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10.1016/J.XPHS.2016.10.001 55 JantaratC.SirathanarunP.BoonmeeS.MeechoosinW.WangpittayaH

Compounded GLP-1 medications are not FDA-approved drug products

Additionally, in the FY 2021 IPPS/LTCH PPS final rule (85 FR 58739 through 58742), we finalized our proposal to provide conditional approval for new technology add-on payment for a technology for which an application is submitted under the alternative pathway for certain antimicrobial products at 412.87(d) that does not receive FDA marketing authorization by the July 1 deadline specified in 412.87(e)(2), provided that the technology otherwise meets the applicable add-on payment criteria

[DOI] [PMC free article] [PubMed] [Google Scholar] Arenas-Jimnez J

Worked Example 3: Retatrutide 10mg with 2mL Bacteriostatic Water Retatrutide 10mg with 2mL bacteriostatic water: Peptide mass: 10mg Bacteriostatic water: 2mL Concentration: 10mg 2mL = 5 mg/mL Peptide per unit: 5 mg 100 = 0.05 mg/unit = 50 mcg/unit Research units needed per protocol (varies by protocol): depends entirely on research design Total doses per vial depend on per-dose research amount For a 2mg research unit: 10mg 2mg = 5 research doses per vial For a 4mg research unit: 10mg 4mg = 2.5 research doses per vial This is why retatrutide pricing on a per-research-unit basis varies significantly depending on research protocol design