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Under the Drug Quality and Security Act (DQSA) of 2013, the FDA maintains lists of bulk drug substances that licensed compounding pharmacies can use to prepare medications for individual patients.[1] These lists are broken into categories: - **Category 1**: Substances nominated for inclusion, under evaluation, and potentially approvable for compounding - **Category 2**: Substances nominated but determined to be inappropriate for compounding — typically due to safety concerns, lack of clinical need, or insufficient evidence of effectiveness - **Category 3**: Substances not yet evaluated **Semax does not appear on any of these lists as an approved compoundable substance.** It has not been nominated and approved for Category 1 status under either the 503A (traditional compounding pharmacy) or 503B (outsourcing facility) frameworks.[1] What this means practically: a licensed compounding pharmacy in the United States cannot legally prepare Semax for patient use and dispense it with a prescription
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