U.S. Prescription Drug Importation

As the affordability of prescription drugs continues to be a top concern for consumers in the United States, drug importation, the practice of importing prescription drugs from another country, has been proposed as an approach to reducing drug costs. Although several states have passed bills that establish drug importation programs, these cannot be implemented without first being authorized by the FDA. Since the FDA created the Final Rule, “Importation of Prescription Drugs” (effective as of November 30, 2020), there has been strong opposition from the pharmaceutical industry and reservations from stakeholders, based on safety concerns and lack of certainty around cost savings. Minimally, drug importation has the potential to lower prices for cash-paying patients. If implemented widely and if it is successful in exerting competitive pricing pressure into the market, drug importation could have a far-reaching impact on patients.

In this report, IPD’s executive clinical pharmacists discuss how drug importation would work under the Final Rule, current and proposed legislation, individual importation, drug importation programs by state, the potential impact of drug importation on the pharmaceutical market, and barriers to drug importation.