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Patients should understand the regulatory status of these compounds

Section 11101(a) of the IRA amended section 1847A of the Act by adding a new subsection (i), which requires the payment of rebates into the Supplementary Medical Insurance Trust Fund for Part B rebatable drugs if the payment limit amount exceeds the inflation-adjusted payment amount, which is calculated as set forth in section 1847A(i)(3)(C) of the Act

The PEN form, the vials or the arginine salt do not change this status it concerns the molecule regardless of the form