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GLP-1 · Compounded

Track 2: compounded semaglutide and tirzepatide

During the shortages of 2022 to 2025, pharmacies made their own versions of semaglutide and tirzepatide, and many people started that way. The shortages are over, and the rules have tightened. This page explains what a compounded GLP-1 is, what FDA has done since, and the mistakes it has seen.

Last updated November 3, 2026 · Reviewed by Grey Peptides Editorial Board · ✓ Every claim sourced · No products sold, no seller named

📋 Key takeaways

Compounded is not approved. FDA does not review compounded drugs for safety, effectiveness or quality before they are sold, and says they should be used only by patients whose needs an FDA-approved drug cannot meet.14

The shortages are over. FDA found the tirzepatide shortage resolved in October 2024 and the semaglutide shortage in February 2025, and the grace periods for compounders have ended.2

Dosing mistakes are the documented harm. FDA has reported people injecting five to 20 times the intended dose of compounded semaglutide after confusing units, millilitres and milligrams.3

Reports keep coming. As of May 31, 2026, FDA had received 990 adverse-event reports for compounded semaglutide and more than 730 for compounded tirzepatide.4

On this page

  1. What compounding is
  2. What changed when the shortages ended
  3. Salt forms: semaglutide sodium and acetate
  4. Dosing errors: the harm FDA has documented
  5. What the reports and tests show
  6. If you are on a compounded GLP-1
  7. Frequently asked questions
  8. Related on Grey Peptides
  9. Sources

What compounding is

Compounding is a pharmacy making a medicine for an individual patient, instead of dispensing a factory-made product. FDA describes it as creating a medication tailored to the needs of an individual patient, for example someone who cannot use the approved version.1 There are two kinds of compounder under federal law:

  • 503A pharmacies: state-licensed pharmacies (and physicians) compounding under section 503A of the Food, Drug, and Cosmetic Act, and not held to the good manufacturing practice rules that drug factories follow.12
  • 503B outsourcing facilities: a category created in 2013 by the Drug Quality and Security Act, registered with and primarily overseen by FDA.1

Either way, the product is not FDA-approved: FDA does not review it for safety, effectiveness or quality before it is sold.14 That is the core difference from Track 1, where the product, its factory and its label have all been reviewed.

What changed when the shortages ended

Federal law generally stops pharmacies from making what are essentially copies of a commercially available drug, but FDA allowed it while semaglutide and tirzepatide were in shortage. When a shortage is resolved, FDA generally considers the drug commercially available again.2 The timeline, from FDA's own page:

  • Tirzepatide: FDA found the shortage resolved on October 2, 2024, and reaffirmed it on December 19, 2024 after re-evaluating. The period in which FDA would not act against 503A pharmacies has ended; for 503B outsourcing facilities it ran until March 19, 2025.2
  • Semaglutide: FDA found the shortage resolved on February 21, 2025. The 503A period ran until April 22, 2025 (or a court's decision, whichever came later) and has ended; the 503B period ran until May 22, 2025.2
  • April 2026: FDA updated its policy to say it would not treat a compounder as making an essentially copied product "regularly or in inordinate amounts" if it fills four or fewer prescriptions of that product in a calendar month.2
  • April 30, 2026: FDA proposed to keep semaglutide, tirzepatide and liraglutide off the list of bulk substances outsourcing facilities may compound from, saying it found no clinical need for them to. The proposal took comments until June 29, 2026, before a final decision.5

Put simply, a compounded GLP-1 is now meant for a narrow case: a patient whose need an approved product cannot meet, such as an allergy to an ingredient (our reasoning from FDA's wording).4 It is not a cheaper version of the same thing for everyone. What FDA's policies mean for a particular pharmacy is a legal question this page cannot answer.

Salt forms: semaglutide sodium and acetate

Some compounded products were made with semaglutide sodium or semaglutide acetate rather than the semaglutide base in the approved drugs. FDA says these salt forms are different active ingredients and that it is not aware of any lawful basis for using them in compounding.4 If a pharmacy's label or paperwork names a salt, ask about it (our reasoning).

Dosing errors: the harm FDA has documented

On July 26, 2024, FDA alerted prescribers, compounders and patients to dosing errors with compounded semaglutide. Patients had given themselves five to 20 times the intended dose.3 The causes FDA named were confusion between millilitres, milligrams and "units", and syringes much larger than the dose: in some cases patients told to draw 5 units drew 50 instead.3 Reported effects included nausea, vomiting, abdominal pain, fainting and headache; some people needed medical care or a hospital stay.3

Why it happens: an approved pen is set to deliver a labelled dose, while a compounded vial comes in a concentration the pharmacy chose, so the reader has to turn a dose into a volume on a syringe (our reasoning). FDA's advice is for compounders and prescribers to supply a syringe sized for the dose and show the patient how to measure it, and for patients to ask their prescriber or compounder exactly how to measure and give it.3

Three things on this site help with that step: the syringe sizes and units page, the pens, vials and dose math guide, and the reconstitution calculator, which takes the vial strength, the water and the prescribed dose and gives the mark on the syringe. None of them sets a dose: that comes from your prescription.

What the reports and tests show

  • FDA's count. As of May 31, 2026, FDA had received 990 reports of adverse events with compounded semaglutide and more than 730 with compounded tirzepatide, some requiring hospital care; dosing errors from patients measuring and injecting the wrong amount were among them.4
  • A study of FDA's reporting database. Of 81,078 reports for liraglutide, semaglutide and tirzepatide from 2018 to 2024, 707 involved compounded products. Compared with approved products, compounded ones had higher reporting odds of preparation errors, contamination, manufacturing issues and hospitalisation (odds ratio 2.35), and lower reporting odds of administration and dosing errors.6 Reporting odds show which problems are reported more often, not how often they happen.
  • An impurity study. Novo Nordisk scientists tested compounded and follow-on semaglutide and liraglutide against the originals and found different impurity profiles, and, for compounded semaglutide exposed to light, large differences in strength and impurities.7 The authors work for the maker of the originals. Our test results page lists the individual measurements.

If you are on a compounded GLP-1

Questions worth asking the prescriber and the pharmacy (our reasoning, from the FDA concerns above):

  • Why an approved product does not meet my need, since that is the case FDA says compounding is for.4
  • Is the pharmacy state-licensed, and is it a 503A pharmacy or a 503B outsourcing facility?14
  • Is the active ingredient semaglutide or tirzepatide itself, not a salt form such as semaglutide sodium or acetate?4
  • What is the concentration in the vial, how many units on my syringe is my dose, and can you show me on the syringe I will use?3
  • How should it be stored, and what should I do if it arrives warm? FDA recommends not using an injectable GLP-1 that arrives warm or not properly refrigerated.4

Report a side effect or a dosing mistake to FDA's MedWatch programme.3 If you are thinking of switching to an approved product, the transition planner and the prescribed track are the next stops.

Frequently asked questions

Is compounded semaglutide the same as Wegovy or Ozempic?

It is meant to contain the same active ingredient, but it is not FDA-approved and FDA does not review it for safety, effectiveness or quality before it is sold.14

Can pharmacies still make compounded semaglutide and tirzepatide?

Only in narrower circumstances than during the shortages. FDA found both shortages resolved and its grace periods for compounders have ended; in April 2026 it said it would not act on four or fewer prescriptions of an essentially copied product a month.2

Why do dosing errors happen with compounded GLP-1s?

FDA found confusion between millilitres, milligrams and units, and syringes much larger than the dose; some patients drew 50 units instead of 5.3

Starting a GLP-1 hub Track 1: a prescribed GLP-1 Track 3: grey-market "research" GLP-1s GLP-1 titration planner GLP-1 pens, vials and dose math GLP-1s and muscle loss Stopping a GLP-1 and weight regain GLP-1 drug interactions Reconstitution calculator Syringes for first-timers

Sources

FDA pages are cited with the date each shows; studies by PMID, checked on PubMed. All read November 3, 2026.

  1. U.S. Food and Drug Administration. Compounding and the FDA: Questions and Answers. Content current as of September 16, 2025; read November 3, 2026. Source
  2. U.S. Food and Drug Administration. FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize (updates of October 2, 2024 to April 1, 2026). Content current as of April 1, 2026; read November 3, 2026. Source
  3. U.S. Food and Drug Administration. FDA alerts health care providers, compounders and patients of dosing errors associated with compounded injectable semaglutide products. July 26, 2024; read November 3, 2026. Source
  4. U.S. Food and Drug Administration. FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss. Content current as of October 1, 2026; read November 3, 2026. Source
  5. U.S. Food and Drug Administration. FDA proposes to exclude semaglutide, tirzepatide and liraglutide from 503B bulks list (press announcement). April 30, 2026; read November 3, 2026. Source
  6. McCall KL, et al. Safety analysis of compounded GLP-1 receptor agonists: a pharmacovigilance study using the FDA adverse event reporting system. Expert Opin Drug Saf. 2026;25(3):581-588. PMID 40285721. Read November 3, 2026. Source
  7. Kopp KL, et al. Impurities and Potential Immunogenicity Associated With Follow-on and Compounded Glucagon-like Peptide-1 Receptor Agonists. Pharm Res. 2026;43(8):2861-2886. PMID 42533250. Funded by Novo Nordisk; the authors are its employees or shareholders. Read November 3, 2026. Source

This section explains GLP-1 medicines in plain words; it is not medical advice, and it does not replace the prescriber or pharmacist who knows your history. Grey Peptides sells nothing, links to no seller and rates none. If you feel unwell after an injection, contact a clinician or Poison Help (1-800-222-1222 in the US); in an emergency call 911.