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Rules for compounding pharmacies need to change

By Margaret A. Hamburg,December 20, 2012

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.

In recent years, some compounding pharmacies have far exceeded the traditional size and scope of compounding. This may pose risks for a variety of reasons. And although compounding pharmacies have changed, our laws haven’t. The current legal framework is not the right fit for the FDA to provide appropriate and efficient oversight of this growing industry.

The meningitis tragedy strongly called attention to the weaknesses in our framework and the need for federal laws that specifically address non-traditional compounding. The FDA has outlined an approach that would preserve the benefits of traditional compounding and the important role states play, while reducing the risks of non-traditional compounding of drugs.

Our approach would ensure that the FDA has access to certain pharmacy records and knows who is in the business of non-traditional compounding. Pharmacies engaged in such business would register with the FDA so we can know which firms to inspect and, when necessary, take appropriate actions. Because state laws vary with respect to compounding pharmacies, there should be appropriate, minimum federal standards for higher-risk compounding practices.

The FDA has also suggested exploring ideas such as labels that clearly inform doctors and patients about the nature and source of the product, and requiring non-traditional compounders to report adverse events associated with their products, as typical drug manufacturers are required to do. In addition, the FDA needs appropriate resources to ensure we have the tools necessary to protect public health.

The FDA stands ready to work with Congress, the states and industry to strengthen our ability to help ensure that only safely compounded products reach patients. We invited governors, public health and state board of pharmacy officials from every state to an FDA-led meeting this week to discuss directions in the oversight of pharmacy compounding.

This isn’t the first time the FDA has sought more authority to crack down on compounding pharmacies. In the past, special interests have interfered, and conflicting federal appellate court rulings in the 5th and 9th circuits have made a confusing system even worse. If we do not work together to find a practical solution that puts patients first, the country will remain vulnerable to more public health crises.