Compounded Semaglutide: Is It Legal & Safe in 2026

January 02, 2026
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

FDA Semaglutide Update in 2026
Compounding Rules for Semaglutide After FDA Stabilization
Semaglutide Base vs Salt: Regulation and Safety
Get Personalized Care from Healthon’s Medical Team
Frequently Asked Questions

Key takeaways

Semaglutide is no longer in FDA shortage, so special compounding allowances have ended.
Compounded semaglutide is generally not legal except in rare, patient-specific medical cases.
Only semaglutide base is FDA-approved; salt forms (e.g., semaglutide sodium) are unapproved and unsafe.
FDA-approved GLP-1 medications are now the standard of care for safety, effectiveness, and regulatory compliance.

Close-up of Ozempic semaglutide injection pen in pharmacy representing FDA-approved GLP-1 therapy contrasted with compounded alternatives

This article explains current FDA requirements, reviews risks associated with unapproved products, and outlines how patients and providers can approach semaglutide therapy responsibly.

FDA Semaglutide Update in 2026

FDA approval concept illustrating federal oversight and regulatory standards governing semaglutide compounding and patient safety

The FDA says there is no longer a shortage of semaglutide injection products like Ozempic and Wegovy. Because of this, the rules for weight loss drug products will now change. Pharmacies are not allowed to make these drugs under the old shortage rules anymore.

Latest Policy Changes and Stabilized Market Conditions

Under federal law, compounding pharmacies are not allowed to make copies of drugs that are already sold in stores. There was an exception before when the drug was on the FDA’s drug shortage list. That rule has changed now. The shortage of semaglutide is over as of early 2025, so that exception no longer works.

The Food and Drug Administration gave pharmacies some extra time, called enforcement discretion, to follow the rule.

Now, the Food and Drug Administration wants all pharmacies to follow the rules. Any pharmacy that keeps making copies of semaglutide, except in some special patient-based cases, is going against federal law and drug administration rules. They could face action from the FDA and the state board of pharmacy for not following the law or for breaking board of pharmacy rules.

Impact on Weight Loss Prescriptions and Patient Access

The end of the shortage has significantly limited access to compounded semaglutide for weight loss. Pharmacies are no longer permitted to produce copies of Wegovy or Ozempic. A prescription for a compounded version is no longer an automatic substitute for an FDA-approved brand-name medication.

The law says compounding is only allowed in certain cases and not as an everyday choice.For you, this means you have to get your prescription drugs from providers who know and follow these new rules. The main focus is now back on FDA-approved products that went through strong clinical trials to show they are safe and work well.

Compounding Rules for Semaglutide After FDA Stabilization

Illustration explaining FDA semaglutide compounding rules, including restrictions after drug shortage stabilization in 2026

With the national supply stabilized, federal compounding rules are now clearly enforced. Pharmacies may not compound copies of FDA-approved drugs when those products are commercially available. These regulations exist to protect patient safety by ensuring the use of medications that have been proven safe and effective.

Pharmacy Obligations Under 2026 Guidelines

Pharmacies must comply with stricter FDA and state board requirements following the end of the shortage. Noncompliance may result in significant legal and financial consequences, including regulatory action. Compounding is now limited to narrow, patient-specific medical needs, not cost or convenience.

Pharmacies must:

Cease production of compounded semaglutide that duplicates FDA-approved products
Dispense compounded medications only when supported by a valid, patient-specific prescription that meets Section 503A criteria

Remaining Legal Pathways for Compounded Semaglutide

Compounded semaglutide may be prescribed only in rare cases where an FDA-approved product cannot be used, such as a documented allergy to an inactive ingredient. In these situations, the compounded formulation must be meaningfully different and medically necessary, not a substitute for commercially available products.

Semaglutide Base vs Salt: Regulation and Safety

It is important to know the difference between semaglutide base and semaglutide salt forms. The FDA has approved Wegovy and Ozempic as drugs because they have semaglutide base as the active ingredient. This is the only approved drug form that the FDA has checked for how well it works and how safe it is.

Some people who make drugs have used salt forms that are not approved, like semaglutide sodium, to make their own drug substances. The FDA has said not to do this. These forms are not the same as the approved drug that uses semaglutide base as the active ingredient.

FDA Control Over Salt Forms Versus Base Ingredient

The FDA has made clear that the active ingredient in approved medications such as Wegovy and Ozempic is semaglutide in its base form. While federal compounding regulations permit the use of bulk drug substances under strict quality and sourcing standards, they do not allow substitution with a different chemical form.

Salt forms such as semaglutide sodium are chemically distinct from the approved base ingredient and have not been evaluated by the FDA for safety or effectiveness. As a result, these salt forms are not considered acceptable for compounding semaglutide.

Use of unapproved salt forms constitutes the creation of a new, unapproved drug, which violates federal regulations and introduces potential safety and efficacy risks for patients.

Approved Ingredients, Unapproved Products, and Patient Risks

Choosing an FDA-approved drug means it has gone through a lot of checks for safety and if it works well. Unapproved products, like those with different things in them such as semaglutide salts, do not give this kind of promise.

These risks are very real. If there is no real check on compounded drugs, doses can be wrong, there can be unwanted stuff in them, or they may be made where it's not clean. This puts people at a higher risk for problems, from small side effects to big health issues. The way adverse event reporting works is not as strong for these products.

Key risks of using unapproved semaglutide products include:

Unknown Ingredients: You do not know what is really in the shot.
Ineffectiveness: The product may not help you with weight loss.
Safety Dangers: There can be a risk for getting an infection, issues you did not expect, or even getting hurt badly.
Lack of Recourse: There is no strong way to report problems as there is for an approved drug.

Get Personalized Care from Healthon’s Medical Team

Doctor monitoring blood pressure while consulting a patient about safe semaglutide use and personalized weight-loss treatment planning

As regulatory oversight increases, selecting a provider that prioritizes compliance and patient safety is critical. Healthon clinicians evaluate treatment eligibility, adhere to federal and state regulations, and guide patients toward safe, evidence-based weight-management options.

With access to compounded semaglutide now highly restricted, FDA-approved GLP-1 therapies remain the standard of care for most patients. Healthon works exclusively with licensed pharmacies and provides clinician oversight to ensure prescriptions align with current FDA guidance.

For professional guidance on appropriate weight-management therapies, contact Healthon to learn more.

Frequently Asked Questions

Is Compounded Semaglutide Still Legal for Patients in the United States?

No. Now that the FDA has said the drug shortage is over, making copies of semaglutide is not allowed under federal law. People can only get these from a compound pharmacy in very few cases. This may happen if they have a strong allergy to something in the approved prescription drugs.

How Does Novanex Ensure Safety Through COA Verification at 503A Pharmacies?

Novanex makes sure all compounded drug ingredients are safe. The company does this by asking its 503A pharmacy partners for a Certificate of Analysis (COA). The COA shows what is in the drug and how pure it is. This check helps Novanex follow federal regulations for quality and safety.

Are There Any Recent FDA Safety Alerts About Compounded Semaglutide?

Yes, the FDA has given many warnings about the risks to patients from unapproved compounded semaglutide, especially ones made from salt forms. These warnings point out that there can be unknown things in these products. They say that the medicine might not work and can even lead to serious harm if it does not meet regulatory requirements.