The Food & Drug Administration most emphatically is not against compounding of drugs, Steven Silverman, a key enforcement officer in that agency, told the National Association of Boards of Pharmacy recently.
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.
Silverman, who is assistant director of the Center for Drug Evaluation & Research Office of Compliance, spoke, along with other FDA staff who work on the issue, at NABP's fall legislative conference, in Arlington, Va.
The agency thinks it is manifestly inappropriate and a disservice to the pharmacy profession, Silverman stressed, to engage in drug manufacturing and call it compounding or to produce drugs with components that are not part of FDA-approved drugs and that have safety and efficacy profiles that are often unknown or undemonstrated.
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 dose 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. …