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Second Regular Session
Seventy-fifth General Assembly
STATE OF COLORADO
REREVISED
This Version Includes All Amendments
Adopted in the Second House
LLS NO. 26-0456.01 Sarah Lozano x3858 HOUSE BILL 26-1262
House Committees Senate Committees
Health & Human Services 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
SENATE
3rd Reading Unamended
April 17, 2026
SENATE
Amended 2nd Reading
April 16, 2026
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 BY4
LICENSED RESIDENT 503B OUTSOURCING FACILITIES OR NONRESIDENT5
503B OUTSOURCING FACILITIES IN THE STATE , THE BOARD SHALL NOT6
ADOPT RULES THAT ARE MORE RESTRICTIVE THAN APPLICABLE FEDERAL7
AND STATE LAW.8
(c) NOTHING IN THIS SECTION SHALL BE CONSTRUED TO CLASSIFY9
LAWFUL COMPOUNDING PRACTICES AS MANUFACTURING OR TO EXPAND OR10
ALTER THE BOARD 'S ENFORCEMENT AUTHORITY AS OF THE EFFECTIVE11
DATE OF THIS SUBSECTION (1.5).12
(d) THE FEDERAL LAW DESCRIBED IN THIS SECTION INCLUDES THE13
STANDARDS RECOGNIZED BY THE FDA FOR STATE -LICENSED RESIDENT14
PHARMACIES, LICENSED RESIDENT 503B OUTSOURCING FACILITIES ,15
STATE-LICENSED NONRESIDENT PHARMACIES , AND NONRESIDENT 503B16
OUTSOURCING FACILITIES , INCLUDING INCORPORATED UNITED STATES17
PHARMACOPEIA STERILE OR NONSTERILE PROCESSING STANDARDS.18
SECTION 4. In Colorado Revised Statutes, 12-280-131, amend19
(2) as follows:20
12-280-131. New drugs - when sales permissible - exemptions.21
(2) This section does not apply:22
(a) To a drug THAT IS PLAINLY LABELED TO BE FOR23
INVESTIGATIONAL USE ONLY AND THAT IS:24
(I) Intended solely for investigational use by experts qualified by25
scientific training and experience to investigate the safety and26
effectiveness of drugs; if the drug is plainly labeled to be for27
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investigational use only OR1
(II) REVIEWED BY AN INSTITUTIONAL REVIEW BOARD;2
(b) TO A COMPOUNDED DRUG OR DEVICE IF THE COMPOUNDING OF3
THE DRUG OR DEVICE IS UNDERTAKEN IN ACCORDANCE WITH APPLICABLE4
FEDERAL AND STATE LAW , INCLUDING THE STANDARDS RECOGNIZED BY5
THE FDA FOR STATE -LICENSED RESIDENT PHARMACIES , LICENSED6
RESIDENT 503B OUTSOURCING FACILITIES, STATE-LICENSED NONRESIDENT7
PHARMACIES, AND NONRESIDENT 503B OUTSOURCING FACILITIES ,8
INCLUDING INCORPORATED UNITED STATES PHARMACOPEIA STERILE OR9
NONSTERILE PROCESSING STANDARDS.10
SECTION 5. Applicability. This act applies to conduct occurring11
on or after the effective date of this act.12
SECTION 6. Safety clause. The general assembly finds,13
determines, and declares that this act is necessary for the immediate14
preservation of the public peace, health, or safety or for appropriations for15
the support and maintenance of the departments of the state and state16
institutions.17
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