CMS Guidance to the States on the FDA Final Regulation “Importation of Prescription Drugs” Related to Section 804 of the Federal Food, Drug, and Cosmetic Act (FFDCA) and the Medicaid Drug Rebate Program

CMS Guidance to the States on the FDA Final Regulation “Importation of Prescription Drugs” Related to Section 804 of the Federal Food, Drug, and Cosmetic Act (FFDCA) and the Medicaid Drug Rebate Program

Today, the Centers for Medicare & Medicaid Services released guidance to states discussing the Food and Drug Administration’s Importation of Prescription Drugs final rule that is revising Section 804 of the Federal Food Drug and Cosmetic Act (FFDCA) and the implications of this regulation on the Medicaid Drug Rebate Program (MDRP).  Specifically, this guidance addresses: States implementation of this final rule; Importation Requirements; and Implications for MDRP. 

 To learn more about this guidance please use the link below:

• Medicaid Drug Rebate Program Notice on FDA Final Regulation Revising Section 804 of the Federal Food Drug and Cosmetic Act (FFDCA) on Reimported Drugs and the Medicaid Drug Rebate Program