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: 2026-04-10
Official status: Senate Third Reading Laid Over to 04/17/2026 - No Amendments
Effective date: Not listed

Plain English Breakdown

The official source material does not provide specific details on penalties beyond fines and license revocation.

Regulation of Compounded Weight-Loss Medication

This bill sets rules for selling, transferring, or 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 and drugs approved by the FDA when required; manufactured in compliance with FDA processes; contains pharmaceutical-grade bulk drug substances accompanied by a certificate of analysis; manufactured at an FDA-registered facility inspected within two years; verified for purity and accurate dosage.
Labels must list all active and inactive ingredients, their quantities, country of origin, and include a warning about lack of FDA approval and potential side effects.
Prohibits false or misleading claims when advertising these medications.
Requires sellers to keep records for at least two years after the medication expires and make them available for inspection by the state board of pharmacy.
Allows fines up to $1,000 per dose and license revocation for violations.

Who It Names or Affects

Pharmacies that compound weight-loss medications
Doctors who prescribe compounded weight-loss medications
Patients receiving compounded weight-loss medications

Terms To Know

Bulk Drug Substance: A substance intended for incorporation into a finished drug product to promote pharmacological activity or other direct effects in the diagnosis, cure, mitigation, treatment, or prevention of disease.
Compounded Weight-Loss Medication: A custom-made drug intended for obesity or weight management that contains an active ingredient named in a FDA-approved drug for obesity or weight management.

Limits and Unknowns

The bill does not specify the exact penalties for violations beyond fines and license revocation.
It is unclear how this regulation will impact small pharmacies that compound medications.
The effectiveness of enforcement by the state board of pharmacy and attorney general remains to be seen.

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.

Bill History

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
ENGROSSED
This Version Includes All Amendments Adopted
on Second Reading 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 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;12
(d) The safety and integrity of compounded weight-loss13
medications and their ingredients are paramount for the health and14
well-being of patients in Colorado;15
(e) Patients in Colorado deserve to have clear information16
regarding the safety of compounded weight-loss medications and their17
ingredients;18
(f) Preserving the physician-patient relationship is critical to19
health outcomes and protecting a prescriber's scope of care with20
individual patients helps to ensure the health of Coloradans; and21
(g) Therefore, the general assembly should take action to protect22
Coloradans by requiring that compounded weight-loss medications are23
sourced from FDA-registered and -inspected facilities and that those24
medications contain safe and pharmaceutical-grade ingredients.25
SECTION 2. In Colorado Revised Statutes, add 6-1-741 as26
follows:27
066-3-
6-1-741. Regulation of compounded weight-loss medication -1
prohibited conduct - labeling requirements - deceptive advertising -2
enforcement by attorney general - rules - definitions.3
(1) Definitions. AS USED IN THIS SECTION, UNLESS THE CONTEXT4
OTHERWISE REQUIRES:5
(a) (I) "BULK DRUG SUBSTANCE" OR "ACTIVE PHARMACEUTICAL6
INGREDIENT " MEANS A SUBSTANCE THAT IS INTENDED FOR7
INCORPORATION INTO A FINISHED DRUG PRODUCT AND IS INTENDED TO8
PROMOTE PHARMACOLOGICAL ACTIVITY OR OTHER DIRECT EFFECTS IN THE9
DIAGNOSIS, CURE, MITIGATION, TREATMENT, OR PREVENTION OF DISEASE10
OR TO AFFECT THE STRUCTURE OR FUNCTION OF THE BODY.11
(II) "BULK DRUG SUBSTANCE" DOES NOT INCLUDE INTERMEDIATES12
USED IN THE SYNTHESIS OF THE SUBSTANCE.13
(b) "C OMPOUNDED WEIGHT-LOSS MEDICATION" MEANS A DRUG14
THAT:15
(I) I S CREATED BY COMBINING , MIXING , OR ALTERING OTHER16
DRUGS OR BULK DRUG SUBSTANCES;17
(II) IS INTENDED TO BE USED BY HUMANS FOR OBESITY OR WEIGHT18
MANAGEMENT OR CONTAINS , OR CLAIMS TO CONTAIN , AN ACTIVE19
INGREDIENT THAT IS NAMED IN A DRUG APPROVED BY THE FDA FOR20
OBESITY OR WEIGHT MANAGEMENT; AND21
(III) IS A GLUCAGON -LIKE PEPTIDE-1 RECEPTOR AGONIST DRUG ,22
ALSO KNOWN AS A "GLP-1 DRUG".23
(c) "DRUG" HAS THE MEANING SET FORTH IN SECTION 12-280-10324
(16).25
(d) "FDA" MEANS THE FEDERAL FOOD AND DRUG26
ADMINISTRATION.27
066-4-
(2) Prohibited conduct.1
(a) A PERSON SHALL NOT ENGAGE IN THE SALE , TRANSFER , OR2
DISTRIBUTION OF A COMPOUNDED WEIGHT -LOSS MEDICATION3
COMPOUNDED UNDER SECTION 503A OF THE "FEDERAL FOOD, DRUG, AND4
COSMETIC ACT", 21 U.S.C. SEC. 353a, UNLESS THE PERSON COMPOUNDING5
THE WEIGHT-LOSS MEDICATION:6
(I) USES BULK DRUG SUBSTANCES THAT:7
(A) C OMPLY WITH THE STANDARDS OF AN APPLICABLE UNITED8
STATES PHARMACOPEIA OR NATIONAL FORMULARY MONOGRAPH , IF A9
MONOGRAPH EXISTS, AND THE UNITED STATES PHARMACOPEIA CHAPTER10
ON PHARMACY COMPOUNDING;11
(B) IF A NATIONAL FORMULARY MONOGRAPH DOES NOT EXIST, ARE12
COMPONENTS OF DRUGS APPROVED BY THE FDA; OR13
(C) IF A NATIONAL FORMULARY MONOGRAPH DOES NOT EXIST AND14
THE BULK DRUG SUBSTANCES ARE NOT COMPONENTS OF DRUGS APPROVED15
BY THE FDA, APPEAR ON THE LIST DEVELOPED BY THE SECRETARY OF THE16
FEDERAL DEPARTMENT OF HEALTH AND HUMAN SERVICES PURS UANT TO17
21 U.S.C. SEC. 353a (b)(1)(A)(i)(III);18
(II) C ONFIRMS THAT , IF A BULK DRUG SUBSTANCE IS USED IN19
ACCORDANCE WITH SUBSECTION (2)(a)(I)(B) OF THIS SECTION, THE BULK20
DRUG SUBSTANCE WAS REVIEWED AS PART OF A NEW DRUG APPLICATION21
THAT THE FDA HAS APPROVED PURSUANT TO SECTION 505 OF THE22
"FEDERAL FOOD, DRUG, AND COSMETIC ACT", 21 U.S.C. SEC. 355;23
(III) V ERIFIES THAT THE BULK DRUG SUBSTANCES IN THE24
COMPOUNDED WEIGHT -LOSS MEDICATION ARE HUMAN25
PHARMACEUTICAL-GRADE PRODUCTS;26
(IV) V ERIFIES THAT THE BULK DRUG SUBSTANCES IN THE27
066-5-
COMPOUNDED WEIGHT-LOSS MEDICATION HAVE A VALID CERTIFICATE OF1
ANALYSIS, INCLUDING THE IDENTIFICATION AND PURITY OF THOSE BULK2
DRUG SUBSTANCES AND THE IDENTIFICATION OF EACH IMPURITY BY3
CHEMICAL NAME AND AMOUNT PRESENT;4
(V) V ERIFIES THAT THE BULK DRUG SUBSTANCES IN THE5
COMPOUNDED WEIGHT -LOSS MEDICATION WERE MANUFACTURED BY A6
MANUFACTURER THAT IS REGISTERED WITH THE FDA IN ACCORDANCE7
WITH 21 U.S.C. SEC. 360; AND8
(VI) V ERIFIES THAT THE BULK DRUG SUBSTANCES IN THE9
COMPOUNDED WEIGHT -LOSS MEDICATION WERE MANUFACTURED BY A10
MANUFACTURER THAT HAS BEEN INSPECTED BY THE FDA AS A HUMAN11
DRUG ESTABLISHMENT AND THE INSPECTION CONFIRMED THAT THE12
MANUFACTURER WAS:13
(A) I N COMPLIANCE WITH CURRENT GOOD MANUFACTURING14
PRACTICE REQUIREMENTS THAT COVERED THE BULK DRUG SUBSTANCES;15
AND16
(B) C LASSIFIED AS "VOLUNTARY ACTION INDICATED " OR "NO17
ACTION INDICATED" BY THE FDA.18
(b) B EFORE A COMPOUNDED WEIGHT -LOSS MEDICATION19
CONTAINING A BULK DRUG SUBSTANCE IS OFFERED FOR SALE IN THE STATE,20
THE MANUFACTURER OR WHOLESALER OF THE COMPOUNDED WEIGHT-LOSS21
MEDICATION SHALL CONDUCT AND DOCUMENT QUALITY CONTROL TESTING22
OF THE BULK DRUG SUBSTANCE PRIOR TO USING THE BULK DRUG23
SUBSTANCE IN THE COMPOUNDED WEIGHT -LOSS MEDICATION , WHICH24
TESTING MUST CONFIRM:25
(I) THE IDENTITY AND CONTENT OF THE BULK DRUG SUBSTANCE;26
AND27
066-6-
(II) THAT ANY IMPURITIES PRESENT IN THE BULK DRUG SUBSTANCE1
ARE IDENTIFIED, CHARACTERIZED, QUANTIFIED, AND JUSTIFIED GIVEN THE2
PRODUCT AND ITS INTENDED USE.3
(c) A PERSON THAT COMPOUNDS , SELLS , DISTRIBUTES , OR4
TRANSFERS A COMPOUNDED WEIGHT-LOSS MEDICATION SHALL NOT:5
(I) DISTRIBUTE A COMPOUNDED WEIGHT-LOSS MEDICATION TO A6
PERSON WHEN THE DISTRIBUTOR IS NOT LEGALLY AUTHORIZED TO7
DISTRIBUTE OR TRANSFER THE BULK DRUG SUBSTANCES USED IN THE8
COMPOUNDED WEIGHT-LOSS MEDICATION;9
(II) D ISTRIBUTE, DISPENSE , OR ADMINISTER A COMPOUNDED10
WEIGHT-LOSS MEDICATION THAT IS COUNTERFEIT , ADULTERATED ,11
MISBRANDED, DIVERTED, OR OTHERWISE IN VIOLATION OF FEDERAL OR12
STATE LAW;13
(III) FAIL TO MAINTAIN REASONABLE SAFEGUARDS TO PREVENT14
CONTAMINATION, DIVERSION, THEFT , OR MISUSE OF THE COMPOUNDED15
WEIGHT-LOSS MEDICATION IN VIOLATION OF APPLICABLE FEDERAL OR16
STATE LAW;17
(IV) SHIP OR DISTRIBUTE FINISHED COMPOUNDED WEIGHT -LOSS18
MEDICATION OR ACTIVE PHARMACEUTICAL INGREDIENTS TO A PERSON NOT19
LEGALLY AUTHORIZED UNDER FEDERAL OR STATE LAW TO RECEIVE ,20
COMPOUND, MANUFACTURE, DISTRIBUTE, OR DISPENSE SUCH DRUGS;21
(V) MAKE A MATERIALLY FALSE OR MISLEADING REPRESENTATION22
THAT THE COMPOUNDED WEIGHT-LOSS MEDICATION IS APPROVED BY THE23
FDA WHEN THE COMPOUNDED WEIGHT -LOSS MEDICATION IS NOT24
APPROVED BY THE FDA;25
(VI) MAKE A MATERIALLY FALSE , MISLEADING, OR UNVERIFIED26
CLAIM REGARDING THE EFFICACY, SAFETY, COMPARATIVE PERFORMANCE,27
066-7-
CLINICAL OUTCOMES , OR OTHER THERAPEUTIC BENEFITS OF THE1
COMPOUNDED WEIGHT-LOSS MEDICATION; OR2
(VII) R EPRESENT DIRECTLY OR BY IMPLICATION THAT THE3
COMPOUNDED WEIGHT -LOSS MEDICATION HAS SUPERIOR EFFICACY OR4
SAFETY COMPARED TO ANOTHER MEDICALLY APPROPRIATE PRODUCT ,5
UNLESS THAT SUPERIORITY HAS BEEN DEMONSTRATED BY6
WELL-CONTROLLED CLINICAL STUDIES AND IS SUPPORTED BY COMPETENT7
SCIENTIFIC EVIDENCE.8
(3) Labeling requirements.9
(a) T HE LABEL OF A COMPOUNDED WEIGHT -LOSS MEDICATION10
MUST:11
(I) LIST EACH OF THE ACTIVE INGREDIENTS IN THE MEDICATION12
AND THE FOLLOWING INFORMATION ABOUT EACH INGREDIENT:13
(A) THE ESTABLISHED NAME OF THE INGREDIENT; AND14
(B) THE QUANTITY OR PROPORTION OF THE INGREDIENT; AND15
(II) CONTAIN THE FOLLOWING STATEMENTS, PRINTED IN A CLEAR16
AND CONSPICUOUS MANNER ON THE LABEL:17
(A) "THIS IS A COMPOUNDED DRUG. COMPOUNDED DRUGS ARE NOT18
APPROVED BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION19
AND HAVE NO EVIDENCE OF SAFETY OR EFFICACY."20
(B) "THIS ITEM IS NOT FOR RESALE."21
(b) A PERSON THAT SELLS , TRANSFERS , OR DISTRIBUTES A22
COMPOUNDED WEIGHT-LOSS MEDICATION TO A PATIENT SHALL PROVIDE23
THE PATIENT WITH THE FOLLOWING INFORMATION:24
(I) ANY SIDE EFFECTS, ADVERSE REACTIONS, CONTRAINDICATIONS,25
PRECAUTIONS, AND WARNINGS ASSOCIATED WITH THE COMPOUNDED26
WEIGHT-LOSS MEDICATION; AND27
066-8-
(II) IF A COMPOUNDED WEIGHT-LOSS MEDICATION CONTAINS AN1
ACTIVE INGREDIENT THAT IS LISTED OR IS CLAIMED TO BE THE SAME AS AN2
ACTIVE INGREDIENT IN A DRUG THAT IS APPROVED BY THE FDA, A3
SUMMARY OF THE RISK INFORMATION DESCRIBED IN SUBSECTION (3)(b)(I)4
OF THIS SECTION THAT IS ON THE LABEL OF THE FDA-APPROVED DRUG.5
(4) Deceptive advertising.6
(a) A PERSON SHALL NOT MAKE A FALSE OR MISLEADING CLAIM ,7
INCLUDING AN UNSUBSTANTIATED CLAIM , ABOUT A COMPOUNDED8
WEIGHT-LOSS MEDICATION WHEN THE PERSON IS ADVERTISING OR9
OTHERWISE PROMOTING THE COMPOUNDED WEIGHT-LOSS MEDICATION.10
(b) A CLAIM ABOUT A COMPOUNDED WEIGHT-LOSS MEDICATION IS11
CONSIDERED MISLEADING IF THE CLAIM DOES NOT INCLUDE:12
(I) A DISCLOSURE OF THE POTENTIAL SIDE EFFECTS , ADVERSE13
REACTIONS, CONTRAINDICATIONS , PRECAUTIONS , AND WARNINGS14
ASSOCIATED WITH ACTIVE INGREDIENTS IN THE COMPOUNDED15
WEIGHT-LOSS MEDICATION;16
(II) A SUMMARY OF THE SPECIFIED RISK INFORMATION FOR AN17
ACTIVE INGREDIENT OF THE COMPOUNDED WEIGHT -LOSS MEDICATION18
THAT IS LISTED OR CLAIMED TO BE THE SAME AS AN ACTIVE INGREDIENT19
IN AN FDA-APPROVED DRUG, WHICH RISK INFORMATION IS CONTAINED ON20
THE LABEL OF THE FDA-APPROVED DRUG;21
(III) A CLEAR, CONSPICUOUS STATEMENT THAT THE PRODUCT IS A22
COMPOUNDED MEDICATION, HAS NOT BEEN APPROVED BY THE FDA AND23
HAS NOT BEEN EVALUATED BY THE FDA FOR SAFETY OR EFFICACY; AND24
(IV) A DISCLOSURE OF THE ENTITIES , SUCH AS SPECIFIC25
PHARMACIES AND OUTSOURCING FACILITIES , THAT ARE USED TO26
COMPOUND THE COMPOUNDED WEIGHT-LOSS MEDICATION.27
066-9-
(5) Records and inspections.1
(a) (I) A PERSON THAT SELLS , TRANSFERS , OR DISTRIBUTES2
COMPOUNDED WEIGHT-LOSS MEDICATION SHALL MAINTAIN ALL RECORDS3
RELATED TO THE ACQUISITION, EXAMINATION, AND TESTING OF THE BULK4
DRUG SUBSTANCES USED IN THE COMPOUNDED WEIGHT-LOSS MEDICATION5
FOR AT LEAST TWO YEARS AFTER THE EXPIRATION DATE OF THE LAST LOT6
OF COMPOUNDED WEIGHT -LOSS MEDICATION CONTAINING BULK DRUG7
SUBSTANCES.8
(II) I F THE ATTORNEY GENERAL REQUESTS RECORDS FROM A9
PERSON THAT SELLS , TRANSFERS , OR DISTRIBUTES COMPOUNDED10
WEIGHT-LOSS MEDICATION, THE PERSON SHALL PROVIDE SUCH RECORDS11
TO THE ATTORNEY GENERAL WITHIN ONE BUSINESS DAY AFTER RECEIVING12
THE REQUEST OR WITHIN ANOTHER REAS ONABLE TIME FRAME AS13
DETERMINED BY THE ATTORNEY GENERAL BASED ON THE CIRCUMSTANCES14
OF THE REQUEST.15
(b) (I) T O DETERMINE COMPLIANCE WITH THIS SECTION , THE16
ATTORNEY GENERAL MAY INSPECT THE PREMISES OF A PERSON THAT17
ENGAGES IN THE COMPOUNDING OF WEIGHT-LOSS MEDICATION, INCLUDING18
A DOMESTIC SUPPLIER, WHOLESALER, REPACKAGER, OR OTHER PROVIDER19
OF BULK DRUG SUBSTANCES USED FOR COMPOUNDING WEIGHT -LOSS20
MEDICATIONS.21
(II) A PERSON THAT REFUSES TO COMPLY WITH AN INSPECTION22
CONDUCTED PURSUANT TO SUBSECTION (5)(b)(I) OF THIS SECTION IS IN23
VIOLATION OF THIS SECTION.24
(6) Enforcement.25
(a) IF THE ATTORNEY GENERAL DETERMINES THAT A PERSON HAS26
VIOLATED THIS SECTION, THE ATTORNEY GENERAL MAY:27
066-10-
(I) A SSESS A FINE IN THE AMOUNT OF UP TO ONE THOUSAND1
DOLLARS PER COMPOUND PACKAGE UNIT OR VIAL OF A COMPOUNDED2
WEIGHT-LOSS MEDICATION THAT IS SOLD, OFFERED FOR SALE, DISPENSED,3
TRANSFERRED, DISTRIBUTED, ADVERTISED, OR PROMOTED IN VIOLATION4
OF THIS SECTION; OR5
(II) PURSUE ANY OTHER REMEDY AVAILABLE UNDER THIS ARTICLE6
1.7
(b) NOTWITHSTANDING SECTION 6-1-103, THE ATTORNEY GENERAL8
HAS EXCLUSIVE AUTHORITY TO ENFORCE THIS SECTION PURSUANT TO THIS9
ARTICLE 1.10
(c) NOTWITHSTANDING ANY OTHER PROVISION OF THIS ARTICLE 1,11
NOTHING IN THIS SECTION PROVIDES THE BASIS FOR, OR IS THE SUBJECT OF,12
A PRIVATE RIGHT OF ACTION FOR A VIOLATION OF THIS SECTION.13
(7) Applicability.14
(a) THIS SECTION APPLIES ONLY TO A PERSON THAT COMPOUNDS15
MORE THAN TWENTY UNITS OF WEIGHT -LOSS DRUGS PER MONTH OR16
COMPOUNDS WEIGHT-LOSS DRUGS IN BATCHES OF MORE THAN TWENTY17
UNITS.18
(b) THIS SECTION DOES NOT APPLY TO:19
(I) T HE COMPOUNDING OF A DRUG ADMINISTERED BY A20
PRACTITIONER AT AN ENTITY LICENSED PURSUANT TO SECTION 25-1.5-10321
(1)(a)(I)(A);22
(II) A LONG -TERM CARE FACILITY , AS DEFINED IN SECTION23
12-280-103 (25);24
(III) A N ASSISTED LIVING RESIDENCE , AS DEFINED IN SECTION25
25-27-102 (1.3);26
(IV) A HOME CARE AGENCY, AS DEFINED IN SECTION 25-27.5-10227
066-11-
(3);1
(V) THE PACE PROGRAM, AS DESCRIBED IN SECTION 25.5-5-412;2
(VI) A N ADULT DAY CARE FACILITY , AS DEFINED IN SECTION3
25.5-6-303 (1); OR4
(VII) THE COMPOUNDING OF A DRUG FOR ANIMAL USE.5
SECTION 3. Applicability. This act applies to conduct occurring6
on or after the effective date of this act.7
SECTION 4. Safety clause. The general assembly finds,8
determines, and declares that this act is necessary for the immediate9
preservation of the public peace, health, or safety or for appropriations for10
the support and maintenance of the departments of the state and state11
institutions.12
066-12-