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alert date:

October 2, 2024

FDA Updates Compounding Policy for GLP-1 Medications

The FDA has determined that the shortage of tirzepatide injections (a GLP-1 antagonist) has been resolved, meaning compounders can no longer create their own formulations of this drug. The FDA is reminding compounders of legal restrictions on making copies of FDA-approved drugs. There are exemptions to this rule during a drug shortage, and since 2022 tirzepatide injections have been in shortage due to increased demand, allowing compounders to formulate the drug. However, with the shortage declared over, compounders are now restricted from creating tirzepatide. Other GLP-1 drugs are still considered in shortage and compounders can still formulate these medications, including semaglutide, liraglutide, and dulaglutide.

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