The U.S. Food and Drug Administration (FDA) has published a final rule establishing a legal framework for the importation of certain prescription drugs from Canada. See Importation of Prescription Drugs, Final Rule (Sept. 24, 2020) (“Final Rule”). The final rule permits states, American Indian tribes, and, in some circumstances, pharmacists and wholesale distributors to submit importation plans to FDA for review and authorization to import certain prescription drugs from Canada. For such plans to be approved, sponsors will have to show that importation of any particular drug would “pose no additional risk to the public’s health and safety” and “result in a significant reduction in the cost of covered products to the American consumer,” 21 U.S.C. § 384(l). The rule is expected to publish in the Federal Register on Thursday, October 1, 2020, and go into effect 60 days after publication.
The proposed rule was published on December 23, 2019, and received over 1,200 public comments. The final rule comes in the wake of Executive Order No. 13938, which required the Secretary of Health and Human Services to finalize the rulemaking for prescription drug importation from Canada as well as the reimportation of insulin products “required for emergency medical care” and waivers to individuals of the prohibition on prescription drug importation. See Exec. Order No. 13938, Increasing Drug Importation to Lower Prices for American Patients (Jul. 24, 2020).
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