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HB26-1262 • 2026

Patient Access to Compounded Medical Items

The act provides that, if the action is undertaken in accordance with applicable federal and state law: A licensed person may compound a drug or device in the state; A state-licensed pharmacy or a dis

Elections Healthcare
Enacted

This bill passed the Legislature and reached final enactment based on the latest official action.

Sponsor
Rep. K. Stewart, Rep. R. Stewart, Sen. M. Ball, Sen. D. Roberts, Rep. J. Bacon, Rep. K. Brown, Rep. C. Clifford, Rep. M. Duran, Rep. C. Espenoza, Rep. L. García, Rep. E. Hamrick, Rep. J. Jackson, Rep. J. Joseph, Rep. S. Lieder, Rep. M. Lindsay, Rep. B. Marshall, Rep. J. McCluskie, Rep. K. McCormick, Rep. K. Nguyen, Rep. J. Phillips, Rep. N. Ricks, Rep. M. Rutinel, Rep. E. Sirota, Rep. L. Smith, Rep. B. Titone, Rep. R. Weinberg
Last action
2026-06-02
Official status
Governor Signed
Effective date
Not listed

Plain English Breakdown

The source text distinguishes between 'current law' exemptions (experts qualified by training) and the new exemptions added by this act (institutional review board reviewed drugs). The summary reflects only what is explicitly stated as part of the act.

Patient Access to Compounded Medical Items

This law allows licensed people and facilities in the state to make, supply, or use custom-made drugs or devices if they follow federal and state rules.

What This Bill Does

  • Allows a licensed person to mix or create a drug or device within the state when following all laws.
  • Permits state-licensed pharmacies and registered outsourcing facilities to send compounded items to health-care providers, other pharmacies, or organizations.
  • Lets health-care providers, pharmacies, and facilities receive, give out, or use these custom-made drugs or devices from approved sources.
  • Stops the State Board of Pharmacy from making rules that are stricter than federal or state laws for outsourcing facilities.
  • Exempts certain investigational drugs reviewed by an institutional review board from sales bans if they are clearly labeled.

Who It Names or Affects

  • Licensed people who compound drugs or devices
  • State-licensed pharmacies and registered 503B outsourcing facilities
  • Health-care providers, other pharmacies, and medical organizations that receive these items
  • The State Board of Pharmacy

Terms To Know

Compound a drug or device
To mix or create a custom medicine or medical tool for specific patients.
503B outsourcing facility
A distribution facility registered with the federal Food and Drug Administration that makes compounded drugs in large amounts.

Limits and Unknowns

  • All actions must follow current federal and state laws.
  • The effective date of the law is not listed in the provided text.

Amendments

These notes stay tied to the official amendment files and metadata from the legislature.

L.007

SEN Health & Human Services

Passed [*]

Plain English: This amendment adds a rule allowing licensed outsourcing facilities, whether located in Colorado or out of state, to compound drugs and devices.

  • The bill now includes 'licensed resident 503B outsourcing facilities' as entities allowed to make compounded medical items.
  • The amendment text only shows the specific words being added, so it does not explain what a '503B outsourcing facility' is or list all other rules that apply to them.
  • Because the full context of the bill was not provided, we cannot describe how this change affects non-outsourcing facilities.
L.001

Second Reading

Lost [**]

Plain English: This amendment changes when the bill becomes law by adding a waiting period and allowing voters to stop it through a referendum.

  • The new rules would not start until August 12, 2026, or later if there is a vote on them.
  • Citizens can file a petition within 90 days of the legislative session ending to put this law up for a public vote in November 2026.
  • If voters reject the law at that election, it will never take effect.
  • This amendment was voted down and did not pass, so these changes are not part of the final bill.
  • The text only explains how to delay or stop the law; it does not describe what the original rules about compounding drugs actually say.
L.003

Second Reading

Lost [**]

Plain English: This amendment would stop the new rules from applying to drugs or devices made only for animals.

  • It adds a rule that says subsection (1.5) does not cover items intended just for veterinary use.
  • The exact details of what 'subsection (1.5)' requires are missing from the provided text.
  • This amendment was voted down and did not become part of the bill because its status is listed as Lost.
L.005

Second Reading

Lost [**]

Plain English: This amendment adds specific legal definitions for two types of pharmacies that follow federal rules under section 503A.

  • It defines a 'state-licensed nonresident 503A pharmacy' as an out-of-state pharmacy licensed by Colorado and regulated by the FDA under 21 U.S.C. Section 353a.
  • It defines a 'state-licensed resident 503A pharmacy' as an in-state pharmacy licensed by Colorado and regulated by the FDA under 21 U.S.C. Section 353a.
  • The amendment only adds definitions to existing laws; it does not explain what specific actions these pharmacies can take or how they differ from other pharmacy types in this bill.
  • This amendment was voted down and did not pass, so the changes described were never made into law.
L.006

Second Reading

Passed [**]

Plain English: This amendment adds a new section explaining that federal law allows two specific ways for pharmacies and facilities to legally mix medications.

  • Removes the word 'and' from page 2, line 14 of the bill.
  • Adds a new paragraph labeled (e) on page 3.
  • The amendment text does not explain what happens to other parts of the list that were removed or changed by striking lines.
  • It is unclear if this change affects how state laws work, as it only describes existing federal rules.

Bill History

  1. 2026-06-02 Governor

    Governor Signed

  2. 2026-05-22 Governor

    Sent to the Governor

  3. 2026-05-22 Senate

    Signed by the President of the Senate

  4. 2026-05-22 House

    Signed by the Speaker of the House

  5. 2026-04-21 House

    House Considered Senate Amendments - Result was to Concur - Repass

  6. 2026-04-20 House

    House Considered Senate Amendments - Result was to Laid Over Daily

  7. 2026-04-17 Senate

    Senate Third Reading Passed - No Amendments

  8. 2026-04-16 Senate

    Senate Second Reading Passed with Amendments - Committee

  9. 2026-04-14 Senate

    Senate Second Reading Laid Over to 04/16/2026 - No Amendments

  10. 2026-04-09 Senate

    Senate Committee on Health & Human Services Refer Amended - Consent Calendar to Senate Committee of the Whole

  11. 2026-03-19 Senate

    Introduced In Senate - Assigned to Health & Human Services

  12. 2026-03-16 House

    House Third Reading Passed - No Amendments

  13. 2026-03-13 House

    House Second Reading Special Order - Passed with Amendments - Floor

  14. 2026-03-10 House

    House Committee on Health & Human Services Refer Unamended to House Committee of the Whole

  15. 2026-02-19 House

    Introduced In House - Assigned to Health & Human Services

Official Summary Text

The act provides that, if the action is undertaken in accordance with applicable federal and state law:
A licensed person may compound a drug or device in the state;
A state-licensed pharmacy or a distribution facility registered with the federal food and drug administration (licensed 503B outsourcing facility) may supply a compounded drug or device to a licensed health-care provider, pharmacy, facility, or organization; and
A licensed health-care provider, pharmacy, facility, or organization may obtain, dispense, or administer a compounded drug or device supplied by a state-licensed pharmacy or a licensed 503B outsourcing facility.
In addition, the act prohibits the state board of pharmacy from adopting rules that are more restrictive than federal or state law regarding the compounding of drugs or devices by licensed 503B outsourcing facilities.
Current law exempts drugs that are intended solely for investigational use by experts qualified by scientific training and experience and that are plainly labeled for investigational use only from the sales and delivery prohibition for new drugs. The act also exempts from the prohibition:
Drugs that are reviewed by an institutional review board and plainly labeled for investigational use only; and
Compounded drugs and devices if the compounding of the drug or device is undertaken in accordance with applicable federal and state law.
(Note: This summary applies to this bill as enacted.)