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Because the PDE record does not provide the unit type used to determine Quantity Dispensed, CMS proposes in 428.203(a)(2) that CMS would crosswalk the information from the PDE record to a drug database that provides the unit type for an NDC, such as Medi-Span or the FDA's Comprehensive NDC Structured Product Labeling (SPL) Data Element (NSDE) file, matching on the NDC of the Part D rebatable drug

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That complaint sought to have the court compel the FDA to make a determination about whether it should add menthol to the list of prohibited tobacco flavors