Compounded semaglutide, tirzepatide and microdosing: what the evidence says

What is the difference between Ozempic and compounded semaglutide?

Ozempic and Wegovy are Novo Nordisk’s brand names for semaglutide, a modified version of GLP-1, a gut hormone that helps control blood sugar and appetite⁴⁸⁵⁰. Eli Lilly sells tirzepatide as Zepbound for weight loss and Mounjaro for type 2 diabetes⁴⁹⁵¹. It acts on the receptors for two gut hormones, GIP and GLP-1⁴⁹.

A 2026 federal appeals ruling describes compounding as “a process by which a pharmacist or doctor combines, mixes, or alters ingredients to create a medication”⁷. Winning FDA approval takes what the court called a “long, comprehensive, and costly testing process”⁷⁸. Compounded drugs are not FDA-approved, and FDA does not review them for safety, effectiveness or quality before they are marketed². Federal law has two routes: state-licensed pharmacies and physicians compound under section 503A, and outsourcing facilities under section 503B¹.

In July 2024, FDA noted that approved semaglutide injections had standard concentrations and came only in prefilled pens⁹. Compounders offered semaglutide in multiple-dose vials and prefilled syringes, and concentrations could vary from one compounder to another⁹. FDA lists a company claiming that “the compounded drug is the same as an FDA-approved drug” as a warning sign².

A study of 93 Colorado websites advertising compounded GLP-1 drugs in 2024 found that 41 referred to FDA approval and 5 called the products “generic”¹⁰. The authors called these “misleading claims regarding the regulatory status” of the products¹⁰. In a 2026 online study of 322 US adults who injected semaglutide or tirzepatide weekly, photos of their medicine showed 83 were using compounded products¹¹. Of those 83, 54 said they were using one of the brand-name drugs¹¹.

Can you still get compounded semaglutide or tirzepatide in 2026?

As of 8 October 2026, FDA’s drug shortage records had no tirzepatide entry⁴. Their only semaglutide entries were three strengths of Rybelsus tablets, marked “To Be Discontinued” rather than in shortage³. That matters because the shortage list is what allowed routine copies¹².

While a drug is on FDA’s shortage list, the 503A limit on making “essentially copies” of it does not apply¹². Outsourcing facilities may then make identical or nearly identical copies, starting from the bulk ingredient¹². Once a shortage is resolved, FDA “generally considers the drug to be commercially available”, so the copy limits apply again¹¹². FDA gave compounders grace periods after each shortage ended¹.

• Tirzepatide: the grace period ended on 5 March 2025 for 503A pharmacies and on 19 March 2025 for outsourcing facilities¹.
• Semaglutide: it ended on 24 April 2025 for 503A pharmacies and on 22 May 2025 for outsourcing facilities¹.

On 1 April 2026, FDA reminded compounders of key conditions under section 503A¹.

• A drug must be compounded “for an individual patient based on receipt of a prescription”¹.
• A pharmacy may not make “essentially copies” of a commercially available drug “regularly or in inordinate amounts”¹.
• FDA counts a product as a copy if it has the same active ingredient “in the same, similar or an easily substitutable strength”¹. The approved drug must also be usable by the same route, such as injection, “regardless of how it is labeled”¹.
• The exception is a change that a prescriber documents as making a “significant difference” for an identified patient¹.
• A semaglutide and vitamin B12 product can still be a copy when both amounts are within 10% of approved strengths¹.
• For now, FDA does not intend to act against a pharmacy that fills four or fewer prescriptions of a copy in a calendar month¹.

Outsourcing facilities may compound from a bulk ingredient only if it is on the 503B bulks list or the drug is in shortage¹. On 1 April 2026, FDA said neither semaglutide nor tirzepatide was on either list¹. On 1 May 2026, FDA proposed not to add semaglutide, tirzepatide or liraglutide to the bulks list¹³. It said supply problems such as backorders do not count as “clinical need”¹³. It also tentatively found no feature of the approved products that makes them “medically unsuitable” for certain patients¹³. FDA later extended the comment period to 30 July 2026¹⁴. In Federal Register searches on 8 October 2026, we found no later notice on the proposal¹⁵¹⁶.

On 18 September 2026, FDA sent a warning letter to a Texas compounding pharmacy that its investigators had inspected in November 2025¹⁷. The letter said its tirzepatide with niacinamide and semaglutide with cyanocobalamin (vitamin B12) “appear to be essentially copies”¹¹⁷. FDA said the volume it produced suggested the differences from the approved drugs were “pretextual”¹⁷. Some prescriptions carried “significant difference” notes that appeared to be “repeated verbatim across many records”¹⁷. FDA said such notes may have been pre-generated for prescribers to pick, rather than written for an identified patient¹⁷. Investigators also noted that drugs meant to be sterile were “prepared, packed, or held under insanitary conditions”¹⁷. Our legal tracker covers the compounding rules for other peptides.

Why are compounded semaglutide and tirzepatide being restricted?

Federal law limits copies of approved drugs, but the limit “is temporarily suspended when the drug product appears on the FDA’s drug shortage list”⁸. A shortage, under the law, is when demand for a drug “exceeds the supply of the drug”⁷¹⁸. FDA added Wegovy to its shortage list on 31 March 2022 and Ozempic on 23 August 2022⁷. Tirzepatide injections were first added on 15 December 2022, and Zepbound joined the list in April 2024⁸¹⁹. FDA said semaglutide injections had been in shortage since 2022 “due to increased demand”¹.

FDA declared both shortages over, and compounders challenged both decisions in court¹¹⁸¹⁹.

• 2 October 2024: FDA declared the tirzepatide shortage resolved¹.
• 7 October 2024: the Outsourcing Facilities Association and a compounding company sued FDA over that decision¹⁹.
• 11 October 2024: at FDA’s request, a court sent the decision back to FDA to reconsider¹⁹.
• 19 December 2024: FDA confirmed that the shortage was over, finding Lilly’s supply “meeting or exceeding demand”¹⁹.
• 21 February 2025: FDA declared the semaglutide injection shortage resolved¹⁸.
• 5 March 2025 and 24 April 2025: a federal court in Texas refused to block FDA’s tirzepatide and semaglutide decisions while the cases went on¹.
• 27 August 2026: a federal appeals court, the Fifth Circuit, upheld FDA in both cases⁷⁸.

In the tirzepatide case, a federal district court ruled for FDA and Eli Lilly, and the compounders appealed⁸. In the semaglutide case, the appeals court said any error in skipping public notice and comment was “harmless” and FDA’s action “not arbitrary or capricious”⁷. In its semaglutide order, FDA acknowledged reports that some patients and pharmacists were not able to obtain the approved drugs¹⁸. It said information from telehealth companies, compounders and others did not “undermine or outweigh” Novo Nordisk’s evidence that supply was meeting or exceeding demand¹⁸.

In short, routine copies were allowed only during the shortages, and FDA found that each maker’s supply was meeting or exceeding demand⁸¹⁸¹⁹. FDA also warns that compounded drugs “pose a higher risk” than approved drugs because it does not review them before they are marketed¹². The tirzepatide ruling also noted that Lilly’s right to exclusively make tirzepatide products “extends to 2027”⁸.

Is compounded semaglutide or tirzepatide as effective as the brand-name drugs?

Searching PubMed on 8 October 2026, we found 39 records on compounded semaglutide or tirzepatide, and none was indexed as a randomized controlled trial⁵²⁰. ClinicalTrials.gov searches that day for compounded semaglutide and compounded tirzepatide returned 8 and 3 studies; none compared a compounded product with a brand-name drug²¹²².

The brand-name drugs, by contrast, were tested in large placebo-controlled trials paid for by their makers²³²⁴. STEP 1, a 68-week trial in 1,961 adults funded by Novo Nordisk, found average weight fell 14.9% on semaglutide versus 2.4% on placebo²³. SURMOUNT-1, a 72-week trial in 2,539 adults supported by Eli Lilly, found weight fell 20.9% on the highest dose versus 3.1% on placebo²⁴. A 2026 editorial argues that data from the big semaglutide trial programs “are not transferable to copies”²⁵. Our semaglutide vs tirzepatide comparison covers the brand-name trials, and our weight-loss ranking grades weight-loss peptides by evidence.

The reports below look back at past patients, follow one person or give expert opinion; none is a controlled trial^2627282930.

• A 2025 study reviewed 94 people who received compounded semaglutide with cyanocobalamin at a commercial wellness studio from June 2023 to January 2024²⁶. They lost 4.57% of their weight on average after 3 months, and the abstract reports no comparison group²⁶. One of the authors’ listed affiliations is a wellness company²⁶.
• A 2026 telehealth study looked back at 1,166 patients who completed at least 52 weeks on compounded or brand-name tirzepatide²⁷. Their average loss at 52 weeks was 22.74%, but the abstract reports compounded and brand-name users together²⁷. Because it counted only patients who stayed 52 weeks, people who stopped early were left out²⁷. The only affiliation listed for its authors is a company that shares the protocol’s name²⁷.
• In a 2025 report, one investigator took compounded tirzepatide for four weeks and lost 5% of their weight, short of a 10% goal²⁸. They regained 5% within two weeks of stopping²⁸.
• A 2025 opinion from an American College of Clinical Pharmacy group found “limited data demonstrating positive clinical outcomes in small cohorts of patients”²⁹. Three of its six authors reported speaking or advisory roles with Eli Lilly or Novo Nordisk²⁹.
• The American Diabetes Association said in 2025 that compounded versions “bypass regulatory measures, raising safety, quality, and efficacy concerns”³⁰.

Two lab studies by Novo Nordisk scientists compared other makers’ semaglutide with the original products³¹³².

• A 2024 study tested 16 injectable and 8 oral “follow-on” semaglutide products, meaning versions made by other companies, against the originals³¹. The injectable ones had new impurities, and several oral ones had “a markedly lower quantity of semaglutide than the label claim”³¹. The authors said the effect of these changes on efficacy and safety “remains unknown”³¹.
• A 2026 study found compounded semaglutide differed from the original in strength and impurities when exposed to light³². The authors said the different impurity profiles “could lead to an undesirable immune response in patients”³².

What side effects do compounded semaglutide and tirzepatide cause?

FDA says many adverse events reported with compounded versions “appear to be consistent” with those of the approved drugs². On the labels, nausea, diarrhea, vomiting and constipation are common side effects⁴⁸⁴⁹. As of 31 May 2026, FDA had received 990 adverse event reports for compounded semaglutide and more than 730 for compounded tirzepatide². Pharmacies that are not outsourcing facilities do not have to report adverse events to FDA, so FDA says such events are likely underreported². FDA also notes it cannot always tell whether a drug caused an event².

In July 2024, FDA warned of dosing errors with compounded semaglutide sold in multiple-dose vials⁹. Most reports described patients who measured their own doses wrongly and took five to 20 times more than the intended dose⁹. In other reports, health care providers miscalculated doses, and patients took five to 10 times more than the intended dose⁹. Some patients sought medical attention or needed a hospital stay⁹. Reported harms included nausea, vomiting, fainting, dehydration, acute pancreatitis (an inflamed pancreas) and gallstones⁹. FDA has also had reports that may be related to doses beyond the label: larger single doses, more frequent doses or faster increases².

Case reports, poison control data and a study of FDA’s adverse event database add detail^33343536.

• A 2023 case series described 3 people who became ill after taking compounded semaglutide incorrectly, two of whom made 10-fold dosing errors³³. All had nausea, vomiting and stomach pain, and most symptoms lasted for days³³.
• California’s poison control system logged 36 exposures to compounded GLP-1 drugs from December 2017 to December 2023, 33 of them from administration errors³⁴.
• A 2026 case report describes a 50-year-old woman with swelling of the lips, tongue and throat four hours after a first injection of compounded semaglutide³⁵. The patient needed a breathing tube and a ventilator for four days and later reported accidentally injecting ten times the appropriate first dose³⁵. The authors judged the swelling, called angioedema, most consistent with a reaction to the GLP-1 drug³⁵.
• A 2026 analysis of FDA’s adverse event database from 2018 to 2024 found 707 reports involving compounded products among 81,078 GLP-1 reports³⁶. Compared with reports on non-compounded products, these more often mentioned stomach pain, diarrhea, nausea, suicidal thoughts or behavior, and an inflamed gallbladder³⁶. They also more often mentioned contamination and preparation or prescribing errors, but less often administration or dosing errors³⁶. The odds of a report mentioning hospitalization were 2.35 times as high for compounded products³⁶. Such reports show associations, not causes³⁶.

FDA has also had complaints of injectable compounded GLP-1 drugs arriving warm or with inadequate ice packs, which can affect quality². The semaglutide risks and tirzepatide risks sections list each label’s warnings.

Why is B12 added to compounded semaglutide, and what are salt forms?

A 2026 paper searched compounding websites in February and March 2025 and found 33 semaglutide or tirzepatide products that differed from approved ones³⁷. Of these, 48% combined the drug with other ingredients, such as cyanocobalamin, niacinamide or ondansetron³⁷. Cyanocobalamin is vitamin B12, niacinamide is a form of niacin (vitamin B3), and ondansetron prevents nausea and vomiting from cancer treatment or surgery¹³⁸³⁹. The authors found “little justification for adding nutrients” to the injections³⁷. They saw a rationale for adding ondansetron, but said evidence for giving it by injection under the skin “is lacking”³⁷.

In 2024, FDA said some compounders add vitamin B12, vitamin B6, L-carnitine or NAD to semaglutide⁹. It said the safety and effectiveness of such combinations “has not been established”⁹. Nominators asked FDA to let outsourcing facilities combine semaglutide or tirzepatide with pyridoxine (vitamin B6) or an anti-nausea drug⁹¹³. In May 2026, FDA said they had not explained why patients could not use an approved product with a separate approved pyridoxine or anti-nausea drug¹³.

From August to October 2025, secret shoppers found 42 of 75 clinics and med spas in two states offering compounded GLP-1 drugs with B vitamins⁵². Lilly scientists found a previously unknown impurity that forms when tirzepatide reacts with some forms of vitamin B12; its clinical effects are unknown⁵³. In a PubMed search on 8 October 2026 for these drugs with add-ins, we found no trial testing whether the add-ins help⁴⁰.

As for salt forms, FDA says the approved drugs contain the base form of semaglutide⁹. FDA says some compounded semaglutide may be made with salt forms, such as semaglutide sodium and semaglutide acetate, which are different active ingredients². FDA says it does not know whether the salts have the same chemical and drug properties as the active ingredient in the approved drugs². It says it knows of no lawful basis for using them in compounding². In a PubMed search on 8 October 2026, we found no record with semaglutide sodium or semaglutide acetate in its title or abstract⁴¹.

The same 2026 paper found 17 single-ingredient products sold as forms placed under the tongue (82%) or tablets that dissolve in the mouth (18%)³⁷. Whether these offer advantages over the brand-name oral tablets “has not been determined”, the authors wrote³⁷.

How is compounded semaglutide different from “research” or fake versions?

A drug compounded under section 503A must be made for an individual patient with a prescription¹. FDA has warned companies that sold unapproved semaglutide, tirzepatide, retatrutide, survodutide or mazdutide falsely labeled “for research purposes” or “not for human consumption”². These products were sold for human use with dosing instructions, and FDA calls them “of unknown quality”². On 23 July 2026, prosecutors announced a 21-month sentence for a man who sold semaglutide and tirzepatide on websites calling them “for research purposes only”⁵⁴.

FDA says it is aware of fraudulent compounded semaglutide and tirzepatide whose labels name pharmacies that do not exist or did not make them². It also warns of counterfeit Ozempic in the US, which may contain the wrong ingredients or too little, too much or none of the drug². Fake “semaglutide” that contained insulin put two people in a coma⁵⁵.

Unapproved “research” versions often fail lab tests⁵⁶. As of 30 September 2026, 74 of one testing service’s latest 196 completed semaglutide tests had failed, and 59 of 196 for tirzepatide⁵⁶⁵⁷. The samples come from users who chose to send them, so the results are not a random sample of the market⁵⁷⁵⁸.

By our count, FDA had posted about 70 GLP-1-related warning letters dated 2025 and about 75 dated 2026 by 8 October 2026⁵⁹. In September 2026, FDA revised an import alert that lets it detain imported GLP-1 drug ingredients without examining them⁶⁰. The alert exempts makers and products on its Green List of sites that appear to follow US manufacturing rules⁶⁰. FDA says 21% of the 48 GLP-1 ingredient sites it evaluated were noncompliant⁶⁰. FDA also says retatrutide and cagrilintide “cannot be used in compounding under federal law”². Our gray-market briefing tracks these cases, and the semaglutide dose page explains why gray-market doses are unreliable.

Does microdosing semaglutide work, and how long does it take?

Microdosing usually means taking a fraction of the maker’s recommended starting dose, or spacing doses further apart, a 2026 commentary says⁴². It calls microdosing an “off-label strategy”, meaning use outside the approved instructions⁴². The aims are fewer side effects, lower cost and access during shortages⁴². The practice spread through patient communities, telemedicine weight-loss programs and clinician anecdotes, the commentary says⁴². A 2025 letter in Diabetes Care says patients, particularly those living with obesity, first adopted the technique after learning about it on social media⁴³.

The commentary says early reports suggest potential benefits, including “reduced nausea, improved adherence, and modest weight loss”⁴². But it also says “high-quality evidence is essentially absent”⁴². The 2025 letter says microdosing is not in clinical guidelines and that “no randomized controlled trials support microdosing”⁴³. In a PubMed search on 8 October 2026, 12 records matched microdosing and GLP-1 terms, and we found no weight-loss trial among them⁶. A ClinicalTrials.gov search the same day found 3 registered microdosing studies, none with results posted⁴⁴.

• A university-led phase 2 trial that began in February 2026 plans to enroll an estimated 30 adults with HIV⁴⁵. All participants take semaglutide for 12 weeks; then one randomly assigned group switches to microdosing and the other stops the drug⁴⁵. The main outcome is weight regain between weeks 12 and 60, and the estimated primary completion date is 31 May 2028⁴⁵.
• A company-sponsored early-phase trial plans to compare microdosed semaglutide, given under the tongue or by injection, with placebo in an estimated 150 healthy adults⁴⁶. Weight is not among its main outcomes⁴⁶. Its record, last updated on 30 July 2025, estimated that data collection for its main outcomes would end on 1 November 2025⁴⁶. No results had been posted by 8 October 2026⁴⁶.
• A company’s observational study of its app-based programs plans to follow an estimated 2,310 people, including groups on standard or “microdose” compounded semaglutide or tirzepatide⁴⁷. It describes microdosing as “below-standard clinical dosing”⁴⁷. It had not started recruiting on 8 October 2026⁴⁷.

We found no completed microdosing trial, so we found no trial data on how long it takes to see results⁶⁴⁴. FDA’s May 2026 notice addressed a claim from the Outsourcing Facilities Association that microdosing trends “have been widely reported”¹³. FDA replied that the New York Times article it cited had no data showing the approved product could not be used for lower doses¹³. Nor, FDA said, did it show the product was otherwise medically unsuitable¹³. The semaglutide dose page and tirzepatide dose page give the approved doses from the labels.

The evidence at a glance

A tier grades the best human evidence for any use, not whether a compound is safe. Whether each one works for the use people take it for, and its legal status: the evidence table. How we grade: our method.

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Sources

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38. 38Niacin: MedlinePlus Medical Encyclopedia MedlinePlus (U.S. National Library of Medicine), 21 Jan 2025. medlineplus.gov
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