On this page
The name on the label can match and the product can still be a different thing. Ozempic is Novo Nordisk's approved injection. A compounded preparation is made by a pharmacy or an outsourcing facility, and FDA does not approve it.
The trial record for the molecule is on the semaglutide research profile. The head-to-head weight trial against tirzepatide is in semaglutide vs tirzepatide. The boxed thyroid warning, which is about rodent tumors and an unknown human risk, is in the semaglutide thyroid warning.
Where Ozempic and compounded semaglutide differ
| Criterion | Ozempic | Compounded semaglutide | Record |
|---|---|---|---|
| FDA approval | Ozempic Approved injection. Initial U.S. approval 2017. | Compounded semaglutide Not FDA-approved. | RecordFDA label; FDA March 3, 2026 |
| Manufacturing oversight | Ozempic Reviewed under a new-drug application before sale. | Compounded semaglutide A 503A pharmacy or physician, or a 503B outsourcing facility. FDA does not review safety, effectiveness, or quality before sale. | RecordFDA |
| Salt form | Ozempic The approved injection uses semaglutide base. | Compounded semaglutide Semaglutide sodium and semaglutide acetate are different active ingredients. FDA is not aware of a lawful basis for those salts in compounding. | RecordFDA |
| Device | OzempicSingle-patient-use pens, and single-dose prefilled syringes, on the May 2026 label. | Compounded semaglutideMultiple-dose vials and prefilled syringes. FDA has warned that patients measuring from a vial have taken the wrong amount. | RecordOzempic label, May 2026; FDA |
| Reports to FDA | OzempicTracked as the approved product. | Compounded semaglutide990 reports associated with compounded semaglutide as of May 31, 2026. FDA says the count is likely low. | RecordFDA |
This page does not list doses. Strengths on the Ozempic label are a prescribing question for a clinician.
What FDA means by the same name
On March 3, 2026, FDA announced 30 warning letters to telehealth companies over compounded GLP-1 products. The agency said the main problems were claims implying sameness with FDA-approved products, and branding that hid the compounder. The letters do not make a compounded product illegal by themselves. They say a specific claim was false or misleading.
FDA's sentence in that announcement is the short version: compounded drugs are not FDA-approved, and the agency does not review their safety, effectiveness, or quality before they are marketed. Compounded drugs are also not generic drugs. Generics are FDA-approved.
FDA described the March letters as the second group since a crackdown it said it launched in September. The announcement does not give a letter count for that earlier month.
A 503A compound is made by a state-licensed pharmacy or physician for an identified patient, from a prescription. A 503B compound is made by an outsourcing facility, which can produce without a patient-specific prescription and has to follow a different set of conditions. Ozempic went through a new-drug application. Neither compounding path is that review.
Salt forms
FDA's page on unapproved GLP-1 drugs says some semaglutide products sold by compounders may be salt forms. Semaglutide sodium and semaglutide acetate, FDA says, are different active ingredients from the ones used in the approved drugs. The agency says it does not have information on whether those salts have the same chemical and pharmacologic properties as the approved ingredient, and that it is not aware of any lawful basis for their use in compounding.
The May 2026 Ozempic label describes the injection as semaglutide in solution, supplied in pens and in single-dose prefilled syringes. It does not describe a sodium or acetate salt as the active ingredient.
Pens, vials, and measuring
The May 2026 Ozempic label (revised May 2026) describes single-patient-use pens that hold multiple weekly doses, and single-dose prefilled syringes. The device is part of the approved product.
FDA has warned that compounded semaglutide is also supplied in multiple-dose vials and in prefilled syringes, and that concentrations can differ by compounder. The agency has received reports of patients measuring the wrong amount from a vial, and of health care providers miscalculating a volume. Some of those reports involved hospitalization. This page does not repeat the volumes.
Reports FDA has counted
As of May 31, 2026, FDA had received 990 reports of adverse events associated with compounded semaglutide, and more than 730 associated with compounded tirzepatide. Federal law does not require state-licensed pharmacies that are not outsourcing facilities to send adverse events to FDA, so the agency says the compounded totals are likely undercounts. Many of the reported events look like events already known from the approved products. A report count does not, by itself, prove that a compounded product caused the event, and it is not a rate.
The shortage, and what ended
| Date | What FDA said | What it changed | Source |
|---|---|---|---|
| Feb 21, 2025 | What FDA saidThe semaglutide injection shortage was resolved. | What it changed503A discretion announced through April 22, 2025. 503B discretion announced through May 22, 2025. | SourceFDA |
| Mar 10, 2025 | What FDA saidCourt case still open. | What it changed503A discretion until April 22, 2025, or the court's decision, whichever was later. 503B until May 22, 2025, or the court's decision, whichever was later. | SourceFDA |
| Apr 24, 2025 | What FDA saidThe district court denied a preliminary injunction. | What it changedThe later of April 22 and the court date is April 24. | SourceFDA update of April 28, 2025 |
| Apr 28, 2025 | What FDA saidFDA said the 503A enforcement-discretion period had ended. | What it changedState-licensed pharmacies and physicians no longer had that shortage discretion for semaglutide injection. | SourceFDA |
| May 22, 2025 | What FDA saidThe 503B date arrived after the court date. | What it changedOutsourcing-facility discretion tied to the shortage ended. | SourceFDA |
| Mar 3, 2026 | What FDA said30 warning letters. | What it changedClaims implying sameness with approved GLP-1 drugs. | SourceFDA |
| May 1, 2026 | What FDA saidFederal Register notice. | What it changedProposal not to include semaglutide, tirzepatide, or liraglutide on the 503B Bulks List. | Source91 FR 23431 |
| Jun 26, 2026 | What FDA saidComment period extended. | What it changedComments due July 30, 2026. | Source91 FR 38719 |
| Oct 15, 2026 | What FDA saidThis page checked. | What it changedNo final 503B determination found. | SourceThis page |
FDA's February 21, 2025 announcement is the shortage decision. The April 22 date was the end FDA first published for 503A pharmacies. The March 10 update added "or the court's decision, whichever is later." The court denied the injunction on April 24, 2025. FDA's April 28 update said the 503A period had ended. For 503B outsourcing facilities, May 22, 2025 was later than the court date, so that is the date FDA had set.
Tirzepatide and semaglutide, FDA wrote in an April 1, 2026 update on the same page, do not appear on the 503B Bulks List or on the drug-shortage list. Tirzepatide's own shortage calendar, which closed in 2024, is on compounded tirzepatide. Health Canada's 2026 generic semaglutide notices, which are not compounded copies, are on generic semaglutide in Canada.
The 2026 proposal to leave semaglutide off the 503B list
On April 30, 2026, FDA announced it was proposing to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulks List, finding no clinical need for outsourcing facilities to compound them from bulk substance. The proposal was published in the Federal Register on May 1, 2026. Comments were first due June 29, 2026. A June 26, 2026 notice extended the deadline to July 30, 2026.
A proposal is not a final determination. FDA said it would consider comments before deciding. We did not find a final Federal Register action on that proposal as of October 15, 2026.
Outsourcing facilities still cannot use a bulk substance for this kind of compounding unless the substance is on the 503B Bulks List or the drug made from it is on the shortage list at the time of compounding, distribution, and dispensing. Semaglutide injection is on neither, according to FDA's April 1, 2026 statement.
Common questions
Is compounded semaglutide the same as Ozempic?
No. Both names refer to semaglutide, and FDA says that shared name does not make the products the same. Ozempic is FDA-approved. Compounded semaglutide is not.
Is compounded semaglutide FDA-approved?
No. FDA said on March 3, 2026 that it does not review compounded drugs for safety, effectiveness, or quality before they are marketed.
Are semaglutide salts the same ingredient as in Ozempic?
FDA says no. Semaglutide sodium and semaglutide acetate are different active ingredients from the base form in the approved drugs, and FDA says it is not aware of a lawful basis for using those salts in compounding.
Can pharmacies still compound semaglutide copies because of the shortage?
The shortage of semaglutide injection was resolved on February 21, 2025. FDA said on April 28, 2025 that 503A enforcement discretion had ended, and 503B discretion ran through May 22, 2025.
Did FDA ban compounded semaglutide in 2026?
FDA proposed, on May 1, 2026, not to add semaglutide to the 503B Bulks List. The comment period closed July 30, 2026. We did not find a final rule as of October 15, 2026.
Do the 990 reports prove compounded semaglutide is more dangerous?
They do not prove a rate or a cause. FDA had 990 reports associated with compounded semaglutide as of May 31, 2026, said many resemble events from the approved drugs, and said the total is likely an undercount.
Sources
Methodology. Status checked October 15, 2026 against FDA's shortage and compounding updates, FDA's unapproved GLP-1 page, the May 2026 Ozempic label, FDA's March 3, 2026 warning-letter announcement, and the Federal Register notices of May 1 and June 26, 2026.
Primary sources.
- FDA, policies for compounders as GLP-1 supply stabilized: https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize
- FDA, concerns with unapproved GLP-1 drugs used for weight loss: https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss
- FDA, dosing errors with compounded injectable semaglutide: https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-patients-dosing-errors-associated-compounded
- Ozempic label, revised May 2026: https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/209637s038lbl.pdf
- FDA, 30 warning letters, March 3, 2026: https://www.fda.gov/news-events/press-announcements/fda-warns-30-telehealth-companies-against-illegal-marketing-compounded-glp-1s
- FDA, proposal to exclude semaglutide, tirzepatide, and liraglutide, April 30, 2026: https://www.fda.gov/news-events/press-announcements/fda-proposes-exclude-semaglutide-tirzepatide-and-liraglutide-503b-bulks-list
- Federal Register, May 1, 2026, cited as 91 FR 23431 in the extension notice: https://www.govinfo.gov/content/pkg/FR-2026-06-26/html/2026-12937.htm
- Federal Register, June 26, 2026, comment period extended to July 30, 2026: https://www.govinfo.gov/content/pkg/FR-2026-06-26/html/2026-12937.htm
Changes. October 15, 2026: first published. The 503A end date is the April 28, 2025 FDA statement that discretion had ended after the April 24 court order, not a flat April 22 close.
