Compounded Semaglutide and Tirzepatide: Are They Legal, and What Changed in 2025 and 2026

Short answer: Compounded semaglutide and tirzepatide are copies mixed by pharmacies, and they are not FDA-approved: the FDA does not check their safety, effectiveness or quality before they are sold.^[1] They spread while both drugs were on the FDA shortage list. Tirzepatide came off in December 2024 and semaglutide in February 2025, and the grace periods for compounders ended by May 22, 2025.^[2] Since then, a pharmacy may legally make a copy only in narrow cases, chiefly when a prescriber documents a change that makes a significant difference for one identified patient.^[3]

New to eating less? Start with what to eat when you're eating less, the guide the rest of Lighter Days builds on.

This page sets out what is true as of November 13, 2026: the shortage dates, what "personalized dosing" means under the law, what the FDA has warned about, what happened in 2025 and 2026, and what to ask before filling a prescription. It names no sellers and quotes no prices, on purpose.

General information, not legal or medical advice. Rules differ by state and change often. Talk to your prescriber and pharmacist about your own prescription.

Compounded vs FDA-approved semaglutide and tirzepatide at a glance

	FDA-approved product (Wegovy, Ozempic, Zepbound, Mounjaro)	Compounded by a 503A pharmacy	Compounded by a 503B outsourcing facility
FDA checks safety, effectiveness and quality before sale	Yes[4][5]	No[1]	No[1]
Who oversees it	FDA	Mainly the state board of pharmacy[1]	Registered with and inspected by the FDA[1]
Federal manufacturing-quality rules	Yes	Not the current good manufacturing practice rules that apply to outsourcing facilities[1]	Yes, current good manufacturing practice[1]
Needs a prescription for one named patient	Prescription required	Yes[2]	No; can make batches
Can copy semaglutide or tirzepatide now (November 2026)	Not applicable	Only in narrow cases (see below)[2]	No; neither drug is on the shortage list or the 503B bulks list[2]
Trial evidence behind the product	The phase 3 trials in its label	None for the compounded product itself	None for the compounded product itself

The last row matters most. Every trial result for semaglutide and tirzepatide, including those in our semaglutide and tirzepatide guides, was measured on the manufactured drug, not on a compounded version.

What is drug compounding? 503A vs 503B

Compounding, as federal courts describe it, is "a process by which a pharmacist or doctor combines, mixes, or alters ingredients to create a medication."^[6] It exists for patients an approved drug does not fit, such as someone allergic to a dye or unable to swallow a tablet.^[3] Federal law has two routes:

• Section 503A: traditional pharmacies. A licensed pharmacist in a state-licensed pharmacy, or a physician, compounds a drug based on a prescription for an individual patient. These pharmacies are overseen mainly by the states and are not held to the manufacturing-quality rules that apply to outsourcing facilities.^[1][2]
• Section 503B: outsourcing facilities. A category created in 2013 by the Drug Quality and Security Act. They register with the FDA, are inspected on a risk-based schedule and must meet current good manufacturing practice requirements. They can make larger batches without a patient-specific prescription.^[1]

Neither route makes the result an approved drug. In the FDA's words, "Compounded drugs are not FDA-approved. This means that FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed."^[1]

Why was compounded semaglutide and tirzepatide everywhere?

Because both drugs were in shortage. Federal law lets compounders make copies of a drug that is on the FDA's shortage list, and both were on it for years.^[2] The dates, from the FDA's own decision documents and policy page:

Date	What happened
March 31, 2022	Semaglutide (Wegovy) added to the FDA drug shortage list; Ozempic followed on August 23, 2022[7]
December 15, 2022	Tirzepatide added to the shortage list[8]
October 2, 2024	FDA says the tirzepatide shortage is resolved; after a lawsuit it re-evaluates the decision[2]
December 19, 2024	FDA confirms tirzepatide is no longer in shortage[8]
February 18, 2025	Grace period ends for 503A pharmacies compounding tirzepatide[2]
February 21, 2025	FDA declares the semaglutide shortage resolved[7]
March 19, 2025	Grace period ends for 503B facilities compounding tirzepatide[2]
April 22, 2025	Grace period ends for 503A pharmacies compounding semaglutide[2]
May 22, 2025	Grace period ends for 503B facilities compounding semaglutide[2]

The grace periods held because a federal court in Texas refused to block the FDA's decisions while a compounding trade group sued: it denied preliminary injunctions on March 5, 2025 for tirzepatide and April 24, 2025 for semaglutide.^[2] On August 27, 2026 the Fifth Circuit Court of Appeals affirmed the FDA in both cases, finding its action "was not arbitrary or capricious."^[9][6]

Is compounded semaglutide legal now? Is compounded tirzepatide legal?

Not as a routine substitute for the approved drug. As of the FDA's April 1, 2026 update, "Tirzepatide and semaglutide do not currently appear on the 503B bulks list or on FDA's drug shortage list."^[2] That leaves a narrow opening, mostly for 503A pharmacies:

• No "essentially a copy". A 503A pharmacy may not regularly compound a drug that is essentially a copy of a commercially available one. The FDA treats a product as a copy when it has the same active ingredient, in a similar or easily substitutable strength, given the same way.^[2] "Similar" generally means within 10%.^[3]
• The exception is one patient at a time. A copy is allowed only if "a prescriber determines that there is a change, made for an identified individual patient, which produces, for that patient, a significant difference from the commercially available drug product."^[3]
• Adding a vitamin does not get around it. The FDA's example: semaglutide with vitamin B12 can still be a copy when each ingredient is within 10% of the commercial strength.^[2]
• A small allowance. The FDA says it does not intend to act against a pharmacy for "four or fewer prescriptions of that compounded drug product during a calendar month."^[2]
• Outsourcing facilities. On April 30, 2026 the FDA proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list, saying it "did not identify a clinical need" for outsourcing facilities to compound them from bulk.^[10] The comment period was extended to July 30, 2026.^[11] We found no final decision as of November 13, 2026.

So "is it legal" has no single answer. A copy made for one patient, for a documented clinical reason, can be. Mass-produced copies sold as a cheaper version of Wegovy or Zepbound are what the FDA, the courts and the drug makers have been acting against.

What does "personalized dosing" mean legally?

Less than marketing suggests. The test is not whether a dose is described as personalized, but whether a prescriber has decided that a specific change produces a significant difference for that patient, and recorded it. The FDA's guidance gives examples of notations that are enough, such as "No Dye X, patient allergy," "Liquid form, patient can't swallow tablet," or a dose the approved product does not come in.^[3] It also says what is not enough:

• "if a prescription identifies only a patient name and drug product formulation, this would not be sufficient."^[3]
• "Other factors, such as a lower price, are not sufficient to establish that the compounded drug product is not essentially a copy."^[3]
• Congress noted that "minor changes in strength" that are not known to be significant can still be copies.^[3]

Semaglutide and tirzepatide are already sold in several approved strengths, which narrows the room for a dose that is truly unavailable.^[4][5] The FDA also tells telehealth companies not to describe a compounded drug as "a generic version of an FDA-approved drug or the same as a drug approved by FDA," or as "clinically proven to produce the same result."^[12]

What has the FDA warned about?

• Dosing errors. In July 2024 the FDA reported patients drawing 5 to 20 times the intended dose from multiple-dose vials, and clinicians miscalculating conversions between milligrams, milliliters and "units," leading to 5 to 10 times the intended dose.^[13] Some of these reports involved patients who needed hospital care.^[14] Approved pens deliver a set dose; a vial and a syringe do not.
• Adverse event reports. As of May 31, 2026, the FDA had received 990 reports of adverse events with compounded semaglutide and more than 730 with compounded tirzepatide.^[14] Reports like these do not prove the drug caused the event, and many events go unreported.
• Salt forms. Some compounders have used semaglutide sodium and semaglutide acetate. The FDA says these are different active ingredients from the one in the approved drugs, and it knows of no lawful basis for compounding with them.^[14]
• Imported ingredients. Under Import Alert 66-80, the FDA can detain GLP-1 active ingredients at the border. It reports that 21% of 48 GLP-1 ingredient sites it assessed were noncompliant.^[15]
• Counterfeits. Counterfeit Ozempic has been found in the US drug supply. Counterfeit drugs "could contain the wrong ingredients," the FDA says.^[14]

Compounded semaglutide side effects: what the reports show

Compounded semaglutide and tirzepatide are the same molecules as the approved drugs only if the product is what it claims to be, so the expected adverse events are the familiar ones: digestive symptoms such as nausea, vomiting, diarrhea and constipation, which the approved labels list as most common.^[4][5] The extra risks come from the product and the dosing:

• A poison center case series described three people who had symptoms after taking compounded semaglutide incorrectly; two had given themselves ten times the intended dose, and one measured in milliliters and units instead of milligrams. All three had nausea, vomiting and abdominal pain, mostly lasting days.^[16]
• An analysis of the FDA's adverse event database from 2018 to 2024 found 707 reports involving compounded GLP-1 products among 81,078. Compared with manufactured products, compounded ones had higher reporting odds for preparation errors, contamination, compounding problems and hospitalization.^[17] Reporting odds show patterns in reports, not rates, and the study was funded by a group that campaigns on drug safety.
• A 2025 secret-shopper study of 75 clinics and medical spas in West Virginia and Oklahoma, after the shortages ended, found 56.0% offering compounded GLP-1 products combined with B vitamins, and 4 of 21 supplier facilities without a license for sterile compounding.^[18]

The American Diabetes Association's 2025 statement says these products "bypass regulatory measures, raising safety, quality, and efficacy concerns."^[19] Anyone on any GLP-1 medication who cannot keep fluids down should call their prescriber. Food-first ideas for unsettled days are in what to eat on queasy days.

What changed in 2025 and 2026?

• April 2025: Eli Lilly sued two compounding pharmacies on April 1 and four telehealth companies on April 23 over compounded tirzepatide. One complaint alleged a company changed patients' additives and doses "at least five times in just eight months."^[20]
• August 5, 2025: Novo Nordisk said it had filed 132 complaints in federal courts across 40 states over compounded semaglutide, and that courts had issued 44 permanent injunctions in similar cases.^[21]
• September 9, 2025: The FDA announced a crackdown on misleading drug advertising, with about 100 cease-and-desist letters and thousands of letters to companies.^[22]
• February 6, 2026: The FDA said it intends to restrict GLP-1 active ingredients used in mass-marketed, non-approved compounded drugs, and that companies "cannot claim that non-FDA-approved compounded products are generic versions or the same as drugs approved by FDA." It warned of possible "seizure and injunction."^[23]
• March 3, 2026: The FDA sent warning letters to 30 telehealth companies for claims implying their compounded GLP-1 products were the same as approved drugs, and for branding that obscured who actually made them.^[24]
• October 2026: Import Alert 66-80 on GLP-1 ingredients was published in its revised form.^[15]

The states. In February 2025 a bipartisan coalition of state and territory attorneys general asked the FDA for "decisive action against the unlawful sale and distribution of counterfeit and illegally sold GLP-1 drugs."^[25] Alabama's attorney general sued a clinic that gave patients research-grade tirzepatide and semaglutide while advertising them as "pharmaceutical-grade," and settled on January 12, 2026.^[26] State pharmacy boards license 503A pharmacies, so your state's board is where to check a pharmacy's license and record.^[1]

Questions to ask your prescriber or pharmacy

These follow from the FDA's guidance and consumer advice, and apply to any GLP-1 prescription that is not an approved, manufacturer-packaged product.

• Why compounded? What change does my prescription make, and what significant difference does it produce for me compared with the approved product? Is that written on the prescription?^[3]
• Who makes it? What is the name of the pharmacy or outsourcing facility that compounds it, and is it licensed by my state's board of pharmacy (and, for an outsourcing facility, registered with the FDA)? The FDA has warned about branding that hides the compounder.^[24][1]
• What exactly is in it? Is the active ingredient the same base form as the approved drug, not a salt such as semaglutide sodium or acetate? What else has been added, and why?^[14]
• How do I measure a dose? In milligrams, milliliters or units? Can I have a syringe sized for my dose? The FDA advises patients not to recalculate a dose themselves.^[13]
• Is a prescription required, and is there a US address and a pharmacist I can call? The FDA's BeSafeRx signs of a safe pharmacy include all three, plus a state license; prices that "seem too good to be true" are a warning sign.^[27]
• How do I report a problem? Adverse events can be reported to the FDA's MedWatch program.^[14]

What stays the same, whichever product you take

A smaller appetite is the shared experience on every GLP-1 medication, approved or compounded, and it makes the quality of each small meal matter more. The 2025 joint advisory on nutrition with GLP-1 therapy puts protein first, suggests small, frequent, nutrient-dense meals with enough fluid, and lists iron, calcium, vitamin D and B12 among nutrients of concern when intake falls.^[28] The numbers are in how much protein on a GLP-1 and how much water to drink on a GLP-1, and the nutrition gap calculator shows which nutrients a smaller plate tends to miss. The full map is our GLP-1 nutrition guide. For the medicines themselves, see our guides to semaglutide, tirzepatide, the oral orforglipron and the investigational retatrutide.

For transparency about why this page exists on our site: we make one product, Zornava Replenish, a lemon-lime daily hydration and nutrient powder for lighter appetite days, including for people on GLP-1 medications. It is a dietary supplement, not a medication, and it is not a substitute for any prescription. It is not on sale yet; early access opens February 9, 2027, and the early-access list is open now.