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Importation Action

Following on from Trump’s Executive Order in July 2020 to increase drug importation, the FDA has issued a “final rule” that will allow certain prescription drugs to be imported from Canada – under specific conditions. The agency has also released Guidance for Industry, which details procedures drug manufacturers should follow “to facilitate importation of prescription drugs, including biological products, that are FDA-approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country.” The imported drugs would have to be relabeled to US standards, and tested for authenticity, degradation, and established specifications and standards.

In a statement, FDA Commissioner Stephen M. Hahn explained that the agency’s Safe Importation Action Plan should help increase competition in the market and lower the prices of prescription medicines.

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  1. FDA, “FDA Takes Actions to Help Lower U.S. Prescription Drug Prices,” (2020). Available at https://bit.ly/30gPZo5

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