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Key takeaways
Compounded semaglutide is an alternative formulation of brand-name semaglutide drugs such as Ozempic, Wegovy, and Rybelsus. It’s made by licensed pharmacists or physicians in compounding pharmacies.
Compounded medications can be made safely, but they also pose safety and quality risks and are not FDA approved.
People considering using compounded semaglutide should be aware there is a higher risk of side effects due to how these drugs are made and the ingredients that may be added to them.
Consumers should also know that some pharmacies use unsafe ingredients in their formulations, and many online pharmacies operate illegally, so it’s important to choose an online pharmacy carefully.
Semaglutide has become a very popular drug that’s in high demand in pharmacies everywhere and is currently also available from compounding pharmacies and online. But not all compounded semaglutide products are safe. In fact, the Food and Drug Administration (FDA) says consumers should exercise a lot of caution when considering using a compounded drug. Here’s what to know about buying semaglutide from a compounded pharmacy or online.
What is semaglutide?
Semaglutide is the active ingredient in the popular diabetes medications Ozempic and Rybelsus and the weight-loss medication Wegovy. It’s a glucagon-like peptide-1 (GLP-1) receptor agonist, which means it mimics a hormone the body naturally produces to regulate appetite and maintain healthy blood sugar levels.
Ozempic is arguably the most popular semaglutide drug, not because of its FDA-approved use for treating Type 2 diabetes but because of the amount of weight people have lost while taking it. That has led to some people taking it off-label (for a non-FDA-approved use) for weight loss—at least until the FDA approved Wegovy specifically for weight loss in 2021. The popularity of these drugs has led to shortages, which have opened up a market for compounded semaglutide.
What is compounded semaglutide?
A compounded drug is any formulation of a drug that has not been produced by its original manufacturer under an official generic or brand-name label. These drugs are often custom-made to accommodate the unique health needs of the person prescribed them. For example, if you are allergic to a nonessential ingredient in the usual manufactured formulation of a drug, you may be able to take a compounded formulation that is made without that ingredient. According to the FDA, compounded drugs need to be created by a licensed pharmacist or healthcare provider within the setting of a licensed pharmacy or other compounding facility.
Typically, the FDA doesn’t allow compounding pharmacies to make a carbon copy of an existing, available drug. There needs to be some kind of modification or alteration made. But if a drug is on the FDA’s shortages list, this restriction is often lifted to allow people to receive the medication they need. Because of periodic shortages, some compounding pharmacies have been able to create compounded semaglutide.
Difference between compounded semaglutide and Ozempic
Compounded semaglutide and Ozempic share the same active ingredient, but they aren’t the exact same drug. While Ozempic, Wegovy, and Rybelsus are all manufactured by Novo Nordisk, compounded semaglutide does not have a single manufacturer or formulation. Every compounding pharmacy makes its own version of the drug based on its access to any ingredients and equipment needed to produce it.
RELATED: Wegovy vs. Ozempic │ Rybelsus vs. Ozempic
According to Michael Lahey, MD, a physician with My Weight Loss Partner in Michigan, this difference between Ozempic and compounded semaglutide is crucial. Ozempic is not only FDA approved for the treatment of Type 2 diabetes and to reduce the risk of cardiovascular death or events such as stroke and heart attack in adults with Type 2 diabetes and cardiovascular disease, but it has also been fully tested for quality, safety, and efficacy.
Compounded semaglutide can’t be tested or FDA approved—there are far too many unique formulations of it made in compounding pharmacies across the country. For example, some compounding pharmacies sell formulations of compounded semaglutide with B12, claiming that the vitamin may boost weight loss results. This has not been proven.
Risks of compounded semaglutide
Buying compounded semaglutide may seem like a beneficial way to get around frequent Ozempic and Wegovy drug shortages and the high cost of brand-name medications. Compounded semaglutide can be made safely and in accordance with state and federal drug laws. However, the lack of oversight and accountability for facilities producing compounded versions of drugs leaves consumers vulnerable to several risks.
What the FDA says
The FDA acknowledges that compounded drugs are sometimes necessary but emphasizes that they should only be used cautiously and under the supervision of a healthcare provider since they do carry additional risks compared to brand-name and generic forms of drugs.
In July of 2024, the FDA alerted consumers to reports it had received about adverse reactions related to compounded semaglutide. Most of these involved dosing mistakes. For example, some types of compounded semaglutide come in a multi-dose vial that requires a person to measure the dose and inject themselves, and some people have accidentally taken excessive amounts of semaglutide in one dose, sometimes enough to qualify as an overdose.
The FDA also warns healthcare providers and patients about other potential pitfalls with compounded semaglutide, including concerns about the legitimacy of online compounding pharmacies, the addition of unsafe ingredients, and even warnings about counterfeit versions of the drug.
Quality concerns
By the time a drug is FDA approved, it has already undergone rigorous quality testing. But compounded semaglutide doesn’t go through the same testing process, so many healthcare providers have concerns about the integrity of these drugs. Although compounding pharmacies are subject to federal quality standards and sometimes state-based oversight, including inspections, there’s no guarantee that every pharmacy is always in compliance or producing safe, high-quality drugs.
Dr. Lahey says some of the biggest overarching quality concerns with compounded semaglutide include:
- A lack of clinical trials testing for efficacy and safety
- Variations in the quality and strength of ingredients from one pharmacy to another
- No defined system for tracking adverse events or issues with production
- Inconsistent quantities of ingredients that affect dosing and effectiveness
- Ingredient changes and possible contamination or impurities
Warnings about semaglutide salts
Some compounding pharmacies are substituting semaglutide with a similar but different form known as semaglutide salts. Semaglutide salts are not the same exact active ingredient found in Ozempic and Wegovy, and researchers don’t know enough about their safety. The FDA has explicitly told compounding pharmacies that semaglutide salts should not be used to make compounded semaglutide.
“While GLP-1 medications are indicated for diabetes treatment, weight loss, and decreasing your cardiovascular disease risk, semaglutide salts have not been proven to be safe or effective in treating these conditions,” says Katrina Mattingly, MD, obesity medicine specialist and chief medical officer of physician-supervised weight loss center Options Medical Weight Loss.
Dr. Mattingly advises consumers to be cautious of compounding pharmacies that sell semaglutide sodium or semaglutide acetate. These are semaglutide salts, and compounded products containing them are not tested for the same safety or effectiveness as FDA-approved drugs.
The dangers of online pharmacies
Online pharmacies can be a convenient way to fill your prescriptions, but they’re not without risks—especially when it comes to a popular, in-demand drug like Ozempic or Wegovy. For every legitimate online pharmacy, there are hundreds trying to make money off consumers by offering them access to drugs they might not be able to obtain otherwise, especially considering that there are no generic versions available yet. In fact, the National Association of Boards of Pharmacy (NABP) says there are an average of 40,000 online pharmacies operating illegally in the United States alone.
According to Dr. Mattingly, it’s important to:
- Research any pharmacy before filling a prescription, including checking the ingredients that will be used in your drug, looking into their quality control measures, and checking for any outstanding citations or violations.
- Check for certifications verifying their quality control and safety measures, like sterile drug manufacturing, handling, and dispensing.
- Ask for a Certificate of Analysis (COA) for the medication you would like to fill, which provides information about the integrity of active pharmaceutical ingredients.
You may also want to review the FDA’s BeSafeRx resources to further educate yourself on buying online prescriptions or use its database of state-licensed online pharmacies to make sure yours is legitimate. You can also use the NABP’s Verify Before You Buy search tool to make sure the online pharmacy you plan to use is safe and operating legally.
Reported compounded semaglutide side effects
In general, the side effects of compounded semaglutide are similar to those of Ozempic, Wegovy, and Rybelsus. For example, some of the commonly reported side effects of brand-name semaglutide and compounded semaglutide include:
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain
- Constipation
However, Dr. Lahey notes that compounded semaglutide could have additional risks, such as allergic reactions to other components that are not used in the original FDA-approved product but are added to a compounding pharmacy’s individual formulation.
Does insurance cover compounded semaglutide?
Typically, insurance companies won’t cover compounded semaglutide, so you would need to pay out of pocket. Dr. Mattingly says insurers often wait until the FDA approves a medication before agreeing to cover it, and since compounded semaglutide isn’t FDA approved, most insurers won’t provide any coverage.
However, this could change in the future. “We may see some of these compounded semaglutide versions gain FDA approval once the patents expire on the brand-name counterparts,” Dr. Mattingly says. If that occurs, some insurance companies may elect to cover one or more of those compounded versions.
Bottom line
Compounded drugs can be beneficial to people who genuinely need them, and they can be made correctly and safely. However, they also pose a risk because they may not be produced consistently, may contain unsafe ingredients, and are not FDA approved like their brand-name or generic counterparts.
But that doesn’t mean compounded semaglutide could never be an option for you. Dr. Mattingly says you should talk to your healthcare provider if you qualify for semaglutide (or currently have a prescription for it) and are having difficulty accessing it because of insurance coverage or drug shortages. The Obesity Medicine Association (OMA) has released a set of guidelines for prescribers and patients to consider when determining whether compounded semaglutide would be the best treatment option available. There are also ways to save on brand-name semaglutide, such as using SingleCare coupons.
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Sources
- Compounding and the FDA: Questions and answers, Food and Drug Administration (2024)
- Compounding when drugs are on FDA’s drug shortages list, Food and Drug Administration (2024)
- FDA alerts healthcare providers, compounders, and patients of dosing errors associated with compounded injectable semaglutide products, Food & Drug Administration (2024)
- FDA’s concerns with unapproved GLP-1 drugs used for weight loss, Food & Drug Administration (2024)
- Tactics criminals use to sell drugs online, National Association of Boards of Pharmacy (2023)
- Frequently asked questions to the 2023 Obesity Medicine Association position statement on compounded peptides: A call for action, Obesity Pillars (2024)