Why is compounded tirzepatide banned? Understanding the FDA's action and safety concerns

October 11, 2025 •

4 min read

Following hundreds of adverse event reports linked to unregulated versions, the U.S. Food and Drug Administration (FDA) implemented a ban on compounded tirzepatide, effectively restricting its production and sale. This pivotal decision was triggered by the resolution of the national drug shortage for FDA-approved tirzepatide products, Mounjaro and Zepbound.

Quick Summary

The FDA banned compounded tirzepatide because the official drug shortage has ended and due to major safety concerns. Unlike FDA-approved versions, compounded products lack regulatory oversight and have been linked to health risks from dosing errors, contamination, and unapproved ingredients.

Key Points

End of Shortage: The ban was enforced after the FDA declared the national shortage of FDA-approved tirzepatide products resolved in late 2024.
No FDA Approval: Compounded tirzepatide never received FDA approval, meaning it was not evaluated for safety, efficacy, or quality standards.
Safety Risks: Health risks include contamination, inconsistent potency, dosage errors from multi-dose vials, and the use of unapproved ingredients or salt forms.
Adverse Event Reports: The FDA received numerous adverse event reports, including serious issues and hospitalizations, linked to compounded versions.
Return to Standard Regulations: With brand-name products now readily available, the FDA reverted to standard regulations prohibiting the compounding of copies.
Patient Impact: The ban requires patients who used cheaper compounded versions to switch to more expensive, FDA-approved brand-name versions.

The End of the Drug Shortage and FDA Authority

Compounding pharmacies were initially permitted to produce compounded versions of tirzepatide, the active ingredient in the brand-name medications Mounjaro and Zepbound, to address a critical supply shortage. The FDA has specific provisions that allow for compounding when an approved drug is listed on the agency’s official shortage list. During 2022 and 2023, high demand led to widespread shortages, prompting many patients to seek more affordable, compounded options.

However, in late 2024, the FDA declared that the shortages for tirzepatide had been resolved, with the manufacturer, Eli Lilly, increasing production to meet demand. This declaration removed the legal justification for compounding pharmacies to continue producing what the FDA considers “essentially copies” of the commercially available, FDA-approved drugs. The FDA set specific deadlines for compounding pharmacies to cease production, with final court rulings upholding the agency's decision in early 2025. Cost is not considered a valid reason for compounding a drug that is commercially available.

Significant Health and Safety Concerns

Beyond the resolved shortage, a primary driver for the FDA's enforcement action was the increasing number of health and safety issues associated with compounded versions. Unlike FDA-approved medications, compounded drugs do not undergo the same rigorous testing for safety, effectiveness, and quality.

Inconsistent Quality and Contamination

Unverified Active Pharmaceutical Ingredients: The FDA is concerned that some compounding pharmacies may have used unverified or unauthorized active pharmaceutical ingredients (APIs), including potentially impure or foreign-made substances.
Unauthorized Ingredients: Many compounded tirzepatide products contained ingredients not found in the FDA-approved versions, such as vitamin B12. The safety and effectiveness of these additives in combination with tirzepatide have not been clinically evaluated.
Use of Different Salt Forms: Some compounders were found to use different salt forms of tirzepatide, which are not the same as the active ingredient in the approved drugs, with unknown properties.
Counterfeit Products: The market for compounded versions also saw a rise in counterfeit drugs sold illegally online. These products could contain incorrect or harmful ingredients, or no active ingredient at all.

Dosage Errors and Adverse Events

The FDA received hundreds of reports of adverse events from compounded GLP-1 drugs, including tirzepatide. Many incidents were linked to dosing errors, as compounded products often came in multi-dose vials rather than the precise, single-use pens of FDA-approved versions. This made self-administration challenging and led to potentially dangerous overdoses, causing severe side effects such as:

Nausea and vomiting
Diarrhea and dehydration
Hypoglycemia (low blood sugar)
Hospitalization in severe cases

The Legal and Regulatory Framework

FDA-approved drugs undergo an extensive and expensive review process to prove they are safe and effective. The FDA also regulates the manufacturing facilities to ensure quality and consistency. Compounded drugs, by contrast, are custom-made for individual patients and do not go through this same premarket review.

Compounding is meant for situations where a specific medical need cannot be met by an FDA-approved drug, such as an allergy to an inactive ingredient. The temporary permission granted during the tirzepatide shortage was an exception to the rule against compounding copies of available medications. With the shortage resolved, that exception was rescinded.

Several legal challenges from compounding pharmacies sought to overturn the FDA’s decision, arguing that the shortage was not fully over or that their products were sufficiently different. However, the courts have consistently sided with the FDA, reinforcing its authority to regulate the drug supply. Furthermore, the manufacturer, Eli Lilly, has taken legal action against entities selling unregulated, compounded versions.

Comparison Table: Compounded vs. FDA-Approved Tirzepatide


Feature	FDA-Approved Tirzepatide (Mounjaro, Zepbound)	Compounded Tirzepatide (Banned)
Regulatory Status	FDA-approved for safety, efficacy, and quality.	Not FDA-approved or reviewed for safety and efficacy.
Manufacturing Oversight	Subject to rigorous FDA inspection and quality control.	Subject to state-level pharmacy board regulations, with less oversight.
Ingredients	Standardized, verified, and consistent active and inactive ingredients.	Potentially variable, including unapproved salt forms or additives.
Dosing	Precise, single-dose injection pens.	Often supplied in multi-dose vials, increasing risk of dosage error.
Clinical Testing	Proven safe and effective through extensive clinical trials.	No clinical trials; effectiveness and safety are unverified.
Risk of Contamination	Minimal due to strict manufacturing standards.	Potential for contamination and counterfeit products.

Conclusion: Navigating the Transition to Regulated Treatment

After a temporary reprieve during the drug shortage, the FDA's ban on compounded tirzepatide became final in 2025 due to both the resolved supply issues and serious safety concerns. The risks associated with unregulated compounded drugs—such as inconsistent quality, dosage errors, and contamination—highlight the importance of the FDA's oversight process. Patients who relied on compounded versions must now transition to the FDA-approved alternatives, Mounjaro or Zepbound. While this may present financial challenges, consulting a healthcare provider about accessing these regulated medications is the safest path forward. Patients should also inquire about manufacturer discount programs and patient assistance options to help manage costs.

For more detailed information on compounding regulations and drug safety, refer to the U.S. Food and Drug Administration's official guidance(https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss).

Frequently Asked Questions

No, compounded tirzepatide is no longer legal for general sale as of early 2025. The FDA has ended the temporary permission for compounding pharmacies to produce it, and court rulings have upheld this decision.

The FDA temporarily allowed the compounding of tirzepatide because the FDA-approved versions, Mounjaro and Zepbound, were on the national drug shortage list due to high demand.

The risks include inconsistent dosing, contamination, use of unapproved or different active ingredients (like salt forms), and lack of proven efficacy. Many reported adverse events were linked to these factors.

Compounded versions lack FDA approval and rigorous testing. They can have different ingredients, storage requirements, and delivery methods (e.g., multi-dose vials vs. auto-injector pens) compared to the standardized, quality-controlled brand-name products.

You should stop using the compounded product and consult your healthcare provider immediately. Your provider can help you transition to an FDA-approved alternative and discuss options to manage the cost.

Yes, but under very limited circumstances. If a specific patient has a medical need that cannot be met by the FDA-approved version (e.g., an allergy to an inactive ingredient), compounding may be permissible. Cost is not considered a valid reason.

The FDA views these as unproven and unregulated. The combination of ingredients has not been studied for safety or effectiveness, and the addition of vitamins does not justify compounding the drug.