The Food and Drug Administration (FDA) has decided to allow compounding pharmacists to continue making compounded versions of tirzepatide, the active ingredient in Eli Lilly’s diabetes and weight loss drugs Mounjaro and Zepbound, while it reconsiders its decision to remove the drug from the nationwide shortage list. This move comes after compounding pharmacists and patients expressed anger and frustration over the FDA’s announcement that the tirzepatide shortage was resolved on October 2.
Compounded versions of tirzepatide and semaglutide, another drug in short supply, have become popular due to their lower cost and availability compared to brand-name drugs. The FDA’s decision to remove tirzepatide from the shortage list meant that compounding pharmacists had to stop filling prescriptions, which caused concern for patients who rely on these medications.
Despite the FDA’s assertion that tirzepatide is not in shortage, patients and caregivers continue to report difficulty in obtaining the drug. Compounded versions are seen as a viable alternative, although drugmakers have pushed back against this practice.
Patients like Simone Williams and Elizabeth Kenly, who have been prescribed compounded tirzepatide, have expressed relief at the FDA’s decision to allow compounding to continue. They emphasize the importance of access to affordable medications and express concerns about the potential impact of the FDA’s decisions on their treatment.
The FDA’s compounding program aims to provide access to compounded drugs for patients in need, although it recommends the use of FDA-approved drugs when available. The agency’s recent decision to allow compounding of tirzepatide provides some peace of mind for patients and pharmacists, ensuring continued access to this important medication.
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