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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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Garvey WT, Batterham RL, Bhatta M, Buscemi S, Christensen LN, Frias JP, et al