Outsourcing Facilities (503B) and cGMP

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.

Written by Newport Beach Compounding Center Staff

As one of the most experienced compounding pharmacies in Newport Beach, We provide a valuable service working together with physicians and patients to create medications tailored to specific requirements. We are specialists in the art and science of pharmacy compounding. Our Team of experts can meet all of your unique pharmaceutical needs.

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