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The FDA explains that compounded drugs are not FDA-approved , meaning the agency does not verify their safety, effectiveness, or quality before marketing (see Compounding and the FDA: Questions and Answers )

Lower concentrations would push injection volumes uncomfortably high

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He also argued the original ban was improper because, in his telling, the FDA acted without a safety signal

Sin embargo, la falta de estudios clnicos en humanos y los riesgos asociados a su uso hacen que sea una opcin arriesgada en este momento