FDA Temporarily Allows Compounded Tirzepatide During Supply Shortages

Table of Contents

II. Tirzepatide’s History on the Shortage List

III. The FDA’s New Decision on Compounded Tirzepatide

Tirzepatide has rapidly become a household name in the world of weight loss and type 2 diabetes management. Its game-changing results for patients have made it one of the most sought-after medications on the market. However, the popularity of tirzepatide has come with its fair share of challenges, primarily in the form of ongoing supply issues. After briefly being removed from the FDA’s shortage list, tirzepatide is back on, leaving patients wondering how long they will have to wait to access this medication.

To address temporary supply issues, the FDA is currently permitting certain compounding pharmacies to produce tirzepatide under specific conditions. However, compounded medications are not FDA-approved and should only be used if prescribed by a licensed provider. This move may help alleviate some access issues, but it also raises important questions: Is compounded tirzepatide safe? And why is tirzepatide back on the shortage list? Let’s dive into the details.

Tirzepatide’s Popularity Boom

Originally developed for type 2 diabetes, tirzepatide mimics hormones in the body that help regulate blood sugar. However, researchers quickly discovered that it also leads to significant weight loss. Clinical trials showed that patients experienced, on average, a 12% reduction in body weight over 72 weeks.

Based on successful clinical trials, the FDA approved tirzepatide for weight loss under the brand name Zepbound in 2023. For patients who had previously struggled to lose weight, tirzepatide was a breakthrough. Soon, tirzepatide was being prescribed not only to diabetes patients but also to those seeking a reliable weight management solution.

This popularity, however, came with a downside. The demand for tirzepatide quickly outpaced the supply, and the medication found itself on the FDA’s shortage list.

Tirzepatide’s History on the Shortage List

As tirzepatide’s popularity surged, the supply couldn’t keep up. Manufacturing delays, combined with the growing number of prescriptions, led to its placement on the FDA’s shortage list. Here’s a timeline of key events surrounding tirzepatide’s availability:

2022: The FDA places tirzepatide on the drug shortage list due to the overwhelming demand for weight loss and diabetes treatment. Under these conditions, compounding pharmacies began producing compounded tirzepatide.
October 2, 2024: The FDA announces that tirzepatide is no longer in shortage and removes it from the list, halting compounded production and prompting backlash.
October 7, 2024: The Outsourcing Facilities Association files a lawsuit, arguing the drug is still in short supply.
October 13, 2024: The FDA agrees to temporarily allow compounding while reconsidering its decision.

Current Status: While the shortage status remains under review, tirzepatide may be compounded by authorized facilities under FDA provisions, and only if prescribed by a licensed healthcare provider.

The FDA’s New Decision on Compounded Tirzepatide

In October 2024, the FDA stated that compounding pharmacies could temporarily resume producing tirzepatide due to ongoing supply issues. Under the Federal Food, Drug, and Cosmetic Act, compounding is permitted when a drug is listed on the FDA’s shortage list. However, compounded tirzepatide is not FDA-approved and should only be prescribed when no FDA-approved alternative is accessible.

This temporary measure may help maintain continuity of care for patients experiencing access delays. However, treatment decisions should be made by a licensed healthcare provider.

Is Compounded Tirzepatide Safe?

Compounded tirzepatide may be prescribed in certain circumstances by a licensed healthcare provider. However, because compounded medications are not FDA-approved and can vary in quality, it’s critical that they are obtained from a qualified compounding pharmacy following appropriate safety protocols.

Compounded medications, including tirzepatide, are made by licensed pharmacists who must follow strict guidelines for safety and quality. Patients should only consider this option if evaluated and prescribed by a provider.

What This Means for Patients

While the FDA is temporarily allowing compounded tirzepatide during the shortage, patients should be aware that this is not a long-term substitute for the brand-name medication. Only a licensed provider can determine whether a compounded version is appropriate. Patients should also note that compounded medications are not reviewed by the FDA for safety, efficacy, or quality.

Patients should ensure the pharmacy they use follows compounding best practices and adheres to legal and regulatory standards. The FDA continues to monitor the supply chain and may adjust its policies as the situation evolves.

Conclusion

The return of tirzepatide to the FDA’s shortage list is frustrating for the many patients who rely on it for weight loss and diabetes management. However, the FDA’s temporary allowance of compounded tirzepatide may provide a short-term solution for patients waiting for the brand-name version.

For patients facing delays, compounded tirzepatide may offer temporary access when prescribed by a provider. Because these formulations are not FDA-approved, they should only be used when clinically appropriate and sourced from a reputable pharmacy.

Ultimately, the answer to the question "Is compounded tirzepatide safe?" lies in consulting a trusted healthcare provider and using a verified compounding pharmacy. As the situation continues to evolve, patients should stay informed and explore appropriate options with their providers.

Disclaimer: Compounded tirzepatide is not FDA-approved. It may only be prescribed by a licensed provider when an FDA-approved alternative is unavailable. Patients should consult with their healthcare provider before beginning any treatment.