Regulation of Compounded Weight-Loss Medication

     The bill establishes regulations for the sale, transfer, or distribution of compounded weight-loss medication, which custom-made medications that, is defined in the bill as a drug that is:

•      Created by combining, mixing, or altering other drugs or drug substances;

       

•      Intended to be used by humans for obesity or weight management and contains an active ingredient that is named in a drug approved by the federal food and drug administration (FDA); and

       

•      A glucagon-like peptide-1 receptor agonist drug, known as a 'GLP-1' drug.

Unlike mass-produced medications, a compound weight-loss medication is 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: FDA.

• 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'.

      The bill establishes that a person engages in a deceptive trade practice when the person :

• Makes a false or misleading claim about a compounded weight-loss medication when advertising or promoting the medication;
• Distributes a compounded weight-loss medication when not legally authorized to distribute or transfer the drug used in the compounded weight-loss medication;
• Makes a materially false or misleading representation that the compounded weight-loss medication is approved by the FDA when the medication is not approved by the FDA; or
• Makes a materially false, misleading, or unverified claim regarding the efficacy, safety, performance, outcomes, or benefits of the compounded weight-loss medication.

      The attorney general has exclusive authority to enforce the bill as a deceptive trade practice under the 'Colorado Consumer Protection Act'. There is no private right of action for a violation of the bill, and the provisions of the bill may only be enforced by the attorney general.

     The bill does not apply to certain facilities or in certain circumstances, including:

• The administration of a compounded weight-loss medication by a practitioner at certain hospitals, clinics, and other health facilities licensed by the department of public health and environment;
• Long term care facilities;
• Assisted living residences;
• Home care agencies;
• The program of all-inclusive care for the elderly or PACE program;
• Adult day care facilities; or
• The compounding of drugs for animal use.

(Note: Italicized words indicate new material added to the original summary; dashes through words indicate deletions from the original summary.)


(Note: This summary applies to the reengrossed version of this bill as introduced in the second house.)