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As of June 2026, the FDA's December 2024 Pharmacy Compounding Advisory Committee evaluation concluded that the criteria weighed against placing AOD-9604 (free base) or AOD-9604 acetate on the 503A Bulks List, and AOD-9604 is currently listed as Nominated but Withdrawn from FDA Category 2

therefore, they have an essential requirement for nutrients present only in animal tissues [8]

Venter C, Meyer RW, Nwaru BI, Roduit C, Untersmayr E, Adel-Patient K, Agache I, Agostoni C, Akdis CA, Bischoff SC, du Toit G, Feeney M, Frei R, Garn H, Greenhawt M, Hoffmann-Sommergruber K, Lunjani N, Maslin K, Mills C, Muraro A, Pali-Schll I, Poulson LK, Reese I, Renz H, Roberts GC, Smith P, Smolinska S, Sokolowska M, Stanton C, Vlieg-Boerstra B, OMahony L

Bac water without proper preservative concentration, sub-spec pH, or contamination causes peptide aggregation regardless of how much was added