Senate Committee of Reference Report
Committee on Health & Human Services
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March 5, 2026
After consideration on the merits, the Committee recommends the following:
SB26-066 be amended as follows, and as so amended, be referred to the Committee of the Whole with favorable recommendation:
Page 1, Line 1Amend printed bill, strike everything below the enacting clause and
Page 1, Line 2substitute:
Page 1, Line 3"SECTION 1. Legislative declaration. (1) The general
Page 1, Line 4assembly finds and declares that:
Page 1, Line 5(a) Compounding pharmacies play an important role in the United
Page 1, Line 6States drug supply chain and allow patients to receive life-saving or
Page 1, Line 7life-improving medication when the commercial market is unable to
Page 1, Line 8support patients' needs;
Page 1, Line 9(b) The United States food and drug administration, referred to in
Page 1, Line 10this section as the "FDA", provides regulatory oversight and sets
Page 1, Line 11internationally recognized standards for drug approval; however, there
Page 1, Line 12has been an increase in the number of companies that develop, dispense,
Page 1, Line 13and market non-FDA-approved compounded medications, notably
Page 1, Line 14weight-loss drugs;
Page 1, Line 15(c) Patients in Colorado are at risk of receiving compounded
Page 1, Line 16weight-loss medications that are not approved by the FDA or are not
Page 1, Line 17manufactured in compliance with the FDA's current good manufacturing
Page 1, Line 18practice requirements;
Page 1, Line 19(d) The safety and integrity of compounded weight-loss
Page 1, Line 20medications and their ingredients are paramount for the health and
Page 1, Line 21well-being of patients in Colorado;
Page 1, Line 22(e) Patients in Colorado deserve to have clear information
Page 1, Line 23regarding the safety of compounded weight-loss medications and their
Page 1, Line 24ingredients;
Page 1, Line 25(f) Preserving the physician-patient relationship is critical to
Page 1, Line 26health outcomes and protecting a prescriber's scope of care with
Page 1, Line 27individual patients helps to ensure the health of Coloradans; and
Page 2, Line 1(g) Therefore, the general assembly should take action to protect
Page 2, Line 2Coloradans by requiring that compounded weight-loss medications are
Page 2, Line 3sourced from FDA-registered and -inspected facilities and that those
Page 2, Line 4medications contain safe and pharmaceutical-grade ingredients.
Page 2, Line 5SECTION 2. In Colorado Revised Statutes, add 6-1-741 as
Page 2, Line 6follows:
Page 2, Line 76-1-741. Regulation of compounded weight-loss medication -
Page 2, Line 8prohibited conduct - labeling requirements - deceptive advertising -
Page 2, Line 9enforcement by attorney general - rules - definitions.
Page 2, Line 10(1) Definitions. As used in this section, unless the context
Page 2, Line 11otherwise requires:
Page 2, Line 12(a) (I) "Bulk drug substance" or "active pharmaceutical
Page 2, Line 13ingredient" means a substance that is intended for
Page 2, Line 14incorporation into a finished drug product and is intended to
Page 2, Line 15promote pharmacological activity or other direct effects in the
Page 2, Line 16diagnosis, cure, mitigation, treatment, or prevention of disease
Page 2, Line 17or to affect the structure or function of the body.
Page 2, Line 18(II) "Bulk drug substance" does not include intermediates
Page 2, Line 19used in the synthesis of the substance.
Page 2, Line 20(b) "Compounded weight-loss medication" means a drug
Page 2, Line 21that:
Page 2, Line 22(I) Is created by combining, mixing, or altering other
Page 2, Line 23drugs or bulk drug substances;
Page 2, Line 24(II) Is intended to be used by humans for obesity or weight
Page 2, Line 25management or contains, or claims to contain, an active
Page 2, Line 26ingredient that is named in a drug approved by the FDA for
Page 2, Line 27obesity or weight management; and
Page 2, Line 28(III) Is a glucagon-like peptide-1 receptor agonist drug,
Page 2, Line 29also known as a "GLP-1 drug".
Page 2, Line 30(c) "Drug" has the meaning set forth in section 12-280-103
Page 2, Line 31(16).
Page 2, Line 32(d) "FDA" means the federal food and drug
Page 2, Line 33administration.
Page 2, Line 34(2) Prohibited conduct.
Page 2, Line 35(a) A person shall not engage in the sale, transfer, or
Page 2, Line 36distribution of a compounded weight-loss medication
Page 2, Line 37compounded under section 503A of the "Federal Food, Drug, and
Page 2, Line 38Cosmetic Act", 21 U.S.C. sec. 353a, unless the person compounding
Page 2, Line 39the weight-loss medication:
Page 2, Line 40(I) Uses bulk drug substances that:
Page 2, Line 41(A) Comply with the standards of an applicable United
Page 2, Line 42States pharmacopeia or national formulary monograph, if a
Page 2, Line 43monograph exists, and the United States pharmacopeia chapter
Page 3, Line 1on pharmacy compounding;
Page 3, Line 2(B) If a national formulary monograph does not exist, are
Page 3, Line 3components of drugs approved by the FDA; or
Page 3, Line 4(C) If a national formulary monograph does not exist and
Page 3, Line 5the bulk drug substances are not components of drugs approved
Page 3, Line 6by the FDA, appear on the list developed by the secretary of the
Page 3, Line 7federal department of health and human services pursuant to
Page 3, Line 821 U.S.C. sec. 353a (b)(1)(A)(i)(III);
Page 3, Line 9(II) Confirms that, if a bulk drug substance is used in
Page 3, Line 10accordance with subsection (2)(a)(I)(B) of this section, the bulk
Page 3, Line 11drug substance was reviewed as part of a new drug application
Page 3, Line 12that the FDA has approved pursuant to section 505 of the
Page 3, Line 13"Federal Food, Drug, and Cosmetic Act", 21 U.S.C. sec. 355;
Page 3, Line 14(III) Verifies that the bulk drug substances in the
Page 3, Line 15compounded weight-loss medication are human
Page 3, Line 16pharmaceutical-grade products;
Page 3, Line 17(IV) Verifies that the bulk drug substances in the
Page 3, Line 18compounded weight-loss medication have a valid certificate of
Page 3, Line 19analysis, including the identification and purity of those bulk
Page 3, Line 20drug substances and the identification of each impurity by
Page 3, Line 21chemical name and amount present;
Page 3, Line 22(V) Verifies that the bulk drug substances in the
Page 3, Line 23compounded weight-loss medication were manufactured by a
Page 3, Line 24manufacturer that is registered with the FDA in accordance
Page 3, Line 25with 21 U.S.C. sec. 360; and
Page 3, Line 26(VI) Verifies that the bulk drug substances in the
Page 3, Line 27compounded weight-loss medication were manufactured by a
Page 3, Line 28manufacturer that has been inspected by the FDA as a human
Page 3, Line 29drug establishment and the inspection confirmed that the
Page 3, Line 30manufacturer was:
Page 3, Line 31(A) In compliance with current good manufacturing
Page 3, Line 32practice requirements that covered the bulk drug substances;
Page 3, Line 33and
Page 3, Line 34(B) Classified as "voluntary action indicated" or "no
Page 3, Line 35action indicated" by the FDA.
Page 3, Line 36(b) Before a compounded weight-loss medication
Page 3, Line 37containing a bulk drug substance is offered for sale in the state,
Page 3, Line 38the manufacturer or wholesaler of the compounded weight-loss
Page 3, Line 39medication shall conduct and document quality control testing
Page 3, Line 40of the bulk drug substance prior to using the bulk drug
Page 3, Line 41substance in the compounded weight-loss medication, which
Page 3, Line 42testing must confirm:
Page 3, Line 43(I) The identity and content of the bulk drug substance;
Page 4, Line 1and
Page 4, Line 2(II) That any impurities present in the bulk drug substance
Page 4, Line 3are identified, characterized, quantified, and justified given the
Page 4, Line 4product and its intended use.
Page 4, Line 5(c) A person that compounds, sells, distributes, or
Page 4, Line 6transfers a compounded weight-loss medication shall not:
Page 4, Line 7(I) Distribute a compounded weight-loss medication to a
Page 4, Line 8person when the distributor is not legally authorized to
Page 4, Line 9distribute or transfer the bulk drug substances used in the
Page 4, Line 10compounded weight-loss medication;
Page 4, Line 11(II) Distribute, dispense, or administer a compounded
Page 4, Line 12weight-loss medication that is counterfeit, adulterated,
Page 4, Line 13misbranded, diverted, or otherwise in violation of federal or
Page 4, Line 14state law;
Page 4, Line 15(III) Fail to maintain reasonable safeguards to prevent
Page 4, Line 16contamination, diversion, theft, or misuse of the compounded
Page 4, Line 17weight-loss medication in violation of applicable federal or
Page 4, Line 18state law;
Page 4, Line 19(IV) Ship or distribute finished compounded weight-loss
Page 4, Line 20medication or active pharmaceutical ingredients to a person not
Page 4, Line 21legally authorized under federal or state law to receive,
Page 4, Line 22compound, manufacture, distribute, or dispense such drugs;
Page 4, Line 23(V) Make a materially false or misleading representation
Page 4, Line 24that the compounded weight-loss medication is approved by the
Page 4, Line 25FDA when the compounded weight-loss medication is not
Page 4, Line 26approved by the FDA;
Page 4, Line 27(VI) Make a materially false, misleading, or unverified
Page 4, Line 28claim regarding the efficacy, safety, comparative performance,
Page 4, Line 29clinical outcomes, or other therapeutic benefits of the
Page 4, Line 30compounded weight-loss medication; or
Page 4, Line 31(VII) Represent directly or by implication that the
Page 4, Line 32compounded weight-loss medication has superior efficacy or
Page 4, Line 33safety compared to another medically appropriate product,
Page 4, Line 34unless that superiority has been demonstrated by
Page 4, Line 35well-controlled clinical studies and is supported by competent
Page 4, Line 36scientific evidence.
Page 4, Line 37(3) Labeling requirements.
Page 4, Line 38(a) The label of a compounded weight-loss medication
Page 4, Line 39must:
Page 4, Line 40(I) List each of the active ingredients in the medication
Page 4, Line 41and the following information about each ingredient:
Page 4, Line 42(A) The established name of the ingredient; and
Page 4, Line 43(B) The quantity or proportion of the ingredient; and
Page 5, Line 1(II) Contain the following statements, printed in a clear
Page 5, Line 2and conspicuous manner on the label:
Page 5, Line 3(A) "This is a compounded drug. Compounded drugs are not
Page 5, Line 4approved by the United States Food and Drug Administration
Page 5, Line 5and have no evidence of safety or efficacy."
Page 5, Line 6(B) "This item is not for resale."
Page 5, Line 7(b) A person that sells, transfers, or distributes a
Page 5, Line 8compounded weight-loss medication to a patient shall provide
Page 5, Line 9the patient with the following information:
Page 5, Line 10(I) Any side effects, adverse reactions, contraindications,
Page 5, Line 11precautions, and warnings associated with the compounded
Page 5, Line 12weight-loss medication; and
Page 5, Line 13(II) If a compounded weight-loss medication contains an
Page 5, Line 14active ingredient that is listed or is claimed to be the same as an
Page 5, Line 15active ingredient in a drug that is approved by the FDA, a
Page 5, Line 16summary of the risk information described in subsection (3)(b)(I)
Page 5, Line 17of this section that is on the label of the FDA-approved drug.
Page 5, Line 18(4) Deceptive advertising.
Page 5, Line 19(a) A person shall not make a false or misleading claim,
Page 5, Line 20including an unsubstantiated claim, about a compounded
Page 5, Line 21weight-loss medication when the person is advertising or
Page 5, Line 22otherwise promoting the compounded weight-loss medication.
Page 5, Line 23(b) A claim about a compounded weight-loss medication is
Page 5, Line 24considered misleading if the claim does not include:
Page 5, Line 25(I) A disclosure of the potential side effects, adverse
Page 5, Line 26reactions, contraindications, precautions, and warnings
Page 5, Line 27associated with active ingredients in the compounded
Page 5, Line 28weight-loss medication;
Page 5, Line 29(II) A summary of the specified risk information for an
Page 5, Line 30active ingredient of the compounded weight-loss medication
Page 5, Line 31that is listed or claimed to be the same as an active ingredient
Page 5, Line 32in an FDA-approved drug, which risk information is contained on
Page 5, Line 33the label of the FDA-approved drug;
Page 5, Line 34(III) A clear, conspicuous statement that the product is a
Page 5, Line 35compounded medication, has not been approved by the FDA and
Page 5, Line 36has not been evaluated by the FDA for safety or efficacy; and
Page 5, Line 37(IV) A disclosure of the entities, such as specific
Page 5, Line 38pharmacies and outsourcing facilities, that are used to
Page 5, Line 39compound the compounded weight-loss medication.
Page 5, Line 40(5) Records and inspections.
Page 5, Line 41(a) (I) A person that sells, transfers, or distributes
Page 5, Line 42compounded weight-loss medication shall maintain all records
Page 5, Line 43related to the acquisition, examination, and testing of the bulk
Page 6, Line 1drug substances used in the compounded weight-loss medication
Page 6, Line 2for at least two years after the expiration date of the last lot
Page 6, Line 3of compounded weight-loss medication containing bulk drug
Page 6, Line 4substances.
Page 6, Line 5(II) If the attorney general requests records from a
Page 6, Line 6person that sells, transfers, or distributes compounded
Page 6, Line 7weight-loss medication, the person shall provide such records
Page 6, Line 8to the attorney general within one business day after receiving
Page 6, Line 9the request or within another reasonable time frame as
Page 6, Line 10determined by the attorney general based on the circumstances
Page 6, Line 11of the request.
Page 6, Line 12(b) (I) To determine compliance with this section, the
Page 6, Line 13attorney general may inspect the premises of a person that
Page 6, Line 14engages in the compounding of weight-loss medication, including
Page 6, Line 15a domestic supplier, wholesaler, repackager, or other provider
Page 6, Line 16of bulk drug substances used for compounding weight-loss
Page 6, Line 17medications.
Page 6, Line 18(II) A person that refuses to comply with an inspection
Page 6, Line 19conducted pursuant to subsection (5)(b)(I) of this section is in
Page 6, Line 20violation of this section.
Page 6, Line 21(6) Enforcement.
Page 6, Line 22(a) If the attorney general determines that a person has
Page 6, Line 23violated this section, the attorney general may:
Page 6, Line 24(I) Assess a fine in the amount of up to one thousand
Page 6, Line 25dollars per compound package unit or vial of a compounded
Page 6, Line 26weight-loss medication that is sold, offered for sale, dispensed,
Page 6, Line 27transferred, distributed, advertised, or promoted in violation
Page 6, Line 28of this section; or
Page 6, Line 29(II) Pursue any other remedy available under this article
Page 6, Line 301.
Page 6, Line 31(b) Notwithstanding section 6-1-103, the attorney general
Page 6, Line 32has exclusive authority to enforce this section pursuant to this
Page 6, Line 33article 1.
Page 6, Line 34(c) Notwithstanding any other provision of this article 1,
Page 6, Line 35nothing in this section provides the basis for, or is the subject of,
Page 6, Line 36a private right of action for a violation of this section.
Page 6, Line 37(7) Applicability. This section does not apply to:
Page 6, Line 38(a) The compounding of a drug administered by a
Page 6, Line 39practitioner at an entity licensed pursuant to section 25-1.5-103
Page 6, Line 40(1)(a)(I)(A);
Page 6, Line 41(b) A long-term care facility, as defined in section
Page 6, Line 4212-280-103 (25); or
Page 6, Line 43(c) The compounding of a drug for animal use.
Page 7, Line 1SECTION 3. Applicability. This act applies to conduct occurring
Page 7, Line 2on or after the effective date of this act.
Page 7, Line 3SECTION 4. Safety clause. The general assembly finds,
Page 7, Line 4determines, and declares that this act is necessary for the immediate
Page 7, Line 5preservation of the public peace, health, or safety or for appropriations for
Page 7, Line 6the support and maintenance of the departments of the state and state
Page 7, Line 7institutions.".