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Meningitis Scare: What Are the Legalities of Pharmacy Compounding?

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The outbreak of meningitis that has claimed 11 lives so far has brought to light a little-understood segment of the pharmaceutical industry: compounding pharmacies, which make their own concoctions of medicines and sell them directly to the public. The steroid-based back pain drug that has been linked to the outbreak was made and marketed by the New England Compounding Center in Framingham, Mass., according to an Oct. 6 statement by the U.S. Food and Drug Administration.

So what exactly are compounding pharmacies, and why are they allowed to make drugs and sell them largely outside of the bounds of the federally-regulated drug industry? I found the answers to some of those questions while researching my book about the anti-aging industry, Selling the Fountain of Youth. Compounding pharmacies have become high-profile members of the anti-aging industry because they offer hormones, supplements, and other medicines often prescribed by anti-aging doctors.

First, a definition of compounding: The traditional role of compounding pharmacists is to take ingredients from commonly-marketed drugs and tailor them to the needs of specific patients. For example, compounders might turn pills into syrups for elderly patients who have trouble swallowing their medicines, or they might put a pain drug into a lollipop for a child with cancer. This is all perfectly legal.

But over the last 15 years or so, a tangled web of conflicting laws and rulings has raised questions about what, exactly, compounding pharmacies are allowed to do. The problems started in 1997 with the Food and Drug Administration Modernization Act (FDAMA), which exempted compounders from having to abide by the strict quality control practices that major pharmaceutical companies have to follow.

Under FDAMA, compounding pharmacies also don't have to seek FDA approval for the medicines they make, provided they use ingredients from drugs that have already been approved and that they don't advertise their products.

According to a recent report by the AP, the New England Compounding Center created the back pain drug -- a steroid called preservative-free methylprednisolone acetate -- by combining a powder-based substance with a liquid. The pharmacy's website says that drug and other products have been recalled voluntarily.

The FDA does claim some control over compounding pharmacists. In 2002, the agency reissued a "compliance policy guide" on compounding, which lays out several requirements. For example, the guide says the FDA can take action against pharmacies that make bulk quantities of compounded drugs in anticipation of receiving prescriptions -- a major no-no for compounding pharmacies, which are supposed to make drugs in response to a physician's prescription.

The FDA reissued the compliance guide in the wake of a Supreme Court ruling in Thompson v. Western States Medical Center -- a case in which a group of compounding pharmacists challenged the advertising restrictions in FDAMA on the grounds that they violated their First Amendment rights. The Supreme Court agreed with the pharmacists, effectively striking down the compounding restrictions in FDAMA as unconstitutional.

Ever since the FDA decided to take control over compounding by reissuing its compliance guide, there's been a war between the compounders, who believe their rights are protected by the Supreme Court, and the FDA, which believes it needs to protect public health by holding these pharmacies to strict standards of manufacturing and marketing.

In 2009, when I was reporting my book, I visited an official at the FDA named Steven Silverman, who had dealt with compounding issues as an assistant director in the FDA's office of compliance. I asked him what could be done to clarify and perhaps strengthen the restrictions on compounding pharmacies. "Congress can amend our legislation to make it clear what it is they want the [FDA] to do," he told me. Or, he said, the FDA could petition the Supreme Court to revisit the issue.

So far, neither one of those scenarios has been pursued. But it will be interesting to see if the current meningitis crisis prompts the federal government to take a fresh look at the rules and regulations governing compounding pharmacies.

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