"This is additional evidence, in our view, that Congress needs to close the regulatory gaps and update FDA authority to reflect what is an evolving pharmaceutical marketplace where need for specific dosage forms or unique variations of sterile compounded products that go above and beyond traditional pharmacy compounding done pursuant to a patient prescription."
The GAO report drew numerous other conclusions, most of which have been reported since September's national compounding drug disaster. That's when an injectable steroid drug compounded by the New England Compounding Center in Framingham, MA, was found to be contaminated with a fungal toxin that has so far killed 63 people and sickened nearly 700 others in 20 states.
These issues are of grave concern to hospitals. According to a U.S. Office of Inspector General report issued in April, 92% of hospitals use compounded products, 92% of these use sterile-to-sterile products and 25% use non-sterile to sterile products.
"Of the hospitals that used nonsterile-to-sterile compounded sterile preparations, 85% outsourced at least some of these products [i.e., purchased them from outside pharmacies].