The End of the Tirzepatide and Semaglutide Shortages

How Compounding Pharmacies Continue to Serve Patients with Unique Needs

The FDA recently declared the shortages of tirzepatide and semaglutide officially resolved, marking a turning point in the availability of these widely used medications for weight management and type 2 diabetes. While this announcement ensures that FDA-approved products like Mounjaro^®/Zepbound^® (tirzepatide) and Ozempic^®/Wegovy^® (semaglutide) are now readily accessible, it also signals a shift in the role of compounding pharmacies and outsourcing facilities. The physicians and pharmacies, which played a critical role during the shortages, are now adapting to continue serving patients with unique healthcare needs through clinically differentiated formulations.

The FDA’s Decision and Its Implications

The semaglutide and tirzepatide shortages, which began in 2022 due to high demand, initially allowed compounding pharmacies and outsourcing facilities to produce copies of these medications under provisions of Section 503A and 503B of the Federal Food, Drug, and Cosmetic Act. ⁴

However, the FDA has determined that by December 2024 for tirzepatide and February 2025 for semaglutide, manufacturers will be able to meet national demand, leading to the removal of these drugs from the shortage list.

As a result, compounding pharmacies and outsourcing facilities will no longer be able to produce copies of these drugs under the emergency provisions.^{1, 2, 3}

Specifically:

• Compounding pharmacies will no longer be able to make copies of semaglutide after April 22, 2025, and tirzepatide after March 19, 2025, unless they can demonstrate a documented clinical difference that addresses specific patient needs, in accordance with Section 503A of the Federal Food, Drug, and Cosmetic Act.
• Outsourcing facilities will no longer be able to produce semaglutide after May 22, 2025, and tirzepatide after March 19, 2025.

This regulatory shift means that outsourcing facilities can no longer produce these drugs in any form and compounding pharmacies can no longer produce copies of these drugs unless they provide a documented clinical difference that meets specific patient needs under Section 503A of the Federal Food, Drug, and Cosmetic Act.⁴

Role of Compounding Pharmacies Post-Shortage  

Even as enforcement tightens, compounding pharmacies remain essential for patients who require customized versions of tirzepatide or semaglutide. Here’s how they continue to make a difference:

Differences in Formulations  

Compounding pharmacies can continue to legally produce tirzepatide or semaglutide with modifications that address unique patient needs. For example:

• Adding Active Pharmaceutical Ingredients: Some compounded formulations include B vitamins, which may offer additional metabolic benefits.

Orally Disintegrating Tablets (ODTs): For patients who struggle with injections or have needle phobia, ODTs may provide a convenient alternative delivery method.^{4, 8}

These modifications are not available in FDA-approved GLP-1 products but may improve treatment adherence and outcomes for certain patients.

Personalized Dosages

While many commercial products are available in fixed doses, compounded medications can be tailored to provide precise dosages that align with individual medical requirements.

This flexibility is particularly valuable for patients who experience side effects at standard doses or require gradual titration.

Allergen-Free Options

Patients with allergies or sensitivities to certain excipients in commercial formulations may benefit from compounded versions that exclude problematic ingredients.

Quality and Sterility Testing

Compounded medications must meet rigorous quality standards. Reputable compounding pharmacies operate under strict protocols, including potency, stability, and sterility testing by independent third-party FDA registered analytical laboratories.⁸

Challenges Ahead

Despite their critical role during shortages, compounding pharmacies face increasing scrutiny from regulatory agencies. Both Eli Lilly (maker of Mounjaro®/Zepbound®) and Novo Nordisk (maker of Ozempic®/Wegovy®) have raised concerns about counterfeit or substandard compounded versions of their drugs.^{1, 8}

To address these concerns, compounding pharmacies must continue to prioritize transparency and adherence to legal requirements.