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FDA procedurally removed it from Category 2 in April 2026 after nominators withdrew their submissions and referred it to the Pharmacy Compounding Advisory Committee, which is scheduled to review it on July 23-24, 2026 for possible inclusion on the approved 503A bulks list

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Without human trial data, clinicians and patients are making decisions based on incomplete information, and the self-reported adverse effect profile — anxiety, palpitations, insomnia, fatigue — is not benign enough to ignore