The FDA's GLP-1 Ingredient 'Green List': How Import Alert 66-80 Works

Compounded semaglutide and tirzepatide start as bulk active pharmaceutical ingredients (APIs), and the FDA's own import alert notes that during the shortages these were supplied by manufacturers around the world, including in China, India, and Europe. Since September 5, 2025, the agency has used a specific border tool, Import Alert 66-80, to decide which of those ingredients get through. Unlike import alerts that name the firms to stop, this one names the firms allowed in.

According to the FDA, section 801 of the Federal Food, Drug, and Cosmetic Act lets it refuse imports that appear to violate the law, which the agency calls the 'appearance standard.' An import alert lets field staff detain shipments without physically examining them first, known as detention without physical examination (DWPE). Firms on an alert's red or yellow list are subject to DWPE; under a green-list alert, only the listed firms are exempt and every other shipment it covers can be detained.

The alert states that the FDA evaluated 48 GLP-1 API sites through inspections and remote records requests and found 21% noncompliant, either because their records showed problems with current good manufacturing practice (CGMP) or because they did not answer in time. It also describes a pattern of sites that register as GLP-1 API makers, offer product for import, refuse records requests, and then deregister within a short period.

The FDA's concern is partly structural. Pharmacies compounding under section 503A are exempt from CGMP requirements, so the alert says quality problems in the bulk ingredient may not be caught once it reaches the pharmacy.

BakerHostetler, a law firm, reported that 37 manufacturers were on the list at launch, with their names initially redacted. The alert page now shows a published date of October 9, 2026, and its revision notes say orforglipron API was added for three listed manufacturers, along with new product codes. Current entries include manufacturers in Belgium, Canada, China, Denmark, India, Ireland, Italy, and Portugal. Firms seeking to be added must submit evidence such as certificates of analysis for recent lots, stability data, and process validation reports, and the FDA says a firm can be removed if compliance lapses.

The FDA says the alert does not stop legal imports from compliant manufacturers and creates no new limits on legal compounding. A green-list entry is also not a drug approval: compounded GLP-1 products remain unapproved by the FDA. For anyone using a compounded GLP-1 drug, a reasonable step is to fill the prescription at a state-licensed pharmacy and ask where its active ingredient comes from, then check that manufacturer against the current list on the FDA's import alert page, which can change.