FDA, State Health Officials Meet to Discuss Regulation of Drug Compounders

On December 18, the U.S. Food and Drug Administration (FDA) convened a meeting with public health officials from all 50 states to discuss changes to the rules that govern compounding pharmacies. The push to change the rules follows a nationwide fungal meningitis outbreak caused by a tainted medication produced by the New England Compounding Center, a Massachusetts compounding pharmacy.

To date, 620 people in 19 states have fallen ill in the meningitis outbreak, and 39 people have died. Regulation of pharmacies falls primarily under state laws but some states are pushing for changes that would place large-scale compounders under federal oversight.

Compounding is vital for patients who cannot be treated with FDA-approved medications and require individually formulated medicines; for example, people allergic to certain dyes or inactive ingredients, or those who need a medication in a form not commonly available. An FDA Consumer Health Information bulletin says that concerns about compounding have arisen in particular over tainted injectible medications like those involved in the meningitis outbreak, the New York Times said.

At Wednesday’s meetings, the New York Times reports, state officials expressed concern about how to define and regulate compounding. Large-scale compounders, they say, have been operating like major drug manufacturers and should be regulated as manufacturers. But Dr. Margaret Hamburg, FDA commissioner, warned that lumping compounders in with manufacturers would mean that compounders would have to file new drug applications for every product they make, a costly and time-consuming process and one that may not be necessary for many compounded products. Dr. Hamburg proposed the creation of a new federal oversight category for compounders.

Carmen Catizone, head of the National Association of Boards of Pharmacy, told the assembled officials that individual states are not equipped to regulate large-scale compounders and the FDA must create a proper path for regulation. The officials at Wednesday’s meeting expressed concern over the safety of products supplied by compounders but they were also concerned about disrupting the timely supply of necessary products and medications, said the New York Times

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