By Timothy W. Martin
Federal and state regulators have identified multiple violations at several custom-mixing pharmacies in recent inspections after a facility of this type was tied to last fall's deadly outbreak of fungal meningitis.
Federal and state regulators have identified multiple violations at several custom-mixing pharmacies in recent inspections after a facility of this type was tied to last fall's deadly outbreak of fungal meningitis.
The findings could lead to tighter regulation for an industry that has mushroomed in the past decade and has drawn intense scrutiny after three batches oftainted steroid injections made by a single compounding pharmacy in Framingham, Mass., were linked to more than 700 cases of fungal meningitis and 50 deaths across 20 states.
Compounding pharmacies create customized medications for hospitals and doctors' offices that aren't available from drug companies. Although usually started as local businesses, some have expanded in recent years to mix drugs for customers nationwide—as was the case with New England Compounding Center, the firm linked to the meningitis outbreak.
The Iowa Board of Pharmacy is currently inspecting more than 80 U.S. compounding pharmacies that do business in its state. In an earlier inspection late last year, it charged five facilities, from Utah to New Jersey, with unlawful drug manufacturing and other infractions. Representatives of the five firms are set to appear at hearings in Des Moines that start in April. All five companies have denied the charges.
"It's time to have the discussion in compounding around what's appropriate and what's not, what's safe and what's not," said Lloyd K. Jessen, the Iowa pharmacy board director. The board's ultimate goal is to visit all 582 pharmacies that compound drugs and hold Iowa licenses, Mr. Jessen said.
At the same time, the U.S. Food and Drug Administration said this month that it found alleged regulatory violations at compounding15 facilities and plans on inspecting about 30 compounding pharmacies by April. The move by the Iowa board, which licenses and regulates pharmacies and their employees, represents the most aggressive and comprehensiveeffort by any federal or state agency to inspect compounding pharmacies in the wake of the outbreak. The charges are administrative, not criminal. They carry a maximum fine of $25,000 and could cause the companies to lose their licenses in Iowa—and perhaps in other states.
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