FDA Publishes Major Revision of Import Alert 66-80 on GLP-1 Bulk Drug Substances

On October 9, 2026, the FDA published a major revision of Import Alert 66-80, titled Detention Without Physical Examination of Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist Bulk Drug Substances. The published date on the alert is October 9, 2026.

This was a revision, not a new alert. Import Alert 66-80 was first established in September 2025, before the window covered by this backfill, and the October 2026 action updated an alert already in force.

The revision updated the guidance in the alert and the evidence firms must submit to be added to the alert Green List. It added orforglipron API to three Green List manufacturers and an orforglipron drug product intermediate to a fourth, and it added new FDA product codes.

The alert states that the FDA evaluated 48 GLP-1 API sites and found 21 percent noncompliant. Firm names on the published Green List are blanked out in the FDA public version, so no Green List companies are named in this post.

Detention under an import alert is an FDA border action, not a product approval decision. The regulatory point is about which bulk substances may enter the United States and under what showing, not about the approval of any finished product, which remains specific to a product and its labeled indication.