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.
16 ISO 5 Classified Aseptic
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.
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
Compounding Facility Entrance
Independent ISO 5 Classified Aseptic Fill Rooms
FDA Inspected In-House Quality Testing Labs
Industry Leading Automation
Frequently Asked Questions
Have you had specific training in sterile 503B compounding?
Do you have access to a technical support team that can help with formulation questions?
Do you have adequate space for compounding sterile products?
Do you meet or exceed United States Pharmacopoeia recommendations for sterile product compounding?
Do you have the proper equipment for compounding sterile products?
Do you have a quality assurance/quality control program in place for final testing of your sterile products and validation of your processes?
Do you use approved grades of pharmaceutical powders when compounding sterile products?
Do you use FDA approved devices for final packaging of sterile products?
How do you protect product integrity during shipping?
How much experience do you have compounding sterile products?
Do you have at least three references that may be contacted to testify to the quality of your products?
How do I place an order?
What is the typical turnaround time from order to delivery?
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).