Compounded Semaglutide and Tirzepatide: What Is Allowed Now

Compounded semaglutide and compounded tirzepatide are pharmacy-made versions of the active ingredients in Wegovy, Ozempic, Zepbound and Mounjaro. They became widely available when those drugs were in shortage, but the FDA declared both shortages over by early 2025. Since then, pharmacies may no longer make routine copies of the approved drugs, and the FDA has stepped up warning letters to compounders, telehealth marketers and online sellers. This guide explains what compounding is, what changed, what is still allowed, and how to check a pharmacy.

Peptide Labs does not sell semaglutide, tirzepatide or any compounded or prescription drug. This article is general information, not medical or legal advice.

What is compounding?

Compounding is the preparation of a medicine by a pharmacist, or under a pharmacist’s supervision, to meet a specific patient’s needs. Classic examples are a liquid version of a tablet for someone who cannot swallow pills, or a formula without a dye the patient is allergic to. Federal law sets up two tracks:

Either way, the finished product is not FDA-approved. That is the central difference from Wegovy or Zepbound, whose safety, effectiveness and manufacturing were reviewed before sale.

The shortage era and why it ended

Demand for semaglutide and tirzepatide outpaced supply in 2022, and both drugs went onto the FDA’s drug shortage list. While a drug is in shortage, federal law gives compounders more room to make copies of it, and a large market for compounded versions grew up, much of it sold through telehealth services. Once the manufacturers could meet demand, the FDA removed both drugs from the list and gave compounders time to wind down:

What compounded semaglutide and tirzepatide are allowed now

With the shortages over, the main rule is that a 503A pharmacy may not compound drugs that are “essentially a copy” of a commercially available approved drug regularly or in large amounts. The FDA treats a compounded product as a copy when it has the same active ingredient, a similar strength and the same route of administration as the approved drug.

There is a narrow exception. A product is not considered a copy if the prescriber determines that a change makes a significant difference for that individual patient, for example removing an ingredient the patient is allergic to. That determination has to be real and patient-specific, and it should be documented. Outsourcing facilities have even less room, because neither semaglutide nor tirzepatide is on the 503B bulks list or the shortage list.

"Personalized dosing" and added vitamins

Some sellers argue that adding a vitamin such as B12, or offering a custom dose, makes their product different. The FDA has pushed back. In a warning letter dated September 18, 2026, the agency told a Houston compounding pharmacy that its tirzepatide-with-niacinamide and semaglutide-with-cyanocobalamin (vitamin B12) products were still essentially copies of the approved drugs. It said the volume produced suggested the claimed differences were “pretextual,” and noted that prescriber notes justifying the differences were repeated word for word across many records.

FDA safety concerns about compounded GLP-1 drugs

The FDA keeps a public page on its concerns about unapproved GLP-1 drugs. As of its September 2026 update, the main issues are:

• Adverse events. By May 31, 2026 the FDA had received 990 adverse-event reports involving compounded semaglutide and more than 730 involving compounded tirzepatide. Reports alone do not prove the product caused the problem, but they are a signal the agency tracks.
• Dosing errors. The FDA has received reports, some requiring hospitalization, that may be linked to dosing errors with compounded injectable semaglutide, including doses above those on the approved labels. Compounded products often come in vials rather than prefilled pens, so patients measure each dose themselves.
• Salt forms. Some compounders have used semaglutide sodium or semaglutide acetate. The FDA has said these are different active ingredients from the one in the approved drugs.
• Counterfeits. The FDA has warned about counterfeit Ozempic in the U.S. supply chain, which could contain the wrong ingredient, the wrong amount, or none at all.
• Imported ingredients. The FDA uses a “green list” import alert to stop GLP-1 active ingredients from sources it has not cleared from entering the country.

Warning letters to telehealth companies and online sellers

Much of the FDA’s recent enforcement has targeted how compounded GLP-1 drugs are marketed:

• September 9, 2025: the FDA sent a batch of warning letters to companies marketing compounded semaglutide and tirzepatide. One, to a large telehealth company, objected to claims such as “same active ingredient as Ozempic and Wegovy” and “clinically proven ingredients,” because they imply a compounded product is the same as an approved one.
• March 3, 2026: the FDA sent 30 warning letters to telehealth companies over claims presenting compounded GLP-1s as effectively the same as the approved drugs, and over private-label branding that obscured which pharmacy actually made the product.
• March 31 and August 24, 2026: the FDA warned online sellers offering semaglutide, tirzepatide and retatrutide labeled “research use only,” finding the products were intended for human use.
• September 18, 2026: the “pretextual differences” letter to a compounding pharmacy described above.

Retatrutide is a separate case: it is an investigational drug with no approved version, so there is no lawful compounded retatrutide. Our retatrutide profile explains its status.

How to check a pharmacy or telehealth service

Whether a prescriber recommends a brand-name drug or, in a genuine patient-specific case, a compounded one, these checks help you avoid unlicensed and unsafe sellers:

1. Look up the pharmacy’s license with your state board of pharmacy. A legitimate pharmacy must be licensed in the state where you live, not only where it is located.
2. If the product comes from an outsourcing facility, confirm the facility appears on the FDA’s list of registered 503B outsourcing facilities.
3. Search the website on NABP’s safe.pharmacy tool. Sites ending in .pharmacy have been verified by NABP; NABP lists thousands of other sites as Not Recommended.
4. Make sure a valid prescription from a licensed prescriber is required, and that the pharmacy has a U.S. address and a licensed pharmacist you can talk to. The FDA’s BeSafeRx page lists these warning signs.
5. Ask which pharmacy compounds the product and which active ingredient it uses. Avoid salt forms such as semaglutide sodium or acetate.
6. Walk away from anything labeled “research use only” or “not for human consumption.”

Compounded vs FDA-approved: the bottom line

The approved brands have been studied in large trials, are made under FDA-inspected manufacturing, and come with a label, a Medication Guide and a recall system. A compounded version has none of that FDA review, even when it is made carefully by a licensed pharmacy. Since 2025 there are also FDA-approved alternatives that did not exist before, including the Wegovy pill and generic liraglutide, covered in our guide to peptides for weight loss. For how the two molecules compare, see semaglutide vs tirzepatide, and for the wider legal picture, are peptides legal?

If cost or access is the reason you are considering a compounded drug, raise it with your prescriber or pharmacist; they can explain coverage and the approved options available to you.

Frequently Asked Questions

Last reviewed September 2026. FDA compounding policy and enforcement change often; check the FDA’s current guidance or ask a pharmacist for the latest details. These statements are general information and are not a substitute for advice from a licensed healthcare provider.