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Overview
On June 15, 2026, the FDA approved Colorado's plan to import about 20 prescription medicines from Canada. The state estimates residents will save 20% to 70% on those drugs, totaling roughly $46 million over three years.
Approval is the easy step. Canada bans exports that could worsen its domestic supply, and drugmakers control what crosses the border. Florida won the same clearance in January 2024, spent $132 million preparing, and imported nothing.
Why it matters
If Colorado can make this work, residents could pay far less for drugs like Ozempic, and other states would have a tested path to copy.
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People Involved
Organizations Involved
The federal agency that regulates drug safety and must approve any state plan to import medicines from Canada.
The Colorado agency that designed the importation program and now has to make it work.
Canada's drug regulator, which has moved to stop bulk exports to the United States.
A drug supply safety nonprofit that opposes bulk drug importation from Canada.
Timeline
May 2019 June 2026
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FDA approves Colorado
Latest ApprovalColorado becomes the second state cleared to import about 20 drugs, including Ozempic and Rinvoq. Polis hopes shipments start within a year.
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Industry group warns Colorado will repeat Florida's costly failure
StatementPartnership for Safe Medicines director Shabbir Imber Safdar said Colorado is 'poised to repeat Florida's failed attempt,' noting Florida spent $132 million and imported nothing.
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Florida's approval extended
RegulatoryThe FDA gives Florida six more months after the state imports no drugs in its first two years.
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Canada moves to block exports
PolicyHealth Canada finalizes rules barring drug exports that could cause or worsen shortages at home.
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Florida becomes first state approved
ApprovalThe FDA approves Florida's plan, the first such authorization. Florida projected up to $180 million in first-year savings.
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Colorado files its application
FilingColorado submits its importation plan to the FDA, starting a wait that would last three and a half years.
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FDA opens the federal path
Rule ChangeThe FDA finalizes a rule letting states apply to import certain drugs from Canada in bulk.
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Colorado creates its importation program
LegislationGovernor Polis signs SB19-005, directing the state to design a plan to import cheaper drugs from Canada.
Historical Context
3 moments from history that rhyme with this story — and how they unfolded.
Florida wins first import approval (2024)
The FDA approved Florida's plan to import drugs for conditions like HIV and mental illness, supplied through state agencies. Florida projected up to $180 million in first-year savings.
Canada finalized rules within days to block exports that could worsen its shortages.
Two years on, Florida imported no drugs and needed a six-month extension in May 2026.
Florida is the direct precedent and cautionary tale. It shows that FDA approval is the start, not the finish.
Canada blocks bulk exports (2020)
After the Trump administration's import rule, Canada issued its first order limiting bulk drug exports. Officials warned the country's smaller market could not safely supply U.S. demand.
The order signaled Canada would not be a passive drug source for U.S. states.
It hardened into a 2024 export prohibition covering all import-eligible drugs.
Canada's stance is the main barrier between Colorado's approval and a real shipment.
Section 804 import rule finalized (2020)
The FDA finalized a rule under a long-dormant 2003 law, creating the first real pathway for states to import drugs from Canada. The Biden administration kept it in place.
Drugmaker group PhRMA sued to block the rule.
The rule survived and became the basis for both Florida's and Colorado's approvals.
This rule is the legal foundation Colorado's program rests on, and the target of industry challenges.
