Monday, September 30, 2013

FDA Inspections Put Compounding Pharmacies In Regulatory Gray Zone

Sobering reading in a  recent report from SC

The FDA has inspected about 70 compounding firms in the past year, said Howard Sklamberg, the director of the FDA Office of Compliance. Sklamberg acknowledged the FDA's authority over compounders is unclear. But he said, "We don't send into a firm lawyers with law books."
"We send scientists and trained professionals who know how sterile drugs are supposed to be made," Sklamberg continued. He said inspectors have found startling conditions, like pharmacists using a coffee filter to filter drugs.