Overview

• The new import alert permits entry only of GLP-1 active pharmaceutical ingredients from facilities the FDA has inspected or evaluated as compliant, with other shipments detained without physical examination.
• The FDA cites dosing errors, unapproved salt forms, and reported adverse events tied to compounded products, stressing that compounding is appropriate only when approved drugs do not meet an individual patient need.
• Patients are urged to obtain prescriptions and use licensed pharmacies or verify online sellers through the FDA's BeSafeRx resources, with the agency pledging aggressive enforcement to protect consumers.
• WHO's updated Model Lists add semaglutide, dulaglutide, liraglutide, and tirzepatide, signaling global clinical importance for diabetes treatment and weight management.
• Reuters has reported that at least eight China-based suppliers provided raw ingredients supporting more than a billion makeshift doses in 2024, and a bipartisan July letter pressed the FDA to coordinate with CBP and curb illegal imports.