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
This follow-up is especially important for individuals with recurrent infections or underlying health conditions that may predispose them to further issues
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Rossing P, Agarwal R, Anker SD, et al