The FDA Green List and compounded GLP-1 Medications Semaglutide & Tirzepatide

With the rising demand for GLP-1 medications such as Wegovy® (semaglutide), Ozempic® (semaglutide), Zepbound® (tirzepatide), and Mounjaro® (tirzepatide), many patients are turning to compounded versions when brand products are unavailable or not covered by insurance. Recently, the FDA issued a new “Green List” (Import Alert 66-80) to regulate which manufacturers can supply the active ingredients (APIs) used in compounding these medications. This blog explains what the FDA Green List is, what it means—and doesn’t mean—for patients using compounded semaglutide or tirzepatide.

What is the FDA Green List?

The FDA issued Import Alert 66-80 (IA-1186) on September 5, 2025 to strengthen oversight of GLP-1 active pharmaceutical ingredients (APIs) imported into the U.S.

• The Green List applies to the raw active ingredients used in compounding — such as semaglutide and tirzepatide APIs.

• It does not apply to brand medications like Wegovy® (semaglutide), Ozempic® (semaglutide), Zepbound® (tirzepatide), or Mounjaro® (tirzepatide), which are fully FDA-approved and manufactured under their own regulatory pathways.

• Being on the Green List means a manufacturer’s API shipments are not automatically detained at the border, because the FDA has reviewed their facility and found it compliant with current Good Manufacturing Practices (cGMPs).

In short: the Green List is a safety checkpoint for compounded APIs, not for brand medications.

Why FDA Involvement Matters

Not all ingredients are created equal. Laboratory-grade chemicals may be fine for research but are not safe for human use, since they aren’t tested for purity, sterility, or consistency. Pharmaceutical-grade APIs, by contrast, must meet strict FDA standards under current Good Manufacturing Practices (cGMPs).

Many of the deeply discounted products sold online are laboratory grade, not pharmaceutical grade. Choosing those is like taking the salt sold at a hardware store for water softeners and sprinkling it on your dinner table — it looks similar but isn’t made for safe consumption.

The FDA’s Green List helps ensure that compounded semaglutide and tirzepatide come from manufacturers producing true pharmaceutical-grade ingredients, not unregulated substitutes.

Why does the FDA Green List matter for patients using GLP-1 medications?

For patients using or interetsed in using compouned semaglutide or tirzepatide, the Green List matters because it reduces the risk of compounded medication being made with APIs from unverified or unsafe sources and provides some regulatory oversight in a growing compounding market.

What happens if a manufacturer isn’t on the Green List?

If a semaglutide or tirzepatide API manufacturer is not on the FDA Green List:

• Their shipments may be detained at the U.S. border until additional evidence of safety and compliance is provided.

• Medications may face delays, extra testing, or refusal for entry.

• These APIs are considered higher risk, since FDA compliance has not been confirmed.

What does being on the FDA Green List not mean?

It’s important to understand the limits of the Green List. Being on the list does not mean:

• The compounded medication itself is FDA-approved (no compounded GLP-1 product is FDA-approved).

• The manufacturer’s inclusion is an FDA “endorsement” of the safety or effectiveness of compounded medications.

• The company will remain on the list permanently — manufacturers can be removed if inspections later reveal compliance issues.

• That every lot is flawless; pharmacies and clinics must still verify Certificates of Analysis (COAs), potency, and purity for each batch.

The Green List only verifies that the manufacturer’s API production meets cGMP standards — it does not make compounded semaglutide or tirzepatide equivalent to brand-name FDA-approved drugs.

How to Choose a Provider for Compounded GLP-1 Medications

If you’re considering compounded semaglutide or tirzepatide, it’s important to know what to look for in a trusted provider. Here are a few key questions patients should ask:

• Is the pharmacy U.S.-licensed?

  • Only work with providers who partner with pharmacies licensed to operate in the United States.

• Do they source from FDA Green List manufacturers?

  • Ask whether the active ingredients (APIs) come from manufacturers that the FDA has inspected and listed as compliant under Import Alert 66-80 (the Green List).

• Do they provide Certificates of Analysis (COAs)?

  • COAs confirm each batch has been tested for identity, purity, and potency.

• Is the medication labeled with a Beyond-Use Date (BUD)?

  • Proper dating shows the medication has been compounded under safe conditions and should not be used past the specified timeframe.

• Do they educate patients on storage and use?

  • A trustworthy provider will explain how to handle, store, and administer compounded medications safely.

By choosing a clinic or pharmacy that meets these standards, patients reduce their risk of receiving unsafe or ineffective compounded products.

Considering compounded semaglutide or tirzepatide? Book your free consultation with Potere Health MD in St. George, Cedar City or Salt Lake City — with both in-person and virtual appointments available.

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Disclaimer: This article is for educational purposes only and is not a substitute for medical advice.

About the Author

Dr. Joshua Silva, MD, is a licensed physician and Medical Director of Potere Health MD. He completed residency training in Occupational and Environmental Medicine from the University of Utah and now specializes in evidence-based weight management, including GLP-1/GIP therapies (semaglutide, tirzepatide). Dr. Silva provides in-person and virtual care for patients throughout Utah.

Sources:

1. FDA Import Alert 66-80 (IA-1186): “Detention Without Physical Examination of Unapproved New Drugs Promoted in the U.S.”

2. FDA: Facts About Current Good Manufacturing Practices (cGMPs)

3. FDA: Current Good Manufacturing Practice (CGMP) Regulations