As of October 2, 2024, the U.S. Food and Drug Administration (FDA) has announced that the shortage of tirzepatide, a glucagon-like peptide 1 (GLP-1) receptor agonist used for the treatment of type 2 diabetes and obesity, has been resolved. This decision comes after Eli Lilly confirmed that the drug's availability and manufacturing capacity can meet the present and projected national demand.
Tirzepatide, marketed under the brand names Mounjaro and Zepbound, was placed on the FDA's drug shortage list in December 2022 due to increased demand following its approval for type 2 diabetes treatment in May 2022 and later for obesity treatment in November 2023. The resolution of this shortage is a significant development for patients relying on this medication.
Legal Restrictions on Compounded Drugs
The FDA has reiterated legal restrictions on compounded drugs. According to section 503A of the Food, Drug & Cosmetic Act, pharmacies are generally prohibited from compounding copies of FDA-approved drugs. However, during a drug shortage, pharmacies may prepare copies under specific conditions to ensure patient access to essential medications. Since tirzepatide is no longer listed as a drug in shortage, compounded forms are no longer permissible under these exemptions.
Section 503B of the FD&C Act further restricts outsourcing facilities from manufacturing compounded drugs that are essentially copies of one or more FDA-approved drugs. This means that any compounded tirzepatide would need to be significantly different from the FDA-approved version unless it is on the drug shortage list.
Potential Impact on Patients
The resolution of the tirzepatide shortage may lead to some patients being cut off from compounded versions of the drug. Patients currently taking compounded GLP-1 receptor agonists may need to transition to FDA-approved versions, which could take time. This transition period might be challenging for some patients, especially those who rely on compounded medications due to cost or other accessibility issues.
Alliance for Pharmacy Compounding CEO Scott Brunner expressed concerns about the abrupt transition for patients taking compounded GLP-1s. He suggested that an informal 'off-ramp' period allowing patients to continue compounded therapy while transitioning to FDA-approved versions would have been beneficial. However, this suggestion was not implemented by the FDA.
Pharmacies may still experience localized supply disruptions as tirzepatide moves through the supply chain from manufacturers and distributors to local pharmacies. This could lead to delays in accessing the newly available FDA-approved versions of the drug.
Ongoing Shortages of Other GLP-1 Receptor Agonists
Despite the resolution of the tirzepatide shortage, other GLP-1 receptor agonists remain in short supply. Dulaglutide (Trulicity), semaglutide (Ozempic/Wegovy), and liraglutide (Saxenda) are still listed as medications in shortage. Semaglutide has all but one dose available, while liraglutide has two forms currently available with three doses having limited availability.
The FDA will continue to work with manufacturers to help resolve these ongoing shortages. The agency will closely monitor the situation and provide any necessary assistance to ensure an adequate supply of these critical medications.
Healthcare professionals should remain vigilant about the challenges posed by localized supply issues and continue monitoring the status of other medications still on the shortage list.
Providers offering weight loss management services and those prescribing these medications should communicate with patients about potential delays and ensure compliance with both state and federal regulations related to telehealth, prescriptions, and compounded drugs.
