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Margaret A. Hamburg

FDA Compliance

A New Breed of Pharmacy Compounding Has Outgrown the Law

FDA must have new authorities to regulate these facilities

Published: Monday, March 25, 2013 - 10:27

The deadly outbreak, in October 2012, of fungal meningitis associated with a compounded medication was a horrible tragedy. I’ve asked myself many times if and how it could have been prevented. I speak for everyone at the FDA when I say that our hearts go out to the many victims, including those still struggling with this devastating infection, and their loved ones.

Although our investigation of this deadly outbreak has been a top priority, our responsibility at the FDA is also to help make sure this doesn’t happen again. We are currently deploying resources to work with states to inspect certain state-licensed pharmacies that produce sterile drug products, which we believe may present the highest risk. During the past two months we have inspected more than 30 facilities, and we will continue to work to protect public health.

But our authorities are limited and not the right fit for the FDA to provide appropriate and efficient oversight of this growing industry. There should be legislation to establish appropriate, minimum federal standards for firms that compound sterile drug products (whether in advance of a prescription or without a prescription) and ship them interstate. The FDA must have clear authority to proactively inspect pharmacies to determine the scope and nature of their operations. Even during this time of heightened awareness, our inspectors are being delayed in their work or denied full access to records at some of the facilities we are inspecting.

Serious problems at compounding pharmacies continue to occur. Just this week there have been two recalls of sterile compounded and repackaged drug products. In one recall, the presence of floating particles, later identified to be a fungus, were reported in five bags of magnesium sulfate intravenous solution, resulting in a nationwide recall of all sterile drug products produced by the pharmacy. In the other recall, all sterile drug products from a second pharmacy were recalled as a result of reports that five patients were diagnosed with serious eye infections associated with the use of repackaged Avastin.

There is a legitimate role for traditional pharmacy compounding. Every day, thousands of pharmacists practice traditional pharmacy compounding—mixing a drug in response to a valid prescription for an individual patient’s need. For example, these drug products could be liquids for patients who can’t swallow pills, or they could be made without certain allergens. These operations are licensed and primarily regulated by the states.

However, a new breed of specialty pharmacy compounding has evolved that has outgrown the law and can pose a threat to the public’s health. New legislation is needed to specifically address such compounding and the safety concerns now established.

These pharmacies produce medications in advance of, or without obtaining, a prescription and distribute them across the country. They make drug products that are intended to be sterile and must be made to exacting standards to prevent dangerous contamination. The magnitude and complexity of these operations have outpaced the current patchwork of state laws that differ in prescription requirements and quality control rules. I firmly believe new legislation is necessary to help the FDA effectively oversee these firms.

To that end, the FDA is working with Congress, states, industry, and all interested stakeholders to develop a basic framework to protect public health. The Senate committee with jurisdiction over this issue has been working hard on a bipartisan basis to craft such a framework. We are hopeful that their efforts will yield strong legislation for patients across the nation.

In the new framework, the FDA believes that certain high-risk, sterile compounding facilities should be subject to federal oversight to ensure that the compounding of sterile drug products at those facilities can be done without putting patients at undue risk, including:
• Requiring compliance with federal quality standards that are appropriate for the compounding of high-risk products and products with exposure to larger numbers of patients
• Requiring federal registration of the compounding facilities that will be subject to federal quality standards so that the FDA will know the facilities’ locations and what drug products are being made at these facilities
• Requiring these high-risk compounding pharmacies to report to the FDA serious adverse reactions to their drugs of which they become aware so that the FDA can act before potential problems get out of hand

For all pharmacy compounding, the FDA believes certain basic protections should be in place. These include:
• Clear authority to examine a pharmacy’s records to more quickly locate the cause of an outbreak or other violations of the law
• Prohibiting compounding of the most complex and highest risk products: drugs and biologics that should only be made for patients by an FDA-registered drug manufacturer under an approved new drug application. The manufacturer will have demonstrated in this application that the product is safe and effective, and can be safely made according to the highest quality standards.

The FDA supports and would like to explore with Congress several other ideas, such as requiring compounded drug products to have clear label statements identifying the nature and source of the product. The labeling statements would provide prescribers and consumers with valuable information about the products they are using or taking so that they can make informed judgments about their use. Of course, funding will be necessary to support the inspections and other oversight activities outlined in this framework. We look forward to working with Congress to explore a funding mechanism, which could include registration or other fees, such as Congress has authorized and the FDA has successfully implemented in other settings.

Protecting the public from unsafe and contaminated drugs is not just an important responsibility for the FDA; it is part of our core mission. We must be able to identify dangerous practices before they result in actual harm, and when necessary, intervene to minimize the damage and prevent tragedies in the future.


About The Author

Margaret A. Hamburg’s picture

Margaret A. Hamburg

Margaret A. Hamburg, M.D., is the commissioner of the U.S. Food and Drug Administration (FDA). The second woman to be nominated for this position, she is an experienced medical doctor, scientist, and public health executive. As the top official of the FDA, Hamburg is committed to strengthening programs and policies that enable the agency to carry out its mission to protect and promote the public health.



Worst Practice Outbreak

One: we all do excessively rely on pharmaceuticals: pharmacies' shoppers weigh far more than supermarkets'. Two: pharmaceuticals' business is continuosly increasing at dramatic rates. I wonder how the human gender has lived for millennia without pills. The Law must not have new authorities: the Law must instead silence the charlatans and shamans who sells the pills, once for all. Because it's us who pay for the pills, and for the Law, too.