FDA Removes Tirzepatide from the National Medication Shortage List: What Does This Mean for Weight Loss Patients?

What is Tirzepatide, and why is it important?

Tirzepatide, sold under brand names like Mounjaro and Zepbound, is a popular medication for treating Type 2 diabetes and supporting weight loss. This drug works by mimicking hormones in your body that control blood sugar and appetite, making it effective for both controlling diabetes and weight management. This dual-action approach not only aids in significant weight management but also supports overall metabolic health, making it a vital tool for those struggling with obesity-related conditions.



What does it mean that Tirzepatide is no longer on the National Medication Shortage List?

When a medication is placed on the National Medication Shortage List, it indicates a limited supply, making it more difficult for patients to access. During the Tirzepatide shortage, compounding pharmacies were allowed to produce versions of Tirzepatide to help meet the demand.

Now that supplies of the branded medications, Mounjaro and Zepbound, have increased, the FDA has removed Tirzepatide from the National Medication Shortage List, as there is no longer a “shortage.” This raises questions about whether compounding pharmacies will still be allowed to produce the drug.

Why were compounding pharmacies allowed to produce Tirzepatide during the shortage?

Compounding pharmacies were allowed to step in and make their own versions of Tirzepatide because there simply wasn’t enough supply from the official manufacturers. The FDA has specific regulations that allow pharmacies to compound drugs during a shortage, provided they follow safety protocols and regulations. This approach serves as a temporary solution to ensure that patients can access this essential medication.

Now that the shortage is over, can compounding pharmacies still produce Tirzepatide?

It gets a little more complicated here. Normally, compounding pharmacies are not permitted to produce copies of medications that are already approved and widely available. Since the FDA has now removed Tirzepatide from the shortage list, compounding pharmacies may now face restrictions on continuing to make it.

However, there remains a pathway for compounding Tirzepatide under specific conditions. For instance, if a patient requires a different dosage or form of medication that isn’t offered by the commercial drug manufacturers, compounding may still be permitted. However, mass production of the drug, as was permitted during the shortage, is no longer an option.

What are the FDA rules that allow compounding to continue?

For compounding pharmacies to legally produce medications like Tirzepatide, two major conditions must be met:

1. Clinical Necessity: The compounded medication must meet a specific need that cannot be addressed by the FDA-approved versions. For example, if a patient needs a dosage or formula that isn’t available from the manufacturer (e.g., liquid instead of an injection), a compounding pharmacy can fill that gap.
2. Components Sourcing: The active ingredients used by compounding pharmacies must be sourced from FDA-approved suppliers. Therefore, Tirzepatide must be manufactured using FDA-approved raw materials.

If these conditions are met, compounding pharmacies may continue producing small, customized batches of Tirzepatide.

What should patients do if they’ve been getting compounded Tirzepatide?

Patients who have been using Tirzepatide from a compounding pharmacy should speak with their provider. If there is still a need for a compounded version, such as a special dosage or formula, their healthcare provider can help determine the best course of action.

In conclusion, the key takeaways regarding Tirzepatide's removal from the shortage list are as follows:

• Tirzepatide (Mounjaro, Zepbound) is no longer in shortage, which means better access to the official branded versions.
• Compounding pharmacies may not be able to produce Tirzepatide on a large scale anymore unless there is a specific medical need.
• Patients using compounded Tirzepatide should consult with their provider regarding their ability to continue with a compounded version if necessary.
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Contact Chronos Body Health & Wellness to get ahead on your Tizepatide treatment plan

Contact the trusted providers at Chronos Body Health & Wellness today to reorder your medications and ensure you're prepared for whatever lies ahead. Our experienced team is dedicated to helping you develop a personalized plan that allows you to continue your treatment seamlessly, without interruption. We’re here to support you every step of the way!