503B Outsourcing Facility

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

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 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.

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.</797>

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 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.

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.

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).

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.

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.