Procedural lapses blamed for contaminated medicine reaching consumers

By Kimberly Kindy, The Washington Post

POSTED: 10/07/13, 3:53 PM EDT |

Thousands of contaminated or potentially tainted medications have made it to market over the past year after laboratories responsible for testing custom-made pharmaceutical products failed to follow proper procedures, FDA records show.

The Food and Drug Administration uncovered the problems during a series of surprise inspections at dozens of specialty pharmacies over the past year, prompted by last fall's deadly meningitis outbreak tied to tainted steroid injections made by one of the pharmacies, New England Compounding Center (NECC).

The FDA found unsanitary conditions and sloppy procedures at 60 specialty pharmacies. Behind each one of these pharmacies, known as compounders, independent testing laboratories were affirming that the drugs were safe, sterile and mixed at the proper strength, FDA records show.

The FDA cited five labs for more than 70 safety problems, including one case in which the repeated appearance of bacteria in a so-called clean room where sterile drugs were being tested called into question the integrity of the testing procedures.

The five laboratories conduct testing for about 90 percent of the nation's large-scale specialty pharmacies, which mass-produce custom-mixed drugs and other medical solutions for doctors, clinics and hospitals.

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