The 30-second summary
- Compounded semaglutide and tirzepatide are versions made by pharmacies, not by the original manufacturer (Novo Nordisk or Eli Lilly).
- They proliferated during the 2022–2024 shortages. With the FDA declaring the shortages resolved, compounding pharmacies are required to stop selling compounded versions in most cases.
- The molecule may be the same name, but compounded products are not subjected to the same manufacturing controls, dose accuracy testing, or safety surveillance as brand drugs.
What "compounded" actually means
Compounding is a long-standing pharmacy practice: a pharmacist mixes ingredients to produce a customised medication for an individual patient. It is legal, regulated, and useful in specific clinical situations, for example, when a patient is allergic to a dye in the commercial product, or needs a paediatric liquid version of a tablet medication.
Compounding was never intended for mass production of an off-the-shelf alternative to brand drugs.
During the 2022–2024 GLP-1 shortages, the FDA invoked a regulation that allows compounded versions of a drug to be produced when the brand is on the FDA Shortage List. This created a window in which thousands of compounding pharmacies, and many telehealth services, produced and sold "compounded semaglutide" and "compounded tirzepatide" at prices well below the brand drugs.
What the FDA has now decided
In October 2024 and February 2025, the FDA declared the semaglutide and tirzepatide shortages resolved. Under federal law, this triggers the unwinding of compounded production:
- Tirzepatide: Compounding pharmacies were given until March/April 2025 to stop. (FDA, Tirzepatide Compounding Q&A.)
- Semaglutide: A similar wind-down schedule, completed in May 2025.
Compounding pharmacies challenged this in court and lost. As of 2026, large-scale compounded GLP-1 production is mostly illegal in the United States. Some small-scale, individually justified compounded prescriptions remain legal under specific exemptions, but the days of "$200/month compounded Wegovy from a telehealth website" are essentially over.
Why the FDA cared
The agency's concerns, documented in public letters and warnings:
- Salt forms. Some compounded products used semaglutide sodium or semaglutide acetate, chemically different from the semaglutide base used in Ozempic and Wegovy. Safety and effectiveness data for these salt forms do not exist.
- Dosing errors. The FDA received hundreds of reports of patients overdosing on compounded GLP-1s. Compounded vials are not in pre-filled pens, users draw doses from a vial with a syringe, and dosing in microliters is genuinely difficult to do safely.
- Sterility and quality control. Brand drugs are manufactured under FDA-inspected good manufacturing practice. Compounding pharmacies vary widely. Several have been shut down for sterility failures.
- Adulterants. Some products marketed as "compounded semaglutide" online have been found to contain other peptides, contaminants, or unknown substances.
The FDA's bottom line, paraphrased: compounded GLP-1s are not a different brand of the same drug. They are a different drug, with different testing, different manufacturing, and different risks.
What this means for you
For most women, the practical answer is straightforward: the brand drugs are now widely available again, and your prescriber is unlikely to recommend a compounded version. The compounding loophole has effectively closed.
If you have been on a compounded product, the most common transition is to the brand drug at the same equivalent dose. This is a prescriber's decision and may involve some titration. Talk to your prescriber before making any change.
"But it was the same molecule"
A common refrain, and one that needs careful unpacking.
The molecule with the same chemical name may or may not be the same physical product. Salt form matters. Concentration matters. Excipients (the non-active ingredients) matter. Sterility matters. Dose-accuracy matters.
A compounded "semaglutide" product that uses semaglutide sodium is not the same as Wegovy's semaglutide base. Whether the difference is clinically important is unsettled, because the dedicated studies have not been done. In a regulated drug approval, that gap would be unacceptable. In compounding, it has been tolerated.
This is the heart of the FDA's case for winding compounding down.
The cost question
The price advantage of compounded GLP-1s was substantial: many telehealth services offered $150–$300 per month, versus $1,000+ for the brand drug at U.S. cash prices.
This is a real problem. The cost of GLP-1 medications in the United States, particularly for those without good insurance coverage, is a major access barrier. The end of large-scale compounding does not solve that problem.
What you can do:
- Push your insurance. Many plans now cover Wegovy and Zepbound for weight loss. The denial-and-appeal cycle is tedious but works more often than people expect.
- Patient assistance programmes from Novo Nordisk and Eli Lilly. Both manufacturers have direct programmes for uninsured or underinsured patients.
- Pharmacy discount programmes can reduce cash prices, though still not to compounded levels.
- Talk to your prescriber about an alternative GLP-1 if cost is a real barrier. Older drugs in the class (liraglutide as Saxenda) are often cheaper.
What this is not
This is not a moral judgment of women who used compounded products during the shortage. The shortage was real, the prices of the brand drug were prohibitive, and many women made a rational decision with the options they had. The situation has now changed; the options have changed; the right answer has changed.
What Steady does with this
Steady's medication selection includes the eight approved GLP-1 products by name. Compounded products are not separately listed. If you switch from a compounded version to the brand, you can log the change in your medication detail view, the symptom and weight tracking continues across the transition so you can see whether your response changes.
Sources
- FDA. FAQs: Tirzepatide Compounded Products. Updated 2025. FDA
- FDA. FAQs: Semaglutide Compounded Products. Updated 2025. FDA
- FDA. Drug Shortages List. FDA Shortages
- Eli Lilly. Patient Affordability Programs. Lilly
Medical disclaimer: Decisions about which medication to take, and from which source, are a conversation with your prescriber. See our full medical disclaimer.