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Compounded semaglutide and tirzepatide: what the FDA says

Updated Sep 27, 2026. Numbers in brackets link to the source each fact comes from.

Compounded semaglutide and tirzepatide are versions mixed by a pharmacy rather than made by the drug’s maker, and the FDA does not check them for safety, effectiveness or quality before they are sold [1]. They are not generics either: a generic drug goes through FDA approval, and a compounded drug does not [2]. This page sets out what the FDA says about them. GLPLens does not list, sell or link to compounded GLP-1s.

What compounding is meant for

Compounding exists for patients an approved drug cannot serve, such as someone allergic to a dye in the approved product, or an older adult or child who needs a liquid instead of a tablet [1] [3]. Compounders may also make versions of a drug that is on the FDA’s shortage list, if conditions in federal law are met [4]. Tirzepatide and semaglutide injections were both in shortage starting in 2022 [17] [19], which is when compounded versions spread.

Two kinds of compounders

Federal law treats two kinds of compounders differently. Sections 503A and 503B of the Food, Drug, and Cosmetic Act set their rules [7] [15].

State-licensed pharmacy (503A) Outsourcing facility (503B)
Main overseer The state board of pharmacy [6] The FDA, which inspects on a risk-based schedule [5]
Manufacturing quality rules (CGMP) Do not apply [7] Apply [7]
Key condition Compounds for an individual patient based on a prescription [12] Uses bulk ingredients only if they are on the 503B bulks list or the drug is in shortage [15]
Must report side effects to the FDA Not required [33] Required [9]

Outsourcing facilities became a separate category in 2013, under the Drug Quality and Security Act [5].

How to look up an outsourcing facility

The FDA keeps a list of registered outsourcing facilities, updated weekly [11]. Outsourcing facilities also report which drugs they made, and the FDA’s Outsourcing Facility Product Report database holds the last two years of those reports [10]. Being on the list means a facility registered. It does not mean the FDA approved anything it makes [1].

For a state-licensed pharmacy, the license check runs through that state’s board of pharmacy. The FDA points out a practical problem: people who buy compounded drugs through a website or telehealth company may not even know which compounder made the drug [8]. Ask for the compounder’s name before anything ships.

What changed when the shortages ended

The FDA declared the tirzepatide injection shortage resolved on December 19, 2024 [18] and the semaglutide injection shortage resolved on February 21, 2025 [19]. Once a shortage is over, the FDA generally treats the drug as commercially available [20], and that changes what each kind of compounder may do:

  • A 503A pharmacy may not regularly compound what are essentially copies of a commercially available drug [13]. The FDA has said it does not intend to act against a pharmacy that fills four or fewer such prescriptions in a calendar month [14].
  • A 503B outsourcing facility may compound from bulk ingredients only if the ingredient is on the FDA’s 503B bulks list or the drug is in shortage [15]. Neither semaglutide nor tirzepatide is on either list [16].
  • On April 30, 2026, the FDA proposed keeping semaglutide, tirzepatide and liraglutide off the 503B bulks list, finding no clinical need [21]. Comments were due June 29, 2026, with a final decision to follow [22]. We have not seen a final decision posted yet.
  • On February 6, 2026, the FDA said it intends to restrict the GLP-1 ingredients used in compounded drugs that companies mass-market [23].

What the FDA warns about

  • Fake labels. The FDA knows of compounded semaglutide and tirzepatide with false label information, sometimes naming pharmacies that do not exist [25].
  • Different ingredients. Some compounders use salt forms such as semaglutide sodium and semaglutide acetate, which are different active ingredients from the ones in approved drugs [26].
  • Dosing mistakes. The FDA has reports of hospitalizations that may be tied to dosing errors with compounded semaglutide injections [27]. Our page on compounded GLP-1 doses explains why.
  • Vials and shipping. The FDA says multi-dose vials should generally be used within 28 days of first use [28], and injectable GLP-1s that arrive warm should not be used [29].
  • Side-effect reports. By May 31, 2026, the FDA had 990 adverse event reports tied to compounded semaglutide and more than 730 tied to compounded tirzepatide, likely an undercount [32] [33].

Marketing has limits too. Companies may not claim that a compounded product is a generic version of, or the same as, an FDA-approved drug [24]. In March 2026 the FDA announced 30 warning letters to telehealth companies over false or misleading claims about compounded GLP-1s [34].

What the FDA recommends

Use a compounded drug only when an FDA-approved drug cannot meet your medical needs [30], and get prescriptions filled at a state-licensed pharmacy [31]. If you take a compounded GLP-1 now, do not stop or switch on your own; ask your prescriber whether an approved medicine fits. Our price table and savings check show what the approved brand-name medicines cost today. The compounded vs brand-name price page compares the two.

Sources

  1. 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. fda.gov, read Sep 27, 2026.
  2. No. A generic drug is approved by FDA under 505(j) of the FD&C Act and meets all of the requirements of that section (including establishing therapeutic equivalence to a brand name drug, among others), while a compounded drug is not approved by FDA. fda.gov, read Sep 27, 2026.
  3. A drug may be compounded for a patient who cannot be treated with an FDA-approved medication, such as a patient who has an allergy to a certain dye and needs a medication to be made without it, or an elderly patient or a child who cannot swallow a tablet or capsule and needs a medicine in a liquid dosage form. fda.gov, read Sep 27, 2026.
  4. Compounders also may prepare compounded versions of a drug on FDA’s drug shortages list if the compounded drug meets certain conditions detailed in federal law. fda.gov, read Sep 27, 2026.
  5. Outsourcing facilities are a category of compounders established in 2013 by the Drug Quality and Security Act. Outsourcing facilities are inspected by FDA according to a risk-based schedule and are subject to increased quality standards. fda.gov, read Sep 27, 2026.
  6. Generally, state boards of pharmacy have primary responsibility for the day-to-day oversight of state-licensed pharmacies that are not registered with FDA as outsourcing facilities. fda.gov, read Sep 27, 2026.
  7. Drugs compounded in outsourcing facilities are subject to current good manufacturing practice (CGMP) requirements. By contrast, drugs compounded by a licensed pharmacist in a state-licensed pharmacy or federal facility, or by a physician, in accordance with the conditions of section 503A of the FD&C Act, are not. fda.gov, read Sep 27, 2026.
  8. Consumers who purchase compounded drugs online, such as through online pharmacies and telehealth platforms, may not know the identity of the compounder that produced the drug, including whether the drug was produced by a compounder whose drugs meet appropriate quality standards and that is appropriately licensed and regulated (e.g., by state regulatory authorities). fda.gov, read Sep 27, 2026.
  9. must meet certain other conditions, such as reporting adverse events and providing FDA with certain information about the products they compound. fda.gov, read Sep 27, 2026.
  10. Outsourcing facilities are required to provide FDA with a list of drugs they compounded during the previous six-month period upon initial registration and in June and December each year. The Outsourcing Facility Product Report searchable database contains information reported to FDA within the last two years (last four reporting periods). fda.gov, read Sep 27, 2026.
  11. This table lists the outsourcing facilities that have submitted registration information that has been determined to be complete by the data lock date for the latest weekly update of the table. fda.gov, read Sep 27, 2026.
  12. The drug product is compounded for an individual patient based on receipt of a prescription. fda.gov, read Sep 27, 2026.
  13. The compounder does not compound, regularly or in inordinate amounts, any that are essentially copies of a commercially available drug product. fda.gov, read Sep 27, 2026.
  14. FDA has stated, at this time, it does not intend to take action against a compounder for compounding a drug product that is essentially a copy of a commercially available drug product regularly or in inordinate amounts if the compounder fills four or fewer prescriptions of that compounded drug product during a calendar month. fda.gov, read Sep 27, 2026.
  15. Outsourcing facilities are restricted from compounding drugs using bulk drug substances (or API) unless: the bulk drug substance appears on a list identifying bulk drug substances for which there is a clinical need, which is referred to as the 503B bulks list or the drug compounded from the bulk drug substance is on FDA’s drug shortage list at the time of compounding, distribution and dispensing. fda.gov, read Sep 27, 2026.
  16. Tirzepatide and semaglutide do not currently appear on the 503B bulks list or on FDA’s drug shortage list. fda.gov, read Sep 27, 2026.
  17. [10/02/2024] The U.S. Food and Drug Administration has determined the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been resolved. Tirzepatide injection has been in shortage since 2022 due to increased demand. fda.gov, read Sep 27, 2026.
  18. [12/19/2024] FDA re-evaluated its determination from October 2, 2024, on the status of the tirzepatide shortage. Today, FDA has issued a new decision determining the tirzepatide injection shortage is resolved. fda.gov, read Sep 27, 2026.
  19. [2/21/2025] FDA has determined the shortage of semaglutide injection products, a glucagon-like peptide 1 (GLP-1) medication, is resolved. Semaglutide injection products have been in shortage since 2022 due to increased demand. fda.gov, read Sep 27, 2026.
  20. When a drug shortage is resolved, FDA generally considers the drug to be commercially available. fda.gov, read Sep 27, 2026.
  21. The U.S. Food and Drug Administration today announced it is proposing to exclude semaglutide, tirzepatide, and liraglutide on the 503B bulks list, finding no clinical need for outsourcing facilities to compound these drugs from bulk substances. fda.gov, read Sep 27, 2026.
  22. The FDA is now inviting interested parties to submit comments electronically through the docket by June 29, 2026. The agency will consider submitted comments before making a final determination. fda.gov, read Sep 27, 2026.
  23. Today, the U.S. Food and Drug Administration is announcing its intent to take decisive steps to restrict GLP-1 active pharmaceutical ingredients (APIs) intended for use in non-FDA-approved compounded drugs that are being mass-marketed by companies fda.gov, read Sep 27, 2026.
  24. In promotional materials, companies cannot claim that non-FDA-approved compounded products are generic versions or the same as drugs approved by FDA. fda.gov, read Sep 27, 2026.
  25. FDA is aware of fraudulent compounded semaglutide and tirzepatide marketed in the U.S. that contain false information on the product label. In some cases, the compounding pharmacies identified on the labels of the products do not exist. fda.gov, read Sep 27, 2026.
  26. These salt forms, including semaglutide sodium and semaglutide acetate, are different active ingredients than are used in the approved drugs. fda.gov, read Sep 27, 2026.
  27. FDA received multiple reports of adverse events, some requiring hospitalization, that may be related to dosing errors associated with compounded injectable semaglutide products. fda.gov, read Sep 27, 2026.
  28. Generally, FDA recommends that vials containing multiple doses of sterile medications be used within 28 days after the first use because there is an increased risk of contamination after 28 days. fda.gov, read Sep 27, 2026.
  29. The agency recommends patients not use any injectable GLP-1 drug that arrives warm or with insufficient refrigeration, as this can affect the drug’s quality. fda.gov, read Sep 27, 2026.
  30. Compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug. fda.gov, read Sep 27, 2026.
  31. Patients should obtain a prescription from their doctor and fill the prescription at a state-licensed pharmacy. fda.gov, read Sep 27, 2026.
  32. As of May 31, 2026, the FDA has received: 990 reports of adverse events associated with compounded semaglutide. more than 730 reports of adverse events associated with compounded tirzepatide. fda.gov, read Sep 27, 2026.
  33. However, federal law does not require state-licensed pharmacies that are not outsourcing facilities to submit adverse events to FDA so it is likely that adverse events from compounded versions of these drugs are underreported. fda.gov, read Sep 27, 2026.
  34. The U.S. Food and Drug Administration today announced the issuance of 30 warning letters to telehealth companies for making false or misleading claims regarding compounded GLP-1 products offered on their websites. fda.gov, read Sep 27, 2026.

This page reports what official sources say; it is not medical advice. Medical disclaimer.