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Sikirica MV, Martin AA, Wood R, Leith A, Piercy J, Higgins V
FDA has issued warning letters to peptide vendors (including GLP-1 actives like Retatrutide, which is marketed as research only), and the agency continues to flag unsafe internet pharmacies
S.LohanaD.KumarP.NandulaS
In addition, because the demonstration will operate outside the Part D benefit, the manufacturers wont be responsible for providing the manufacturer price discount on eligible GLP-1s (10% in the Part D initial benefit phase and 20% in the catastrophic phase.) While many prior section 402 demonstrations have had to conform to budget neutrality rules by the Office of Management and Budget (OMB), some demonstrations have been able to move forward without this requirement
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