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Nijhof IS, Casneuf T, van Velzen J, van Kessel B, Axel AE, Syed K, et al

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