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The FDA does not approve or review drugs from compounding pharmacies it just monitors the active ingredients the facilities use

Specifically, the activity of the SLC7A11, SLC3A2, and GYS1 genes increases, whereas the activity of the OXSM, NUBPL, NDUFA11, NCKAP1, and LRPPRC genes decreases (Zhu et al., 2023) (Table 1)

Giretti, M

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The agency cited safety risks including potential carcinogenicity, immunogenicity, and concerns about impurities and noted that most of these substances had never undergone rigorous human clinical trials