FDA Creates ‘Green List’ of GLP-1 Drug Ingredients Approved for Entry in the U.S.

The U.S. Food and Drug Administration has created a “green list” import alert to stop unapproved and unverified glucagon-like peptide 1 (GLP-1) drug ingredients from entering the United States.

Due to shortages of the FDA-approved GLP-1 drugs, like semaglutide and tirzepatide, which are used for type 2 diabetes and weight management, some patients have used compounded versions of the drugs.

These compounded drugs are not approved by the FDA, and serious concerns with these drugs have been identified, including dosing errors, unapproved salt forms, and adverse events that have led to hospitalization.

The green list includes active pharmaceutical ingredients (APIs) in the GLP-1 drugs that have been inspected by the FDA and are determined to be in compliance with FDA standards. Ingredients not on the green list are subject to detention without examination at the border.

“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,” the FDA writes in a statement.

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 get a prescription from their doctor and to fill the prescription at a licensed pharmacy or use the FDA’s BeSafeRx campaign to determine where to safely buy medications online.

“Americans should be confident that the prescription drugs they take are safe,” FDA Commissioner Marty Makary, M.D., M.P.H., said in an agency statement. “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.”

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