On October 2, 2024, the Food and Drug Administration (FDA) announced that it removed tirzepatide injection, a glucagon-like peptide 1 receptor agonist (GLP-1 RA) marketed by Eli Lilly, from its drug shortages list. Tirzepatide is the active ingredient in Mounjaro® which was approved in 2022 for the treatment of type 2 diabetes, and also Zepbound®, which was approved in 2023 for chronic weight management. The FDA also provided clarification of the legal limitations regarding drug compounding, a practice that has become very popular in producing tirzepatide and other GLP-1 RAs during the shortage. The FDA cited sections of the Federal Food, Drug and Cosmetic (FD&C) Act that restrict compounding of drugs that are commercially available, but not in shortage, and that restrict outsourcing facilities from compounding copies of any drugs that are FDA-approved and not in shortage.
