Sterile Compounding Services

Sterile-to-Sterile | API-to-Sterile | Biologic
Produced with industry-leading automation and quality control, delivered with top-tier service.

Trusted By

7,300+ customers choose FSS US as their trusted 503B compounder — along with some of the largest GPOs and IDNs in the country.

Operating Room (OR) Anesthesia

Operating Room (OR) Anesthesia

Reduce waste and cut down on the number of touchpoints in surgery preparation. FSS' ready-to-use OR anesthesia solutions are prepared to meet stringent testing processes developed across three decades.
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Ophthalmics

Ophthalmics

Support safety and improved efficiency with high-quality ophthalmic products. Learn more about our Avastin® purchase programs and other solutions.
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Pain Management

Pain Management

Give your patients peace of mind with preservative-free corticosteroids. We offer unit-of-use alternatives made under stringent cGMP guidelines.
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Specialty Presentations

Specialty Presentations

From topical anesthesia to urology (mito-bladder) and dialysis, Fagron Sterile Services US (FSS) provides compounding solutions prepared in state-of-the-art cleanroom environments.
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Licensure

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.

Process

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.

Execution

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

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