Drug importation is the practice of importing prescription drugs that were manufactured, either domestically or abroad, to sell in another country.
In 2000, Congress enacted the Medicine Equity and Drug Safety (MEDS) Act, which added Section 804 to the Food and Drug Cosmetic Act (FDCA), to allow pharmacists and wholesalers to import prescription drugs directly from certain industrialized countries.1
The Medicare Modernization Act of 2003 (MMA) amended Section 804 by specifying that wholesalers and pharmacists can only import prescription drugs from Canada.1
In September 2020, the HHS released a final rule on “Importation of Prescription Drugs”, which outlined a plan for states, tribes, wholesalers, or pharmacists to import Canadian drugs. This final rule is being challenged in court by the Pharmaceutical Research and Manufacturers of America.1
Numerous states have either enacted drug importation laws (Colorado, Florida, Maine, New Hampshire, New Mexico, and Vermont), have pending legislation, or exploratory committees on the topic.1
The federal and state governments recognize the potential savings of drug importation, and this has bolstered the many, recent policy proposals. However, the potential cost savings of importation have to be weighed against patient safety, considerations of the economic and research and development consequences, as well as the limitation of importation (i.e. other country’s available supply).
Federal and state level importation programs hinge on supply availability in the Canadian pharmaceutical market. The Canadian population is however a fraction of the US, only 37.6 million; so it seems implausible that the Canadian pharmaceutical market could sustain U.S. demand.1 Seemingly aware of this fact, in late 2020, Canada even banned the export of some prescription medicines to prevent a shortage.2 Beyond statewide programs, individuals can currently import pharmaceuticals for personal use through FDCA’s personal importation policy which allows the FDA discretion in importation prohibition. Personal drug importation is approved on a case-by-case basis, but lenience is often given to individuals who import a small amount (e.g., a 90 day supply). The product must be deemed to not pose an unreasonable risk, and the importing individual must certify in writing that the product is only for personal use.1
About 20 states have introduced drug importation legislation; six have passed laws; and five have submitted programs to HHS for review. As of March 2021, no importing under these laws had started.3
Roughly 4 million Americans import medicines for personal use each year.4
The FDCA definition of prescription drugs under Section 804 excludes controlled substances, biologic products, and medications that are either infused or injected intravenously.1
Scheckel, C.J., Vincent Rajkumar, S. Drug importation: limitations of current proposals and opportunities for improvement. Blood Cancer J. 11, 132 (2021). https://doi.org/10.1038/s41408-021-00522-3
BBC News. Canada bans mass exports of prescription drugs.https://www.bbc.com/news/world-us-canada-55119428. Published 2020.
Levitt G. State Drug Importation Laws. What’s the deal?. Ask PC. 2022. https://www.pharmacychecker.com/askpc/state-drug-importation-laws/#!.
Galewitz P. Trump Approves Final Plan to Import Drugs From Canada ‘for a Fraction of the Price’. Kaiser Health News. https://khn.org/news/trump-approves-final-plan-to-import-drugs-from-canada-for-a-fraction-of-the-price/#:~:text=About%204%20million%20Americans%20import,other%20countries%2C%20according%20to%20surveys. Published 2020.