FDA creates a GLP-1 API "green list" and Import Alert 66-80

On September 5, 2025, the FDA announced a "green list" import alert designed to keep GLP-1 active pharmaceutical ingredients (APIs) from unverified foreign sources out of the U.S. supply chain ^[1]. Two weeks later, on September 19, 2025, the agency issued Import Alert 66-80, which authorizes field staff to detain shipments of GLP-1 bulk drug substances from any manufacturer not on that list — without opening or testing the boxes first ^[3].

The mechanism is called detention without physical examination, or DWPE. Under it, an FDA division can hold an incoming shipment based on the appearance of a violation rather than on lab results ^[3]. The green list is the carve-out: it names foreign facilities that FDA has inspected or otherwise evaluated and that "appear to be in compliance with the FDA's rigorous standards" ^[1]. Everything else is presumed suspect at the border ^[1][2].

What FDA found

The alert lays out the agency's reasoning. Shortages of approved GLP-1 drugs pushed pharmacies toward compounding with APIs bought from suppliers in China, India and Europe ^[2]. FDA evaluated 48 registered GLP-1 API sites through on-site inspections and remote records requests under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act. It found 21% were noncompliant — either their records showed manufacturing-practice problems, or they simply did not answer FDA's request on time ^[2].

FDA also described a recurring pattern: firms register as GLP-1 API makers, offer product for import, refuse to answer records requests, and then deregister — all within a short window ^[2].

There is a regulatory gap behind the concern. API manufacturers must follow current good manufacturing practice (CGMP) rules, but pharmacies compounding under section 503A are exempt from CGMP, including the requirement to verify that incoming ingredient meets specifications for impurities or potency ^[2]. So a quality problem in the powder may never be caught downstream ^[2].

"By strengthening oversight of imported APIs and cracking down on illegal drugs entering the U.S., we are taking aggressive action to protect consumers from poor-quality or dangerous GLP-1 drugs," FDA Commissioner Marty Makary said ^[1]. CDER Director George Tidmarsh called border enforcement "a critical part of this work" ^[1].

The green list as published covers firms in Belgium, Canada and China, with product codes for semaglutide, tirzepatide, liraglutide, exenatide, and certain peptide entries tied to retatrutide ^[2]. The alert has been revised since launch; the version published August 21, 2026 added orforglipron API to three green-listed manufacturers, added an orforglipron drug-product intermediate to one, and created new product codes ^[2]. Frier Levitt, a law firm tracking the action, describes the targeted substances as including semaglutide, tirzepatide, liraglutide, exenatide, dulaglutide and related peptides ^[3].

Why it matters for patients

FDA is explicit that this does not, by itself, outlaw compounding. The agency says the action "does not stop the legal importation into the U.S. market of GLP-1 APIs from compliant API manufacturers, nor does it create any new limits on the legal compounding of GLP-1 drugs" ^[4].

Practically, though, it raises the cost and difficulty of sourcing cheap overseas powder. Getting onto the green list requires submitting certificates of analysis for the last ten API lots, release specifications and test methods, stability data, process validation reports, batch records, out-of-specification test results, and five years of complaint and recall summaries ^[2]. Shipments that are detained give importers about 10 business days to respond, and a refusal is final and cannot be appealed — the goods must be exported or destroyed within 90 days ^[3].

FDA's underlying safety concerns remain posted: dosing errors with compounded injectable semaglutide, some requiring hospitalization; unapproved salt forms such as semaglutide sodium and semaglutide acetate; fraudulent labels naming pharmacies that do not exist; and products shipped warm ^[4]. As of May 31, 2026, FDA had received 990 adverse event reports tied to compounded semaglutide and more than 730 tied to compounded tirzepatide, while noting such reports are likely undercounted because state-licensed pharmacies are not required to file them ^[4].

What happens next

Manufacturers can petition to be added to the green list at any time, and FDA says it may remove a firm if later information shows shipments no longer comply ^[2]. The agency says it will keep working with state regulators and take enforcement action as needed ^[1]. How much the alert has shifted compounded GLP-1 pricing or availability is not addressed in these sources.