Asserting that the kinds of compounding the agency brings enforcement actions against are "outliers," operations that really don't come under the rubric of traditional compounding, Silverman said, "There has been a certain amount of hysteria generated by a select few organizations" that the agency's objective is to end compounding.

Steven Silverman presenting at NABPs fall legislative conference.

Silverman labeled as problematic situations in which the product is an exact copy of an FDA-approved drug when there's no shortage of the approved drug. It's also a problem, he said, when the product is a "very close copy" of an FDA-approved drug and whatever differences there are don't really reflect patients' needs.

The volume of products a pharmacy compounds is not, by itself, a determining factor for FDA action, Silverman said. He indicated that among the questions the FDA asks, to draw the distinctions between legitimate practices and outliers, are: What kinds of processes are the compounding providers following to ensure a safe and reliable product? Is the product distinct in a meaningful way from FDA-approved drugs? Is there maintenance of a relationship with individual patients?

Michael Levy, director of the division of new drugs and labeling compliance at FDA, also spoke at the session. "Except in very limited quantities, pharmacies should not compound drugs before receiving prescriptions for them," he said. The agency becomes very concerned when it sees pharmacies compounding mass doses of drugs that differ from FDA-approved drugs only in terms of factors such as dosage, strength, or preservative.

A firm that gets a warning letter about compounding, Silverman said, is obligated to resolve the issues or show the agency that the concerns don't actually exist. Beyond that, the agency's enforcement actions can involve seizing all drugs that violate the Food, Drug, & Cosmetic Act and bringing injunctions against responsible persons to prevent continued violation.

Pharmacy boards

"We view the roles of state pharmacy boards in regulation of all pharmacy including compounding as critical," Silverman said. According to the agency staff, after a complaint about compounding comes into the FDA or to one of its district offices, the state board is contacted usually within a few weeks.

Silverman also indicated that the FDA wants to look for opportunities to engage in coordinated action with state boards against outlier pharmacies in compounding.

Compliance guidance

Asked about the revised Compliance Policy Guide on compounding, which has been anticipated for several years, Silverman said that the staff is actively working to revise it and does hope to have it out soon. The FDA also hopes, he said, to issue it in a way that allows the agency to generate and consider public comment on it.

Compounding, Silverman said, "is not an area that consists, for the most part, of black and white. There are lots of grays. And it is a challenge to strike the appropriate balance that allows patients access to what can be lifesaving drugs, but, on the other hand, ensures that people are not using the cloak of pharmacy compounding in a way that undermines" the law and the drug approval process or puts patients at risk.

THE AUTHOR is a writer based in the Washington, D.C., area.