Products

FDA Registered 503B Outsourcing Facility

Choose Quality.
Choose Consistency.
Choose Fagron Sterile Services.

Fagron Sterile Services provides a broad portfolio of high-quality preparations that set the standard for patient safety, competitive pricing, regulatory guidance and clinical expertise.

Count on Fagron Sterile Services, one of the largest FDA registered 503B Human Drug Outsourcing Facilities in the country, for all your outsourcing needs. We specialize in ophthalmology, corticosteroids, IV admixture, urology, dialysis and other high quality sterile pharmaceutical preparations.

Licensure

503B Human Drug Outsourcing

Fagron Sterile Services is registered with the 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

  • 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

Providing high-quality sterile preparations that are produced with industry-leading automation and quality control systems.

Corticosteroids

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

Dialysis

Provide safe treatment solutions for patients on dialysis by using quality products developed by clinical experts and produced following cGMP standards.

Operating Room (OR) Syringes

Time and accuracy matter in the operating room. Our OR solutions are prepared with the most stringent testing processes available. No preparation is released until all testing has been completed. We understand the importance of quality, accuracy and efficiency.

Ophthalmics

Increase safety and improve efficiency with high-quality ophthalmic products. We set the standard for safety, competitive pricing and clinical expertise.

Topical Anesthesia

Use an economical, easy-to-administer sterile solution to provide patients rapid topical anesthesia. Lidocaine-Epinephrine-Tetracaine (LET) solution provides and maintains anesthesia without the use of controlled substances.

Urology (Mito Bladder)

Ensure your patients receive safe and effective mito bladder therapy for intravesical use. We offer leading urology solutions produced in state-of-the-art hazardous drug clean room environments.

Miscellaneous

Choose high quality solutions for pain management and other specialty pharmaceutical preparations. We build industry leading safety, quality and clinical expertise in every product we make.