FDA Given Authority Over Drug Compounding Pharmacies

Following more than 750 incidents of a rare strain of fungal meningitis and other related infections last year, the New England Compounding Center (NECC), in Framingham, Massachusetts recalled all of its products and was been stripped of its pharmacy license in late 2012. FDA Safety Recalls.pdf

The unprecedented outbreak was linked to contaminated injectable steroid medications from NECC – which were shipped around the country. Update on Fungal Meningitis Outbreak

As a result, a bill that would give the Food and Drug Administration more power to police compounding pharmacies recently passed in Congress – marking an important step to a safer drug supply in the United States.

Known as the Drug Quality and Security Act, the bill stops short of giving the F.D.A. complete authority over pharmacies that mix drugs for individual patients – a process known as compounding – but still provides new safeguards, improving the oversight of high risk drug-compounding. New York Times Report on Drug Compounding

Compounding has surged in popularity in recent years, with more than ninety percent of hospitals outsourcing some of their sterile compounding.