be costly, even leading to canceled surgeries. Don’t wait weeks for your product to ship — a common problem among 503Bs. We are an outsourcing partner you can rely on.
Explore our state-of-the-art 503B outsourcing facilities
Frequently asked questions
Fagron Sterile Services US has many references and would be pleased to provide them upon request.
Fagron Sterile Services US uses both internal and outside, independent verification for all compounded products. Our policies and procedures ensure that each product is compounded consistently, every time.
Fagron Sterile Services US utilizes only FDA approved equipment, containers, and closure devices in the processing and packaging of all compounded sterile preparations.
The staff at Fagron Sterile Services US (FSS) has been thoroughly trained in sterile product compounding. All FSS' compounding training is from accredited programs and no operator is allowed to perform sterile compounding activities until they have demonstrated competency for their job requirements and completed the appropriate training.
Fagron Sterile Services US employs pharmacists that can be reached 24/7 to field your drug specific questions.
Yes, Fagron Sterile Services US (FSS) is among the largest 503B Outsourcing Facilities in the country. With over 14,000 ft² of cGMP compliant cleanroom space and industry-leading automation, FSS has large-scale 503B Outsourcing capabilities.
Fagron Sterile Services US meets or exceeds USP <797> requirements and are continually improving procedures. Our plants are also inspected semi-annually against 21CFR 210 & 211.</797>
Fagron Sterile Services US (FSS) uses the most current technology and reliable equipment for sterile product compounding. FSS regularly certifies its sterile compounding equipment with third-party validation and adheres to a comprehensive set of Standard Operating Procedures covering process, equipment, personnel, environment, and validation.
All Fagron Sterile Services US products are compounded from API obtained from FDA registered manufacturers.
All products are shipped via UPS Second Day with validated shipping processes to ensure the integrity of each and every preparation you require.
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 has been leading the compounding industry on a global scale for over 30 years. Fagron Sterile Services US has been compounding sterile products across three decades.
All products are shipped via UPS Second Day service and expedited overnight shipping can be arranged upon customer request. If temperature control is required or if other requirements for shipment exist, Fagron Sterile Services US ensures only validated packaging solutions are used to ensure a safe, stable CSP is delivered to your door.
