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Despite Supreme Court ruling on compounding, questions remain

On a 5-4 vote, the U.S. Supreme Court has struck down a federal regulation of pharmaceutical compounding. While the decision backs pharmacists who sued to block restrictions on compounding that were part of the Food & Drug Administration Modernization Act of 1997 (FDAMA), the future of compounding remains unclear to some.

"This is not an uncomplicated subject," said John Rector, senior v.p. for government affairs and general counsel for the National Community Pharmacists Association. "We've had a lot of conversation about just what the decision means for pharmacists."

Both supporters and opponents of compounding found support in the Supreme Court decision. David Sparks, president of Professional Compounding Centers of America, said the Court makes it clear that the states, not the federal government, have jurisdiction over compounding. According to Sparks, that means compounding pharmacies can stop worrying about the FDA and concentrate on working with their state boards of pharmacy. "The language of the decision makes it clear that compounding is part of the practice of pharmacy," he said. "The Supreme Court upheld a lower court decision made more than a year ago. Compounding is regulated by the states."

Larry Sasich, pharmacy research associate with Public Citizen Health Group, said the decision gives the FDA an opportunity to reassert its jurisdiction over compounding. Public Citizen had slammed FDAMA for legalizing compounding. Now that the compounding section has been invalidated, the FDA is again free to prosecute compounders. "Public Citizen and other independent consumer groups were opposed to the compounding provisions in FDAMA," he explained. "It allowed an enormous end run around the FDA provisions designed to protect public health. This gives the agency an opportunity to take action against some of the most egregious compounders."

The International Academy of Compounding Pharmacists is trying to avoid both extremes. "This throws the issue back into the FDA's court," said IACP executive director L. D. King. "It gives emphasis to regulation at the state level, but the FDA could proceed by regulation or legislation. We are urging our members to follow the good compounding practices published by the U.S. Pharmacopoeia."

The FDA isn't sure what comes next. "The agency is analyzing the decision and will comment later," said an FDA spokesman. He said the agency is also evaluating new legislation to clarify jurisdiction and regulatory issues in compounding.

One thing all sides seem to agree on is that the decision, Thompson v Western States Medical Center, turns back the clock on compounding regulation. Though the case focused on advertising restrictions, the court threw out the entire section of FDAMA that dealt with compounding. That resurrects all the old debates over compounding versus manufacturing and state regulation versus federal regulation.

"The decision leaves us exactly back where we were before passage of FDAMA," said Kenneth Baker, v.p. and general counsel for Pharmacists Mutual Insurance Co. "The FDA was closing drugstores because they were violating guidelines on compounding. But if you look at the guidelines, there is no clear jurisdiction."

FDAMA was an attempt to resolve the gray area between compounding and manufacturing. Compounding was explicitly exempted from most FDA regulation. But compounders were also prohibited from advertising their products and engaging in other activities the FDA considered part of drug manufacturing.

Western States Medical Center, a compounding pharmacy based in Las Vegas, challenged the advertising ban. Pharmacists claimed that banning advertising was an unconstitutional violation of commercial free speech. The U.S. District Court in Nevada agreed, ruling in favor of Western States. So did the U.S. Court of Appeals in San Francisco and the Supreme Court.

Writing for the majority, Justice Sandra Day O'Connor declared that the FDAMA advertising ban "would prevent pharmacists with no interest in mass-producing medications, but who serve clienteles with special medical needs, from telling doctors treating those clients about alternative drugs available through compounding." The government needs to be able to draw a line between compounding and manufacturing to protect public health, she noted. But restricting speech with an advertising ban should be the last resort, not the first.

O'Connor listed some ways the FDA might separate compounding and manufacturing. Suggestions included banning the use of commercial-scale manufacturing or testing equipment by compounders, prohibiting R.Ph.s from compounding before an Rx is received, and blocking wholesale commerce of compounded products for eventual resale to consumers.

The Court concluded that "the government has not offered any reason why such possibilities, alone or in combination, would be insufficient to prevent compounding from occurring on such a scale as to undermine the new drug approval process."

Fred Gebhart

Fred Gebhart. Despite Supreme Court ruling on compounding, questions remain.

Drug Topics

2002;10:28.