Legally Import Drugs From Other Countries ?

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Under most circumstances, it is against the law for individuals to import FDA-approved drugs from foreign countries for personal use. However, following modifications introduced by the MMA, there are exceptions that permit the personal importation of prescription drugs not approved by the FDA for use in the United States on a case-by-case basis. The FDA has issued guidance outlining specific scenarios where the importation of non-FDA approved drugs for personal use might be considered.

For instance, personal importation is typically allowed if the treatment is for a severe medical condition, there is no viable treatment available within the U.S., and the drug is not commercially available to U.S. residents. Normally, a three-month supply is the limit, and individuals are required to provide written confirmation that the drug is for personal use, along with information about the treating physician.

It’s worth noting that FDA enforcement of the ban on importing FDA-approved drugs for personal use appears to be limited. Even when personal importation of a drug is technically illegal, existing laws direct the FDA to exercise discretion when allowing personal drug importation, particularly when the product is “clearly intended for personal use and does not seem to pose an unreasonable risk to the user,” as reinforced by FDA guidelines.

In July 2020, during the Trump Administration, an executive order directed the HHS Secretary to finalize rulemaking related to states importing specific drugs from Canada. It also instructed HHS to take steps to enable individuals to import prescription drugs from foreign countries and allow insulin products manufactured in the United States and sent abroad to be reimported.

In response, the previous Administration issued two requests for proposals, and HHS and FDA began accepting proposals for these two pathways in September 2020. However, the Biden Administration received no proposals for implementation via either of these pathways and officially withdrew both requests for proposals in June 2021.

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