EXPERTS IN STERILE PHARMACEUTICAL SOLUTIONS

503B HUMAN DRUG OUTSOURCING

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

FREQUENTLY ASKED QUESTIONS

In choosing a Sterile Compounding Pharmacy, both patient safety and professional liability must be considered. Consider asking these questions when evaluating a compounding lab partner.

Have you had specific training in sterile 503B outsourcing?

The staff at JCB has been thoroughly trained and validated in sterile product compounding. All of JCB's compounding training is from accredited programs.

Do you offer continuing education specific to sterile product compounding?

JCB partners with Fagron Academy, a state-of-the-art professional educational center that aims to expand pharmacists and pharmacy technicians knowledge and skills in pharmaceutical compounding. To learn more on ACPE accredited clinical and technical training courses, visit www.fagronacademy.us

Do you have access to a technical support team that can help with formulation questions?

JCB regularly works with outside, independent support organizations on formulations.

Do you have adequate space for compounding sterile products?

Yes, as companies of Fagron, JCB and Fagron Sterile Services are among the largest 503B Outsourcing Facilities in the country. With over 14,000 sq ft of cGMP compliant cleanroom space and industry-leading automation, JCB has large-scale 503B Outsourcing capabilities.

Do you meet or exceed United States Pharmacopoeia recommendations for sterile product compounding?

JCB meets or exceeds USP <797> requirements and are continually improving procedures.

Do you have the proper equipment for compounding sterile products?

JCB uses the most current technology and reliable equipment for sterile product compounding. JCB regularly certifies its sterile compounding equipment with third party verification.

Do you have a quality assurance/quality control program in place for final testing of your sterile products and validation of your processes?

JCB uses outside, independent verification for all compounded products. Our policies and procedures ensure that each product is compounded the same every time.

Do you use approved grades of pharmaceutical powders when compounding sterile products?

All of JCB's products are compounded from FDA approved chemicals and pharmaceutical grade powders.

Do you use approved devices for final packaging of sterile products?

JCB only utilizes approved packaging solutions.

How do you protect product integrity during shipping?

All products are shipped via expedited courier service. If temperature control is required or if other requirements for shipment exist, JCB ensures those requirements are met.

How much experience do you have compounding sterile products?

JCB has over 40 years of combined compounding experience.

Do you have at least three references that may be contacted to testify to the quality of your products?

JCB has many references and would be pleased to provide upon request.

How do I place an order?

Orders may be placed utilizing the following methods:

What is the typical turnaround time from order to delivery?

Order placed prior to 2:30 pm CST are typically processed and shipped the same day.Transit time is dependent on method of delivery chosen.

Will my package stay cold enough?

All refrigerated products are shipped overnight with cold packs to insure product remains within temperature range specifications.