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After further consideration of comments received in response to the initial guidance and of the process through which a claim is determined to have 340B status, we noted in the CY 2025 PFS proposed rule (89 FR 61972) that CMS is no longer pursuing this policy at this time but may consider it in future rulemaking

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Most people receiving compounded tirzepatide with B12 expect a clear liquid, similar to what they see in advertisements for brand-name pens

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Batch testing ensures consistency across supply