Semaglutide
medicationA GLP-1 medication that reduces appetite, approved for weight management and type 2 diabetes.
24 providers
Guide
Compounded tirzepatide and semaglutide: how do they differ from the brands?
Compounded tirzepatide and compounded semaglutide are pharmacy-made products using the active ingredients of Zepbound and Wegovy. They are not FDA-approved: FDA did not review their safety, effectiveness or quality. They spread during the 2022 to 2025 shortages; with both shortages over, FDA says pharmacies may not routinely copy the brands, and compounding should be reserved for a documented individual need.
What is drug compounding?
Compounding is preparing a customized medication for a patient, usually in a pharmacy, when an FDA-approved drug does not meet that patient’s needs. Compounded drugs are not FDA-approved: FDA does not verify their safety, effectiveness or quality before they are marketed. FDA
A 503A pharmacy is a state-licensed pharmacy that compounds for an identified individual patient on a valid prescription. Unlike a 503B facility, it is not held to federal manufacturing (CGMP) standards. 21 U.S.C. 353a
A 503B outsourcing facility is a facility that compounds sterile drugs, has registered with FDA, must follow current good manufacturing practice (CGMP) requirements, and is inspected by FDA on a risk-based schedule. FDA
Federal law generally bars 503A pharmacies from regularly compounding drugs that are essentially copies of a commercially available drug. Compounders may prepare versions of a drug on FDA’s shortage list if they meet conditions set out in federal law. FDA
Why was compounded semaglutide and tirzepatide so common in 2024?
Because both drugs were on FDA’s shortage list, which allowed pharmacies to compound copies. Semaglutide and tirzepatide were in shortage from 2022. FDA declared the tirzepatide shortage resolved in October 2024 and the semaglutide shortage resolved in February 2025, then gave compounders grace periods that ended in the spring of 2025. FDA
- 2022
Semaglutide and tirzepatide are added to FDA’s drug shortage list, opening the shortage exception for compounders. FDA
- Oct 2, 2024
FDA determines the tirzepatide shortage is resolved. FDA
- Dec 19, 2024
After a re-evaluation, FDA reaffirms that the tirzepatide shortage is over. FDA
- Feb 18, 2025
The grace period ends for 503A pharmacies compounding tirzepatide. FDA
- Feb 21, 2025
FDA determines the semaglutide shortage is resolved. FDA
- Mar 19, 2025
The grace period ends for 503B outsourcing facilities compounding tirzepatide. FDA
- Apr 22, 2025
The grace period ends for 503A pharmacies compounding semaglutide. FDA
- May 22, 2025
The grace period ends for 503B outsourcing facilities compounding semaglutide. FDA
What did FDA do about compounded GLP-1 drugs in 2026?
FDA moved on marketing and on supply. On March 3, 2026 it warned 30 telehealth companies for implying compounded GLP-1s were the same as approved drugs, or for selling them under their own brand without saying they were compounded. On April 30, 2026 it proposed removing semaglutide, tirzepatide and liraglutide from the 503B bulks list. FDA (Mar 2026)
FDA also placed GLP-1 active ingredients on an import alert, and says it is not aware of any lawful basis for compounding with semaglutide salt forms. FDA
- Mar 3, 2026
FDA announces warning letters to 30 telehealth companies over how they marketed compounded GLP-1s. FDA (Mar 2026)
- Apr 30, 2026
FDA proposes excluding semaglutide, tirzepatide and liraglutide from the list of bulk ingredients 503B facilities may compound from, citing insufficient clinical need. Comments closed June 29, 2026. FDA (Apr 30, 2026)
- May 31, 2026
FDA’s count reaches 990 adverse event reports tied to compounded semaglutide and more than 730 tied to compounded tirzepatide. FDA
Is compounded semaglutide the same as Wegovy or Ozempic?
No. A compounded product may contain the same active ingredient, but it has not been through FDA review for safety, effectiveness or quality. FDA says telehealth companies should not describe a compounded drug as a generic of an approved drug, as the same as an approved drug, or as FDA-approved. FDA
The Obesity Medicine Association, The Obesity Society and the Obesity Action Coalition advise patients to use FDA-approved GLP-1 medications rather than compounded alternatives. Jan 2024
| Item | Brand-name (Wegovy, Zepbound) | Compounded |
|---|---|---|
| FDA-approved | Yes | No |
| FDA reviews safety, effectiveness and quality before sale | Yes | No |
| Who makes it | The drug’s manufacturer, under federal manufacturing standards | A 503A pharmacy, or a 503B outsourcing facility |
| Basis for making it in 2026 | An approved application | Limited: the shortages that allowed widespread copies ended in 2024 and 2025 |
Is compounded tirzepatide still available in 2026?
Only in narrow cases. Tirzepatide is no longer on FDA’s drug shortage list or the 503B bulks list, so pharmacies may not make copies of Zepbound or Mounjaro. A 503A pharmacy may compound it only if a prescriber documents that a change produces a significant difference for an identified patient. FDA
An “essentially a copy” product is, in FDA’s words, one with the same active ingredient as the commercially available drug, in the same, similar or an easily substitutable strength, given by the same route. FDA
FDA declared the tirzepatide shortage resolved on October 2, 2024, and the grace periods for compounders ended on February 18, 2025 for 503A pharmacies and March 19, 2025 for 503B outsourcing facilities. FDA
On April 30, 2026, FDA proposed excluding tirzepatide from the list of bulk ingredients 503B outsourcing facilities may compound from, finding no clinical need. Public comments closed June 29, 2026. FDA (Apr 30, 2026)
As of May 31, 2026, FDA had received more than 730 adverse event reports associated with compounded tirzepatide. FDA
What should you know about compounded semaglutide?
Compounded semaglutide is not Wegovy or Ozempic and is not FDA-approved. FDA warns that some compounded semaglutide uses salt forms, such as semaglutide sodium or semaglutide acetate, which are different active ingredients from the approved drugs, and says it knows of no lawful basis for compounding with them. FDA
FDA declared the semaglutide shortage resolved on February 21, 2025. The grace periods ended on April 22, 2025 for 503A pharmacies and May 22, 2025 for 503B outsourcing facilities. FDA
As of May 31, 2026, FDA had received 990 adverse event reports associated with compounded semaglutide. FDA has also warned companies selling semaglutide falsely labeled “for research purposes” or “not for human consumption.” FDA
Is compounded semaglutide still legal in 2026?
Compounding itself is not banned, but the basis for mass-produced copies is gone. With the shortages resolved, federal law generally stops pharmacies from regularly making copies of commercially available drugs, and FDA says compounded versions should only be used when an approved drug cannot meet a patient’s medical need. FDA
Section 503A limits regular compounding of drugs that are essentially copies of a commercially available drug, unless a change is made for an identified patient that produces a significant difference. 21 U.S.C. 353a
What should you ask a telehealth provider about a GLP-1 prescription?
Ask whether the medication is the FDA-approved brand or a compounded product, and if compounded, which licensed pharmacy makes it and why an approved drug will not work for you. FDA says a telehealth company should not imply it is the compounder or that a compounded drug is FDA-approved. FDA
- Is this the brand-name drug or a compounded version, and does the label on what I receive say which?
- If compounded, is the pharmacy a state-licensed 503A pharmacy or an FDA-registered 503B facility?
- Is the clinician who prescribes it licensed in my state? Telehealth.HHS.gov
- What does the total cost include: the medication, a membership, labs and follow-ups? Hims
- Can you help with insurance or a prior authorization for the brand-name drug? Ro
- Who do I contact about side effects, and how quickly will they respond?
Start My Journal with these.
Adds Semaglutide, Tirzepatide, Liraglutide to My Journal, with the questions to ask a clinician. It stays in this browser, and nothing on it is a commitment.
Where to get each
Licensed providers that list each one on DiscoverMedica, by name. The full list is on each compound’s page.
- See all 37 offers for Semaglutide
- See all 29 offers for Tirzepatide
- See all 15 offers for Liraglutide
Prices as listed by the provider when we checked; they change.
Compounded tirzepatide and semaglutide: questions, answered
Is compounded semaglutide FDA-approved?
No. Compounded drugs are not FDA-approved, and FDA does not verify their safety, effectiveness or quality before they are sold. Only the brand-name products, Wegovy, Ozempic and Rybelsus, are FDA-approved semaglutide.
Why did so many telehealth companies sell compounded GLP-1s?
Semaglutide and tirzepatide were on FDA’s drug shortage list from 2022, which let pharmacies compound copies. FDA declared the tirzepatide shortage over in October 2024 and the semaglutide shortage over in February 2025, and the compounding grace periods ended in the spring of 2025.
How many adverse events has FDA linked to compounded GLP-1s?
As of May 31, 2026, FDA had received 990 adverse event reports associated with compounded semaglutide and more than 730 associated with compounded tirzepatide. Reports alone do not prove the drug caused each event, but FDA cites them among its concerns.
Can a telehealth company call compounded semaglutide a generic?
FDA says no. Its guidance to telehealth companies says a compounded drug should not be described as a generic version of an FDA-approved drug, as the same as an approved drug, or as FDA-approved.
Is compounded tirzepatide FDA-approved?
No. Compounded tirzepatide is not FDA-approved, and FDA did not review it for safety, effectiveness or quality. The only FDA-approved tirzepatide products are Zepbound and Mounjaro.
Can pharmacies still make compounded tirzepatide?
Not as copies of the brand. The tirzepatide shortage ended in October 2024 and the grace periods ended in early 2025. A 503A pharmacy may still compound it when a prescriber documents that a change produces a significant difference for an identified patient.
Is compounded semaglutide the same as generic semaglutide?
No. Compounded semaglutide is not FDA-approved, and FDA says telehealth companies should not describe a compounded drug as a generic version of an approved drug or as the same as an approved drug.
Sources
- FDA: Compounding and the FDA, questions and answers
- 21 U.S.C. 353a: Pharmacy compounding, section 503A (US Code)
- FDA: Information for outsourcing facilities (503B)
- FDA: FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize
- FDA (Mar 2026): FDA warns 30 telehealth companies about marketing of compounded GLP-1s
- FDA (Apr 30, 2026): Proposal to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list
- FDA: Concerns with unapproved GLP-1 drugs used for weight loss
- FDA: Telehealth companies, what to know when promoting compounded drugs
- Obesity Medicine Association, The Obesity Society and Obesity Action Coalition: statement on compounded GLP-1s (Jan 2024)
- Telehealth.HHS.gov: Getting started with licensure
- Hims: Weight loss
- Ro: Weight loss, how it works
Last reviewed October 7, 2026. Every source above was checked on or before that date. Educational information only, not medical advice; it does not replace a conversation with a licensed clinician. DiscoverMedica does not employ clinicians.
Compounds in this guide
Tirzepatide
medicationA weekly GIP and GLP-1 medication approved for weight management, sleep apnea and type 2 diabetes.
22 providers
Liraglutide
medicationAn older, daily GLP-1 injection for weight management and diabetes, now available as a generic.
12 providers