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The patients at highest risk were those on higher doses, those with pre-existing borderline B12 levels, those with a history of metformin use (which independently depletes B12), and those over age 60

trauma such as a fracture would not

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To potentially move them into Category 1 or final Bulks List status, the most effective approach is to present a persuasive case for their clinical efficacy and safety to the Pharmacy Compounding Advisory Committee (PCAC) and submit it to the FDA