Monday, December 3, 2012

Public Citizen to FDA - RE: Compounding Pharmacies

Updated June 6, 2024

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This is interesting reading for those of you who are following the role of the FDA in compounding pharmacy oversight.

Public Citizen to FDA: Reinspect Compounding Pharmacies Across the Country | The Legal Examiner Cleveland:

"In an 11-page letter to FDA Commissioner Margaret Hamburg, consumer watchdog group Public Citizen asked the agency to follow up on warning letters it issued to compounding pharmacies committing NECC-like violations.

Since 2003, the FDA has sent at least 18 warning letters to 16 compounding pharmacies, Public Citizen’s letter stated. In light of the 2012 fungal meningitis outbreak, the group would like the FDA to either reinspect those pharmacies or to verify that recent reinspections confirmed that those pharmacies cleaned up their act."

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Public Citizen's Letter to the FDA re:  Compounding Pharmacies (PDF)

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