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Deficient: B12 levels below 200 pg/mL

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discard if the solution is discolored or contains particulate matter

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We stated in the CY 2025 PFS proposed rule (89 FR 61974) that CMS intends to use the shortage lists maintained by the FDA Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) to determine whether a Part D rebatable drug is currently in shortage [700] during an applicable period