The U.S. Food and Drug Administration has established a “green list” import alert to prevent unapproved and unverified glucagon-like peptide 1 (GLP-1) drug ingredients from entering the United States.
Background on Compounded GLP-1 Drugs
Due to shortages of FDA-approved GLP-1 medications, such as semaglutide and tirzepatide, which are used for type 2 diabetes and weight management, some patients have turned to compounded versions of the drugs.
These compounded drugs are not approved by the FDA, and serious concerns have been identified with them, including dosing errors, unapproved salt forms, and adverse events that have led to hospitalization.
How the Green List Works
The green list includes active pharmaceutical ingredients (APIs) in GLP-1 drugs that have been inspected by the FDA and determined to be in compliance with FDA standards. Ingredients not on the green list are subject to detention without examination at the border.
The FDA stated: “This is part of the agency’s decisive steps to safeguard consumers from illegal GLP-1 active ingredients imported from overseas to ensure patient safety and a secure drug supply chain.”
Patient Guidance
According to the FDA, compounded drugs should only be used when an FDA-approved drug does not meet a patient’s medical needs. Patients are advised to obtain a prescription from their doctor and fill the prescription at a licensed pharmacy or use the FDA’s BeSafeRx campaign to determine where to safely buy medications online.
FDA Commissioner Marty Makary, M.D., M.P.H., said in an agency statement: “Americans should be confident that the prescription drugs they take are safe. By strengthening oversight of imported APIs and cracking down on illegal drugs entering the U.S., we are taking aggressive action to protect consumers from poor-quality or dangerous GLP-1 drugs.”
This regulatory action aims to protect patients from potentially harmful compounded GLP-1 medications while ensuring the integrity of the U.S. drug supply chain during ongoing shortages of FDA-approved weight loss and diabetes medications.
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