Additionally, the FDA recommended that pharmacies not use this firm for sterility and other quality attributes at this time. Since that announcement, the agency has contacted many compounding pharmacies specifically requesting a recall of sterile medications tested by Front Range. Several IACP members have conducted additional in-house testing on their lots -- all showing and confirming that the Front Range results were aligned with their own.
In a statement to its clients, Front Range Laboratories stated: "We are not in the business of manufacturing and do not conduct business with entities that manufacture finished drug products. We are not aware of a single client registered with the FDA as a drug manufacturer. Yet, during this recent inspection, our operations were inspected against the FDA's Current Good Manufacturing Practice (or cGMP) regulations which, by definition, do not legally apply to compounding pharmacies unless they are acting as manufacturers."