Drug Topics - October 8, 2007 - (Page 6)

6 DRUG TOPICS OCTOBER 8, 2007 www.drugtopics.com > > > Latebreakers In Depth FDA says it’s not against compounding Kathryn Foxhall he Food & Drug Administration most emphatMichael Levy, director of the division of new drugs ically is not against compounding of drugs, and labeling compliance at FDA, also spoke at the sesSteven Silverman, a key enforcement officer in sion. “Except in very limited quantities, pharmacies that agency, told the National Association of Boards should not compound drugs before receiving prescripof Pharmacy recently. tions for them,” he said. The agency becomes very conAsserting that the kinds of cerned when it sees pharmacies compounding mass doscompounding the agency brings es of drugs that differ from FDA-approved drugs only in enforcement actions against are terms of factors such as dosage, strength, or preservative. Compounding “is not “outliers,” operations that really A firm that gets a warning letter about compoundan area that consists, don’t come under the rubric of ing, Silverman said, is obligated to resolve the issues or traditional compounding, Silvershow the agency that the concerns don’t actually exist. for the most part, man said, “There has been a cerBeyond that, the agency’s enforcement actions can inof black and white. tain amount of hysteria generated volve seizing all drugs that violate the Food, Drug, & by a select few organizations” that and bringing injunctions against There are lots of grays.” the agency’s objective is to end Cosmetic Actto prevent continued violation. responsible persons Steven Silverman, assistant director, compounding. FDA Office of Compliance Silverman, who is assistant diPharmacy boards rector of the Center for Drug Evaluation & Research “We view the roles of state pharmacy boards in regulaOffice of Compliance, spoke, along with other FDA tion of all pharmacy including compounding as critistaff who work on the issue, at NABP’s fall legislative cal,” Silverman said. According to the agency staff, afconference, in Arlington, Va. ter a complaint about compounding comes into the The agency thinks it is manifestly inappropriate and FDA or to one of its district offices, the state board is a disservice to the pharmacy profession, Silverman contacted usually within a few weeks. stressed, to engage in drug manufacturing and call it Silverman also indicated that the FDA wants to look compounding or to produce drugs for opportunities to engage in coordiwith components that are not part of nated action with state boards against FDA-approved drugs and that have outlier pharmacies in compounding. safety and efficacy profiles that are often unknown or undemonstrated. Compliance guidance Silverman labeled as problematic Asked about the revised Compliance situations in which the product is an Policy Guide on compounding, exact copy of an FDA-approved which has been anticipated for severdrug when there’s no shortage of the al years, Silverman said that the staff approved drug. It’s also a problem, Steven Silverman presenting at is actively working to revise it and NABP’s fall legislative conference. he said, when the product is a “very does hope to have it out soon. The close copy” of an FDA-approved drug and whatever difFDA also hopes, he said, to issue it in a way that allows the ferences there are don’t really reflect patients’ needs. agency to generate and consider public comment on it. The volume of products a pharmacy compounds is Compounding, Silverman said, “is not an area that not, by itself, a determining factor for FDA action, Silconsists, for the most part, of black and white. There verman said. He indicated that among the questions are lots of grays. And it is a challenge to strike the apthe FDA asks, to draw the distinctions between legitipropriate balance that allows patients access to what mate practices and outliers, are: What kinds of processcan be lifesaving drugs, but, on the other hand, enes are the compounding providers following to ensure sures that people are not using the cloak of pharmacy a safe and reliable product? Is the product distinct in a compounding in a way that undermines” the law and meaningful way from FDA-approved drugs? Is there the drug approval process or puts patients at risk. maintenance of a relationship with individual patients? THE AUTHOR is a writer based in the Washington, D.C., area. T Photo: Kathryn Foxhall http://www.drugtopics.com

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Drug Topics - October 8, 2007 Latebreakers Latebreakers in Depth Letters Rx Care Community Practice JP at Large 150 Years of American Pharmacy Hospital Practice Are You Getting Pharmacy's Message Across? Self-Care Government and Law Legal Q&A The Pharmacist as First Responder in Disaster Relief Technology Update New Products Advertisers Index Statement of Ownership Classified Viewpoint

Drug Topics - October 8, 2007

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