The US FDA has established a “green list” of imported GLP-1 drug ingredients deemed safe and allowed into the country, while keeping out those from unverified foreign sources.

The FDA has approved several GLP-1 drug products for the treatment of type 2 diabetes and weight management. Shortages have led to compounding of products using the active pharmaceutical ingredients (APIs) from around the world, including China, India, and Europe. The “green list” includes GLP-1 APIs from facilities that FDA has inspected or valuated that appear to be in compliance with safety standards applicable to US-manufactured APIs.

The agency had identified drugs compounded from GLP-1 APIs that appeared to be adulterated. It subsequently conducted inspections and remote regulatory assessments of 48 manufacturing sites. Of those, 21% were deemed noncompliant under a section of the Federal Food, Drug, and Cosmetic Act. There also appeared to be a pattern in which sites would register as GLP-1 API manufacturers, offer the product for import, refuse to answer FDA request for records, and then deregister.

Fraudulent compounded semaglutide and tirzepatide have been marketed in the US, containing false information on the product label. In some cases, the compounding pharmacy identified on the label didn’t exist. In others, the pharmacy listed didn’t compound the product.

At least one reported adverse event — redness, site swelling, pain, and a red lump at the injection site — was associated with a product labelled as compounded tirzepatide from a pharmacy that didn’t compound the product.

Adverse events including nausea, vomiting, diarrhea, abdominal pain, and constipation have also been reported that may be related to dosing errors with compounded products. “Healthcare professionals should be vigilant when prescribing compounded semaglutide or tirzepatide products and determining appropriate doses and titration and dosing schedules for patients,” the agency said.

Retatrutide and cagrilintide are not FDA-approved and can’t be used in compounding. Similarly, salt forms of semaglutide — semaglutide sodium and semaglutide acetate — have been used in compounding. “The agency does not have information on whether these salts have the same chemical and pharmacologic properties as the active ingredient in the approved drug, and we are not aware of any lawful basis for their use in compounding,” the agency said.

The FDA recommends:

• Compounded drugs only be used in patients whose medical needs cannot be met by an FDA-approved drug.
• Patients should obtain a prescription from their doctor and fill the prescription at a state-licensed pharmacy.
• Visit FDA’s BeSafeRx campaign for resources to safely buy prescriptions online.
• Patients are advised to speak with their doctors about prescriptions.

As of July 31, 2025, FDA had received 605 reports of adverse events associated with compounded semaglutide and 545 associated with tirzepatide. “It is not always possible to determine if the adverse event directly resulted from the use of the drug or if other factors may have contributed to these adverse events,” the agency said.

As always, FDA encourages healthcare professionals, patients, and compounders to report adverse events or quality problems with these or any medications to the Medwatch Adverse Event Reporting Program.

Miriam E. Tucker is a freelance journalist based in the Washington DC area. She is a regular contributor to Medscape Medical News, with other work appearing in the Washington Post, NPR’s Shots blog, and Diatribe. She is on X @MiriamETucker and BlueSky @miriametucker.bsky.social.