FDA Should Lean on Hospitals to Outsource Compounding, IG Report Says

June 19, 2019

The FDA should urge hospitals to make sure they’re using registered compounding pharmacies, government auditors say in a new report.

HHS’ Inspector General found that compounding pharmacies overwhelmingly comply with federal safety and quality standards but that the FDA has to do a better job of stressing the importance of registered compounders for America’s hospitals. Unregistered compounders may “pose a public health threat,” the auditors wrote.

“Hospitals are the frontline of patient safety and safely compounded drugs are necessary for effective patient care,” the Inspector General said.

The auditors provided a list of unregistered compounders to the FDA and officials have already begun inspections, the agency told the Inspector General.

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