HB26-1262 • 2026

Patient Access to Compounded Medical Items

The bill 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 di

Elections Healthcare

Passed Legislature

This bill passed both chambers and reached final enrollment, even if later executive action is not shown here.

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. J. Phillips, Rep. M. Rutinel, Rep. E. Sirota, Rep. B. Titone, Rep. R. Weinberg
Last action: 2026-04-09
Official status: Senate Committee on Health & Human Services Refer Amended - Consent Calendar to Senate Committee of the Whole
Effective date: Not listed

Plain English Breakdown

Checked against official source text during the last sync.

Patient Access to Compounded Medical Items

This bill allows licensed individuals in Colorado to compound drugs or devices, sets rules for pharmacies and facilities that supply compounded items, and prohibits the State Board of Pharmacy from making stricter rules than federal and state laws.

What This Bill Does

Allows a licensed person to make (compound) drugs or medical devices in the state if they follow federal and state laws.
Permits state-licensed pharmacies and distribution facilities registered with the FDA as 503B outsourcing facilities to supply compounded drugs or devices to licensed healthcare providers, pharmacies, facilities, or organizations.
Enables licensed healthcare providers, pharmacies, facilities, or organizations to obtain, dispense, or administer compounded drugs or devices from state-licensed pharmacies or 503B outsourcing facilities.
Prohibits the State Board of Pharmacy from adopting rules that are more restrictive than federal and state laws regarding compounding drugs or devices.
Adds exceptions for investigational drugs reviewed by an institutional review board and plainly labeled as such.

Who It Names or Affects

Licensed healthcare providers, pharmacies, facilities, and organizations in Colorado
Individuals licensed to compound drugs or medical devices

Terms To Know

Compounding: The process of mixing ingredients to create a medication tailored for an individual patient.
503B Outsourcing Facility: A facility registered with the FDA that prepares, compounds, or labels drugs in large quantities and distributes them to multiple healthcare providers.

Limits and Unknowns

The bill does not specify an effective date.
It is unclear how this legislation will be enforced by regulatory bodies.

Amendments

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

L.007

SEN Health & Human Services

Passed [*]

Plain English: The amendment adds a requirement that licensed resident and nonresident 503B outsourcing facilities can compound drugs or devices in the state, as long as it follows federal and state laws.

Adds language to specify that both resident and non-resident 503B outsourcing facilities are allowed to compound drugs or medical devices within the state if they comply with applicable federal and state regulations.

The amendment text does not provide details on what specific actions these facilities must take beyond compliance with laws, leaving some aspects of their operations unclear.

L.001

Second Reading

Lost [**]

Plain English: The amendment changes when and how a new law about patient access to compounded medical items will take effect, adding conditions for it to be approved by voters.

Changes the effective date of the bill to occur after a ninety-day period following the end of the legislative session in May 2026, unless a referendum petition is filed and approved by voters at the November 2026 election.

The amendment text does not specify all details about how the referendum process would work or what happens if the referendum fails. These specifics are left unclear in the provided material.

L.003

Second Reading

Lost [**]

Plain English: The amendment adds a new section to the bill that excludes drugs or devices intended only for veterinary use from certain provisions.

Adds an exclusion clause stating that subsection (1.5) does not apply to drugs or devices meant exclusively for animals.

The amendment text is incomplete and lacks context about what specific provisions of subsection (1.5) are being excluded.
It's unclear how this exclusion will affect the overall intent and application of the bill regarding patient access to compounded medical items.

L.005

Second Reading

Lost [**]

Plain English: The amendment adds definitions for 'state-licensed resident 503A pharmacy' and 'state-licensed nonresident 503A pharmacy' in Colorado Revised Statutes.

Adds new definitions to the Colorado Revised Statutes for state-licensed pharmacies that are subject to FDA regulations under section 353a of the U.S. Code.

The amendment text is incomplete and does not provide full context, making it difficult to explain all potential impacts.
It's unclear how these new definitions will be applied or enforced in practice.

L.006

Second Reading

Passed [**]

Plain English: The amendment changes a part of the bill that talks about how licensed pharmacies can make compounded drugs and devices, adding details about federal laws that allow this practice.

Removes the word 'and' from page 2, line 14 of the printed bill.
Replaces text on page 3 with new language to include federal law pathways for compounding human drug products.

The amendment's text is incomplete and does not provide full details about all changes made.

Bill History

2026-04-09 Senate
Senate Committee on Health & Human Services Refer Amended - Consent Calendar to Senate Committee of the Whole
2026-03-19 Senate
Introduced In Senate - Assigned to Health & Human Services
2026-03-16 House
House Third Reading Passed - No Amendments
2026-03-13 House
House Second Reading Special Order - Passed with Amendments - Floor
2026-03-10 House
House Committee on Health & Human Services Refer Unamended to House Committee of the Whole
2026-02-19 House
Introduced In House - Assigned to Health & Human Services

Official Summary Text

The bill 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 bill 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.
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 bill 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 the reengrossed version of this bill as introduced in the second house.)

Current Bill Text

Read the full stored bill text

Second Regular Session
Seventy-fifth General Assembly
STATE OF COLORADO
REENGROSSED
This Version Includes All Amendments
Adopted in the House of Introduction
LLS NO. 26-0456.01 Sarah Lozano x3858 HOUSE BILL 26-1262
House Committees Senate Committees
Health & Human Services
A BILL FOR AN ACT
CONCERNING PRESERVING PA TIENT ACCESS TO COMPOUNDED101
MEDICAL ITEMS.102
Bill Summary
(Note: This summary applies to this bill as introduced and does
not reflect any amendments that may be subsequently adopted. If this bill
passes third reading in the house of introduction, a bill summary that
applies to the reengrossed version of this bill will be available at
http://leg.colorado.gov.)
The bill 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
HOUSE
3rd Reading Unamended
March 16, 2026
HOUSE
Amended 2nd Reading
March 13, 2026
HOUSE SPONSORSHIP
Stewart K. and Stewart R., Bacon, Brown, Clifford, Duran, Espenoza, Garcia, Hamrick,
Jackson, Joseph, Lieder, Lindsay, Marshall, McCluskie, McCormick, Phillips, Rutinel, Sirota,
Titone, Weinberg
SENATE SPONSORSHIP
Ball and Roberts,
Shading denotes HOUSE amendment. Double underlining denotes SENATE amendment.
Capital letters or bold & italic numbers indicate new material to be added to existing law.
Dashes through the words or numbers indicate deletions from existing law.
(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 bill 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.
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 bill 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.
Be it enacted by the General Assembly of the State of Colorado:1
SECTION 1. Short title. The short title of this act is the2
"Colorado Patient Access and Compounding Clarity Act".3
SECTION 2. Legislative declaration. (1) The general assembly4
finds and declares that:5
(a) Sterile and nonsterile compounded medical items are used and6
relied upon on a daily basis in hospitals, surgical centers, behavioral7
health treatment facilities, and other care settings across Colorado;8
(b) Federal standards for sterile and nonsterile compounding have9
evolved in recent years, and state law should reflect that framework to10
ensure clarity and continuity;11
(c) Modernizing Colorado's laws regarding compounding12
promotes patient safety, reduces unnecessary regulatory duplication, and13
supports uninterrupted access to essential medications; 14
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(d) Preserving the availability of high-quality compounded1
medical items is vital for Colorado patients and the providers that serve2
them; and3
(e) Federal law recognizes 2 lawful pathways for the4
compounding of human drug products under sections 503a and 503b of5
the "Federal Food, Drug, and Cosmetic Act". These provisions establish6
the framework under which licensed pharmacies and outsourcing7
facilities may prepare compounded medications in accordance with8
federal standards to meet patient needs.9
SECTION 3. In Colorado Revi sed Statutes, 12-280-120, add10
(1.5) as follows:11
12-280-120. Compounding - dispensing - sale of drugs and12
devices - rules - definition.13
(1.5) (a) I F THE ACTION IS UNDERTAKEN IN ACCORDANCE WITH14
APPLICABLE FEDERAL AND STATE LAW:15
(I) A LICENSED PERSON MAY COMPOUND A DRUG OR DEVICE IN THE16
STATE, INCLUDING THE COMPOUNDING OF A DRUG OR DEVICE IN A STERILE17
OR NONSTERILE ENVIRONMENT;18
(II) A STATE-LICENSED RESIDENT PHARMACY, LICENSED RESIDENT19
503B OUTSOURCING FACILITY, STATE-LICENSED NONRESIDENT PHARMACY,20
OR NONRESIDENT 503B OUTSOURCING FACILITY MAY SUPPLY A21
COMPOUNDED DRUG OR DEVICE TO A LICENSED HEALTH-CARE PROVIDER,22
PHARMACY, FACILITY, OR ORGANIZATION; AND23
(III) A LICENSED HEALTH-CARE PROVIDER, PHARMACY, FACILITY,24
OR ORGANIZATION MAY OBTAIN , DISPENSE , OR ADMINISTER A25
COMPOUNDED DRUG OR DEVICE SUPPLIED BY A STATE-LICENSED RESIDENT26
PHARMACY, LICENSED RESIDENT 503B OUTSOURCING FACILITY ,27
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STATE-LICENSED NONRESIDENT PHARMACY , OR NONRESIDENT 503B1
OUTSOURCING FACILITY.2
(b) I N ADOPTING RULES TO IMPLEMENT THIS SECTION OR3
OTHERWISE REGULATE THE COMPOUNDING OF DRUGS OR DEVICES IN THE4
STATE, THE BOARD SHALL NOT ADOPT RULES THAT ARE MORE RESTRICTIVE5
THAN APPLICABLE FEDERAL AND STATE LAW.6
(c) NOTHING IN THIS SECTION SHALL BE CONSTRUED TO CLASSIFY7
LAWFUL COMPOUNDING PRACTICES AS MANUFACTURING OR TO EXPAND OR8
ALTER THE BOARD 'S ENFORCEMENT AUTHORITY AS OF THE EFFECTIVE9
DATE OF THIS SUBSECTION (1.5).10
(d) THE FEDERAL LAW DESCRIBED IN THIS SECTION INCLUDES THE11
STANDARDS RECOGNIZED BY THE FDA FOR STATE -LICENSED RESIDENT12
PHARMACIES, LICENSED RESIDENT 503B OUTSOURCING FACILITIES ,13
STATE-LICENSED NONRESIDENT PHARMACIES , AND NONRESIDENT 503B14
OUTSOURCING FACILITIES , INCLUDING INCORPORATED UNITED STATES15
PHARMACOPEIA STERILE OR NONSTERILE PROCESSING STANDARDS.16
SECTION 4. In Colorado Revised Statutes, 12-280-131, amend17
(2) as follows:18
12-280-131. New drugs - when sales permissible - exemptions.19
(2) This section does not apply:20
(a) To a drug THAT IS PLAINLY LABELED TO BE FOR21
INVESTIGATIONAL USE ONLY AND THAT IS:22
(I) Intended solely for investigational use by experts qualified by23
scientific training and experience to investigate the safety and24
effectiveness of drugs; if the drug is plainly labeled to be for25
investigational use only OR26
(II) REVIEWED BY AN INSTITUTIONAL REVIEW BOARD;27
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(b) TO A COMPOUNDED DRUG OR DEVICE IF THE COMPOUNDING OF1
THE DRUG OR DEVICE IS UNDERTAKEN IN ACCORDANCE WITH APPLICABLE2
FEDERAL AND STATE LAW, INCLUDING THE STANDARDS RECOGNIZED BY3
THE FDA FOR STATE -LICENSED RESIDENT PHARMACIES , LICENSED4
RESIDENT 503B OUTSOURCING FACILITIES, STATE-LICENSED NONRESIDENT5
PHARMACIES, AND NONRESIDENT 503B OUTSOURCING FACILITIES ,6
INCLUDING INCORPORATED UNITED STATES PHARMACOPEIA STERILE OR7
NONSTERILE PROCESSING STANDARDS.8
SECTION 5. Applicability. This act applies to conduct occurring9
on or after the effective date of this act.10
SECTION 6. Safety clause. The general assembly finds,11
determines, and declares that this act is necessary for the immediate12
preservation of the public peace, health, or safety or for appropriations for13
the support and maintenance of the departments of the state and state14
institutions.15
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