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.

Outsourcing Facilities (503B) and cGMP

Posted By Brian Williamson on Wed, Mar 12, 2014 @ 16:03 PM

The definition of high-risk sterile compounding is “Starting with a non-sterile Active Pharmaceutical Ingredient (API) and creating a sterile product.”   We have written many articles about how important quality is in high-risk sterile compounding.  JCB Labs has gone to great lengths and considerable expense to develop a facility and processes that satisfy cGMP practices and are capable of producing a sterile product every time.  This is what the FDA expects from pharmacies that, like JCB Labs, are registered as 503B Outsourcing Facilities.

Please go to this link to see a very well written article concerning the importance of vetting your high-risk compounding pharmacy. The information might be invaluable to you and your facility as you decide where to get your compounded products.

Tag: Outsourcing, 503B, outsourcing facility, cGMP, sterile,