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FDA Moves Forward with State Drug Import Plans

May 31, 2022


Despite a long history of difficulties in this area, FDA once again is taking steps to facilitate the import of less costly prescription drugs from Canada by states, Indian Tribes, and other entities. The Canadian government has objected to the plan, manufacturers challenge the legality of the process, and the complex requirements for establishing state import plans has stymied implementation.

New FDA guidance for establishing import programs states upfront that its main purpose is to “achieve a significant reduction in the cost of covered products” for Americans, while “posing no additional risk to the public’s health and safety.”

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