What will happen to compounded semaglutide?

October 10, 2025 •

4 min read

On February 21, 2025, the U.S. Food and Drug Administration (FDA) officially declared the national shortage of Ozempic and Wegovy resolved, triggering a cascade of regulatory actions that directly impact what will happen to compounded semaglutide. This decision has led to a major crackdown on compounding pharmacies that have been producing unauthorized versions of the popular weight-loss and diabetes medication.

Quick Summary

The FDA has ended its temporary allowance for compounded semaglutide, with compounding pharmacies ceasing production of unauthorized versions. The shift means patients must transition to FDA-approved options, with compounding now limited to very specific medical needs.

Key Points

FDA ban is in effect: The FDA ended its temporary authorization for compounding semaglutide after declaring the national drug shortage over on February 21, 2025.
Limited exceptions for compounding: Compounding is now restricted to specific clinical needs, such as a patient allergy to a brand-name ingredient.
Higher safety risks: Compounded versions lack FDA review, leading to risks like inconsistent dosing, use of unapproved salt forms, impurities, and contamination.
Dosing errors are a major concern: Reports show that the use of multi-dose vials for compounded semaglutide has led to accidental overdoses, sometimes requiring hospitalization.
Patients must transition: Individuals on compounded semaglutide must consult their healthcare provider to switch to a safe, FDA-approved alternative.
Manufacturer lawsuits target compounders: Pharmaceutical companies are taking legal action against compounding pharmacies and advocating for further restrictions on compounding GLP-1 drugs.

The FDA Ban and End of the Semaglutide Shortage

For years, surging demand for FDA-approved semaglutide products, namely Ozempic (for Type 2 diabetes) and Wegovy (for weight loss), outpaced the supply, leading to a nationwide shortage. To address this public health issue, the FDA exercised enforcement discretion, allowing compounding pharmacies to produce and sell compounded versions of the drug. These compounded versions, often significantly cheaper, filled a crucial gap for patients who could not access or afford the brand-name medications.

However, the landscape changed dramatically on February 21, 2025, when the FDA announced that the semaglutide shortage was over. This move reinstated the standard regulatory framework, eliminating the emergency provision that allowed for widespread compounding. The FDA set clear deadlines for compounding pharmacies to stop producing and distributing compounded semaglutide products that are essentially copies of the approved versions. State-licensed pharmacies (503A) faced a deadline of April 22, 2025, while larger, FDA-registered outsourcing facilities (503B) had until May 22, 2025.

The Risks and Dangers of Compounded Semaglutide

The FDA's decision to end its enforcement discretion was fueled by growing safety concerns related to the unapproved compounded versions. Unlike FDA-approved medications that undergo rigorous review for safety, efficacy, and quality, compounded drugs are not subject to the same stringent standards. This lack of oversight has led to serious issues:

Use of unapproved ingredients: The FDA has warned that some compounding pharmacies have used semaglutide salt forms, such as semaglutide sodium and semaglutide acetate, instead of the approved base form. There is no scientific basis to suggest these salt forms have the same safety and effectiveness as the active ingredient in Ozempic and Wegovy.
Dosing errors: Reports have shown severe dosing errors with compounded semaglutide, sometimes resulting in patients self-administering multiple times the intended dose. This is often due to confusion over measurements and the use of multiple-dose vials, unlike the pre-filled pens of FDA-approved products.
Inconsistent potency and purity: A study by Novo Nordisk revealed that some compounded semaglutide products contained impurities as high as 33% and were not as potent as labeled. These inconsistencies can lead to unpredictable side effects or ineffective treatment.
Contamination and storage issues: Compounded products are not manufactured under the same sterile conditions as FDA-approved drugs, increasing the risk of contamination. The FDA has also noted issues with improper storage and shipping of compounded injectables, which can compromise the product's quality.

Patient Impact and Transition to Regulated Medication

For patients who have relied on compounded semaglutide, the FDA's decision means a significant change in their treatment plan. The most immediate impact is the need to transition away from compounded versions to FDA-approved alternatives. Here's what that transition entails:

Consulting a healthcare provider: Patients must speak with their doctor to develop a new treatment plan. This is crucial for managing the switch safely, addressing dosage needs, and exploring the best-approved alternative.
Increased cost barriers: With the termination of cheaper compounded options, many patients face the higher cost of branded semaglutide medications like Ozempic and Wegovy. Although manufacturers and some platforms offer savings cards and discounted programs, the financial burden can be substantial for those without sufficient insurance coverage.
Limited availability for new patients: While the shortage is officially over, new patients may still find access challenging due to high demand and the titration process required to start treatment.

Compounded vs. FDA-Approved Semaglutide: A Comparison


Feature	FDA-Approved Semaglutide (Ozempic/Wegovy)	Compounded Semaglutide
Regulation	FDA-approved; rigorous review for safety, quality, and efficacy.	Not FDA-approved; limited state-level regulation and oversight.
Ingredients	Contains only the pure, tested active ingredient, semaglutide base.	May contain different salt forms (sodium, acetate), unauthorized additives, or impurities.
Manufacturing	Produced by manufacturers like Novo Nordisk under strict, consistent quality control standards.	Made in smaller batches by compounding pharmacies with varying quality controls.
Delivery	Pre-filled, single-dose injection pens (Ozempic, Wegovy) or oral tablets (Rybelsus).	Often comes in multiple-dose vials requiring manual measurement with syringes, increasing risk of dosing errors.
Cost	High list price, though patient cost varies with insurance and savings programs.	Historically cheaper, but availability is now severely restricted.
Safety & Efficacy	Clinically tested and proven safe and effective for approved indications.	Not evaluated by the FDA; efficacy and safety cannot be guaranteed.

The Future of Compounding and GLP-1s

Compounding is not going away entirely. The practice remains legal for pharmacies to create customized medications for patients with specific medical needs that cannot be met by FDA-approved products. This could include a patient with an allergy to a dye in the branded version or a unique dosage requirement. However, a significant legal battle is brewing.

Novo Nordisk, the manufacturer of Ozempic and Wegovy, has been aggressively pursuing legal action against compounding pharmacies and clinics that market knockoff versions of their drugs. Additionally, the company has petitioned the FDA to add semaglutide to the "Demonstrable Difficulties for Compounding" (DDC) list. If successful, this petition would classify semaglutide as too complex to compound, effectively banning its compounding under nearly all circumstances. A similar petition was submitted for tirzepatide by Eli Lilly, indicating a broader industry effort to curtail compounded GLP-1s.

Conclusion: Prioritizing Patient Safety

The shift away from widespread compounded semaglutide marks a critical return to a more regulated pharmaceutical environment. While compounded versions offered a temporary, lower-cost solution, their lack of rigorous testing and oversight posed significant health risks, including dosing errors and the use of unapproved ingredients. The end of the official drug shortage has enabled the FDA to enforce stricter rules, protecting patients from potential harm associated with these unregulated products.

Patients currently using compounded semaglutide are advised to consult their healthcare provider immediately to formulate a transition plan to safe, FDA-approved alternatives. Though branded options may be more expensive, resources exist to help manage costs, and the guaranteed safety and quality are invaluable. This regulatory turn ensures that patient safety remains the paramount priority in the medication supply chain. For more detailed guidance, patients can consult official FDA resources on compounded drugs.

Note: The FDA's official position on compounded GLP-1 drugs is available on their website.

Frequently Asked Questions

The FDA restricted compounded semaglutide after determining that the national shortage of brand-name Ozempic and Wegovy was resolved. With the emergency supply issue over, the FDA could return to enforcing its standard policy that prohibits compounding drugs that are essentially copies of readily available, FDA-approved medications.

The key difference is regulatory oversight. FDA-approved versions (Ozempic, Wegovy) undergo rigorous testing for safety, quality, and efficacy. Compounded versions do not have FDA approval, meaning they are not tested for consistency, and can contain different, unapproved ingredients, including salt forms of semaglutide.

As of May 22, 2025, it is no longer legal for compounding pharmacies to produce or sell compounded semaglutide that is an 'essentially a copy' of the FDA-approved drugs. Compounding is now permitted only in very limited cases, such as when a patient has a medically documented allergy to an inactive ingredient in the brand-name product.

You should immediately schedule an appointment with your healthcare provider. They can help you develop a transition plan to switch to a safe, FDA-approved alternative like Ozempic, Wegovy, or another GLP-1 medication before your current supply runs out.

The FDA issued warnings due to reports of adverse events, including dosing errors, inconsistent potency, impurities, and the use of unapproved semaglutide salts. The agency emphasizes that compounded products pose higher risks because they lack the rigorous testing and quality control of FDA-approved drugs.

Yes, Novo Nordisk, the manufacturer of Ozempic and Wegovy, has filed numerous lawsuits against compounding pharmacies and medical spas for illegally marketing and selling compounded semaglutide. Several of these legal actions have resulted in injunctions against the defendants.

For many patients, especially those without adequate insurance coverage, the end of cheaper compounded options creates a significant financial barrier to treatment. This may disproportionately affect lower-income individuals. While patient assistance and savings programs exist, the high list price remains a concern.