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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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Impact on End Product Pricing and Market Positioning SAG costs more per kilogram

It's all about how the medication is being used and what your specific plan documents say about it

doi:10.1093/ehjdh/ztab088