FDA Reconsiders Tirzepatide Shortage, Takes No Action on GLP-1 Compounders

The FDA announced on Thursday that it will not take enforcement action against compounding pharmacies for certain regulatory violations while it reexamines the removal of Eli Lilly’s weight loss and diabetes drug tirzepatide from the national shortage list. This decision marks an important development for both compounding pharmacies and online medical companies that prescribe these medications.

Recently, the FDA disclosed through court documents that it was reconsidering its earlier decision to remove tirzepatide from the shortage list. The agency took a further step on Thursday by stating its intent to treat compounders consistently during this period. Specifically, the FDA clarified that it does not plan to take action against compounders for certain violations related to the Federal Food, Drug, and Cosmetic Act.

This move is considered a significant victory for compounding pharmacies and the online medical companies that prescribe these drugs. Although Novo Nordisk’s semaglutide remains on the shortage list, the FDA’s removal of tirzepatide had raised concerns that compounders might no longer be able to produce these treatments. These compounded medications are often less expensive than their brand-name counterparts and are in high demand among those seeking them for weight loss.

Trade associations representing compounders have argued that the shortage of tirzepatide persists despite the FDA’s decision. Earlier this month, the Outsourcing Facilities Association filed a lawsuit against the FDA, claiming that the tirzepatide shortage continues. Additionally, the Alliance for Pharmacy Compounding (APC) wrote a letter to the FDA urging it to reinstate tirzepatide on the shortage list and called for greater clarity on the matter.

The APC welcomed the FDA’s Thursday announcement, describing it as a victory for patients who rely on compounded versions of Eli Lilly’s Mounjaro and Zepbound. Scott Brunner, the CEO of APC, expressed satisfaction with the FDA’s clarification, noting that the previous resolution of the tirzepatide shortage had left many patients without access to their prescriptions and no quick alternative. He stated that the FDA’s recent clarification is excellent news for those patients and their healthcare providers.

However, Brunner cautioned that this clarification should not be seen as a carte blanche for unrestricted compounding. The FDA’s announcement does not shield compounders from actions taken by state pharmacy boards or potential legal challenges from Eli Lilly.

As of the time of reporting, Eli Lilly and the FDA have not responded to requests for comment. The APC has advised compounding pharmacies to consult with their state pharmacy boards before resuming the distribution of compounded tirzepatide.