State drug importation programs, from Vermont's 2018 law to Colorado's 2026 authorization

On June 15, 2026, FDA authorized Colorado's plan to import certain prescription drugs from Canada, making it the second state cleared under section 804 of the Federal Food, Drug, and Cosmetic Act. The agency's authorization letter¹ said nothing could be imported until the state's importer filed a Pre-Import Request and FDA granted it.

Florida, the first state, has held an authorization since January 2024 and had not imported a single drug as of mid-2026. Its importer "has not contracted with a foreign manufacturer," the state's Agency for Health Care Administration said in its report for the second quarter of 2026⁸. FDA's latest extension of Florida's authorization runs to Nov. 6, 2026.

Seven states have passed laws to set up wholesale importation programs, five have filed proposals with FDA, one was turned down and two have been authorized. What follows covers the federal rule those states must meet, where each stands, why generic drugs play almost no part, and what federal officials changed in 2025 and 2026. GxRadar's earlier explainer on section 804 covers the statute's history in more detail.

The federal rule states have to meet

FDA's final rule, "Importation of Prescription Drugs," was published Oct. 1, 2020, and is codified at 21 CFR part 251. States and Indian tribes may sponsor a Section 804 Importation Program, or SIP, built around a Canadian foreign seller and a licensed US importer, according to the rule¹⁰. The statute excludes controlled substances, biological products such as insulin, infused and intravenously injected drugs, and several other categories, the Congressional Research Service noted in its March 2026 summary¹¹.

Each drug must be tested in the United States for authenticity and degradation, relabeled with FDA-approved labeling and brought in through a single port. FDA told Colorado that the only authorized port is Detroit and that a complete Pre-Import Request must arrive at least 30 calendar days before a shipment, in its letter¹.

Clock rules matter as much as testing rules. An authorization lasts two years from the first shipment's entry, not from the date of the letter, and it terminates if no shipment is entered within a year of authorization. FDA may extend an authorization for up to two years at a time if asked at least 90 days ahead, the Colorado letter¹ says.

FDA never put a dollar figure on the program's effect. "We are unable to estimate the cost savings from this final rule," the agency wrote in the rule's economic summary¹⁰, citing unknowns about which drugs would be imported and how much cheaper they would be.

Where each state stands

A November 2024 report by Virginia's Secretary of Health and Human Resources, written after the state's legislature ordered a feasibility study, compiled the status of other states using data from the National Conference of State Legislatures. Its findings, updated with FDA's later letters, are below.

Sources: Virginia Secretary of Health and Human Resources (2024)⁹; FDA letters to Florida² and Colorado¹. North Dakota and Virginia passed laws creating study groups rather than programs, the Virginia report says.

New Hampshire's case shows how much depends on finding a seller. FDA rejected its proposal "because the state could not identify a Canadian wholesale distributor (foreign seller) to provide the drugs," according to the Virginia report⁹.

Florida's four extensions

Florida's program was the first out of the gate and has spent the longest waiting. Florida says FDA delayed a ruling from 2020 through 2023 with repeated requests for information and granted authorization in January 2024 only "after two lawsuits," according to the state's quarterly report⁸ says. The program covers 14 medications for people served by state-run programs such as Medicaid and the Department of Corrections.

When FDA authorized the plan, it listed what Florida still had to do before any drug crossed the border: submit drug-specific information, test for authenticity and compliance with specifications, relabel, and report quarterly on savings and safety, its January 5, 2024 announcement⁴ said. Florida pays its contracted importer a flat fee of about $14 million a year and projected savings of $183 million for federal fiscal 2023-24, the Virginia report⁹ found.

Sources: FDA's November 2025 extension letter³ and May 2026 extension letter².

Florida blames the stall on supply. Implementation "has been delayed due to significant resistance from pharmaceutical manufacturers, who ultimately control the supply chain for their products," and Canada "has expressed hesitation," its report⁸ says. On Nov. 27, 2020, Canada's health minister signed an interim order barring licensed distributors from selling certain drugs meant for Canadian patients for use abroad if the sale could cause or worsen a shortage, according to the Canada Gazette¹².

Why generics are mostly left out

State programs have concentrated on expensive brand-name and specialty drugs, and the reason is price. "Because generic drugs in Canada tend to cost more than in the United States, Florida focused on high-cost drugs for importation, such as specialty drugs," the Virginia report⁹ says. Florida started with 130 candidate drugs and narrowed the list to 14.

Federal price research points the same way. In 2018, US prices for unbranded generics were 84 percent of prices in 32 comparison countries, a RAND analysis for HHS found¹³. Against Canada, the US index for unbranded generics was 56.7, with Canadian prices set at 100, in Table C.1 of the full report¹⁴. The GxRadar generic price index has fallen further since then, to 47.4 in October 2026 against 100 in January 2014.

The exclusion list removes other categories where shortages have been common, such as IV products, covered in GxRadar's piece on the 2024 IV fluid shortage. Shortages are handled under a different authority, described in temporary importation during shortages.

What federal officials changed in 2025 and 2026

Executive Order 14273, signed April 15, 2025, gave FDA 90 days to "streamline and improve the Importation Program under section 804" to make it "easier for States to obtain approval without sacrificing safety or quality," the order says¹⁵. On May 21, 2025, FDA said states could submit draft proposals for informal pre-review and meet with agency staff, in a press release⁶.

In July 2025 FDA published specific enhancements⁷. States may use a "static baseline approach" to savings, holding domestic and foreign prices, exchange rates and tariff rates constant, and may "assume that tariffs have a neutral impact." By March 2026, HHS and FDA were giving states presentations on projecting savings and requesting meetings, according to FDA's section 804 page⁵.

Colorado's plan differs from Florida's in whom it serves. Colorado intends to reach consumers in the commercial insurance market, has an annual appropriation of $2.1 million and estimates savings of $50.9 million over three years, the Virginia report⁹ says. Florida limited its program to public payers. Other state cost-control efforts, such as prescription drug affordability boards, work through payment limits rather than imports. Individuals bringing medicine across the border fall under a separate policy, explained in GxRadar's piece on FDA's personal importation policy.

Two dates come next. Florida's current extension expires Nov. 6, 2026, and Colorado's importer must file an entry for a first shipment by June 15, 2027, one year after authorization, or the program ends under 21 CFR 251.6(c).