FDA stand on compounding criticized

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Public Citizen has written FDA asking it to stop making “misleading” statements about pharmacy compounding that could lead healthcare providers to treat patients with compounded drugs without understanding that they are not as safe as FDA-approved drugs.

The group objects to agency announcements encouraging hospitals and other HCPs to buy medical products from registered compounding or outsourcing facilities. “Because compounded products are fundamentally higher-risk than FDA-approved products,” it said, “[HCPs] should only rely on compounded products after first carefully assessing whether an FDA-approved product is available.” It added that “not all [HCPs] are aware that they should be making this assessment.”

The organization said it was concerned by a December blog post in which FDA commissioner Margaret Hamburg wrote that the agency “will be encouraging [HCPs] and health networks to consider purchasing compounded products from facilities that are registered with FDA.”

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