Outsourcing Services
Sterile-to-Sterile, API-to-Sterile & Biologic compounding produced with industry-leading automation, quality & customer service
Explore our sterile outsourcing services
Doses are produced with industry-leading automation and quality control systems, so you and your patients can count on FSS — one of the most advanced DEA and FDA-registered 503B outsourcing providers in the United States.
Critical Care
Reduce waste and cut down on the number of touchpoints in surgery preparation. Fagron Sterile Service US's ready-to-administer critical care solutions are prepared through cGMP-compliant operations in state-of-the-art DEA and FDA-registered and inspected 503B outsourcing facilities inspected against 21 CFR 210 and 211 for pharmaceutical manufacturing.
Labor & Delivery
From the beginning, Fagron Sterile Services US (FSS) is here to support your patient care needs with a reliable supply of sterile medications, including oxyTOCIN, so that you can focus on what matters most.
Ophthalmics
Support safety and improved efficiency with high-quality ophthalmic products. Ask about our Avastin® purchase programs and other solutions.
Pain management
Give your patients peace of mind with preservative-free corticosteroids. We offer unit-of-use alternatives made under stringent cGMP guidelines.
Specialty presentations
From topical anesthesia to urology (mitoMYcin-bladder) and dialysis, FSS provides outsourcing solutions prepared in state-of-the-art cleanroom environments.
503B Human Drug Outsourcing
Fagron Sterile Services is registered with the DEA and FDA as a 503B Outsourcing Facility with an exclusive focus on sterile products. This dedication to sterile products has led to the development of technology and systems that enhance quality assurance and patient safety. We are State Board of Pharmacy licensed, registered with the FDA as a 503B outsourcing facility and follow cGMP, GDP and cGLP guidelines.
Efficiency by Design
Fagron Sterile Services is confident in our people and our abilities for a good reason. We deliver your compounded sterile preparation on time and on budget with principled agility and personal accountability. The efficiency fostered by our integral relationships with our clients and hands-on management style promotes personal accountability in everything we do.
Attention to Detail
With Fagron Sterile Services you will experience a level of service and accountability that has been lost in layers of red tape and bureaucracy at other companies. Couple this focus with our principled agility and we will help you keep pace with the most demanding of projects and timelines.
Validation
- Process Validation: Aseptic Fill, Sterilization, Depyrogenation, All Compounding Activities, IQ, OQ, PQ on all equipment
- Validation of Testing Methods: Stability Over Time, Endotoxin, Fungal, Sterility
- Validated SOPs
