GOVERNMENT and LAW

STRUCK DOWN

Court attacks FDA's role in compounding drugs and throws federal regulations into gray area

Pharmacy compounding regulation remains unsettled in the wake of a federal appeals court decision that struck the entire compounding section from a 1997 law that overhauled the Food & Drug Administration. The FDA has not yet decided whether to appeal the 3-0 decision issued last month by the 9th U.S. Circuit Court of Appeals in San Francisco.

"This certainly leaves us in a federal regulatory gray area," said L. D. King, executive director of the International Academy of Compounding Pharmacists. "There is great uncertainty about how pharmacy compounding will be regulated in the future. Historically, IACP has held that pharmacy compounding is primarily regulated by the states. In the absence of federal law, we will look to the states for regulatory guidance."

Carmen A. Catizone, executive director of the National Association of Boards of Pharmacy, said if the decision stands, "then we're back to the FDA's compliance policy guidelines" and whether the agency wants "to go back to the position that every compounded drug is a new drug and, therefore, needs a New Drug Application."

Pharmacy thought that dispute was settled with a post-midnight bargain struck just before Congress passed the 1997 FDA Modernization Act. That act made clear that the states regulate compounding—just as R.Ph.s had long argued. But the act also clearly spelled out a role for the FDA. It created an FDA advisory committee on compounding and required it to come up with a list of drug substances that may be used in compounding as well as a list of Rxs that are too difficult to compound. Provisions were included for regulation of the interstate distribution of compounded Rxs, with a memorandum of understanding (MOU) suggested for the FDA and state boards of pharmacy to address investigations and complaints about problems with compounded Rxs and shipments of "inordinate amounts." In states that did not sign an MOU with the FDA, interstate distribution would be limited to 5% of the total Rxs filled by the pharmacy. Pharmacists were allowed to advertise that they were compounding but not what Rx products or classes.

It was over the last provision that the FDA was sued by seven compounding pharmacies that argued that their free-speech rights under the First Amendment would be abridged by the advertising restrictions. The U.S. District Court in Nevada ruled in favor of the pharmacies in 1999. The FDA appealed but told the circuit court that if the advertising section was found unconstitutional, the entire compounding section should be scrapped. That is what the court did.

"The government asserts that increased distribution of compounded drugs is dangerous because of the health risks associated with large numbers of patients taking such drugs," the appeals court observed. "The government neither explains nor supports this contention. In fact, most of the evidence runs to the contrary. Compounding is not only legal under state law, but most states require their pharmacists to know how to compound. The government has failed to show that its interest in striking a balance between ensuring compounding availability and limiting widespread compounding is substantial."

The National Community Pharmacists Association hailed the decision as "an astounding victory for independent pharmacy practitioners." John Rector, NCPA's general counsel, called it "a big, big deal." He said NCPA would urge the Bush Administration not to challenge the decision and to oppose any future legislation that tried to reestablish a role in compounding regulation for the FDA.

NABP's Catizone advised state boards "to continue to regulate compounding as a part of the practice of pharmacy and if they see instances of what they feel is manufacturing, then report those to the FDA." He said that states should make the distinction between compounding and manufacturing based on their practice acts.

With the uncertainty surrounding the FDA's role in compounding, Catizone predicted it would "embolden some of the larger compounders—the ones that have been aggressively trying to expand compounding, pushing the envelope that the FDA challenged. But for the average pharmacists who compound for their patients, I don't think it's going to have a significant impact."

Michael F. Conlan

Mike Conlan. Court attacks FDA's role in compounding drugs and throws regs into gray area.

Drug Topics

2001;5:66.