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In the CY 2025 PFS proposed rule (89 FR 61979), we stated that when determining what information should be included on rebate reports, we considered the statutory requirements outlined in section 1860D-14B(a)(1) of the Act to determine which data elements are necessary to review the Preliminary Rebate Report for error (described later in this section) and to protect proprietary information

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However, those symptoms will resolve themselves within a few hours

Preservative-free sterile water is used instead for a small number of compounds, such as NAD+, that are sensitive to benzyl alcohol