Compounded Tirzepatide No Longer Available After March 19, 2025

The shortage of tirzepatide injections has made the FDA issue an important update to stop compounding of tirzepatide injections. This drug is known to benefit patients of  type 2 diabetes and also support weight loss efforts. The shortage was reported in 2022 due to the increased demand and this order signifies that manufacturers should have the capacity to meet both current and projected demand for the drug, marketed under brand names such as Mounjaro and Zepbound.

As per the updated FDA guidance, pharmacies and outsourcing facilities must cease compounding tirzepatide injections by specific deadlines. State-licensed pharmacies operating under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) have been given 60 calendar days from the date of the FDA’s announcement to comply, with compounding prohibited from February 18, 2025, onwards. Outsourcing facilities under section 503B have been provided a slightly longer grace period of 90 calendar days, with compounding required to stop by March 19, 2025.

Background on the Shortage

The national shortage of tirzepatide, which began in 2022, was driven by an unprecedented rise in demand. The drug’s efficacy in aiding weight management and controlling blood sugar levels has made it a popular choice for patients. However, during the shortage, many patients turned to compounded versions of tirzepatide as a more accessible or affordable alternative. These compounded versions, typically prepared by licensed compounding pharmacies, offered a workaround during a time when brand-name versions were scarce.

With the resolution of the shortage, the FDA’s decision to prohibit the compounding of tirzepatide aligns with its commitment to ensuring patient safety and compliance with federal regulations. The FDA’s announcement emphasizes the importance of transitioning back to FDA-approved, manufacturer-produced tirzepatide to maintain drug quality and patient safety.

Risks of Compounded Tirzepatide

While compounded medications are regulated and inspected to some extent, they do not go through the same rigorous testing and quality assurance as FDA-approved drugs. Experts have highlighted the potential risks associated with compounded GLP-1 receptor drugs like tirzepatide. These risks include variability in drug potency, contamination, and other safety concerns.

Peter Ax, founder and CEO of UpScriptHealth, stated, “When you purchase a drug that is compounded, there’s inherently more risk compared to one manufactured in an FDA-approved facility.” This sentiment underscores the FDA’s move to phase out compounded versions of tirzepatide now that the shortage has been resolved.

Rising Costs and Counterfeit Products

The high cost of branded GLP-1 receptor drugs, often exceeding $1,000 per month without insurance, has been a driving factor for patients seeking compounded alternatives. During the shortage, some compounding pharmacies offered purported tirzepatide injections for as little as $100 to $200 monthly. However, this affordability came with significant risks. Reports of counterfeit products and fake online pharmacies further complicated the landscape, posing serious threats to patient health and safety.

Scott Brunner, CEO of the Alliance for Pharmacy Compounding, noted that as many as 40% of online pharmacies may be unregistered and unlicensed, heightening the danger of counterfeit or unsafe drugs entering the market.

Moving Forward

To address ongoing concerns and ensure patient access to safe medications, the FDA has advised stakeholders to monitor its Drug Shortages Database for further updates. As the grace periods for compounding tirzepatide near their end, healthcare providers, patients, and pharmacies must prepare for the transition back to FDA-approved versions of the drug.

This development serves as a reminder of the importance of regulatory oversight in ensuring drug quality and patient safety. Patients should consult their healthcare providers for guidance and avoid purchasing medications from unverified sources.

References

• FDA Guidance on Tirzepatide
• Business Insider Report
• Barron’s Coverage
• Investor’s Insights