If you’re considering Compounded Semaglutide to lose weight or treat Type 2 Diabetes, you may be wondering if this medication is safe compared to the branded, FDA-approved versions, Ozempic and Wegovy.
You’re right to do so. Safety is paramount when it comes to your health, and there’s a lot of confusion out there at the moment. We’ll give you a better understanding of what compounding pharmacies are, why there are safety concerns around Compounded Semaglutide, what the FDA recommends, and how to do your due diligence to make sure that the medication you’re buying online is safe.
What Is Semaglutide?
Semaglutide is part of a class of medications called glucagon-like peptide-1 (GLP-1) receptor agonists. It’s an active ingredient that works by mimicking a hormone called GLP-1, released by your gastrointestinal tract after eating. This hormone slows down how quickly your stomach empties, and helps your body produce more insulin to regulate your blood sugar levels. It also interacts with your brain to reduce appetite, making you feel fuller for longer – which helps you lose weight. [1]
There are two brand-name (non-compounded) injectable medications that have the active ingredient semaglutide: Ozempic and Wegovy.
Semaglutide has gone through rigorous testing and clinical trials for weight loss, and is only available by prescription. [2]
What Is Compounding?
Compounding is when a pharmacy combines, mixes or changes ingredients to create a medication that’s tailored to the needs of an individual patient. [3]
What Is Compounded Semaglutide?
Compounded Semaglutide means the medication is custom-made for you by a compounding pharmacy. It has the same active ingredient in it as Ozempic or Wegovy: semaglutide. However, it may also have different or extra ingredients to the more well-known, brand-name medications.
Compounded Semaglutide for weight loss will therefore not be exactly the same as Ozempic and Wegovy, but it does contain the same active ingredient. With brand-name weight loss medications, the treatment is also usually packaged in pre-filled pens that you inject yourself with. On the other hand, Compounded Semaglutide usually comes in vials and you inject it using a syringe.
Why Would Someone Choose Compounded Semaglutide Over Ozempic Or Wegovy?
For many Americans, the biggest obstacle stopping people from using Ozempic or Wegovy is the cost. Most insurance plans don’t cover them, so people will often have to pay for it themselves.
With nationwide shortages of semaglutide, and prices starting at $1300 per month for some branded versions, Compounded Semaglutide offers people a way to get access to these weight loss drugs without the need to wait, and at a much lower cost. Compared to the branded versions, Compounded Semaglutide from Levity costs just $295 every four weeks.
Before you can start taking it, you still need a prescription for Compounded Semaglutide. To see if you qualify, complete an online consultation with one of our healthcare providers today.
Is Compounded Semaglutide Safe?
Yes, Compounded Semaglutide is safe as long as it’s prepared by state-licensed compounding pharmacies that meet state requirements. Even when formulated according to federal law, semaglutide isn’t subject to FDA-approval, but Levity only works with compounding pharmacies that are LegitScript certified and regularly undergo inspections and meet the highest quality standards.
Here’s a checklist to help make sure the provider you buy from is safe:
- Prescribers are certified US-based clinicians.
- No disciplinary actions.
- Does not use salt forms of semaglutide.
- The pharmacy performs batch testing on all products to verify potency, sterility and pH levels.
How Can Patients Stay Safe, According To The FDA?
Not all compounding pharmacies in the US are compounding semaglutide. Some are “bad actors.” The FDA has recently cracked down on compounders responsible for inappropriate or illegal actions. But some are trustworthy.
So how can you tell which ones you can trust? Here’s what the FDA wants you to know.
Check the active ingredient is semaglutide, not another form
Illegal compounders may use different active ingredients or add harmful ingredients that aren’t evidence-based or recommended for the same purposes as semaglutide. They may be salt formulations called semaglutide salts, such as semaglutide sodium and semaglutide acetate. Neither of these salt forms have been shown to be safe or effective.
Make sure the bottle, packaging or vial says semaglutide and not semaglutide sodium or semaglutide acetate. What’s more, if it says “Research Use Only” or similar on the bottle, do not use it. It may be a counterfeit product.
You should only obtain drugs with a prescription from a licensed healthcare provider
Your medication should only come from state-licensed pharmacies or outsourcing facilities. You should also always be asked to meet certain requirements because companies need to do a thorough check to make sure you're eligible for a prescription. If a company is offering compounded semaglutide without a prescription or a consultation with a licensed clinician, they’re probably a “bad actor.”
Buying online from unregulated, unlicensed sources puts you at risk
Some unregulated providers may be selling unsafe products that haven’t gone through the necessary approval checks. They could give you the wrong dosing instructions, and might not meet the FDA’s rigorous quality and safety standards. [4] [5]
Are Compounding Pharmacies Legal?
Yes, compounding pharmacies are legal. They’re allowed to alter semaglutide formulations from the branded versions, so long as they operate at a state-licensed facility and follow the FDA and state requirements for quality.
Also, when a drug is on the FDA Drug Shortages List, like semaglutide, these injections can be made and distributed with fewer restrictions. [6]
Some products online aren’t legitimate. But, if you do the right research on Compounded Semaglutide before you buy it, choosing this option is safe and can be as effective as Ozempic and Wegovy.
Remember, always make sure your prescriptions are coming from a compounding pharmacy that abides by the FDA and state’s rigorous quality and safety standards. If you’re still concerned, ask your physician where they’re sending your prescriptions, so you can check your semaglutide is coming from a reliable source.
How Do I Start Compounded Semaglutide Safely?
Want to start your weight loss journey? Joining Levity gives you exclusive access to health coaching, clinical support and check-ins, a prescription from licensed US-based clinicians and monthly shipping to your door. To find out if Compounded Semaglutide or any of our other proven treatments are right for you, start a free online consultation here.
References
- Chao AM, Tronieri JS, Amaro A, Wadden TA. Clinical Insight on Semaglutide for Chronic Weight Management in Adults: Patient Selection and Special Considerations. Drug Design, Development and Therapy [Internet]. 2022 Dec;Volume 16:4449–61. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9807016/
- Singh G, Krauthamer M, Bjalme-Evans M. Wegovy (semaglutide): a new weight loss drug for chronic weight management. Journal of Investigative Medicine [Internet]. 2021 Oct 27;70(1):jim-2021-001952. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8717485/
- National Academies of Sciences E, Division H and M, Policy B on HS, Therapy C on the CU of TP with CBHR, Jackson LM, Parker RM, et al. An Overview of Compounding [Internet]. www.ncbi.nlm.nih.gov. National Academies Press (US); 2020. Available from: https://www.ncbi.nlm.nih.gov/books/NBK562881/
- Center. FDA alerts health care providers, compounders of dosing errors [Internet]. U.S. Food and Drug Administration. 2024 [cited 2024 Sep 9]. Available from: https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-patients-dosing-errors-associated-compounded
- Lambson JE, Flegal SC, Johnson AR. Administration errors of compounded semaglutide reported to a poison control center—Case series. Journal of the American Pharmacists Association [Internet]. 2023 Jun 29; Available from: https://www.sciencedirect.com/science/article/abs/pii/S1544319123002315
- FDA. Medications Containing Semaglutide Marketed for Type 2 Diabetes or Weight Loss. FDA [Internet]. 2023 May 31; Available from: https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/medications-containing-semaglutide-marketed-type-2-diabetes-or-weight-loss