Drug importation under section 804

On January 5, 2024, FDA authorized Florida to import certain prescription drugs from Canada, the first state program the agency had ever approved¹ under a law Congress passed in December 2003. Under FDA's rules, the authorization would end after a year unless the state's importer filed entry papers for a first shipment. No shipment came. FDA has since extended Florida's deadline four times, most recently on May 6, 2026², to November 6, 2026.

A second state joined in June 2026, when FDA authorized Colorado's program. As of Florida's latest quarterly report, no drug had been imported under its program, and Colorado's authorization was less than five months old.

Section 804 of the Federal Food, Drug, and Cosmetic Act is the only federal pathway for states to buy drugs in bulk from another country's market for resale at home. Supporters see it as a way to tap lower Canadian prices; the record so far shows how many conditions stand between an authorization and a pharmacy shelf.

What the statute requires

Section 1121 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, signed December 8, 2003⁵, rewrote section 804 to allow importation of prescription drugs from Canada. The law came with a switch. It takes effect only if the HHS secretary certifies to Congress that importation will "pose no additional risk to the public's health and safety" and "result in a significant reduction in the cost of covered products to the American consumer."

For 17 years, "no prior Health and Human Services (HHS) Secretary has made the certification required under section 804(l)(1)," FDA wrote in its 2020 final rule⁶. The certification was made alongside that rule, which HHS Secretary Alex Azar signed on September 23, 2020, according to the published text⁶.

How the 2020 rule works

FDA's final rule, "Importation of Prescription Drugs," was published on October 1, 2020, and took effect on November 30, 2020. It is codified at 21 CFR part 251. FDA had proposed it on December 23, 2019.

Under the rule, states and Indian tribes submit a Section 804 Importation Program, or SIP, proposal to FDA. Each program needs a Canadian foreign seller, a US importer that is a licensed wholesale distributor, and drugs that match FDA-approved products. The rule lets pharmacists and wholesalers co-sponsor programs and, "in certain future circumstances," sponsor them directly, according to its summary⁶.

Not every drug qualifies. It excludes controlled substances, biological products, infused drugs (including peritoneal dialysis solution), intravenously injected drugs, drugs inhaled during surgery and drugs injected into the spinal canal or eye. That list rules out much of what has run short in recent years, such as the IV fluids described in our piece on the 2024 IV fluid shortage, and leaves mostly tablets, capsules and some self-injected drugs. Biologics are outside the pathway altogether, a distinction our explainer on biosimilars and generics covers.

Before any shipment, the importer must file a Pre-Import Request at least 30 days ahead, and the drug must be tested in a US laboratory for authenticity, degradation and compliance with FDA specifications, then relabeled to match FDA-approved labeling. Every shipment must come in through a single port of entry, Detroit, which FDA called "currently the only authorized port" in its letter to Colorado³.

Two authorizations, a timeline

Sources: FDA authorization and extension letters, the 2020 final rule and the Canada Gazette. Florida revised its proposal five times before approval, according to FDA's May 2026 extension letter². Colorado revised its proposal four times, the last on December 4, 2025, FDA's letter to Colorado says³.

Authorization does not start the clock on the two-year approval period. That period begins only when the importer files an entry for the first shipment. If no entry is filed within a year of authorization, the program terminates, which is why Florida has needed repeated extensions. Colorado's one-year window runs to June 2027.

Why no drugs have arrived

Florida's own reporting is blunt. Its program covers 14 medications, meant for residents served by state-run programs such as Medicaid, but implementation "has been delayed due to significant resistance from pharmaceutical manufacturers, who ultimately control the supply chain for their products," the state Agency for Health Care Administration wrote in its quarterly report for the second quarter of 2026¹⁰. The report said the state's importer had not contracted with a manufacturer and listed no drugs imported.

Florida's report also cited Canada. On November 27, 2020, days before the US rule took effect, Canada's health minister signed an interim order barring certain drugs meant for the Canadian market from being distributed for use outside Canada if the sale could cause or worsen a shortage there, according to the Canada Gazette notice approving the order¹¹. The order applies to holders of a Canadian drug establishment licence, including wholesalers and distributors, the kind of seller a state program would buy from.

Colorado's program is sponsored by the state Medicaid agency, the Department of Health Care Policy and Financing, to which FDA addressed its authorization letter³. That letter says nothing may be imported until the importer files a Pre-Import Request and FDA grants it.

What changed in 2025 and 2026

Executive Order 14273, "Lowering Drug Prices by Once Again Putting Americans First," signed April 15, 2025⁷, directed FDA to make section 804 easier to use. On May 21, 2025, FDA said it would let states submit draft proposals for informal pre-review and would help streamline the required cost-savings analysis, in a press release⁸.

In July 2025, FDA published specific enhancements⁹. States may use a "static baseline approach" for savings estimates, holding domestic and foreign prices, exchange rates and tariff rates constant, and may "assume that tariffs have a neutral impact." By March 2026, FDA and HHS were giving states presentations on projecting savings and requesting meetings, according to FDA's section 804 page⁴.

None of this touches the cost of an individual prescription today, and the federal government has pursued other price measures in parallel, from Medicare price negotiation to most-favored-nation pricing models. For readers comparing prices now, our guides to asking for the cash price and to NADAC benchmarks cover what can be checked at a pharmacy counter.

Florida's current extension runs out on November 6, 2026. FDA's section 804 page, last updated June 15, 2026, lists the May 2026 letter as Florida's most recent extension.