FDA creates GLP-1 ingredient green list, making other imports subject to border detention

The FDA announced on September 5, 2025 that it has created a "green list" of GLP-1 active pharmaceutical ingredients (APIs), making shipments of those ingredients from any facility not on the list subject to detention at the U.S. border without physical examination ^[1]. Import Alert 66-80, which directs FDA field staff to carry out that policy, was issued on September 19, 2025, according to a law firm account of the alert ^[3].

Under the policy, GLP-1 APIs from facilities the FDA has inspected or otherwise evaluated and found to appear in compliance with its manufacturing standards go on the green list ^[1]. APIs from other sources are subject to detention without physical examination, meaning field staff can hold a shipment without physically testing or inspecting it first ^[3].

The alert covers GLP-1 receptor agonist bulk drug substances, including semaglutide, tirzepatide, liraglutide, exenatide, dulaglutide and related peptides ^[3]. The published green list includes facilities in Belgium, Canada and China ^[2]. FDA's import alert page carries a published date of August 21, 2026, reflecting a revision: that version added orforglipron API for three manufacturers and an orforglipron drug product intermediate for one manufacturer, along with a new product code for orforglipron ^[2]. The effective date of the original alert is stated differently in the two accounts available: the law firm report dates it to September 19, 2025, while the current alert page shows the August 21, 2026 revision date ^[2][3].

What FDA says it found

FDA says shortages of approved GLP-1 products led to increased compounding using APIs from foreign sources, including manufacturers in China, India and Europe ^[2]. The agency evaluated 48 GLP-1 API sites, through onsite inspections and requests for records, and found 21% were noncompliant under section 501 of the Federal Food, Drug, and Cosmetic Act, either because their responses showed evidence of noncompliance with current good manufacturing practice or because they did not respond in a timely way ^[2]. FDA also described a pattern of sites that register as GLP-1 API manufacturers, offer product for import, refuse to answer FDA records requests and then deregister within a short period ^[2].

FDA has previously cited dosing errors, use of unapproved salt forms such as semaglutide sodium and semaglutide acetate, and adverse events, some requiring hospitalization, in connection with compounded versions of semaglutide and tirzepatide ^[1][4]. As of May 31, 2026, the agency had received 990 reports of adverse events associated with compounded semaglutide and more than 730 associated with compounded tirzepatide ^[4]. FDA notes it is not always possible to determine whether an adverse event was caused by the drug or by other factors ^[4].

Why it matters for patients

Compounded drugs are not FDA-approved, and the agency does not review them for safety, effectiveness or quality before they are marketed ^[4]. The import alert does not stop legal importation of GLP-1 APIs from compliant manufacturers, and FDA says it does not create any new limits on the legal compounding of GLP-1 drugs ^[4].

In practical terms, the raw ingredient behind a compounded semaglutide or tirzepatide prescription may now come from a smaller set of suppliers. Whether individual compounding pharmacies or telehealth platforms have changed suppliers, raised prices, stopped selling compounded GLP-1 products or seen shipping delays has not been reported. The number of shipments actually detained since the alert took effect has also not been disclosed.

What happens next

Manufacturers can ask to be added to the green list by sending evidence of compliance to the FDA's Division of Import Operations; the agency recommends submitting that information before shipping, to avoid delays at the border ^[2]. A firm can also be removed from the list if FDA later concludes its products are no longer made in compliance with the law ^[2].

For a detained shipment, importers generally have 10 business days, or up to 20 calendar days, to submit evidence of compliance, and a failure to respond usually leads to a refusal of admission that is final and cannot be appealed ^[3]. Refused goods must be exported or destroyed within 90 days under FDA or Customs oversight, and importers that do not comply can face liquidated damages of as much as three times the commercial value of the goods ^[3]. FDA says it will continue working with state regulators and taking enforcement action as needed ^[1].