FDA Guidance on “Copied” Drug Products

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  • December 04, 2018

Because compounded products are not regulated by the FDA, they can pose higher health risks to patients than FDA-approved drugs. This document on a specific policy detail includes FDA guidance to avoid compounded drug products if there is an FDA-approved option that serves the same purpose. In the guidance, the FDA says that using compounded products when FDA-approved alternatives exist “would create significant public health risks because patients would be unnecessarily exposed to drug products that have not been shown to be safe and effective and that may have been prepared under substandard manufacturing conditions.”

Read the details of the guidance here.

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