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 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.)