Compounded Semaglutide for Weight Loss: Is It Safe to Use?

What Is Compounded Semaglutide for Weight Loss?

Compounded semaglutide is in high demand due to the short supply of FDA-approved semaglutide medications for weight loss and diabetes. Semaglutide is a glucagon-like peptide-1 receptor agonist (GLP1-RA), which means that it increases the production of glucagon-like peptide-1, a hormone that decreases blood glucose, slows gastric emptying, and reduces appetite. Semaglutide is a medication approved for the treatment of both type 2 diabetes and obesity under different brand names and dosage formulations.¹

Certified compounding pharmacies manufacture compounded semaglutide using the drug’s active ingredient, often combining it with other vitamins, minerals, or other substances that are considered generally safe to consume.

Are Semaglutide Compounds Legal?

Certified, state-licensed compounding pharmacies can legally compound semaglutide in accordance with United States Pharmacopeia standards, using ingredients that comply with their regulations.² While mass compounding copies of commercially available drugs is not allowed, federal law does allow compounding of drugs that are on the FDA drug shortage list, as those are not considered to be commercially available.¹

In contrast, counterfeit compounded semaglutide products are increasingly common. Some illegal formulations have different (even harmful) active ingredients, are based in salts or other substances, or have unsafe delivery devices (either the needles or the delivery pen). Many of these illegal products are produced in other parts of the world by unregulated companies and are then sold online through third-party websites, bypassing all drug safeguards.

Is Compounded Semaglutide the Same as Ozempic or Wegovy?

Semaglutide is a patented product, and it currently has no FDA-approved generic version available. Ozempic and Wegovy are both brand names of injectable semaglutide, and Rybelsus is the only version of semaglutide available as an oral medication. Each one is available in different dosages and approved for different medical indications. Ozempic and Rybelsus are approved for the treatment of type 2 diabetes, and Wegovy is approved for the treatment of obesity.

Commercially available semaglutide is monitored and regulated by the FDA in the standard drug approval process. In contrast, the exact formulation of compounded semaglutide varies by the compounding pharmacy. It may be combined with other vitamins and minerals with the goal of enhancing the drug effects, or it may be developed in a different ingredient base, such as an acetate or a salt.

Testing & FDA Approval

The goal of the FDA in regulating pharmaceutical drugs is to ensure the intended benefits of the drug outweigh the potential risks it may cause. Drug approval by the FDA requires a multi-phase structured process whereby clinical data is obtained and applied to the target population.³

The clinical data obtained in the testing phases is then scrutinized for possible benefits and potential risks. Strategies are put in place to mitigate potential risks, with labeling and detection processes. Occasionally, drugs are considered for accelerated approval when they have the potential to treat life-threatening conditions or make ground-breaking impacts.

Ingredients

The lack of uniformity, quality control, and regulatory oversight of compounded drugs, compared to drugs that are commercially produced and FDA-regulated, poses significant risks. Compounded medications may have inconsistent dosages, variable efficacy, potential contamination, and altered ingredients.²

When semaglutide is compounded, the active ingredient may vary, as well as the base of the compound drug. Recent counterfeit forms of semaglutide are based on acetates and salts, which can be harmful. Illegally produced semaglutide products can have a variety of harmful ingredients, which may cause severe problems or even be fatal.

Medication Delivery & Storage

Semaglutide is available in both oral and injectable forms, but it is the injectable form that demonstrates the most significant weight loss and is in a current drug shortage. This injection is given once weekly, and the medication must be refrigerated. When semaglutide is compounded, strict attention must be given to ensure the dose is precise and accurate and the medication is safely stored.

Is Compounded Semaglutide Safe to Use for Weight Loss?

Compounded medications, including any compounded form of semaglutide, present potential dangers. The lack of uniformity, quality control, and regulatory oversight of compounded drugs, compared to commercially produced and regulated drugs, are risks that must be considered. Compounded medications can have inconsistent dosages, variable efficacy, and potential contamination.

Although some formulations are legally produced, general FDA guidance recommends not using a compound form of a drug that is commercially available, even in the instance of a drug shortage. The FDA has issued warnings against compounded forms of semaglutide, as many of them do not contain the same active ingredients as the approved semaglutide formulations.⁴ For patients who are considering the use of compounded semaglutide, it may be helpful to work closely with trusted healthcare providers and compounding pharmacists to ensure the safety, effectiveness, and consistency of the compounded form.

Risks of Compounded Semaglutide for Weight Loss

Commercially produced semaglutide is known to present many potential adverse effects. Gastrointestinal side effects are common, including nausea, vomiting, constipation, and even pancreatitis. Allergic reactions may occur in the form of rash, hives, or even anaphylaxis in rare cases. Patients with a history of thyroid carcinoma or multiple endocrine neoplasia type 2 should not take semaglutide, as it can increase the risk of medullary thyroid cancer.

With compounded semaglutide, there is a potential risk of incorrect dosing based on a lack of regulatory oversight. Illegally produced semaglutide products have been identified as well, which are much more likely to contain harmful ingredients. While commercially available semaglutide has been through the FDA phase testing and approvals for long-term safety and efficacy, compounded semaglutide does not have proven safety data.⁴

Dangers of Off-Label Use of Semaglutide

Semaglutide is a great option for some individuals, but it is not recommended for others based on individual characteristics, other health problems, medical histories, family histories, and more. It should be utilized only under the guidance of a knowledgeable, licensed healthcare practitioner when all potential side effects and benefits can be discussed and considered.

When semaglutide is used off-label in a compounded form, adverse effects are not only more likely, but they are also more likely to be dangerous or even fatal.⁵ Semaglutide requires regular monitoring of tolerance, vital signs, and laboratory testing.

Potential for Abuse & Misuse

As the incidence and biopsychosocial toll of obesity increases and it becomes increasingly more difficult to treat, more and more individuals are seeking quick weight loss solutions. Successful, lasting treatment of obesity requires a lifelong commitment to a multidisciplinary treatment plan, including diet, exercise, lifestyle modifications, treatment of other conditions, and, often, pharmacotherapy in a monitored environment. When medications for weight loss are used in an unmonitored setting, it is easy for them to be misused in attempts to achieve quick weight loss success. However, this can be dangerous and even fatal when dosages are changed and monitoring parameters are missed.

Do You Need a Prescription for Compounded Semaglutide?

For legally-made compounded semaglutide, a prescription is required. Compounding pharmacies cannot sell drugs to an individual without a prescription from a licensed healthcare practitioner. However, many online websites and other retailers selling illegally-formed semaglutide may offer it to individuals without medical prescriptions. Semaglutide made with “research peptides” or “research chemicals” are marketed as derivatives of the glucagon-like peptide-1 hormone, and their sale is marketed to licensed healthcare practitioners, although individuals can still purchase the drug.

Alternatives to Compounded Semaglutide for Weight Loss

Semaglutide is a member of the drug class called glucagon-like peptide-1 receptor agonists, which act to increase the production of glucagon-like peptide-1 in the body. There are additional drugs within this pharmaceutical class that are also FDA-approved for the same indications of type 2 diabetes and obesity.

The most similar alternatives to compounded semaglutide include the following:

• Liraglutide (Saxenda, Victoza)
• Dulaglutide (Trulicity)
• Tirzepatide (Mounjaro, Zepbound)

In addition, medications from other drug classes are also effective for the treatment of obesity and type 2 diabetes. These include oral medications like phentermine, phentermine-topiramate, bupropion-naltrexone, and others.

Prescription Weight Loss Medications

In addition to semaglutide, there are other injectable medications that treat type 2 diabetes and/or obesity. Like semaglutide, liraglutide has different dosages approved for the treatment of type 2 diabetes and obesity. However, it is given once daily, not once weekly. Dulaglutide is approved for type 2 diabetes treatment but not obesity treatment, and it is given once weekly.

Tirzepatide (brand name Mounjaro) is a new drug that is somewhat different. In addition to being a glucagon-like peptide-1 receptor agonist, it is also a gastric inhibitory peptide agonist, increasing its weight loss potential. It is also approved for the treatment of both type 2 diabetes and obesity at differing dosages.

Over-the-Counter Remedies & Supplements for Weight Loss

Pharmaceutical supplements and over-the-counter medications can help may potentially prompt weight loss. However, they can also be harmful if not used under the direction of a knowledgeable licensed health professional. Some examples include choline, caffeine, cinnamon, vitamin B12, chromium, glucomannan, green tea extract, garcinia, apple cider vinegar, conjugated linoleic acid, and orlistat.⁶

While the results on the efficacy of these supplements for weight loss are mixed, there is significant potential for adverse effects. Many of them have tolerable upper limits and substantial interactions with other medications and illnesses, so using them only under the guidance of a healthcare professional is recommended.

Lifestyle Changes for Weight Loss

Lifestyle changes are vital for weight loss success. Proper nutrition not only includes the optimal amount of calories and ratio of macronutrients, but also prioritizing whole, real foods and minimizing processed foods. Regular physical exercise is important to maintain lean body mass and metabolism. Managing chronic physical and psychosocial stress is crucial to losing weight or maintaining a healthy weight. Chronic stress affects appetite, sleep, metabolism, and more, and it has weight implications when left unchecked.

Questions to Ask Your Healthcare Team About Compounded Semaglutide

You may want to know more about compounded semaglutide, including the potential risks and benefits of using it. Here are some topics to consider at your next medical appointment.

Questions to ask your care team about compounded semaglutide include:

1. Is it safe to take semaglutide with my other medications? What about taking other medications with compounded semaglutide?
2. Is it safe to take semaglutide with my medical history and current medical conditions?
3. Would compounded semaglutide be considered a safe alternative to Wegovy, Rybelsus, or Ozempic?
4. Am I at risk for side effects from weight loss medications or supplements if I am already taking other medications, such as antidepressants?
5. If I start taking compounded semaglutide while on other medications for diabetes, will I need to adjust my medication dosages?
6. How can compounded semaglutide be safely used along with insulin?
7. What weight loss medications should I consider for fewer side effects?
8. Can compounded semaglutide be a helpful component of a weight management plan for individuals struggling with obesity, and how does it compare to commercial options?
9. What are some alternatives to compounded semaglutide?
10. How do I obtain compounded semaglutide from a trusted source?
11. Do I perform the semaglutide injections myself?
12. What other components of a healthy weight loss program should I consider?
13. How does the weight loss with oral semaglutide compare to injectable semaglutide?
14. How does compounded semaglutide compare to branded medications, such as Trulicity or Mounjaro?