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Unlike standard sterile water, which must be used immediately after opening, bacteriostatic water is designed for extended usability when handled under proper aseptic conditions

"Validation often involves the use of an appropriate challenge

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In the CY 2025 PFS proposed rule (89 FR 61955), we stated that when determining what information should be included on rebate reports, we considered the statutory requirements outlined in section 1847A(i)(1)(A) 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

The staff is amazing as well