Cheryl Clark, for HealthLeaders Media, August 8, 2013
Problems discovered in federal inspections of compounding facilities include "inappropriate or inadequate, or both, clothing for sterile processing… insufficient microbiological testing, and other practices that create risk of contamination," says the GAO.
The U.S. Food and Drug Administration, stepping up its scrutiny, is finding multiple, serious sterility problems with compounding pharmacies that distribute to hospitals and doctors, says a report from the Government Accountability Office.
Prepared for Congress, the GAO report says the FDA in February went beyond its typical "for-cause inspections" criteria and targeted 31 compounding pharmacies that met any two of the following criteria:
- Whether a warning letter had been issued to the pharmacy in in the past 10 years
- Whether the pharmacy compounded sterile injectable drugs.
- Whether there were adverse drug events reported.
- Whether there were complaints from the FDA district office or from others.
By April 29, FDA had cited 30 of the 31 pharmacies for "objectionable conditions." In some cases the issues were sufficiently serious to generate warning letters to those companies.
The problems included "inappropriate or inadequate, or both, clothing for sterile processing, lack of appropriate air filtration systems, insufficient microbiological testing, and other practices that create risk of contamination," the GAO investigators wrote.
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