FDA Confirms Tirzepatide Availability, Compounders Express Concerns, While Semaglutide Shortage Persists
Tirzepatide Availability:
The FDA has determined that the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been resolved as of October 2, 2024, and reaffirmed this decision on December 19, 202425.
Semaglutide Shortage:
Despite all versions of Ozempic and Wegovy being listed as "available," semaglutide remains on the FDA's drug shortage list, indicating ongoing supply issues14.
Compounders' Concerns:
Compounders are concerned that the resolution of the tirzepatide shortage could limit access to cheaper, compounded versions of the drug, potentially affecting patients who cannot afford the FDA-approved versions14.
Supply Chain Disruptions:
Even with the shortage resolved, patients and prescribers may still experience intermittent localized supply disruptions as products move through the supply chain25.
Legal Restrictions:
The FDA reminds compounders of legal restrictions on making copies of FDA-approved drugs, emphasizing that compounded drugs are not approved by the FDA and must meet specific conditions under the Federal Food, Drug and Cosmetic Act2.
Ongoing Semaglutide Shortage:
The shortage of semaglutide is expected to continue into 2025, with Novo Nordisk advising that supply will remain limited throughout the year3.
Sources:
1. https://www.verywellhealth.com/glp-1-shortages-ending-8738577
2. https://www.fda.gov/drugs/drug-safety-and-availability/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize
3. https://www.tga.gov.au/safety/shortages/information-about-major-medicine-shortages/about-ozempic-semaglutide-shortage-2022-2025