USA – FDA finalizes insanitary conditions guidance for compounders

Eight years after a fungal meningitis outbreak linked to the New England Compounding Center killed dozens of patients across the country, the US Food and Drug Administration (FDA) has finalized guidance on addressing insanitary conditions at compounding facilities.

The outbreak triggered criticisms of FDA’s oversight of drug compounders and prompted Congress to create a new pathway for larger compounders to register with the agency as outsourcing facilities via the Drug Quality and Security Act in 2013.

“While some compounders work hard to meet quality standards, too often, FDA investigators continue to observe poor conditions at compounding facilities that impact drug quality and have the potential to harm patients who use the drugs. These insanitary conditions include dirt, mold, insects, trash, peeling paint, unclean exhaust vents and dirty high-efficiency particular air (HEPA) filters, among many examples,” said Patrizia Cavazzoni, MD, acting director of the Center for Drug Evaluation and Research…