Compounded Tirzepatide: Availability, FDA Status, and Patient Access

What is Compounded Tirzepatide?

Compounded tirzepatide refers to pharmacy-prepared formulations made in response to individual patient needs. These are not FDA-approved and differ from commercially manufactured medications such as Mounjaro® and Zepbound®.

Licensed pharmacists may prepare compounded versions only when a prescriber documents that a patient requires a meaningful difference, such as avoiding allergens, adjusting dosage strength, or altering delivery format.

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FDA Status and Warnings on Compounded GLP-1s

• Shortage Resolution: On October 3, 2024, the FDA officially determined that the national tirzepatide supply was sufficient, ending the shortage designation.
• Enforcement Deadlines:
  
  • 503A pharmacies (state-licensed): stopped compounding by February 18, 2025.
  • 503B outsourcing facilities: stopped by March 19, 2025.
• FDA Concerns: The agency received 545 adverse event reports linked to compounded tirzepatide and discovered mislabeled or falsified products.

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When Will Tirzepatide Be Available? (Brand vs. Compounded)

• FDA-approved medications containing tirzepatide (Mounjaro®, Zepbound®) are available through licensed providers and retail pharmacies.
• Compounded tirzepatide may still be prescribed in rare cases, but only if a provider documents a clinically significant difference from FDA-approved products.
• Lilly has expanded access through LillyDirect’s self-pay program and large-scale investments in manufacturing to meet demand.

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Patient Pathways to Access Compounded Tirzepatide

Patients may encounter compounded tirzepatide only under narrow circumstances, such as:

• Needing a non-standard dosage strength
• Requiring a formulation without certain allergens
• Alternative delivery methods if standard injections cannot be used

For most patients, access is now through FDA-approved prescriptions. Providers can also help patients explore financial support programs that lower costs of brand-name medications.

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Safety Considerations and Provider Guidance

• Providers are required to document clinical necessity for any prescription for compounded medications containing tirzepatide.
• Compounded formulations can vary in potency and quality, requiring closer monitoring.
• The FDA advises providers to prescribe compounded GLP-1s only when FDA-approved options are not medically appropriate.

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Conclusion

When the FDA declared the tirzepatide shortage was over, it also restricted most compounding of the medication. As of March 19, 2025, compounded versions may only be prescribed when a provider determines a clinically significant difference for a specific patient.

Patients now have reliable access to FDA-approved tirzepatide through traditional prescriptions and LillyDirect self-pay options. Compounded tirzepatide may still be available in rare situations, but the safest option is to use an FDA-approved medication prescribed by your doctor.