Colorado Bill Regulates Compounded Weight-Loss Medications

Detected March 11th, 2026

Summary

Colorado's SB26-066 establishes regulations for compounded weight-loss medications not approved by the FDA. The bill requires specific manufacturing standards, ingredient disclosures, and patient warnings, and prohibits misleading advertising. The State Board of Pharmacy can issue fines and revoke licenses for violations.

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What changed

Colorado Senate Bill 26-066 proposes new regulations for the sale, transfer, and distribution of compounded weight-loss medications that have not received FDA approval. The bill mandates that such medications must be made from FDA-approved bulk drug substances, manufactured in compliance with FDA processes, and come from FDA-registered and inspected facilities. Labels must clearly state that the medication is not FDA-approved, lacks adequate evidence of safety and efficacy, and includes a warning about potential side effects. Additionally, providers must make specific disclosures to patients, and advertising must not contain false or misleading claims.

Entities involved in selling, transferring, or distributing these compounded medications must maintain records for at least two years past the expiration date and make them available for inspection by the state board of pharmacy. Violations can result in fines of up to $1,000 per dose, and the state board of pharmacy may revoke pharmacy or business licenses. The Colorado Attorney General is also empowered to enforce the bill as a deceptive trade practice under the Colorado Consumer Protection Act. The bill is currently in the 2026 Regular Session and is considered a draft until enacted.

What to do next

Review SB26-066 for applicability to compounded weight-loss medication sales, transfers, or distributions.
Ensure all compounded weight-loss medications meet the specified manufacturing, ingredient, and labeling requirements.
Update patient disclosure procedures and advertising practices to comply with the bill's prohibitions on false or misleading claims.

Penalties

Fines of up to $1,000 per dose and potential revocation of pharmacy or business licenses.

Source document (simplified)

SB26-066

Regulation of Compounded Weight-Loss Medication

| Type | Bill |
| --- | --- |
| Session | 2026 Regular Session |
| Subjects | Civil Law Public Health |
Concerning the regulation of compounded weight-loss medications that have not been approved by the United States food and drug administration.

Recent Bill (PDF) Recent Fiscal Note (PDF) Bill Summary:

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.)