On April 12, 2018 FDA posted yet another recall announcement by a registered outsourcing facility (here). Ever since the New England Compounding Center’s problems associated with the meningitis outbreak, FDA has been diligently inspecting compounders registered as outsourcing facilities with the Agency. Today’s announcement highlights a continued sterility assurance concern by the FDA.
This latest announcement piqued my interest and I went back into the list of registered outsourcers to see what I could see. Bottom line is that there are 72 registered outsourcing facilities as of 3/30/18. Of the 72, 13 have had no FDA 483s, warning letters, requests for a regulatory meeting with the FDA. Which means that 69 of the facilities have either open issues (meaning the FDA has not yet made a final determination as to their status based on previous inspections), received a 483 or received a warning letter. The FDA list (here) notes that their list does not contain any actions by State Boards of Pharmacy.
The game of sterile drug preparation is apparently as difficult as FDA claims it is, as most of the actions relative to outsourcers who are required to follow cGMPs have been driven by sterile drug compounding. While there appears to be a way to go, the services of outsources are essential to some hospitals and patients. This is a complex arena that draws a fine line between classical drug compounding and drug manufacturers. The FDA will ultimately decide exactly where that line will be drawn.