Importation of Prescription Drugs: Overview of the Final Rule, FDA Guidance and Obstacles to Implementation

In the National Association of Boards of Pharmacy’s (NABP) Innovations publication, health care associates Jonathan Keller, PharmD, and Winnie McBride discuss the Importation of Prescription Drugs final rule issued by the United States Food and Drug Administration (FDA) and the secretary of the U.S. Department of Health and Human Services.

Keller and McBride outline key points of the final rule, which took effect in November 2020 and allows for the importation of certain prescription drugs from Canada in order to achieve a reduction in the cost of covered products under specific conditions that ensure no additional risk to the public’s health and safety.

The authors also examine 1) ongoing FDA education and compliance efforts, 2) an NABP initiative to protect the U.S. drug supply chain and 3) state action and ongoing litigation. Keller and McBride note that due to several obstacles, it remains to be seen whether the final rule will be implemented effectively.