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Colorado wins FDA approval to import prescription drugs from Canada

Colorado wins FDA approval to import prescription drugs from Canada

Rule Changes

The second state cleared to buy cheaper Canadian medicines, including Ozempic, though no state has imported a single pill yet

June 15th, 2026: FDA approves Colorado

Overview

Updated Jun 16

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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Key Indicators

2
States approved
Colorado joins Florida as the only states cleared to import drugs from Canada.
20–70%
Projected savings
Estimated price cut on covered drugs, per the governor's office.
$46M
Projected 3-year savings
State estimate for combined premium and out-of-pocket savings if the program runs.
~20
Drugs covered
Includes Ozempic and Rinvoq, but not insulin.
0
Pills imported so far
Neither approved state has brought in any Canadian drugs to date.
~3.5 yrs
Wait for approval
Time from Colorado's December 2022 application to the June 2026 decision.

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People Involved

Jared Polis
Jared Polis
Governor of Colorado
Leading the state's importation push
 Kim Bimestefer
Kim Bimestefer
Executive Director, Colorado Department of Health Care Policy and Financing
Overseeing program implementation
 Shabbir Imber Safdar
Shabbir Imber Safdar
Executive Director, Partnership for Safe Medicines
Publicly opposing Colorado's importation program

Organizations Involved

U.S. Food and Drug Administration
U.S. Food and Drug Administration
Federal regulatory agency
Approved Colorado's program; oversees state imports

The federal agency that regulates drug safety and must approve any state plan to import medicines from Canada.
Colorado Department of Health Care Policy and Financing
Colorado Department of Health Care Policy and Financing
State Agency
Building and running the importation program

The Colorado agency that designed the importation program and now has to make it work.
Health Canada
Health Canada
Federal Agency (Canada)
Blocking exports that could worsen Canadian shortages

Canada's drug regulator, which has moved to stop bulk exports to the United States.
PS
Partnership for Safe Medicines
Industry nonprofit
Opposing state drug importation programs as unsafe and ineffective

A drug supply safety nonprofit that opposes bulk drug importation from Canada.

Timeline

May 2019 June 2026

8 events Latest: June 15th, 2026 · 3 months ago
Tap a bar to jump to that date

  1. FDA approves Colorado

    Latest Approval

    Colorado becomes the second state cleared to import about 20 drugs, including Ozempic and Rinvoq. Polis hopes shipments start within a year.

  2. Industry group warns Colorado will repeat Florida's costly failure

    Statement

    Partnership 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.

  3. Florida's approval extended

    Regulatory

    The FDA gives Florida six more months after the state imports no drugs in its first two years.

  4. Canada moves to block exports

    Policy

    Health Canada finalizes rules barring drug exports that could cause or worsen shortages at home.

  5. Florida becomes first state approved

    Approval

    The FDA approves Florida's plan, the first such authorization. Florida projected up to $180 million in first-year savings.

  6. Colorado files its application

    Filing

    Colorado submits its importation plan to the FDA, starting a wait that would last three and a half years.

  7. FDA opens the federal path

    Rule Change

    The FDA finalizes a rule letting states apply to import certain drugs from Canada in bulk.

  8. Colorado creates its importation program

    Legislation

    Governor Polis signs SB19-005, directing the state to design a plan to import cheaper drugs from Canada.

Scenarios

1

Colorado imports its first Canadian drugs

Possible Resolves by Q2 2027

Discussed by: Governor Jared Polis; STAT

Colorado lines up a willing Canadian supplier, relabels the drugs to FDA standards, and gets the first shipment to patients. Polis has said he hopes this happens within a year. Success would make Colorado the first state to turn approval into actual savings, beating Florida to the milestone.

2

Colorado's program stalls like Florida's

Possible Resolves by Q2 2027

Discussed by: STAT; KFF analysts

Canada's export ban and drugmaker resistance keep suppliers from selling. Colorado's approval sits unused, mirroring Florida, which imported nothing in its first two years and needed an extension. The legal clearance proves easier to win than the commercial reality of sourcing drugs across a hostile border.

3

A third state wins FDA approval

Uncertain Resolves by End of 2027

Discussed by: National Academy for State Health Policy (NASHP)

Other states with pending or planned applications, such as those that passed importation laws, secure FDA clearance. A third approval would show the federal pathway is becoming routine, even if no state has yet imported a drug. It would also widen pressure on Canada and drugmakers.

4

Federal pathway is rolled back or dropped

Unlikely Resolves by End of 2027

Discussed by: PhRMA; legal analysts at JD Supra

Industry lawsuits or a policy reversal narrow or end the import rule before any drugs flow. Drugmakers have long opposed importation on safety and supply grounds. A court ruling or FDA retreat could freeze both approved states and any applicants.

Historical Context

3 moments from history that rhyme with this story — and how they unfolded.

November 2020

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.

Then

The order signaled Canada would not be a passive drug source for U.S. states.

Now

It hardened into a 2024 export prohibition covering all import-eligible drugs.

Why this matters now

Canada's stance is the main barrier between Colorado's approval and a real shipment.

September 2020

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.

Then

Drugmaker group PhRMA sued to block the rule.

Now

The rule survived and became the basis for both Florida's and Colorado's approvals.

Why this matters now

This rule is the legal foundation Colorado's program rests on, and the target of industry challenges.

January 2024

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.

Then

Canada finalized rules within days to block exports that could worsen its shortages.

Now

Two years on, Florida imported no drugs and needed a six-month extension in May 2026.

Why this matters now

Florida is the direct precedent and cautionary tale. It shows that FDA approval is the start, not the finish.

Sources

(9)
+3
STAT KRDO CNBC Health Canada KFF Colorado General Assembly Partnership for Safe Medicines Colorado Public Radio Denver7