Federal regulators have set up a screening checkpoint at the border for the raw ingredients used in compounded weight loss drugs, and updated guidance published this week lays out a set of problems that reach patients directly, including medicine arriving warm and vials labeled with pharmacies that do not exist.
The FDA has established what it calls a green list import alert covering GLP-1 ingredients with potential quality concerns. The alert is designed to stop those ingredients from entering the U.S. supply chain while allowing continued importation from manufacturers that appear to meet the agency's manufacturing standards based on inspection or other evaluation.