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Friday, April 12, 2013

FDA Finds Safety Issues at 30 Compounding Pharmacies

This photo provided by the Minnesota Department of Health shows shows vials of the injectable steroid product made by New England Compounding Center implicated in a fungal meningitis outbreak that were being shipped to the CDC from Minneapolis.(Minnesota Department of Health/AP)

This photo provided by the Minnesota Department of Health shows shows vials of the injectable steroid product made by New England Compounding Center implicated in a fungal meningitis outbreak that were being shipped to the CDC from Minneapolis.(Minnesota Department of Health/AP)

Unidentified “black particles” in vials of medicine. Rust and mold in rooms meant to be sterile. Inadequate testing for microbes. Tears in gloves worn by staff working on medicine.

Those are among the potentially dangerous safety problems the Food and Drug Administration has found at what are called “compounding pharmacies” during inspections conducted between February and April, according to The Washington Post.

Compounding pharmacies can mass produce medications but they are regulated under different laws from drug manufacturers.

Filthy conditions at a compounding pharmacy in Massachusetts were responsible for a fungal meningitis outbreak that killed 53 people across the U.S. and sickened hundreds of others.

This is the first set of FDA inspections at compounding pharmacies since that outbreak.

The agency is still analyzing the data, but the findings have already led to recalls and temporary suspensions of drug production.

Guest:

  • Lena H. Sun, health reporter for The Washington Post.

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