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Prepare Sterile Solution: Reconstitute lyophilized peptide powder using bacteriostatic water with a clean syringe

Closing this knowledge gap is a priority for the Society, as an SC injection is potentially less painful and significantly easier to self-administer, offering clear opportunities for enhanced patient autonomy and improved long-term outcomes

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We proposed that the data from these submissions would be used to assess the usability of such data to implement section 1860D-14B(b)(1)(B) of the Act, which requires the exclusion from the total number of units for a Part D rebatable drug those units for which a manufacturer provided a discount under the 340B Program starting January 1, 2026

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