Bill Name: Senate Bill 66 (SB 66)

Primary Sponsor: Sen. John Carson, Sen. Iman Jodeh, Rep. Jamie Jackson

Status: 03/17/2026 Senate Third Reading Laid Over to 03/18/2026

AmSpa’s Take: Compounding has been a hot button issue recently. This bill appears to be part of a national effort to regulate weight-loss medication compounding.

Analysis: Currently, in Colorado, as in most states, compounding rules are primarily directed at regulating the practice of pharmacies. These cover the practice generally. If passed, SB 66 would create special requirements for compounding pharmacies and practitioners when compounding weight-loss medication including those containing glucagon-like peptide-1s (GLP-1) such as semaglutide and tirzepatide.

SB 66 would prohibit any person or entity to sell, transfer or distribute compounded weight-loss medication unless the compounder complies with all requirements of this bill. 

These requirements include that the compounder: 

1. Use a bulk drug substance that has a monograph, is part of a Food and Drug Administration (FDA) approved drug, or appears on an FDA bulk drug substance list;
2. If the FDA approved drug labeling specifies a process for manufacturing, that the bulk drug substance followed that practice;
3. Confirms that the bulk drug substance is human pharmaceutical grade;
4. Verifies that the substance has a valid certificate of analysis;
5. Verifies that the bulk drug substance was manufactured in a establishment that is registered with the FDA; and
6. Verifies that the establishment has been inspected by the FDA and is in compliance with good manufacturing practice and has is classified as “voluntary action indicated” or “no action indicated” by the FDA.

Before a compounded weight-loss medication can be sold, the manufacturer or wholesaler must conduct and document quality control testing of the bulk drug substance including the identity of any bulk drug substance and any impurities identified. Additionally, anyone compounding, selling, distributing, or transferring compounded weight-loss medications must: 

• Not distribute the medication if not legally authorized to handle or obtain the bulk drug substances used in it.
• Not distribute, dispense, or administer a compounded weight-loss medication that is counterfeit, adulterated, misbranded, diverted, or otherwise illegal under federal or state law.
• Maintain reasonable safeguards to prevent contamination, diversion, theft, or misuse of the medication, in compliance with applicable federal/state laws.
• Not ship or distribute finished compounded weight-loss medication (or its active pharmaceutical ingredients) to anyone not legally authorized to receive, compound, manufacture, distribute, or dispense such drugs.
• Not falsely or misleadingly claim that the compounded medication is FDA-approved when it is not.
• Not make materially false, misleading, or unverified claims about the medication's efficacy, safety, comparative performance, clinical outcomes, or other therapeutic benefits.
• Not claim that the compounded medication is superior in efficacy or safety to another medically appropriate product, unless superiority is proven by well-controlled clinical studies and supported by competent scientific evidence.

Compounded weight-loss medication must contain appropriate labeling. This includes listing all active ingredients, their quality and proportion. It must also include a statement that reads: “This is a compounded drug. Compounded drugs are not approved by the United States Food and Drug Administration and have no evidence of safety or efficacy.” And that “This item is not for resale.” Patients must receive information about any side effects, contraindications, precaution, and warnings associated with the compounded weight-loss medication and a summary of the risk information if it includes an active ingredient present in an FDA approved drug.

SB 66 also requires that all advertisements of weight-loss medication must be truthful and not misleading. In this case, this means that it includes any unsupported claims about the product. Advertisements are also misleading unless they include all of the following:  

• Disclosure of potential side effects, adverse reactions, contraindications, precautions, and warnings related to the active ingredients in the compounded medication, including any identified through clinical trials, research, or other appropriate sources.  
• A summary of specific risk information from the label of any FDA-approved drug when the compounded medication contains an active ingredient found in such an approved drug.  
• A clear and noticeable statement that the product is a compounded medication, has not been approved by the FDA, and has not been evaluated by the FDA for safety or effectiveness.
• A disclosure of the specific pharmacies and outsourcing facilities that are used to compound the weight-loss medication.

Practices that sell, transfer, or distribute compounded weight-loss medication must maintain all records related to the medications for at least 2 years after the expiration date of the medication. These records must be provided to the attorney general upon request and within one business day. Enforcement penalties can include a fine of up to $1,000 per compound package unit or any other remedy provided under current law.  

Multiple states have introduced similar bills aimed at more closely regulating compounding of medications specifically for weight-loss medications. If you would like additional information, to read the language of this bill or to contact the sponsors or committee, you can find the information you need through here: SB 66.