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That matters because compounded drugs (whether under FDCA 503A or 503B) may be exempt from certain approval requirements, but they are not FDAapproved and those exemptions are conditioned on meeting specific statutory requirements

28(22) Chen T, Cheng L, Ma J, Yuan J, Pi C, Xiong L, Chen J, Liu H, Tang J, Zhong Y, Zhang X, Liu Z, Zuo Y, Shen H, Wei Y, Zhao L (2023) Molecular mechanisms of rapid-acting antidepressants: new perspectives for developing antidepressants

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12 GLP-1s reduce liver fat by about 58%, a reduction that sounds modest but represents a major relative drop in stored fat

Growing evidence indicates that gut microbes play an active role in metabolic health