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Step 2: Sanitize the Vials Pop off the plastic caps from the tirzepatide vial and the bacteriostatic water vial

For optimal stability, Bacteriostatic Water should be stored at controlled room temperature in a clean, dry environment away from excessive heat and direct light exposure

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Further, as discussed in more detail in another section of this final rule with comment period, although the new requirements at 180.50 will be effective January 1, 2026, we are delaying enforcement of these requirements to April 1, 2026, to provide hospitals with more time to comply