503B Outsourcing Facility

FDA registered 503B compounding facility with over 14,000 ft2 of dedicated cGMP clean room suites

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.

compounding facility product testing
503b sterile compounding facility

16 ISO 5 Classified Aseptic
Processing Environments

We leverage two FDA registered 503B compounding pharmacies centrally located in Wichita, KS. Our 503B outsourcing facilities contain over 14,000 ft2 of space, dedicated to cGMP cleanrooms. 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.

503b outsourcing facility automation
packaging pharmaceuticals outsourcing

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

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  • Education
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Have you had specific training in sterile 503B compounding?
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.
Do you have access to a technical support team that can help with formulation questions?
Fagron Sterile Services US employs pharmacists that can be reached 24/7 to field your drug specific questions.
Do you have adequate space for compounding sterile products?
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.
Do you meet or exceed United States Pharmacopoeia recommendations for sterile product compounding?
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.
Do you have the proper equipment for compounding sterile products?
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.
Do you have a quality assurance/quality control program in place for final testing of your sterile products and validation of your processes?
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.
Do you use approved grades of pharmaceutical powders when compounding sterile products?
All Fagron Sterile Services US products are compounded from API obtained from FDA registered manufacturers.
Do you use FDA approved devices for final packaging of sterile products?
Fagron Sterile Services US utilizes only FDA approved equipment, containers, and closure devices in the processing and packaging of all compounded sterile preparations.
How do you protect product integrity during shipping?
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.
How much experience do you have compounding sterile products?
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.
Do you have at least three references that may be contacted to testify to the quality of your products?
Fagron Sterile Services US has many references and would be pleased to provide them upon request.
How do I place an order?
Orders may be placed utilizing the following methods: Online: shop.fagronsterile.com Email: CustomerCare@fagronsterile.com Phone: 1.316.773.0405 Toll Free Phone: 1.877.405.8066
What is the typical turnaround time from order to delivery?
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).
Will my package stay cold enough?
All products are shipped via UPS Second Day with validated shipping processes to ensure the integrity of each and every preparation you require.