On September 25, 2020, the U.S. Centers for Medicare and Medicaid Services (CMS) issued guidance that addresses the treatment of certain imported drugs under the Medicaid Drug Rebate Program. Specifically, CMS states its positions, which constitute only subregulatory guidance, on whether such imported prescription drugs qualify as Covered Outpatient Drugs (CODs) and the impact of such imported drugs on Medicaid price reporting obligations.
On September 24, 2020, FDA issued Final Guidance (No. 2020-449) addressing the importation of certain FDA-approved drugs that are authorized for sale in a foreign country in which the drugs were originally intended to be marketed. The Final Guidance refers to the FDA-approved drugs that may be imported as multimarket approved (MMA) products.
On the same day, FDA also issued a Final Rule (No. 2020-199) that sets up a legal framework for allowing the importation of certain prescription drugs from Canada.
Additional information summarizing these developments can be found here.
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