State Importation Revamped: FDA Announces Enhancements to State Importation for Eligible Prescription Drugs

The United States Food and Drug Administration (FDA) generally prohibits importing prescription drugs into the U.S. because there is no assurance that such drugs meet FDA standards. However, in an effort to provide U.S. consumers access to prescription drugs at lower prices, without imposing additional risk to public health and safety, FDA developed the time-limited Section 804 import program (SIP) to allow certain parties to import eligible prescription drugs from Canada. As described in the Final Rule and 21 C.F.R. § 251, the SIP allows for States and Indian Tribes, or in certain future circumstances pharmacists and wholesalers (collectively referred to as SIP Sponsors) to submit importation program proposals to FDA for review and authorization so long as certain requirements are met.

On May 21, 2025, FDA announced significant enhancements to the SIP as part of its efforts to implement Executive Order Lowering Drug Prices by Once Again Putting Americans First. These “enhancements” include plans to pre-review SIP proposals and collaborate with individual states and tribes to offer initial feedback, all with the goal of alleviating their burdens. Additionally, FDA is developing a user-friendly tool to assist states in crafting proposals. FDA will also offer support to simplify the required cost savings analysis included in these proposals and provide input on the information such parties may rely on when estimating cost savings.

Several states, including Colorado, Maine, New Hampshire, and New Mexico, have submitted SIP proposals to FDA, but only Florida has received two-year authorization from FDA thus far. Notably however, and despite being proactive, Florida has yet to begin importing prescription drugs from Canada and, in turn, was granted a six month extension (i.e., until July 6, 2025) in December 2024. During this time, Florida will be expected to submit its Pre-Import Request to FDA for authorization. Only then, and after the filing of an electronic import entry for consumption related to a shipment of eligible prescription drugs under the authorized SIP, will Florida be able to import the eligible drug.

It is not clear what impact, if any, FDA’s announcement will have on the SIP. Regardless, navigating the current FDA landscape takes careful planning and execution.Buchanan’s White Collar Practice Group and Life Sciences Industry Group are available to address any questions you may have and assist in developing a strategic plan to maximize opportunities and reduce risks.