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.

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,