FDA Launches Green List to Protect Americans from Illegal Imported GLP-1 Drug Ingredients

https://www.fda.gov/news-events/press-announcements/fda-launches-green-list-protect-americans-illegal-imported-glp-1-drug-ingredients?utm_medium=email&utm_source=govdelivery On Friday, the FDA announced that it has established a “green list” import alert to help stop potentially dangerous GLP-1 (glucagon-like peptide-1) active pharmaceutical ingredients (APIs) from unverified foreign sources from entering the U.S. market. 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. Certain GLP-1 drugs, including semaglutide and tirzepatide, are FDA-approved for specific uses such as treating type 2 diabetes and, in certain cases, chronic weight management. However, the agency is aware that some patients are turning to compounded versions of these drugs, which are not approved by the FDA. To protect patients who use these compounded drugs, the green list will include GLP-1 APIs from facilities the agency has inspected or evaluated that appear to be in compliance with the FDA’s rigorous standards – standards applicable to all APIs manufactured in the United States. Active pharmaceutical ingredients from other sources are subject to detention without physical examination.