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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

Yesterday: FDA approves Colorado

Overview

A Coloradan paying full price for Ozempic could soon pay 20% to 60% less, because the drug crossed the border from Canada. On June 15, 2026, the Food and Drug Administration approved Colorado's plan to import about 20 prescription medicines from Canada. The state is the second to win that approval, after Florida.

The approval clears a legal hurdle that stood for decades. Federal law long blocked states from importing drugs in bulk. But no state has actually imported a single pill yet, because Canada bans exports that could worsen its own shortages, and drugmakers control the supply.

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.
20–60%
Projected savings
Estimated price cut on covered drugs through premiums and out-of-pocket costs.
~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

Organizations Involved

Timeline

May 2019 June 2026

7 events Latest: Yesterday
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. Florida's approval extended

    Regulatory

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

  3. Canada moves to block exports

    Policy

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

  4. 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.

  5. Colorado files its application

    Filing

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

  6. FDA opens the federal path

    Rule Change

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

  7. Colorado creates its importation program

    Legislation

    Governor 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.

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.

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.

Sources

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