What is compounded semaglutide? Is it available? Is it safe?

Key Points

• Compounded semaglutide uses the same active ingredient as Ozempic and Wegovy, but is made by specialized pharmacies
• The FDA banned compounded versions in May 2025 after declaring the Ozempic shortage resolved, with rare exceptions only for specific medical needs
• Safety risks include inconsistent dosing between batches, potential contamination, and a lack of robust clinical trial data
• Insurance rarely covers compounded versions, while brand-name medications offer manufacturer savings programs that reduce monthly costs

In early 2022, millions of people were unable to find their prescribed Ozempic and Wegovy medications anywhere. During the nearly three-year shortage that followed, specialized compounding pharmacies stepped in with an alternative. They offered the same active ingredient at lower costs.

The catch? These custom-made versions bypass the rigorous testing required by the FDA to ensure safety and consistency, but were a good alternative in a pinch. When the drug shortage ended, the FDA banned the sale of compounded semaglutide after May 2025.

This article examines what compounded semaglutide actually is, what happened during the Ozempic drug shortage, and explores available semaglutide options.

What is compounded semaglutide?

Compounded semaglutide is a custom-made version of Ozempic and Wegovy, FDA-approved semaglutide medications. Compounded drugs are mixed in specialized pharmacies using the same active ingredient found in FDA-approved medicines.

Compounded semaglutide was in high demand as an alternative option when Ozempic and Wegovy were scarce a few years ago. However, when the Ozempic shortage was resolved, the FDA restricted the availability of compounded semaglutide.

When are compounded drugs available?

1. During supply issues

The FDA permitted the sale of compounded semaglutide when there was a widespread shortage of FDA-approved versions, such as Ozempic and Wegovy. Consumer demand far exceeded what the drug manufacturer could produce.

During this time, pharmacies could offer compounded semaglutide under specific terms:

• Custom preparations could only be made during officially recognized supply disruptions
• People could gain access to compounded versions when standard retail channels could not provide approved medications

Everything changed in February 2025. The FDA announced that Ozempic and Wegovy supply problems had ended and set final deadlines for pharmacies to stop making compounded semaglutide:

• Individual pharmacy locations: Required to stop by April 22, 2025
• Commercial compounding operations: Discontinue production by May 22, 2025

So, compounded semaglutide was not available after May 22, 2025, except in exceptional medical circumstances where standard formulations are ineffective.

2. When custom doses are needed

The FDA may permit compounded semaglutide if there is a strong medical reason why you may need a dosage that is not commercially available. A healthcare provider will need to determine if you require a significantly different dose and provide a prescription accordingly.

3. To address allergies

If one of the inactive ingredients in a drug makes you break out or feel sick, you may need pharmacy-made alternatives without those problematic substances.

Compounded semaglutide vs. Ozempic, Wegovy, and Rybelsus

What’s the difference between compounded semaglutide and the commercially available versions?

The FDA-approved versions of semaglutide are based on:

• Tons of clinical studies and research on real people
• Obtaining consistent results with each dose
• Stringent quality control measures that the manufacturer must comply with
• Clear instructions for usage

Compounded versions of semaglutide:

• Are not FDA-approved
• Have a difference in quality between different pharmacies
• May not have the same mix of ingredients each time
• Do not have proof that they actually work (no validated efficacy data)

Is compounded semaglutide safe?

The FDA expresses concern over compounded drugs because they are riskier than approved formulations for a few reasons.

1. No official safety testing

Compounded semaglutide has not been tested through rigorous clinical trials. On the other hand, FDA-approved medications, like Ozempic, Wegovy, and Rybelsus, are studied in extensive clinical trials involving real patients. This extensive testing is to ensure they are effective and do not cause serious harm.

2. Unpredictable doses

The amount of medication in compounded versions can vary significantly between different batches and pharmacies. One pharmacy might make its version weaker, while another makes it stronger.

This inconsistency makes it difficult to predict how you will respond to the dosage. It can also make it difficult for your healthcare provider to adjust doses safely.

3. Contamination during manufacturing

Making medications requires extremely clean conditions and high-quality ingredients. While compounding pharmacies are also regulated, since they create custom formulations, they are not subject to the same strict production standards as pharmaceutical companies. This could lead to issues like bacterial contamination, impurities, and the use of lower-grade ingredients.

4. Experimental chemical forms

Some compounders may use modified versions of the semaglutide ingredient that differ from those in FDA-approved semaglutide. The effects of these modified versions on the human body remain uncertain, as they have not been studied in clinical trials.

5. Unclear instructions

Compounded medications can come with unclear instructions that are hard to follow. You might not know how much to take, where to inject it, or how to store it properly. Without standardized packaging and clear guidance, you may make mistakes when taking your medication.

For example, the FDA has warned of instances where people have taken five to twenty times the intended dosage of semaglutide. Some people who took incorrect doses required hospitalization.

Is compounded semaglutide cheaper than semaglutide?

Yes, compounded semaglutide may be less expensive than FDA-approved semaglutide products, like Ozempic, Wegovy, and Rybelsus. However, here's the thing: that lower price comes with risks, as these versions do not undergo the extensive safety testing and approval process that FDA-approved versions do.

The list price (without insurance) of FDA-approved semaglutide can range from $998 to $1,349 per month. You can get them for as low as $10-$25 per month if your insurance covers them and if you qualify for the drug manufacturers' savings programs.

Compounded semaglutide side effects

Compounded semaglutide versions are expected to have similar side effects to Ozempic and Wegovy, with some additional risks.

"Compounded semaglutide may carry additional risks and side effects beyond those seen with FDA-approved versions," explains Eapen, MD. "Quality can vary between different pharmacies, and some ingredients used by certain compounding facilities may not be as thoroughly studied as the formulations found in branded medications. Additionally, the FDA has issued warnings about adverse events linked to patients taking incorrect doses of compounded semaglutide, which adds another layer of concern for safety."

Semaglutide side effects include:

• Nausea
• Vomiting
• Throwing up
• Diarrhea or constipation
• Stomach pain
• Headaches and feeling tired
• Not feeling hungry

Does insurance cover compounded semaglutide?

Most of the time, insurance companies do not cover compounded semaglutide. Since the FDA restricted most compounded semaglutide versions in 2025, compounded semaglutide is no longer available (except in specific circumstances).

Government insurance, like Medicare and Medicaid, almost never covers compounded drugs.

Compounded semaglutide is typically not covered by insurance because:

• Insurance usually covers only FDA-approved medications
• You often need special approval first
• You have to prove you really need it on a case-by-case basis

If you are eligible for compounded semaglutide as a medical exception, please contact your insurance provider to learn if they will cover the cost of the compounded meds.

Final thoughts: Compounded semaglutide

Compounded semaglutide offered relief to those who needed Ozempic and Wegovy for a few years during an active shortage. However, once the supply issue was addressed, the FDA restricted the sale of compounded semaglutide, except in very specific cases for medical exceptions.

While the cost of Ozempic, Wegovy, and Rybelsus (oral semaglutide) may be high, the drug manufacturers offer savings programs for those with private or employer-sponsored insurance.

For individuals without insurance, there may be assistance programs available to help qualifying individuals access semaglutide medications at reduced costs.

In clinical trials, semaglutide was effective for weight loss and blood sugar control when combined with a nutritious diet and regular exercise. Plus, since semaglutide lowers appetite and side effects include digestive issues like nausea, vomiting, and abdominal discomfort, it is not always easy to get the proper nutrients in the diet.

A weight loss dietitian can create a custom semaglutide diet plan that works for you.

Frequently asked questions (FAQs)

What is the difference between semaglutide and compounded semaglutide?

Semaglutide is the active ingredient in FDA-approved medications such as Ozempic and Wegovy, which have undergone extensive clinical trials and regulatory review. Compounded semaglutide uses the same ingredient but is prepared by individual pharmacies without FDA approval or the same rigorous testing standards.

Is compounded semaglutide effective?

Compounded semaglutide contains the same active ingredient as FDA-approved versions, so that it may work similarly. However, since each pharmacy prepares it differently without standardized testing, there is no reliable data on its effectiveness. Results vary among users, with some reporting success while others see little benefit. The FDA recommends using approved semaglutide medications when available, as they have established safety and efficacy profiles based on clinical trials.

Can you lose weight on compounded semaglutide?

Weight loss is possible since compounded semaglutide contains the same active ingredient as Wegovy. However, results aren't guaranteed due to inconsistent quality and dosing between different compounding pharmacies. The FDA has issued warnings about hospitalizations related to dosing errors with compounded versions. For more reliable weight loss outcomes and better safety assurance, FDA-approved Wegovy is recommended when accessible through insurance coverage or patient assistance programs.

Get a personalized weight loss diet plan from a registered dietitian.

The views expressed by authors and contributors of such content are not endorsed or approved by Fay and are intended for informational purposes only. The content is reviewed by Fay only to confirm educational value and audience interest. You are encouraged to discuss any questions that you may have about your health with a healthcare provider.