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The tirzepatide shelf life depends on formulation type and storage conditions, and exceeding recommended storage times can result in degraded peptide that does not perform as expected

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For example, note that the vertical line arising from -10% in Figure 1 intersects the ZEPBOUND 15 mg and placebo curves at approximately 83.5%, and 18.8%, respectively, which correspond to the values shown in Table 2

Body processes slow down when these reactions take longer to complete

Comment: A commenter mentioned our proposed regulation text edits and noted that the changes discussed in the preamble did not align with what was included in the regulation text at the end of the proposed rule and suggested that there may have been an inadvertent drafting error