SB26-066 • 2026

Regulation of Compounded Weight-Loss Medication

The bill establishes regulations for the sale, transfer, or distribution of compounded weight-loss medication, which custom-made medications that, is defined in the bill as a drug that is: Created by

Healthcare

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: 2026-05-05
Official status: House Committee on Health & Human Services Postpone Indefinitely
Effective date: Not listed

Plain English Breakdown

Using official source text because the generated explanation was unavailable or could not be confirmed against the official bill text.

Regulation of Compounded Weight-Loss Medication

The bill establishes regulations for the sale, transfer, or distribution of compounded weight-loss medication, which custom-made medications that, is defined in the bill as a drug that is: Created by combining, mixing, or altering other drugs or drug substances; Intended to be used by humans for obesity or weight management and contains an active ingredient that is named in a drug approved by the federal food and drug administration (FDA); and A glucagon-like peptide-1 receptor agonist drug, known as a 'GLP-1' drug.

What This Bill Does

The bill establishes regulations for the sale, transfer, or distribution of compounded weight-loss medication, which custom-made medications that, is defined in the bill as a drug that is: Created by combining, mixing, or altering other drugs or drug substances; Intended to be used by humans for obesity or weight management and contains an active ingredient that is named in a drug approved by the federal food and drug administration (FDA); and A glucagon-like peptide-1 receptor agonist drug, known as a 'GLP-1' drug.
Unlike mass-produced medications, a compound weight-loss medication is 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: FDA.
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.

Limits and Unknowns

This entry is temporarily using official source text because the generated explanation could not be confirmed against the official bill text during the last sync.

Amendments

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

L.003

SEN Health & Human Services

Passed [*]

Plain English: SB066_L.003 SENATE COMMITTEE OF REFERENCE AMENDMENT Committee on Health & Human Services.

SB066_L.003 SENATE COMMITTEE OF REFERENCE AMENDMENT Committee on Health & Human Services.
SB26-066 be amended as follows: 1 Amend printed bill, strike everything below the enacting clause and 2 substitute: 3 "SECTION 1.
Legislative declaration.
(1) The general 4 assembly finds and declares that: 5 (a) Compounding pharmacies play an important role in the United 6 States drug supply chain and allow patients to receive life-saving or 7 life-improving medication when the commercial market is unable to 8 support patients' needs; 9 (b) The United States food and drug administration, referred to in 10 this section as the "FDA", provides regulatory oversight and sets 11 internationally recognized standards for drug approval; however, there 12 has been an increase in the number of companies that develop, dispense, 13 and market non-FDA-approved compounded medications, notably 14 weight-loss drugs; 15 (c) Patients in Colorado are at risk of receiving compounded 16 weight-loss medications that are not approved by the FDA or are not 17 manufactured in compliance with the FDA's current good manufacturing 18 practice requirements; 19 (d) The safety and integrity of compounded weight-loss 20 medications and their ingredients are paramount for the health and 21 well-being of patients in Colorado; 22 (e) Patients in Colorado deserve to have clear information 23 regarding the safety of compounded weight-loss medications and their 24 ingredients; 25 (f) Preserving the physician-patient relationship is critical to 26 health outcomes and protecting a prescriber's scope of care with 27 individual patients helps to ensure the health of Coloradans; and 28 (g) Therefore, the general assembly should take action to protect 29 Coloradans by requiring that compounded weight-loss medications are 30 sourced from FDA-registered and -inspected facilities and that those 31 medications contain safe and pharmaceutical-grade ingredients.

L.005

SEN Health & Human Services

Passed [*]

Plain English: SB066_L.005 SENATE COMMITTEE OF REFERENCE AMENDMENT Committee on Health & Human Services.

SB066_L.005 SENATE COMMITTEE OF REFERENCE AMENDMENT Committee on Health & Human Services.
SB26-066 be amended as follows: 1 Amend proposed committee amendment (SB066_L.003), page 6, lines 11 2 and 12, strike "AS A DECEPTIVE TRADE PRACTICE".
3 Page 6, lines 15 and 16, strike "SECTION OR A VIOLATION OF THIS ARTICLE 4 1." and substitute "SECTION.".
5 Page 6, strike lines 24 through 29.

L.008

Second Reading

Passed [**]

Plain English: SB066_L.008 Amendment No.

SB066_L.008 Amendment No.
___________ SB26-066 SENATE FLOOR AMENDMENT Second Reading BY SENATOR Jodeh 1 Amend the Health and Human Services Committee Report, dated March 2 5, 2026, page 6, strike lines 37 through 43 and substitute: 3 "(7) Applicability.
4 (a) THIS SECTION APPLIES ONLY TO A PERSON THAT COMPOUNDS 5 MORE THAN TWENTY UNITS OF WEIGHT-LOSS DRUGS PER MONTH OR 6 COMPOUNDS WEIGHT-LOSS DRUGS IN BATCHES OF MORE THAN TWENTY 7 UNITS.
8 (b) THIS SECTION DOES NOT APPLY TO: 9 (I) THE COMPOUNDING OF A DRUG ADMINISTERED BY A 10 PRACTITIONER AT AN ENTITY LICENSED PURSUANT TO SECTION 25-1.5-103 11 (1)(a)(I)(A); 12 (II) A LONG-TERM CARE FACILITY, AS DEFINED IN SECTION 13 12-280-103 (25); 14 (III) AN ASSISTED LIVING RESIDENCE, AS DEFINED IN SECTION 15 25-27-102 (1.3); 16 (IV) A HOME CARE AGENCY, AS DEFINED IN SECTION 25-27.5-102 17 (3); 18 (V) THE PACE PROGRAM, AS DESCRIBED IN SECTION 25.5-5-412; 19 (VI) AN ADULT DAY CARE FACILITY, AS DEFINED IN SECTION 20 25.5-6-303 (1); OR 21 (VII) THE COMPOUNDING OF A DRUG FOR ANIMAL USE.".

L.009

Second Reading

Lost [**]

Plain English: SB066_L.009 Amendment No.

SB066_L.009 Amendment No.
___________ SB26-066 SENATE FLOOR AMENDMENT Second Reading BY SENATOR Frizell 1 Amend the Health and Human Services Committee Report, dated March 2 5, 2026, page 6, line 42, strike "OR".
3 Page 6, strike line 43 and substitute: 4 "(c) THE COMPOUNDING OF A DRUG FOR ANIMAL USE; 5 (d) A PRACTITIONER, AS DEFINED IN SECTION 12-280-103 (40), 6 WHO PRESCRIBES, ORDERS, DISPENSES, OR ADMINISTERS A COMPOUNDED 7 WEIGHT-LOSS DRUG IN THE COURSE OF PROFESSIONAL PRACTICE; OR 8 (e) A LICENSED PHARMACY, PHARMACIST, OUTSOURCING FACILITY, 9 WHOLESALER, OR DISTRIBUTOR THAT COMPOUNDS, PREPARES, DISPENSES, 10 SELLS, TRANSFERS OR DISTRIBUTES A COMPOUND WEIGHT-LOSS DRUG IN 11 SUBSTANTIAL COMPLIANCE WITH SECTION 503A OR 503B OF THE 12 "FEDERAL FOOD, DRUG, AND COSMETIC ACT", 21 U.S.C.
SECS.

L.016

Third Reading

Passed

Plain English: SB066_L.016 Amendment No.

SB066_L.016 Amendment No.
___________ SB26-066 SENATE FLOOR AMENDMENT Third Reading BY SENATOR Jodeh 1 Amend engrossed bill, page 3, strike lines 12 through 25 and substitute 2 "practice requirements; and 3 (d) Therefore, the general assembly should take action to protect 4 Coloradans by requiring that compounded weight-loss medications are 5 sourced from FDA-registered and -inspected facilities and that those 6 medications contain safe and pharmaceutical-grade ingredients.".
7 Page 4, line 2, strike "labeling requirements - deceptive advertising -".
8 Page 4, line 3, strike "rules -".

Bill History

2026-05-05 House
House Committee on Health & Human Services Postpone Indefinitely
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 medication, which
custom-made medications that,

is defined in the bill as a drug that is:

Created by combining, mixing, or altering other drugs or drug substances;

Intended to be used by humans for obesity or weight management and contains an active ingredient that is named in a drug approved by the federal food and drug administration (FDA); and

A glucagon-like peptide-1 receptor agonist drug, known as a 'GLP-1' drug.
Unlike mass-produced medications,
a compound weight-loss medication
is 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:

FDA.

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'.

The bill establishes that a person engages in a deceptive trade practice when the person
:

Makes a false or misleading claim about a compounded weight-loss medication when advertising or promoting the medication;

Distributes a compounded weight-loss medication when not legally authorized to distribute or transfer the drug used in the compounded weight-loss medication;

Makes a materially false or misleading representation that the compounded weight-loss medication is approved by the FDA when the medication is not approved by the FDA; or

Makes a materially false, misleading, or unverified claim regarding the efficacy, safety, performance, outcomes, or benefits of the compounded weight-loss medication.

The attorney general has exclusive authority to enforce the bill as a deceptive trade practice under the 'Colorado Consumer Protection Act'. There is no private right of action for a violation of the bill, and the provisions of the bill may only be enforced by the attorney general.

The bill does not apply to certain facilities or in certain circumstances, including:

The administration of a compounded weight-loss medication by a practitioner at certain hospitals, clinics, and other health facilities licensed by the department of public health and environment;

Long term care facilities;

Assisted living residences;

Home care agencies;

The program of all-inclusive care for the elderly or PACE program;

Adult day care facilities; or

The compounding of drugs for animal use.
(Note: Italicized words indicate new material added to the original summary; dashes through words indicate deletions from the original summary.)
(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. 26-0540.01 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-