Magazine article Drug Topics

Struck Down

Magazine article Drug Topics

Struck Down

Article excerpt

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. …

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