FDA Green List Established for Pharmaceutical Imports of GLP-1 APIs
The alert represents a new layer of oversight on pharmaceutical imports. It ensures that only FDA-reviewed sources are allowed to supply GLP-1 APIs to the U.S. market.
On September 5, 2025, the U.S. Food and Drug Administration (FDA) introduced a new “green list” import alert to prevent certain pharmaceutical imports from entering the U.S. market.
The alert specifically targets shipments containing illegal or unsafe active pharmaceutical ingredients (APIs), particularly those related to GLP-1 (glucagon-like peptide-1) drugs that are used in FDA-approved medications for type 2 diabetes and chronic weight management.
This measure aims to protect U.S. consumers from receiving low-quality compounded drugs containing foreign-made APIs that may be produced without proper quality controls.
However, it does not stop the legal importation of GLP-1 APIs from compliant manufacturers.
The FDA’s green list, outlined in Import Alert 66-80, identifies foreign manufacturers of GLP-1 APIs that are exempt from Detention Without Physical Examination (DWPE).
It addresses concerns about certain GLP-1 pharmaceutical imports that pose safety risks to patients and threaten the drug supply chain.
Only facilities that have been inspected or evaluated by the FDA and found compliant are placed on the green list.
The FDA will continue to update the list as additional facilities are reviewed and approved.
The GLP-1 APIs that can enter the U.S. from approved facilities are:
Countries with approved facilities include:
Shipments from green list facilities in these countries will be allowed entry into the U.S. without further examination.
APIs imported from other manufacturing sites will be automatically detained at U.S. borders until importers provide sufficient documentation to demonstrate compliance with FDA requirements.
At Cole International, we constantly monitor changing trade regulations and offer customs and compliance consulting services to help businesses navigate these changes.
Additionally, we provide timely and efficient customs brokerage services to help U.S. importers streamline their customs clearance processes.
If you import GLP-1 ingredients into the U.S., please reach out to one of our trade professionals to verify if your shipment is on the green list and discuss how we can help ensure your compliance.