Research

FDA Green List GLP-1: What It Means for Your Vial

Creator: Elena Marsh, Health Writer
Published: 2026-09-23

Twenty state attorneys general say FDA's list of cleared GLP-1 ingredient makers can be gamed, pointing to a Chinese supplier FDA caught relabeling semaglutide. What that case shows about where compounded semaglutide comes from, and what it doesn't change.

Elena Marsh, Health Writer September 23, 2026 7 min read

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The short version

On September 17, 2026, attorneys general from 20 states asked the National Security Council to tighten oversight of FDA's green list of GLP-1 ingredient makers, warning it could become a "laundering channel." That is their argument, not an FDA finding.
The case they cite is documented: FDA's May 1, 2026 warning letter says a green-listed Chinese supplier relabeled semaglutide bought from a plant not on the list. Both U.S. batches were recalled, and FDA removed the firm from the list on February 27, 2026.
FDA launched the green list on September 5, 2025; its import alert says about 1 in 5 of the 48 GLP-1 ingredient sites FDA evaluated were out of compliance. Its September 21, 2026 version lists 21 firm entries, 12 of them in China.
Under section 503A, the bulk ingredient in a compounded prescription must come from an FDA-registered establishment with a valid certificate of analysis. FDA says the green list creates no new limits on legal compounding.
The practical difference between a prescribed vial and a gray-market one is traceability: a named, state-licensed pharmacy answers to its board and can trace a recalled ingredient lot, while an anonymous seller offers none of that.

The FDA green list — GLP-1 ingredient makers the agency has checked and spared from automatic holds at the border — is under fire from 20 states. On September 17, 2026, their attorneys general wrote to Secretary of State Marco Rubio arguing that the list gives Chinese suppliers a trusted lane that can hide poor-quality semaglutide and tirzepatide ingredients. Their lead example is real, and FDA documented it first. For someone on compounded semaglutide, the news is narrower than it sounds. It's about where the raw ingredient in a vial comes from, and that's something a patient can ask about.

What happened

The letter, led by Alabama Attorney General Steve Marshall and released September 18, asks the National Security Council to help treat Chinese-sourced GLP-1 ingredients as a national-security threat. In the attorneys general's words, FDA gave "Chinese suppliers a green light to ship unapproved, knock-off product to America without detention or inspection," and "a Green List can quickly become a laundering channel rather than a safeguard."

That's their argument, not a finding by FDA or a court. The strongest evidence in the letter comes from FDA itself.

It's a warning letter FDA sent on May 1, 2026 to a Chinese maker of peptide ingredients. FDA had put the company on the green list on September 5, 2025, the day the list launched. Inspectors visited that November and found it had bought semaglutide ingredient from outside suppliers, including a plant that wasn't on the green list, then relabeled the batches under its own name and changed their manufacturing and retest dates. Two batches reached the U.S. FDA wrote that naming itself instead of the real manufacturer "may have been an attempt to circumvent safeguards."

The company began recalling both batches in February 2026. On February 27, FDA took it off the green list and put it on Import Alert 66-40, the red list for drug makers that haven't met manufacturing standards.

Citing Axios reporting that some Chinese makers linked to fentanyl-precursor supply chains now sell peptides, the letter asks whether that could include GLP-1 ingredients. It names no GLP-1 supplier with such ties. And it compares the moment to the 2007 heparin contamination, when a tainted blood thinner was linked to several U.S. deaths and hundreds of adverse reactions worldwide (Szajek et al., Nature Biotechnology 2016).

As of September 23, 2026, the day this article was written, the green list was still in force. FDA's posted version of Import Alert 66-80 carried a published date of September 21, 2026, and listed 21 firm entries, 12 of them in China, with company names redacted. On September 19, FDA added another Chinese peptide-ingredient maker to the 66-40 red list, covering all of its drugs.

The FDA green list — GLP-1 ingredients at the border

An API, or active pharmaceutical ingredient, is the drug itself as a raw powder, before anyone turns it into an injection. A compounding pharmacy buys it in bulk and prepares vials from it.

An import alert lets FDA hold shipments at the border without examining them first, which the agency calls detention without physical examination. The importer then has to show the shipment is sound.

Since September 5, 2025, foreign GLP-1 ingredient can be held that way unless its maker is on the green list: sites that, in the import alert's words, "appear to be in compliance" with manufacturing rules. The alert says FDA evaluated 48 GLP-1 ingredient sites and found about 1 in 5 (21%) out of compliance.

Why the border matters so much: the import alert notes that pharmacies compounding under section 503A are exempt from federal manufacturing-grade rules (CGMP), including the rule to confirm an ingredient meets specifications for impurities and potency. So FDA sees "a heightened risk" that a problem baked into the ingredient isn't caught during compounding.

Where compounded semaglutide comes from

Compounded semaglutide typically starts as bulk powder bought from an outside manufacturer. During the shortages, FDA says, those makers were "located around the world, including China, India, and Europe."

Federal law sets the bar. Under section 503A, a bulk ingredient used for a patient-specific prescription must be "manufactured by an establishment that is registered" with FDA, foreign plants included, and "accompanied by valid certificates of analysis." A certificate of analysis is a lab report for that batch covering identity and purity.

The relabeling case shows the limit of paperwork: once someone changes the label and the dates, the certificate no longer tells you which plant made the powder.

Does the maker change what ends up in the vial? One 2024 study suggests it can. Scientists at Novo Nordisk, which makes Ozempic and Wegovy, tested 16 injectable semaglutide ingredients and products from other makers against the original. They reported "new impurities and impurity patterns," including trace metals and residual solvents (leftovers from manufacturing). What that means for safety or results is unknown, and it's worth knowing who ran the study (Hach et al., Pharmaceutical Research 2024).

For the basics, including FDA's salt-form concern, see compounded semaglutide explained.

Tirzepatide is in the same supply chain

The same warning letter faulted the company's tirzepatide ingredient. FDA said it shipped tirzepatide lots to the U.S. before stability studies supported the retest date on them, and in 2024 before it had finished validating its tests for strength and impurities. The attorneys general name tirzepatide too, along with retatrutide, which the letter itself notes is still in phase 3 trials.

What the letter does not mean

It doesn't change the rules. FDA's own GLP-1 page, last updated September 1, 2026, says the green list "does not stop the legal importation" of GLP-1 ingredients from compliant makers, "nor does it create any new limits on the legal compounding of GLP-1 drugs."

It doesn't show that compounded semaglutide in general is made from bad ingredient. The documented case is two batches from one supplier, found on inspection and recalled.

And "made in China" isn't FDA's test. The list includes Chinese sites alongside ones in Europe, Canada and India; what counts is FDA's review of each site.

Nor does it change what a compounded prescription is. Through Promise, semaglutide and tirzepatide are dispensed as compounded medications, which are different from FDA-approved products: the formulations offered here are not FDA-approved. A licensed provider may still prescribe a compounded formulation where the rules allow it; that decision is between you and your doctor. FDA's separate proposal to keep both drugs off the 503B bulks list is its own story.

What a prescribed route answers to

Here's the real difference from a gray-market vial: an anonymous seller labeled for laboratory use may have no pharmacy of record, no board to answer to and no way to reach you with a recall (gray-market peptides covers that trade). A state-licensed pharmacy filling a prescription has a board: FDA says state boards of pharmacy have "primary responsibility for the day-to-day oversight" of those pharmacies, and the ingredient rules above still apply. A pharmacy that records lot numbers can trace a recalled ingredient to the prescriptions it went into.

FDA's GLP-1 page also warns about compounded vials whose labels name pharmacies that don't exist, or real pharmacies that didn't make them.

Questions a patient can bring to a prescriber or pharmacy:

Which pharmacy prepares my prescription, and which state board licenses it?
Where does its semaglutide ingredient come from, and is that site registered with FDA? The public green list hides company names, so the pharmacy is the one who can answer.
Does each ingredient lot arrive with a certificate of analysis, and is the finished vial tested too? A certificate isn't finished-vial testing.
If an ingredient lot is recalled, how would I hear about it?

They're fair questions for any prescriber or pharmacy. At Promise, a licensed provider reviews every request, and not everyone qualifies.

What to watch next

First, whether the National Security Council or FDA answers the letter in public. Second, the list itself: FDA says its import alert databases update in real time, so removals show up there first. Third, inspections. The relabeling came to light on site, not at the border.

Common questions

What is the FDA green list for GLP-1 ingredients?

It's a list inside FDA Import Alert 66-80, launched September 5, 2025, of foreign manufacturing sites whose GLP-1 ingredients FDA has reviewed and that appear to follow manufacturing rules. Shipments from those sites are spared automatic border holds. GLP-1 ingredient from sites not on the list can be detained without examination until the importer shows it is sound.

Does the attorneys general letter mean compounded semaglutide is unsafe?

Not on its own. The letter is an argument for tighter oversight. Its documented example is one Chinese supplier that FDA found relabeling semaglutide bought from other plants; the two U.S. batches were recalled and the company was removed from the green list. The letter doesn't change compounding rules, and FDA says the green list creates no new limits on legal compounding.

Where does compounded semaglutide come from?

A licensed pharmacy prepares it for a named patient from a bulk ingredient bought from an outside manufacturer. FDA says those makers are located around the world, including China, India and Europe. Federal law requires the ingredient to come from an FDA-registered establishment with a valid certificate of analysis, and foreign GLP-1 ingredient from a site not on the green list can be held at the border.

Is compounded semaglutide FDA-approved?

No. FDA-approved versions of these molecules exist, but the compounded formulations offered here are not FDA-approved. Brand products such as Ozempic and Wegovy went through FDA review; a compounded preparation is made by a licensed pharmacy for one patient and isn't reviewed before it's dispensed. A licensed provider may still prescribe it where the rules allow; that decision is between you and your doctor.

What happened to the Chinese supplier FDA caught relabeling semaglutide?

FDA inspected it in November 2025 and found it had relabeled semaglutide bought from outside suppliers, including a plant not on the green list. The company began a voluntary recall of the two U.S. batches on February 19, 2026. On February 27, FDA removed it from the green list and added it to Import Alert 66-40, and a warning letter followed on May 1, 2026.

How can I find out where my pharmacy's semaglutide ingredient comes from?

Ask the pharmacy or the prescriber. The public version of FDA's green list redacts company names, so a patient can't check it directly. Useful questions: which pharmacy prepares the prescription and which state licenses it, whether the ingredient's maker is registered with FDA, whether each lot comes with a certificate of analysis, and how a recall would reach you.