FDA Import Alert 66-80: Where Compounders' Semaglutide API Comes From

Compounders buy raw semaglutide and tirzepatide from ingredient manufacturers, many of them overseas, and since September 2025 FDA has controlled that flow with Import Alert 66-80, a "green list" system. GLP-1 active ingredients from foreign manufacturers FDA has inspected or evaluated can enter the U.S.; shipments from anyone else can be detained at the border without physical examination. For patients, the alert turns "where did my pharmacy's API come from?" into a question with a checkable answer.

What "API" means and why its source matters

The active pharmaceutical ingredient (API), also called a bulk drug substance, is the raw drug before it's made into a finished product. A compounding pharmacy buys semaglutide or tirzepatide API as powder and turns it into injectable vials. Whatever is in that powder, including impurities or the wrong molecular form, ends up in the vial.

That's why FDA treats API sourcing as a distinct risk for compounded drugs. Pharmacies compounding under section 503A "are exempt from CGMP requirements," FDA writes in the import alert, so there is "a heightened risk that any quality concerns associated with the bulk drug substance" won't be caught during compounding (FDA Import Alert 66-80). In practice, a 503A compounder may rely heavily on its supplier's paperwork.

The legal baseline before the green list

Federal compounding law already set minimum rules for API. Under section 503A, a bulk drug substance must be manufactured by an establishment registered with FDA, "including a foreign establishment," and must be "accompanied by valid certificates of analysis" (21 U.S.C. 353a).

State boards add detail. Kansas's April 2026 statement requires pharmaceutical-grade API (not research, investigational, food, or supplement grade), from an establishment registered with FDA as a manufacturer of that substance, with a COA "that identifies the original manufacturer" (Kansas Board of Pharmacy). North Carolina says products labeled "research use only," or made by unregistered facilities, may not be used for compounding under any circumstances (NCBOP).

Registration, though, is a paperwork step. It tells FDA a facility exists and what it makes. It doesn't mean FDA has inspected the site. The import alert exists because FDA concluded registration alone wasn't keeping bad API out.

How Import Alert 66-80 works

An import alert tells FDA field staff how to handle certain shipments. Import Alert 66-80 is titled "Detention Without Physical Examination of Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist Bulk Drug Substances" (FDA). It flips the usual default: instead of FDA needing to find a problem with a shipment, foreign GLP-1 API is presumed detainable unless its manufacturer and product are on the green list.

Source: FDA Import Alert 66-80; FDA press release; Frier Levitt.

DWPE, short for detention without physical examination, means FDA can hold a shipment without testing it. Under FDA's general detention process, the importer then gets a short window to submit evidence that the product complies; Frier Levitt notes FDA generally allows 10 business days, and refused goods must be exported or destroyed within 90 days (Frier Levitt).

The alert covers GLP-1 receptor agonist bulk substances broadly. Product codes on the current list include semaglutide, tirzepatide, liraglutide, exenatide, dulaglutide, and orforglipron, along with some catch-all peptide and hormone codes (FDA).

What FDA found that led to the alert

The import alert's "Reason for Alert" section lays out FDA's evidence. Two findings stand out:

• A meaningful noncompliance rate. "Of the 48 GLP-1 API sites FDA evaluated, it found that 21% were noncompliant" under the adulteration provisions of the FD&C Act, either because records showed CGMP problems or because the sites didn't answer FDA's records requests in time (FDA).
• A register-and-vanish pattern. FDA describes "a pattern of sites that register as GLP-1 API manufacturers, offer GLP-1 APIs for import, refuse to answer FDA's requests," and then deregister within a short period (FDA).

The second finding explains why registration alone isn't reassuring. A site can be "FDA-registered" on the day a pharmacy buys from it and gone from the registry months later. FDA's press release tied the program to concerns it had already identified with compounded semaglutide and tirzepatide, including dosing errors, unapproved salt forms, and adverse events, some requiring hospitalization (FDA).

Who is on the green list

The October 9, 2026 posting groups green-listed manufacturers by country: Belgium, Canada, China, Denmark, India, Ireland, Italy and Portugal, with China accounting for the largest number of entries (FDA Import Alert 66-80). Each entry lists the specific products that firm is cleared for. A manufacturer green-listed for liraglutide is not automatically cleared for semaglutide.

Firms get on the list by petitioning FDA's Division of Import Operations with evidence of CGMP compliance. FDA lists examples such as certificates of analysis, specifications, stability data, batch records, out-of-specification results, SOPs, and complaint and recall summaries, and it says firms can be removed if their products no longer appear to comply (FDA). The list changes, so any check should use the live FDA page, not a screenshot.

Registered, green-listed, or neither

Sources: FDA Import Alert 66-80; FDA press release (September 5, 2025); 21 U.S.C. 353a; NCBOP.

What the alert doesn't do

FDA is careful about the alert's limits. Its GLP-1 concerns page says the green list does not stop legal importation of GLP-1 APIs from compliant manufacturers and does not create new limits on legal compounding (FDA, updated October 1, 2026). Compounding still has to meet every other federal and state condition.

That matters because green-listed API isn't a permission slip. As of April 2026, FDA says semaglutide and tirzepatide are not on the 503B bulks list or the drug shortage list (FDA), and 503A pharmacies remain bound by the limits on making copies of approved drugs. Our 503A vs. 503B explainer covers those rules.

Nor does the alert reach gray-market channels that never route through a pharmacy. FDA reports it has warned API distributors for selling retatrutide, an investigational drug, to compounders, and states that "Retatrutide and cagrilintide cannot be used in compounding under federal law" (FDA).

What this means for you as a patient

You can't inspect a pharmacy's supplier, but you can ask questions that map onto the alert:

1. Who made the API? Ask the pharmacy to name the original manufacturer, which its certificate of analysis should identify.
2. Is that maker FDA-registered, and is it on the GLP-1 green list for this specific drug? A pharmacy sourcing carefully should know.
3. Is it the base form? Salt forms are a separate disqualifier; see our explainer on semaglutide sodium.
4. Does the pharmacy test incoming API itself? Some do; it's a reasonable thing to ask.

Then check the pharmacy's license and disciplinary history with its state board. Sourcing answers are only as trustworthy as the pharmacy giving them.

Sources

1. FDA, Import Alert 66-80 (posted October 9, 2026)
2. FDA, FDA Launches Green List to Protect Americans from Illegal Imported GLP-1 Drug Ingredients (September 5, 2025)
3. Frier Levitt, FDA Issues Import Alert on GLP-1s Following Launch of "Green List" (October 2025)
4. FDA, FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss (updated October 1, 2026)
5. FDA, FDA Clarifies Policies for Compounders as National GLP-1 Supply Begins to Stabilize
6. 21 U.S.C. 353a, Pharmacy compounding (Cornell LII)
7. Kansas Board of Pharmacy, Statement on Compounded GLP-1 and GIP Receptor Agonists (updated April 22, 2026)
8. North Carolina Board of Pharmacy, Statement Concerning Semaglutide Compounding (April 2023)

Medical disclaimer: This article is general information, not medical advice, and does not replace a licensed clinician who knows your history. Approvals, labels, coverage and prices change; check the linked sources and talk with your prescriber or pharmacist before making decisions about any medication.