What is compounded Tirzepatide?

Medical Disclaimer: This article is for educational purposes only and does not constitute medical advice. Compounded medications are not FDA-approved and may carry different risks than FDA-approved medications. Always consult with a qualified healthcare provider before considering any medication options.

Important Current Status Update: As of March 19, 2025, the FDA has ended enforcement discretion for compounded tirzepatide. Most compounding of tirzepatide is no longer legally permitted following the resolution of the drug shortage. Only FDA-approved medications (Mounjaro® and Zepbound®) are now available for most patients.

In the world of weight loss medications, Tirzepatide has been making waves. But what happens when compounding enters the picture? Here’s what you need to know about compounded Tirzepatide and what it means for those on their weight loss journey.

Active Ingredient: Tirzepatide

Tirzepatide is a dual agonist — it activates GLP-1 receptors and GIP (glucose-dependent insulinotropic polypeptide) receptors. The added GIP activity may enhance weight loss and blood sugar control compared to GLP-1–only drugs.

In the U.S., Tirzepatide is available as: Mounjaro and Zepbound

Key Takeaways

• Compounded tirzepatide is no longer available as of March 2025 due to FDA enforcement policy changes
• The FDA ended compounding after resolving the drug shortage
• Very limited exceptions may exist for specific medical needs under strict conditions
• Only FDA-approved commercial versions (Mounjaro or Zepbound) are now legally available for most patients

Can Tirzepatide Be Compounded?

Pharmaceutical compounding is the art and science of creating personalized medications tailored to meet specific patient needs. In fact, this practice has been around for centuries and still continues to play a vital role in modern healthcare.

During the shortage period (2022-2025), tirzepatide could be compounded. The FDA allowed compounding tirzepatide when commercial products were unavailable due to shortage conditions. This involved creating customized versions of the medication in compounding pharmacies with adjustments in dosage, form, or ingredients that might not be available in commercial products like Mounjaro or Zepbound.

Current Status: The FDA has officially determined that the shortage of tirzepatide injection products is now resolved as of December 19, 2024. With the shortage resolved, the legal basis for most compounding has ended. There are still exceptions available for compounding but are rare.

What is compounded Tirzepatide?

During the shortage period, compounded tirzepatide was a customized version of tirzepatide, the active ingredient in medications like Mounjaro and Zepbound. It was created by licensed pharmacists in compounding pharmacies to meet specific patient needs when commercially available products were unavailable.

Compounded tirzepatide typically contained:

• Tirzepatide: The active ingredient that may support weight loss efforts
• A diluent: A substance used to dissolve the tirzepatide
• Potentially other ingredients: Depending on the specific formulation

Some compounded versions included additional ingredients like vitamin B12, leading to products labeled as “compounded tirzepatide with B12.”

Key Differences From Commercial Tirzepatide

The differences between compounded and commercial tirzepatide are significant:

• Regulatory oversight: The FDA approved commercial tirzepatide, but never approved compounded versions.

• Quality control: Commercial products undergo strict testing, while compounded drugs did not.

• Clinical evidence: Commercial tirzepatide has robust clinical trial data; compounded versions lacked this evidence.

• Manufacturing standards: Commercial medications follow FDA Good Manufacturing Practice; compounded products didn’t.

Is Compounded Tirzepatide Safe?

Quality and Safety Issues: Experts have highlighted the potential risks associated with compounded GLP-1 receptor drugs like tirzepatide. For example, these risks include variability in drug potency, contamination, and other safety concerns.

FDA’s Safety Position: The FDA regulates and inspects compounded drugs to some degree, but they don’t undergo the same rigorous testing as FDA-approved products. As Peter Ax, founder and CEO of UpScriptHealth, said:

“When you purchase a drug that is compounded, you take on more risk compared to one manufactured in an FDA-approved facility.”

What This Means for Patients

If You Were Previously Using Compounded Tirzepatide:

If you relied on compounded Tirzepatide, you’ll need to discuss alternative options with your healthcare provider. You may need to switch to an FDA-approved GLP-1 and GIP medication.

Important Steps to Take:

• Consult with your healthcare provider about FDA-approved alternatives
• Discuss insurance coverage options for commercial products
• Review potential cost-saving programs offered by manufacturers
• Explore patient assistance programs if cost is a concern

Cost Considerations: For many, compounded versions were more affordable. Brand-name GLP-1 and GIP medications can be expensive. However, both Eli Lilly and Novo Nordisk now offer direct-pay programs and manufacturer coupons that may help reduce costs.

Current FDA-Approved Options

Available FDA-Approved Tirzepatide Products:

• Mounjaro® (tirzepatide): FDA-approved for type 2 diabetes management
• Zepbound® (tirzepatide): FDA-approved specifically for chronic weight management

Both products have undergone extensive clinical trials demonstrating safety and efficacy, are manufactured under strict FDA oversight, and have consistent quality control standards.

Very Limited Exceptions That May Still Exist

Rare Circumstances Where Compounding Might Still Be Permitted:

Pharmacies may still compound tirzepatide under Section 503A if a physician determines a patient requires a significant modification, such as an alternative formulation due to an allergy. However, this justification must be explicitly documented on the prescription.

Important Requirements for Any Exception:

• First, it must involve significant medical necessity.

• Second, it requires detailed physician documentation.

• In addition, it cannot be “essentially a copy” of commercial products.

• Finally, it must meet strict quality and safety standards.

Conclusion

The era of widely available compounded tirzepatide ended in March 2025 after the FDA declared the shortage resolved. This development serves as a reminder of the importance of regulatory oversight in ensuring drug quality and patient safety.

Key takeaways:

• First, compounded tirzepatide is no longer legally available for most patients.

• As a result, FDA-approved products (Mounjaro® and Zepbound®) are now the primary options.

• However, very limited exceptions may exist for specific medical circumstances.

• Finally, professional medical guidance is essential for transitioning to approved alternatives.

Get Started with Tirzepatide for Weight Loss

Ready to explore if Tirzepatide is right for your weight loss journey? Heally makes it easy to connect with healthcare professionals who can guide you through your options, including both FDA-approved Tirzepatide or Semaglutide.

Our platform offers virtual consultations with experienced providers who can assess your individual needs and determine the best course of action for your weight loss goals. Whether you’re interested in Mounjaro, Zepbound, or other GLP-1’s, Heally can help you navigate your options safely and effectively.

Don’t let questions about Tirzepatide hold you back from achieving your weight loss goals. Take the first step towards a healthier you today. Schedule your virtual consultation on Heally and start your personalized weight loss journey!

Sources

1. U.S. Food and Drug Administration (FDA): Compounding Laws and Policies
2. FDA Drug Shortage Database and Policy Updates
3. Eli Lilly and Company: What is Tirzepatide and how does it work?
4. National Library of Medicine: Tirzepatide: A Novel Dual Glucose-Dependent Insulinotropic Peptide and Glucagon-Like Peptide-1 Receptor Agonist 
5. Federal Court Records: Outsourcing Facilities Association v. FDA

1. FDA Label: MOUNJARO (Tirzepatide Injection) Medication Guide
2. FDA Label: ZEPBOUND (Tirzepatide Injection) Medication Guide

Important Medical Information and Disclaimers

MEDICAL DISCLAIMER: This information is for educational purposes only and is not intended as medical advice. Tirzepatide is available as FDA‑approved prescription medications—Mounjaro® (for type 2 diabetes) and Zepbound® (for chronic weight management and obstructive sleep apnea in adults with obesity). Always consult a qualified healthcare provider before starting any treatment.

INDIVIDUAL RESULTS VARY: Outcomes with tirzepatide vary significantly between individuals. Results may be influenced by treatment adherence, lifestyle modifications, individual metabolism, growth and development (in adolescents), underlying health conditions, and emotional wellbeing.

IMPORTANT SAFETY INFORMATION:

• Common side effects: nausea, vomiting, diarrhea, constipation, abdominal discomfort, decreased appetite, and injection-site reactions.

• Serious side effects: have included pancreatitis, gallbladder disease, acute kidney injury, hypoglycemia, and severe allergic or injection-site reactions.

• Thyroid considerations: Animal studies demonstrated thyroid C‑cell tumors; the relevance to humans is unknown. Zepbound/Mounjaro is contraindicated for individuals with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

COMPOUNDED VERSIONS WARNING: The FDA has issued alerts regarding compounded tirzepatide, warning that these custom formulations may lack the safety, consistency, and efficacy of FDA-approved medications.

FDA ADVERSE EVENT REPORTING: You are encouraged to report negative side effects of prescription medications. Visit FDA MedWatch at www.fda.gov/medwatch or call 1‑800‑FDA‑1088.