FDA Reconsiders Removal of Eli Lilly’s Tirzepatide from Shortage List, Boosting Compounding Pharmacies

Reconsideration Decision:
The FDA has announced it will reconsider removing Eli Lilly's tirzepatide, a GLP-1 drug used for type 2 diabetes and weight loss, from its official shortage list. This decision comes after a trade group representing compounding pharmacies challenged the FDA's initial removal, citing concerns about patient access to the medication.

Compounding Pharmacies:
Compounding pharmacies, which mix and sell their own versions of tirzepatide, will be allowed to continue selling these compounded drugs while the FDA conducts another review of the drug's supply status.

Legal Background:
The FDA initially declared the tirzepatide shortage resolved on October 2, 2024, stating that the drug's manufacturer could meet present and projected national demand. However, compounding pharmacies argued that the decision was arbitrary and lacked lawful process, potentially depriving patients of a vital treatment.

Supply Concerns:
Despite the FDA's initial declaration that the shortage was resolved, patients and prescribers may still face intermittent localized supply disruptions as the products move through the supply chain.

Regulatory Framework:
The FDA reminds compounders of legal restrictions on making copies of FDA-approved drugs, emphasizing that compounded drugs must meet specific conditions to qualify for exemptions under the Federal Food, Drug and Cosmetic Act.