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Full reconstitution guide Advanced calculator Dosing & Reconstitution Guide A single practical dilution with accurate once-daily dosing, step by step Standard FDA-Approved Protocol (3 mL = ~3.33 mg/mL) Reconstitute: Add 3.0 mL bacteriostatic water to one 10 mg vial final concentration ~3.33 mg/mL (3,333 mcg/mL)

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After consideration of public comments regarding the proposed changes to amend 410.79(b) and (d)(1), we are finalizing as proposed and will continue to monitor use of this flexibility to approximate the demand for beneficiaries to restart their program for other reasons

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