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.
FDA Alerts Providers, Compounders, and Patients of Dosing Errors with Compounded Semaglutide
The FDA issued an alert to providers, compounders, and patients of dosing errors associated with compounded injectable semaglutide products, due to reports of adverse events, some requiring hospitalization, that may be related to overdoses due to dosing errors associated with compounded semaglutide injectable products. Dosing errors have resulted from patients measuring and self-administering incorrect doses of the drug and health care providers miscalculating doses of the drug. The FDA encourages patients to talk with their health care provider or compounder about how to measure and administer the intended dose of compounded semaglutide. Many of the patients who received vials of compounded semaglutide lacked experience with self-injections, according to the adverse event reports Adverse events included gastrointestinal effects (e.g., nausea, vomiting, abdominal pain), fainting, headache, migraine, dehydration, acute pancreatitis and gallstones.
