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The FDA placed it in 503A Category 2 ("may present significant safety risks") in 2023, effectively barring compounding pharmacies from using it, then removed it from that category in April 2026 after nominators withdrew their submission, without adding it to the approved Category 1 compounding list

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As shown in Figure 3 A and C, the sample distribution pattern in the scores plot showed both control group and NLF group have a clear separation from ALF group, indicating that the ACs profile of the ALF children was significantly different from that of the other two groups