Experts in Sterile Compounded Solutions
JCB is registered with the FDA as a 503B Outsourcing Facility. Registration with the Food and Drug Administration for compounding pharmacies is voluntary and all registered facilities are subject to FDA inspections.

FREQUENTLY ASKED QUESTIONS

In choosing a 503B Human Drug Outsourcing Facility, 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 product compounding?

The staff at JCB has been thoroughly trained and validated in sterile product compounding.

Was the training you received from an accredited program or firm (i.e., ACPE, JCAHO, etc.)?

All of JCB's compounding training is from accredited programs.

Have you invested in continuing education specific to sterile product compounding?

JCB continues to participate in sterile product training and participates in compounding committee work.  JCB leadership also has experience in teaching sterile and non-sterile compounding.

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. Our current clean room is 2,000 sq ft and our new clean room will be 12,000 sq ft!

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

JCB meets applicable cGMP standards and we continually improve our 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?

The pharmacists at JCB have over 80 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.