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However, treatment with this drug should be cautiously monitored because of adverse side-effects, such as dizziness, sleepiness, cognitive dysfunction, swelling, and weight gain

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Standardized processes are required for clinical translation where manufacturing processes will be standardized

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The FDA issued a notice in 2023 indicating BPC-157 cannot be compounded under section 503A or 503B of the Federal Food, Drug, and Cosmetic Act because it does not appear on approved bulk substance lists