Proposed Colorado bill looks to regulate compounded GLP-1 medications

Colorado General Assembly News

Proposed Colorado bill looks to regulate compounded GLP-1 medications
Colorado House Of RepsentativesColorado Pharmacists SocietyColorado Senate
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Colorado state lawmakers are debating regulations about compounded GLP-1 medications. Senate Bill 26-066 is designed to regulate the ingredients in compounded weight loss medications.“We simply want to make sure that patients who receive GLP-1, compounded weight loss drugs, are aware of the ingredients in their drugs,” Colorado Sen.

Iman Jodeh, D-Arapahoe County, said. “What the bill aims to do is to make sure that those ingredients are coming from FDA approved suppliers.”Online, the U.S. Food and Drug Administration said it’s aware that some Americans are using unapproved versions of GLP-1 medications, including semaglutide and tirzepatide, as an option for weight loss.“This can be risky for patients, as unapproved versions do not undergo FDA’s review for safety, effectiveness and quality before they are marketed,” the website states.Sen. Jodeh is one of the bill sponsors and wanted to be clear about the objective.“I want to be really clear, we are not trying to get rid of compounding pharmacies,” Sen. Jodeh said. “We are definitely not trying to get rid of their practice. As a matter of fact, we want to make sure that they continue to compound. We protected doctors and hospitals to make sure that they can write those prescriptions for people who need to have customized GLP-1 weight loss drugs.”To understand the difference, we asked Dr. Katy Irani, a bariatric surgeon with HCA HealthOne, about the difference between a non-compounded and compounded medication.“Drugs that come from a non-compounded pharmacy, those drugs are being made in a very regulated fashion,” Dr. Irani said. “Meaning they're created to have a certain purity and composition, and then, all medications have some fillers in them. Those fillers are regulated. The doses are regulated. It's very, very strict.”When it comes to compounded medications, the regulation can vary.Here is what Legislative Chair of the Colorado Pharmacists Society Gina Moore wrote in an email:“All pharmacies and commercial manufacturers of injectable drugs conduct quality control and sterility testing before being released to a patient. In regards to efficacy, compounding pharmacies should be purchasing the source ingredient from an FDA-registered distributor. These distributors also test the active ingredients to ensure the ingredients are accurately labeled and there aren't impurities. In September of 2025, the FDA established a 'green list' to identify those manufacturers of GLP-1 source ingredients that comply with FDA standards. There have been reports of some pharmacies, med spas, and online companies selling source ingredients that may subject patients to risk. I'm not aware of any pharmacies in Colorado, but the FDA has issued warning letters to compounders in the US.”Sen. Jodeh said the bill is about balancing the medical need for compounded GLP-1s and safety.“For example, if someone has an allergic reaction to one of the ingredients and the doctor says, I need to compound a specific GLP-1 weight loss drug for you that is protected in the bill. We have quite a few carve outs for other folks that need to continue to do that,” Sen. Jodeh.State lawmakers have heard from many people who said GLP-1s have made a positive difference for them, and critics are worried this could impact access. Compounded GLP-1s are often much cheaper than name brand medications and more accessible during a shortage. Sen. Jodeh said state lawmakers took that feed back and re-worked parts of the bill.“We need to protect our patients, and there needs to be more transparency around patient safety and what our patients are consuming,” Sen. Jodeh added. “So that they can, in fact, make an informed decision for themselves if they choose to continue to take GLP-1 drugs that are not FDA approved with ingredients coming from those sources.”Another reason the proposed bill is focused on GLP-1 drugs is because of it’s popularity for both medical reasons but also the cosmetic side of it.“There's plenty of patients who come in with lower BMI who are like, I just want to get down to that high school weight,” Dr. Irani said. “And most of us are not going to prescribe medications for that, but they can get them online and things like that.”Dr. Irani also said if the medication isn’t well regulated it can impact efficacy and have side effects. She said the best way to find a good compounding pharmacy is through a health professional. Sen. Jodeh said if this passes, it would be up to the attorney general to enforce and companies found to violate the law would be fined.

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