Shortage resolved for Eli Lilly’s GLP-1, tirzepatide-compounders reminded of restrictions

FDA announced on October 2, 2024 that the shortage had been resolved for Eli Lilly’s GLP-1 drug, tirzepatide. Tirzepatide is indicated as an adjunct therapy for weight management and glycemic control. The shortage lasted from December 15, 2022 to October 2, 2024. During the shortage many compounders-both 503A and 503B facilities-stepped in to meet patient needs. At the same time FDA announced resolution of the shortage, FDA took the opportunity to remind compounders of restrictions on compounding copies of FDA-approved drugs that are no longer on shortage. For Section 503A pharmacies, limitations on compounding copies are lifted only for the period the FDA-approved drug is on FDA’s drug shortages list. For Section 503B outsourcing facilities, FDA has flexibility to allow 503B facilities to continue to fill orders received before the shortage was resolved. FDA may take action, however, if a 503B facility continues to take and fill new orders after the drug is removed from the shortage list, or if the facility continues to fill orders more than 60 days after the shortage is resolved. Through these policies FDA strives to ensure patient needs can be met, but that compounded copies of FDA-approved drugs are not used when the FDA-approved product is commercially available.