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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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Doctors need to diagnose a Vitamin B12 deficiency or a condition that needs it
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Supplied as lyophilised powder for in-vitro research use only, not a licensed medicine
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