FDA Chief Asking For More Control Over Drug Compounding

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Pharmaceutical compounding is the creation of a particular pharmaceutical product to fit the unique needs of a patient. To do this, compounding pharmacists combine or process appropriate ingredients using various tools.

The commissioner of the federal Food and Drug Administration will recommend changes in the regulatory landscape for compounding pharmacies, placing those that produce drugs on a large scale in a new category that would give the agency greater powers to police them, The New York Times reports.

The commissioner, Dr. Margaret Hamburg, will tell the House Committee on Energy and Commerce during a hearing on Wednesday that compounding in its traditional form, — mixing medicine for individual patients — should be preserved, but that pharmacies that have in effect turned into mini-drug companies should be placed under the agency’s oversight, according to her written testimony posted by the committee.

Pharmacy compounding has come under a spotlight in recent months since the New England Compounding Center in Framingham, Mass., produced thousands of vials of pain medicine contaminated with fungus that caused a national meningitis outbreak, sickening more than 400 people and killing 32. Dr. Hamburg’s testimony was her first substantive comment on regulatory problems in the compounding industry since the outbreak, and outlines the changes that the Obama administration will seek.

Among the changes proposed by Dr. Hamburg are requiring larger compounders to register with the F.D.A. and abide by its so-called good manufacturing practice, which requires drug producers to report any problems with their products to the agency. She is also recommending new labeling requirements that would make the origin and the risks of a compounded drug clear. She is also requesting that some products, including drugs with complex dosage forms, be banned for compounders.

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