SB26-066 • 2026

Regulation of Compounded Weight-Loss Medication

The bill establishes regulations for the sale, transfer, or distribution of compounded weight-loss medications, which are custom-made medications that, unlike mass-produced medications, are not subjec

Passed Legislature

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

Sponsor: Sen. J. Carson, Sen. I. Jodeh, Rep. J. Jackson
Last action: 2026-04-20
Official status: Introduced In House - Assigned to Health & Human Services
Effective date: Not listed

Plain English Breakdown

The bill summary provided does not specify all details about ingredient approval requirements.

Regulation of Compounded Weight-Loss Medication

This bill sets rules for selling and distributing custom-made weight-loss medications that are not approved by the FDA.

What This Bill Does

Requires compounded weight-loss medications to be made from ingredients approved by the FDA when needed.
Needs these medications to be manufactured in compliance with FDA processes and at facilities registered with and inspected by the FDA within two years.
Labels must list all ingredients, their quantities, origins, and include a warning about lack of FDA approval and potential side effects.
Prohibits false or misleading claims about compounded weight-loss medications when advertising them.
Requires sellers to keep records for at least two years after the medication expires.

Who It Names or Affects

People who sell, transfer, or distribute compounded weight-loss medications
Patients receiving these medications

Terms To Know

Bulk Drug Substance: A substance intended for incorporation into a finished drug product to promote pharmacological activity.
Compounded Weight-Loss Medication: A custom-made drug intended for obesity or weight management that contains an active ingredient named in an FDA-approved drug for the same purpose.

Limits and Unknowns

The bill does not apply to certain healthcare settings like long-term care facilities and assisted living residences.
It is unclear when exactly this act will take effect, as it depends on whether a referendum petition is filed against it.

Amendments

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

L.003

SEN Health & Human Services

Passed [*]

Plain English: The amendment adds new regulations for compounded weight-loss medications in Colorado to ensure they are made from FDA-registered and inspected facilities with safe ingredients.

Adds a legislative declaration stating the need for regulation of compounded weight-loss drugs due to safety concerns.
Establishes definitions for key terms such as 'bulk drug substance' and 'compounded weight-loss medication'.
Prohibits the sale, transfer, or distribution of compounded weight-loss medications unless they meet specific FDA standards and are made from ingredients that comply with certain quality control measures.

The amendment text is truncated at the end, so some details about enforcement and penalties may be missing.
Some technical terms related to drug manufacturing processes might not be fully explained for a general audience.

L.005

SEN Health & Human Services

Passed [*]

Plain English: The amendment removes references to deceptive trade practices and specific violations in the bill text.

Removes the phrase 'AS A DECEPTIVE TRADE PRACTICE' from the bill.
Strikes out a reference to a violation of this article's section and replaces it with just 'SECTION.'
Eliminates lines that describe penalties for violations.

The exact impact on enforcement or legal consequences is not clear without additional context.

L.008

Second Reading

Passed [**]

Plain English: The amendment changes the conditions under which certain regulations apply to compounded weight-loss medications.

Regulations now only apply to individuals who compound more than twenty units of weight-loss drugs per month or in batches larger than twenty units.
The amendment excludes specific entities such as long-term care facilities, assisted living residences, home care agencies, and others from these regulations.

The exact impact on practitioners administering compounded drugs at licensed entities is unclear due to technical language.

L.009

Second Reading

Lost [**]

Plain English: The amendment changes the list of entities regulated by the bill to include those who compound drugs for animals and adds specific requirements for practitioners and pharmacies that deal with compounded weight-loss medications.

Adds a new category (c) regulating the compounding of drugs for animal use.
Modifies existing categories to specify that practitioners must comply with certain federal laws when prescribing, ordering, dispensing, or administering compounded weight-loss drugs.
Updates the requirements for licensed pharmacies, pharmacists, outsourcing facilities, wholesalers, and distributors who compound, prepare, dispense, sell, transfer, or distribute compounded weight-loss drugs.

The exact nature of 'substantial compliance' with federal laws is not detailed in this amendment text.
It's unclear how the addition of animal drug compounding will affect human weight-loss medication regulations.

L.016

Third Reading

Passed

Plain English: The amendment adds requirements for compounded weight-loss medications, including sourcing from FDA-registered facilities and prohibiting false claims about their safety or effectiveness.

Adds new rules to ensure that compounded weight-loss medications are made in FDA-registered and inspected facilities using safe ingredients.
Prohibits misleading advertising and distribution of these medications by unauthorized persons.
Specifies that the Attorney General can enforce these regulations as part of existing deceptive trade practice laws.

The amendment text does not provide specific penalties for violations, which may be addressed elsewhere in the bill or future amendments.

Bill History

2026-04-20 House
Introduced In House - Assigned to Health & Human Services
2026-04-17 Senate
Senate Third Reading Passed with Amendments - Floor
2026-04-10 Senate
Senate Third Reading Laid Over to 04/17/2026 - No Amendments
2026-04-09 Senate
Senate Third Reading Laid Over to 04/10/2026 - No Amendments
2026-04-08 Senate
Senate Third Reading Laid Over to 04/09/2026 - No Amendments
2026-04-07 Senate
Senate Third Reading Laid Over to 04/08/2026 - No Amendments
2026-04-06 Senate
Senate Third Reading Laid Over to 04/07/2026 - No Amendments
2026-03-30 Senate
Senate Third Reading Laid Over to 04/06/2026 - No Amendments
2026-03-27 Senate
Senate Third Reading Laid Over to 03/30/2026 - No Amendments
2026-03-26 Senate
Senate Third Reading Laid Over to 03/27/2026 - No Amendments
2026-03-25 Senate
Senate Third Reading Laid Over to 03/26/2026 - No Amendments
2026-03-24 Senate
Senate Third Reading Laid Over to 03/25/2026 - No Amendments
2026-03-23 Senate
Senate Third Reading Laid Over to 03/24/2026 - No Amendments
2026-03-20 Senate
Senate Third Reading Laid Over to 03/23/2026 - No Amendments
2026-03-19 Senate
Senate Third Reading Laid Over to 03/20/2026 - No Amendments
2026-03-18 Senate
Senate Third Reading Laid Over to 03/19/2026 - No Amendments
2026-03-17 Senate
Senate Third Reading Laid Over to 03/18/2026 - No Amendments
2026-03-16 Senate
Senate Second Reading Passed with Amendments - Committee, Floor
2026-03-10 Senate
Senate Second Reading Laid Over to 03/16/2026 - No Amendments
2026-03-05 Senate
Senate Committee on Health & Human Services Refer Amended to Senate Committee of the Whole
2026-01-28 Senate
Introduced In Senate - Assigned to Health & Human Services

Official Summary Text

The bill establishes regulations for the sale, transfer, or distribution of compounded weight-loss medications, which are custom-made medications that, unlike mass-produced medications, are not subject to approval by the federal food and drug administration (FDA). A person may not sell, transfer, or distribute a compounded weight-loss medication unless the person confirms that the medication:
Is made from bulk drug substances and drugs that are approved by the FDA when such approval is required;
Was manufactured in compliance with FDA processes;
Contains bulk drug substances that are pharmaceutical grade and are accompanied by a certificate of analysis containing information that is material to the safety and efficacy of the bulk drug substances;
Was manufactured at a facility that is registered with the FDA and passed an FDA inspection within the previous 2 years; and
Is verified for purity and accurate dosage.
Labels for compounded weight-loss medications must list all active and inactive ingredients, the quantity of those ingredients, and the ingredients' country of origin. There must also be a warning on the label stating that the compounded weight-loss medication has not been FDA-approved, has inadequate evidence of safety or efficacy, and has known and unknown side effects. A person must also provide certain disclosures to a patient when prescribing compounded weight-loss medications.
The bill prohibits the use of false or misleading claims, including unsubstantiated claims, when advertising or promoting compounded weight-loss medications.
A person that sells, transfers, or distributes compounded weight-lost medication must keep records related to the compounded weight-loss medication for at least 2 years after the date of expiration of the compounded weight-loss medication and make those records available for inspection by the state board of pharmacy.
The state board of pharmacy may issue fines of up to $1,000 per dose of compounded weight-loss medications that are sold or distributed in violation of the bill and may revoke a pharmacy or business license for violations.
The attorney general has authority to enforce this bill as a deceptive trade practice under the "Colorado Consumer Protection Act".
(Note: This summary applies to this bill as introduced.)

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. 26-0540.01 Christopher McMichael x4775 SENATE BILL 26-066
Senate Committees House Committees
Health & Human Services
A BILL FOR AN ACT
CONCERNING THE REGULATION OF COMPOUNDED WEIGHT -LOSS101
MEDICATIONS THAT HAVE NOT BEEN APPROVED BY THE UNITED102
STATES FOOD AND DRUG ADMINISTRATION.103
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 establishes regulations for the sale, transfer, or distribution
of compounded weight-loss medications, which are custom-made
medications that, unlike mass-produced medications, are not subject to
approval by the federal food and drug administration (FDA). A person
may not sell, transfer, or distribute a compounded weight-loss medication
SENATE
Amended 3rd Reading
April 17, 2026
SENATE
Amended 2nd Reading
March 16, 2026
SENATE SPONSORSHIP
Jodeh and Carson,
HOUSE SPONSORSHIP
Jackson,
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.
unless the person confirms that the medication:
! Is made from bulk drug substances and drugs that are
approved by the FDA when such approval is required;
! Was manufactured in compliance with FDA processes;
! Contains bulk drug substances that are pharmaceutical
grade and are accompanied by a certificate of analysis
containing information that is material to the safety and
efficacy of the bulk drug substances;
! Was manufactured at a facility that is registered with the
FDA and passed an FDA inspection within the previous 2
years; and
! Is verified for purity and accurate dosage.
Labels for compounded weight-loss medications must list all
active and inactive ingredients, the quantity of those ingredients, and the
ingredients' country of origin. There must also be a warning on the label
stating that the compounded weight-loss medication has not been
FDA-approved, has inadequate evidence of safety or efficacy, and has
known and unknown side effects. A person must also provide certain
disclosures to a patient when prescribing compounded weight-loss
medications.
The bill prohibits the use of false or misleading claims, including
unsubstantiated claims, when advertising or promoting compounded
weight-loss medications.
A person that sells, transfers, or distributes compounded
weight-lost medication must keep records related to the compounded
weight-loss medication for at least 2 years after the date of expiration of
the compounded weight-loss medication and make those records available
for inspection by the state board of pharmacy.
The state board of pharmacy may issue fines of up to $1,000 per
dose of compounded weight-loss medications that are sold or distributed
in violation of the bill and may revoke a pharmacy or business license for
violations.
The attorney general has authority to enforce this bill as a
deceptive trade practice under the "Colorado Consumer Protection Act".
Be it enacted by the General Assembly of the State of Colorado:1
SECTION 1. Legislative declaration. (1) The general assembly2
finds and declares that:3
(a) Compounding pharmacies play an important role in the United4
States drug supply chain and allow patients to receive life-saving or5
066-2-
life-improving medication when the commercial market is unable to1
support patients' needs;2
(b) The United States food and drug administration, referred to in3
this section as the "FDA", provides regulatory oversight and sets4
internationally recognized standards for drug approval; however, there5
has been an increase in the number of companies that develop, dispense,6
and market non-FDA-approved compounded medications, notably7
weight-loss drugs;8
(c) Patients in Colorado are at risk of receiving compounded9
weight-loss medications that are not approved by the FDA or are not10
manufactured in compliance with the FDA's current good manufacturing11
practice requirements; and12
(d) Therefore, the general assembly should take action to protect13
Coloradans by requiring that compounded weight-loss medications are14
sourced from FDA-registered and -inspected facilities and that those15
medications contain safe and pharmaceutical-grade ingredients.16
SECTION 2. In Colorado Revised Statutes, add 6-1-741 as17
follows:18
6-1-741. Regulation of compounded weight-loss medication -19
prohibited conduct - enforcement by attorney general - 20
definitions.21
(1) Definitions. AS USED IN THIS SECTION, UNLESS THE CONTEXT22
OTHERWISE REQUIRES:23
(a) (I) "BULK DRUG SUBSTANCE" OR "ACTIVE PHARMACEUTICAL24
INGREDIENT " MEANS A SUBSTANCE THAT IS INTENDED FOR25
INCORPORATION INTO A FINISHED DRUG PRODUCT AND IS INTENDED TO26
PROMOTE PHARMACOLOGICAL ACTIVITY OR OTHER DIRECT EFFECTS IN THE27
066-3-
DIAGNOSIS, CURE, MITIGATION, TREATMENT, OR PREVENTION OF DISEASE1
OR TO AFFECT THE STRUCTURE OR FUNCTION OF THE BODY.2
(II) "BULK DRUG SUBSTANCE" DOES NOT INCLUDE INTERMEDIATES3
USED IN THE SYNTHESIS OF THE SUBSTANCE.4
(b) "C OMPOUNDED WEIGHT-LOSS MEDICATION" MEANS A DRUG5
THAT:6
(I) I S CREATED BY COMBINING , MIXING , OR ALTERING OTHER7
DRUGS OR BULK DRUG SUBSTANCES;8
(II) IS INTENDED TO BE USED BY HUMANS FOR OBESITY OR WEIGHT9
MANAGEMENT OR CONTAINS , OR CLAIMS TO CONTAIN , AN ACTIVE10
INGREDIENT THAT IS NAMED IN A DRUG APPROVED BY THE FDA FOR11
OBESITY OR WEIGHT MANAGEMENT; AND12
(III) IS A GLUCAGON -LIKE PEPTIDE-1 RECEPTOR AGONIST DRUG ,13
ALSO KNOWN AS A "GLP-1 DRUG".14
(c) "DRUG" HAS THE MEANING SET FORTH IN SECTION 12-280-10315
(16).16
(d) "FDA" MEANS THE FEDERAL FOOD AND DRUG17
ADMINISTRATION.18
(2) Prohibited conduct. A PERSON ENGAGES IN A DECEPTIVE19
TRADE PRACTICE WHEN , IN THE COURSE OF THE PERSON 'S BUSINESS ,20
VOCATION, OR OCCUPATION, THE PERSON:21
(a) M AKES A FALSE OR MISLEADING CLAIM , INCLUDING AN22
UNSUBSTANTIATED CLAIM , ABOUT A COMPOUNDED WEIGHT -LOSS23
MEDICATION WHEN THE PERSON IS ADVERTISING OR OTHERWISE24
PROMOTING THE COMPOUNDED WEIGHT-LOSS MEDICATION;25
(b) DISTRIBUTES A COMPOUNDED WEIGHT-LOSS MEDICATION TO A26
PERSON WHEN THE DISTRIBUTOR IS NOT LEGALLY AUTHORIZED TO27
066-4-
DISTRIBUTE OR TRANSFER THE BULK DRUG SUBSTANCES USED IN THE1
COMPOUNDED WEIGHT-LOSS MEDICATION;2
(c) MAKES A MATERIALLY FALSE OR MISLEADING REPRESENTATION3
THAT THE COMPOUNDED WEIGHT-LOSS MEDICATION IS APPROVED BY THE4
FDA WHEN THE COMPOUNDED WEIGHT -LOSS MEDICATION IS NOT5
APPROVED BY THE FDA; OR6
(d) M AKES A MATERIALLY FALSE , MISLEADING, OR UNVERIFIED7
CLAIM REGARDING THE EFFICACY, SAFETY, COMPARATIVE PERFORMANCE,8
CLINICAL OUTCOMES , OR OTHER THERAPEUTIC BENEFITS OF THE9
COMPOUNDED WEIGHT -LOSS MEDICATION WHEN THE PERSON IS10
ADVERTISING OR OTHERWISE PROMOTING THE COMPOUNDED WEIGHT-LOSS11
MEDICATION.12
(3) Enforcement.13
(a) P URSUANT TO SECTION 6-1-105 (1)(qqqq), THE ATTORNEY14
GENERAL MAY ENFORCE THIS SECTION AS A DECEPTIVE TRADE PRACTICE.15
16
(b) NOTWITHSTANDING SECTION 6-1-103, THE ATTORNEY GENERAL17
HAS EXCLUSIVE AUTHORITY TO ENFORCE THIS SECTION PURSUANT TO THIS18
ARTICLE 1.19
(c) NOTWITHSTANDING ANY OTHER PROVISION OF THIS ARTICLE 1,20
NOTHING IN THIS SECTION PROVIDES THE BASIS FOR, OR IS THE SUBJECT OF,21
A PRIVATE RIGHT OF ACTION FOR A VIOLATION OF THIS SECTION.22
(4) Applicability. THIS SECTION DOES NOT APPLY TO:23
(a) T HE COMPOUNDING OF A DRUG ADMINISTERED BY A24
PRACTITIONER AT AN ENTITY LICENSED PURSUANT TO SECTION 25-1.5-10325
(1)(a)(I)(A);26
(b) A LONG -TERM CARE FACILITY , AS DEFINED IN SECTION27
066-5-
12-280-103 (25);1
(c) A N ASSISTED LIVING RESIDENCE , AS DEFINED IN SECTION2
25-27-102 (1.3);3
(d) A HOME CARE AGENCY , AS DEFINED IN SECTION 25-27.5-1024
(3);5
(e) THE PACE PROGRAM, AS DESCRIBED IN SECTION 25.5-5-412;6
(f) A N ADULT DAY CARE FACILITY , AS DEFINED IN SECTION7
25.5-6-303 (1); OR8
(g) THE COMPOUNDING OF A DRUG FOR ANIMAL USE.9
SECTION 3. In Colorado Revised Statutes, 6-1-105, add10
(1)(qqqq) as follows:11
6-1-105. Unfair or deceptive trade practices - definitions.12
(1) A person engages in a deceptive trade practice when, in the13
course of the person's business, vocation, or occupation, the person:14
(qqqq) VIOLATES SECTION 6-1-741.15
SECTION 4. Act subject to petition - effective date -16
applicability. (1) This act takes effect at 12:01 a.m. on the day following17
the expiration of the ninety-day period after final adjournment of the18
general assembly (August 12, 2026, if adjournment sine die is on May 13,19
2026); except that, if a referendum petition is filed pursuant to section 120
(3) of article V of the state constitution against this act or an item, section,21
or part of this act within such period, then the act, item, section, or part22
will not take effect unless approved by the people at the general election23
to be held in November 2026 and, in such case, will take effect on the24
date of the official declaration of the vote thereon by the governor.25
(2) This act applies to conduct occurring on or after the applicable26
effective date of this act.27
066-6-