Compounded Semaglutide: Is It Legal & Safe in 2025?

December 11, 2025
Blog
Journal

Authors

Reviewed by Dr. Rasoul Montazeri

Triple Board Certified Physician and The Founder

Niayesh Najafi

Medical student and researcher in Health Sciences

Table of contents

Overview of Compounded Semaglutide in 2025
Legal Status of Compounded Semaglutide in the US
FDA Guidance: Salt vs. Base Forms of Semaglutide
How State Regulations Affect Patient Access
Semaglutide Safety: Evaluating Compounded Products
Let’s Build Your Health Plan Together
Frequently Asked Questions

Key takeaways

Limited Use: Compounded semaglutide is only allowed for medically necessary variations when FDA-approved products are unavailable.
Safety Concerns: Compounded semaglutide is not FDA-approved, so safety, dosage, and quality can be unreliable.
State Regulations: Rules vary by state, so patients must ensure pharmacies comply with local regulations.
COA Verification: Always request a Certificate of Analysis (COA) to verify the purity, potency, and identity of the active ingredient.

Ozempic semaglutide injection pens and packaging representing FDA-approved GLP-1 therapy for diabetes and obesity, contrasted with compounded alternatives

The legal and safety framework for compounded semaglutide in 2025 continues to evolve as FDA guidance and state-level oversight expand. Although compounded formulations helped fill access gaps during the national GLP-1 shortage, these products remain unapproved and subject to strict regulatory limits. With commercial supply restored, regulators have reinforced the requirement that compounded semaglutide only be used when clinically justified and prepared by compliant 503A pharmacies.

Overview of Compounded Semaglutide in 2025

As 2025 progresses, the end of the national semaglutide shortage has significantly reduced the need for compounded alternatives. With FDA-approved products widely available again, compounding is no longer permitted for general access. Compounded semaglutide may only be considered in narrowly defined circumstances where a patient requires a formulation unavailable commercially. Patients and clinicians should rely on FDA-approved medications whenever possible, as these products have undergone full safety, efficacy, and quality review.

Legal Status of Compounded Semaglutide in the US

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), 503A pharmacies may only compound medications when an FDA-approved product is unavailable or a patient requires a medically necessary variation. Because semaglutide is no longer on the FDA Drug Shortages List, most compounding permissions have ended. Limited exceptions remain for patients with documented clinical needs, such as allergies to excipients in the commercial formulation. Economic preference or convenience does not qualify as lawful justification for compounding.

FDA Guidance: Salt vs. Base Forms of Semaglutide

Illustration explaining FDA oversight of semaglutide compounding, highlighting restrictions on salt forms and new 2025 regulatory guidance

The FDA has recently shared more information about how to use different types of semaglutide in compounded products. The FDA says pharmacies should not use semaglutide salts such as semaglutide sodium or semaglutide acetate. These salts are not the same as the active ingredient in the approved product, which contains the base form of semaglutide. The FDA has not looked at how safe these salt versions are or how well they work.

Now, the FDA says the GLP-1 drug shortage is over, and the commercially available drug can be found again. This changes the rules for compounding, because pharmacies could only make copies during the shortage. These rules go into effect in 2025. They say compounding is not meant to make drugs that closely match another approved product. Instead, there has to be a good medical reason for a patient to get a compounded version.

How State Regulations Affect Patient Access

While federal laws set basic rules, each state adds its own rules for compounding pharmacies. The board of pharmacy in each state makes and checks these rules. Some states have warned people or created limits about compounded semaglutide, so people might not get it in some situations.

Rules about compounding pharmacies can be very different depending on where you live. So, it helps to stay updated about your state. You can check your state’s board of pharmacy website or talk to a licensed pharmacist. This can help you know if compounded semaglutide is an option for your medical needs. It also lets you be sure that you will get it from someone who follows all the rules and is trusted.

Semaglutide Safety: Evaluating Compounded Products

Young woman self-injecting medication at home illustrating proper administration of GLP-1 therapies and emphasis on safety with compounded semaglutide

Your health should always be on top. That is why it is important to think about the safety of compounded products. These products from compounding pharmacies are not tested like FDA-approved drugs. This means we do not know if they are safe or work well, and this can lead to safety concerns. The side effects and right ways for drug administration may not be clear.

The risks often change based on where compounding pharmacies make the medicine. As more brand-name drugs become available, it is good to learn about the dangers that come from compounded alternatives. You need to know what signs to look for so you make sure any drug you use is safe. It also helps you stay aware of product availability and make a good choice for your health.

Major Risks of Compounded Semaglutide

Using compounded semaglutide has some potential risks that you need to talk about with your doctor. Because these products are not FDA-approved, you cannot be sure about their strength, how clean they are, or how safe they will be. This leads to big safety concerns.

If the drug administration or dosage is not right, the treatment may not work well or you may get more side effects. Some of the main risks include:

Unknown Ingredients: The product could have other active ingredients that are not listed, or it might contain different salt forms of semaglutide.
Incorrect Dosage: The amount of medicine in each dose might be higher or lower than what you need, which can change how safe or useful it is.
Contamination: If the drug is not made in a clean way, you could get an infection.
Unexpected Side Effects: The way the drug is made could bring new or worse side effects or allergic reactions compared to the approved drug.

These potential risks show why it is so key to get compounded medicines only from a pharmacy that you trust and that follows all rules.

Steps Patients Can Take to Ensure Semaglutide Safety

You can take steps to keep yourself safe when you think about using compounded semaglutide. The most helpful thing is to talk with your healthcare team. They will help you know if the compounded drug is right for your medical needs. This is very true now that drug shortage management is not such a big problem.

To keep patients safe, do these things:

Only take compounded drugs if you get a prescription from a licensed healthcare provider.
Use a pharmacy in your state that follows good quality standards.
Ask the pharmacy for a Certificate of Analysis (COA) for the active ingredient.
Share your full medical history and ask about any insurance requirements if you are looking for other options.
Never buy semaglutide from an online source if you do not have a real prescription.

Doing these things helps you use your options in a safe way and lets you make good choices about your treatment.

Why COA Verification Matters for Safety

A Certificate of Analysis, or COA, is a paper you get from a third-party lab. This shows the identity, purity, and strength of the active ingredient in drug products. For people using compounded drug products, checking the COA is a big part of being safe.

Good compounding pharmacies will give you this paper if you ask for it. This helps you and your doctor feel sure that you will get the medicine that is written on your prescription. The key reasons to ask for a COA are:

Confirms Purity: It shows that the active ingredient does not have things in it that could hurt you.
Verifies Potency: It proves that the drug has the right strength.
Guarantees Identity: It checks to be sure the correct active pharmaceutical ingredient is used (for example, the right form of semaglutide base, not an unapproved salt).

Asking to see a COA is one simple and good way to deal with safety concerns when you take compounded drug products from compounding pharmacies.

Let’s Build Your Health Plan Together

Doctor discussing semaglutide safety, regulatory updates, and personalized treatment recommendations with patient in clinical setting

Selecting the right treatment approach requires collaboration between patient and provider. While compounded semaglutide may be appropriate in rare, clinically justified situations, FDA-approved medications remain the preferred standard. Healthon clinicians evaluate each patient’s medical history, prescription needs, and access considerations to design safe, compliant, and effective weight-management plans.

Frequently Asked Questions

Does the FDA approve compounded semaglutide for weight loss in 2025?

No, the FDA does not give FDA approval to any drugs that are made by mixing or changing drugs, like compounded semaglutide for weight loss. Only the commercial product, like Wegovy, is an approved product. The FDA has checked commercial products like this to make sure they are safe and work well.

Has the semaglutide shortage resolved and how does this affect compounding legality?

Yes, the FDA says the drug shortage for semaglutide is over. Since there is now good product availability from the manufacturer, most pharmacies can no longer make copies of a commercially available drug. The law is clear about this once the drug is no longer hard to get.

What should patients look for when sourcing compounded semaglutide safely?

To keep patients safe, the semaglutide should come from a licensed and trusted 503A compounding pharmacy. You need to have a valid prescription for it. Always request COA verification to check the purity and strength of the ingredient. Talk with your provider about any possible side effects.