FDA created a green list to block to import of potentially dangerous compounding ingredients.
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Green means go, but not for compounded GLP-1s.

The immense popularity of GLP-1 medications has created a higher-than-normal demand for compounded versions of the medications. During a shortage in 2023 and 2024, FDA briefly loosened its regulations about compounding medications to help alleviate supply-chain issues. However, the shortage was declared ended and the normal regulations are back to being fully enforced.

What ingredients are not restricted by FDA's green list?

That hasn’t stopped the apparent flow of compounded GLP-1 medications. Major drug makers such as Novo Nordisk and Eli Lilly have taken significant steps to block the compounding of their medications. Both companies have cited safety concerns as the reason for blocking compounding, although they both have a clear financial concern in the matter as well.

On Friday, September 5, FDA announced a “green list” that controls certain pharmaceutical ingredients from entering the United States.¹ The list is focused solely on ingredients used for compounding GLP-1s and aims to block entrance from what it describes as “unverified foreign sources.” According to the agency, the list was created to ensure that consumers are not being exposed to potentially dangerous compounded medications created from ingredients from illegal sources.

In a news release, FDA commissioner Marty Makary, MD, MPH, explained, “Americans should be confident that the prescription drugs they take are safe. 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.”

George Tidmarsh, MD, PhD, and director of FDA’s Center for Drug Evaluation and Research, added, “Our priority is protecting public health by ensuring all active ingredients used in GLP-1 drugs are obtained from compliant manufacturers. Targeting illegal foreign GLP-1 active ingredients at the border is a critical part of this work.”

The release reiterates that compounded GLP-1s are not FDA approved. However, due to the high number of people seeking them out, the agency hopes that this move will ensure that people using compounded medications are at least using drugs sourced from facilities that meet FDA’s safety standards.

APIs from unverified or unapproved sources will be detained without physical examination.

On a section of its website devoted directly to compounded GLP-1 medications,² FDA makes the following recommendations to consumers:

• Carefully check labels for spelling errors or incorrect addresses.
• Ensure that the medication is provided by a licensed pharmacy.
• Contact pharmacies if there is any doubt that medication may have a fraudulent label.
• Talk to a doctor with any questions about medications.

In April, Eli Lilly filed a lawsuit against multiple telehealth companies it says were offering patients illegal versions of its popular weight loss drug Zepbound.³ In a statement to NPR, and spokesperson for Eli Lilly said, “"Anyone continuing to sell mass compounded tirzepatide is breaking the law and deceiving patients. We will continue to take action to stop those who threaten patient safety and urgently call on regulators and law enforcement to do the same."

The lawsuit included the following companies: Mochi Health, Willow Health, Fella Health and Delilah, and Henry Meds.

Novo Nordisk published a lengthy statement on its site explaining its position on compounded semaglutide.⁴ The post begins, “Novo Nordisk is committed to raising awareness about and combating the manufacturing and spread of unauthorised, unlawful and unsafe semaglutide active pharmaceutical ingredients (APIs) and semaglutide medicines, as well as other illegal activities that threaten patient safety and the integrity of our products.”

Novo continues to go over the various regulations it says compounding violates and describes the negative impact the practice has on patient safety.

Sources

1. FDA Launches Green List to Protect Americans from Illegal Imported GLP-1 Drug Ingredients. FDA. September 5, 2025. https://www.fda.gov/news-events/press-announcements/fda-launches-green-list-protect-americans-illegal-imported-glp-1-drug-ingredients
2. FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss. FDA. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss
3. Eli Lilly sues companies selling alternative versions of its weight loss drug. NPR. April 23, 2025. Accessed September 8, 2025. https://www.npr.org/sections/shots-health-news/2025/04/23/nx-s1-5374063/eli-lilly-sues-companies-selling-alternative-versions-of-its-weight-loss-drug
4. Our position on illicit compounding of semaglutide. Novo Nordisk. https://www.novonordisk.com/sustainable-business/esg-portal/principles-positions-and-policies/illicit-compounding-position.html