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And you would never know the difference by looking at the vial, because most degradation happens at the molecular level, invisible to the naked eye

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Under FDA 21 CFR Part 803, here is how the timelines break down for different stakeholders: The 5-Day Rule (Manufacturers) This is for the most critical situations

We stated in the CY 2025 PFS proposed rule (89 FR 61965) that we understand that statutory provisions at section 1860D-14B of the Act require that CMS establish the payment amount benchmark period at the dosage form and strength level, and that allowing manufacturers to reset the payment amount benchmark period for a new NDC-9 of an existing Part D rebatable drug may not fully align with this directive