Despite FDA's new compounding guidelines, confusion reigns

GOVERNMENT and LAW

Despite FDA's new compounding guidelines, confusion reigns

Barely a month after losing a vital Supreme Court case, the FDA has a new Compliance Policy Guide (CPG) to replace provisions of the Food & Drug Administration Modernization Act (FDAMA) that were struck down by the high court on April 30 (see Drug Topics, May 20). At the same time, the FDA is considering new legislation to replace FDAMA compounding provisions.

FDA did not consult with pharmacy organizations or open the CPG to advance comment.

"Without FDAMA, there was no law that specifically allowed pharmacy compounding," explained an FDA official during a background briefing. "We wanted to reassure traditional compounders that our enforcement activities will not interfere with traditional pharmacy compounding practices." As far as FDA is concerned, traditional compounders—pharmacists who make up individual batches of drugs to fill a specific Rx for a specific patient—aren't even covered by the new CPG. The real target, said the official, is high-volume operations that have more in common with pharmaceutical manufacturing than with compounding—manufacturers that attempt to evade the new-drug, adulteration, or misbranding provision of the Food, Drug & Cosmetic Act by calling themselves compounders. FDA enforcement could include warning letters, seizure, injunction, and prosecution.

But don't expect federal enforcement agents knocking on pharmacy doors—at least not immediately. "The states are still the primary regulators of pharmacy practice and pharmacy compounding," said David Horowitz, acting director for compliance at FDA's Center for Drug Evaluation & Research.

The new CPG sets out nine factors to consider in determining whether a pharmacy is engaged in manufacturing. FDA will look, for example, at pharmacists or pharmacies that compound significant amounts of a drug in anticipation of prescriptions, drugs removed or withdrawn from the U.S. market for safety considerations, or drugs for resale to third parties. The guidelines include a list of 63 drug products taken off the U.S. market for safety reasons.

FDAMA, based on a CPG issued in 1992, used similar criteria to distinguish between compounding and manufacturing. It also set limits on out-of-state sales by compounders and banned the advertising or promotion of compounded drugs.

Compounding R.Ph.s sued to block FDAMA's advertising ban. When the case reached the Supreme Court as Thompson v. Western States Medical Center, a 5:4 majority upheld a lower court decision invalidating the entire FDAMA compounding section.

Reaction to the new guidelines was mixed. Susan Bishop, manager of regulatory affairs and political action for the American Pharmaceutical Association, said pharmacists who were hoping for guidance from the FDA would find more confusion than clarification. Rather than a strict distinction between compounding and manufacturing, the agency is laying out broad directions for enforcement and reserving the right to change course without warning. "I don't know if I would call the document useful," Bishop said. It doesn't give pharmacists any comfort to hear that they may be breaking the law, but that FDA might also decide to change its mind on whether or not they're breaking the law.

Critics of compounding offered similar complaints. Larry Sasich, pharmacist and research associate for Public Citizen's Health Research Group, is still waiting for the FDA to draw a clear distinction between compounding and manufacturing. "This is a fuzzy line when we need a bright line to prevent unethical compounders from harming the public," he said. "Ethical pharmacists understand the intent here. The problem is people pushing the compounding envelope in the pursuit of profits. Pharmacy has been getting a black eye from this segment of the profession."

Houston-based Professional Compounding Centers of America (PCCA), a large supplier of compounding materials and training, declined to comment on the new guidelines. "We tend to follow the lead of the IACP [International Academy of Compounding Pharmacists]," said PCCA spokeswoman Dagmar Klimo.

IACP was cautiously supportive. "It's a start, an interim step," said executive director L. D. King. "At least it gives pharmacists an indication of FDA's concerns." What the CPG doesn't offer, he said, is precision, noting that the guidelines are filled with ambiguous terms such as "limited quantities" and "in anticipation" that could carry a variety of meanings and interpretations, depending on the circumstances. "We look forward to working with the FDA and other pharmacy groups to develop legislation that is workable for all of us," he said.

FDA is accepting comments on the guidelines for an indefinite period, a spokesman said. Specific provisions are open for revision as the agency sees a need.

Fred Gebhart

Fred Gebhart. Despite FDA's new compounding guidelines, confusion reigns.

Drug Topics

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