The tragedy caused by the fungal meningitis outbreak in Massachusetts this fall has made clear that the legal framework around compounding pharmacies needs to change. When it comes to federal oversight of prescription medicine, the law tries to draw a line between typical drug manufacturers and traditional compounding pharmacies. But some compounding pharmacies have evolved beyond small-scale community operations to become large-volume facilities that operate in many states. These pharmacies have outgrown the law. Congress needs to act.
Traditional compounding pharmacies play an important role in our health-care system. For decades, trusted pharmacists have performed a valuable service by customizing medications for patients who need them, such as creating a liquid medication for a sick child who cannot swallow a pill. Such compounding pharmacists and pharmacies are licensed and overseen primarily by state boards of pharmacy. They don’t have to get approval from the Food and Drug Administration (FDA) or follow federal standards for quality manufacturing.