New FDA Rules Permit States to Import Drugs from Canada
- October 23, 2020
- Jason Reddish , Feldesman Tucker Leifer Fidell LLP
On September 25, 2020, the Food and Drug Administration (FDA) finalized long-awaited regulations (Final Rule) to implement Section 804 of the Food, Drug and Cosmetic Act (FDC&A), allowing the importation of prescription drugs originally sold in Canada into the United States for resale.[1] Importation of drugs from Canada, where many branded drugs are sold at a fraction of their American prices, has been presented as a source of cost savings for American consumers for over 20 years. The rules permit states to propose importation plans, though the process is onerous and requires participation by many stakeholders on both sides of the border.
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