FDA Introduces 'Green List' for Approved GLP-1 Drug Ingredients to Enhance Import Safety

The U.S. Food and Drug Administration (FDA) has implemented a new 'green list' import alert system that designates approved active pharmaceutical ingredients (APIs) in GLP-1 drugs. This initiative aims to prevent unverified and unapproved GLP-1 drug ingredients from entering the United States, bolstering drug safety and consumer protection.

GLP-1 receptor agonists, including semaglutide and tirzepatide, play a crucial role in managing type 2 diabetes and aiding weight loss. However, shortages have led some patients to seek compounded versions of these medications, which are not approved by the FDA. The use of such compounded drugs has raised concerns due to risks like incorrect dosing, unapproved salt forms, and severe adverse events resulting in hospitalizations.

The green list encompasses ingredients that have been inspected and verified to meet FDA standards, allowing those APIs to be imported without detention. Ingredients not listed are subject to detention at the border, reducing the risk of unsafe products reaching patients.

This measure reflects the FDA's commitment to safeguarding patient health by controlling the quality of imported drug components. The agency emphasizes that compounded drugs should only be used when no approved alternatives are suitable, advocating for prescriptions from licensed healthcare providers and using resources like the FDA’s BeSafeRx campaign to identify legitimate pharmacies.

FDA Commissioner Marty Makary highlighted that strengthening import oversight and cracking down on illegal drugs are vital steps in ensuring the safety and efficacy of prescription medications for Americans.