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Its compounding-pathway status is unsettled: ibutamoren mesylate was nominated for inclusion on FDA's Section 503A bulk drug substances list, and the Pharmacy Compounding Advisory Committee reviewed the nomination at its October 29, 2024 meeting and voted against recommending it for the list, citing concerns about the strength of the safety and efficacy evidence

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The ABLE database is comprised of anonymized information, and as a result, the study was exempt from the requirement for informed consent by the IRB