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In addition, events raising questions about the safety of certain marketed pharmaceuticals may result in increased cautiousness by the FDA, EMA, and other comparable foreign regulatory authorities in reviewing new drugs based on safety, efficacy or other regulatory considerations and may result in significant delays in obtaining regulatory approvals

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doi: 10.1016/j.celrep.2019.02.015 95 LiuJSunJWangFYuXLingZLiHet al

When compounding in compliance with federal and state law, compounded drugs are not subject to FDA approval and are not evaluated for safety or efficacy