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.
The guidance comes four years after the agency’s initial draft and two years after a revised draft guidance was released for comment.
The newly finalized document is largely similar to the most recent draft with minor clarifications regarding processing beta-lactams, the handling of radiopharmaceuticals, and physician compounding and repackaging activities. (Related: New FDA guidance tackles insanitary conditions at compounding facilities, Regulatory Focus 3 August 2016; Compounding: FDA revises insanitary conditions guidance, finalizes guidance on radiopharmaceuticals, Regulatory Focus 25 September 2018).
The most significant change in the final guidance is a shift a risk management approach to prevent the occurrence of insanitary conditions. Now, instead of focusing primarily on corrective actions compounders can take to address insanitary conditions, the guidance provides recommendations for prevention.
“It is critical that all compounding facilities prevent the occurrence of any insanitary conditions within their facility … Prevention of insanitary conditions begins with the identification of risks associated with a process, procedure, or facility. Risk management tools offer a way to evaluate risk and to develop controls designed to prevent the occurrence of insanitary conditions within a compounding facility,” FDA writes in the guidance.
FDA, Guidance