News, musings and commentary on dietary supplements & pharmaceutical law issues, technology, and litigation.
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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.