Drug facts

What is compounded semaglutide?

Quick answer

Semaglutide prepared by a pharmacy rather than sold as an approved product like Wegovy or Ozempic. It is not FDA-approved, has no label of its own and is not a generic. It also comes with a specific warning: FDA says some compounded semaglutide may be a salt form — a different active ingredient from the one in the approved products.

The short answer, in full1

FDA defines compounding as a practice in which a licensed pharmacist or physician, or someone supervised by a pharmacist at an outsourcing facility,

combines, mixes or alters ingredients of a drug to create a medication tailored to the needs of an individual patient.

It sits next to a plain statement of what that does not include: 2

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.

So compounded semaglutide is a medicine made for a person, not a product reviewed for a population. The comparisons with the two approved injections are on compounded semaglutide vs Wegovy and compounded semaglutide vs Ozempic.

What is actually in the vial3

On the label — Wegovy / Ozempic

Wegovy: semaglutide in a clear, colorless solution with a short list of inactive ingredients, at a fixed dose per pen.

In a compounded vial

Semaglutide — or, FDA warns, possibly semaglutide sodium or semaglutide acetate — at a concentration the pharmacy chose, sometimes with B12 or another add-in, under a beyond-use date the pharmacy set.

Each of those differences has a page. The salt forms, which FDA says are different active ingredients with no lawful basis for compounding that it knows of, are on does compounded semaglutide work? The concentration, and why the same dose is a different mark on a different syringe, is on units and milligrams. Add-ins are on B12, B6 and glycine, and the beyond-use date and FDA’s 28-day rule on how long compounded semaglutide lasts.

Not a generic, and not a tablet5

FDA approves a generic only when it meets the requirements for matching the brand; a compounded drug, in FDA’s words, “is not approved by FDA.” There is no generic semaglutide.

Semaglutide is also approved in more forms than people expect. Besides the Wegovy and Ozempic injections, there are approved tablets — Rybelsus, Ozempic tablets and, on Wegovy’s own current label, Wegovy tablets at 1.5, 4, 9 and 25 mg. None of them is what a compounding seller sells as “oral semaglutide”; that distinction is on is there an oral semaglutide?

Who may make it now4

Wegovy went onto FDA’s shortage list in March 2022 and Ozempic in August 2022, and the shortage is what allowed broad compounding. On 21 February 2025 FDA determined it resolved. State-licensed 503A pharmacies had until 22 April 2025 to stop making what is essentially a copy on the strength of the shortage, and 503B outsourcing facilities until 22 May 2025 — after which an outsourcing facility has no route to bulk semaglutide at all.

A 503A pharmacy can still compound for a named patient, but not essentially a copy of the approved drug unless a prescriber documents that the patient needs something significantly different. How large sellers continue anyway — and the policy most of them rely on — is on is compounded semaglutide still legal?

What FDA has counted3

As of 31 May 2026 FDA had received 990 reports of adverse events associated with compounded semaglutide. A report is not proof the drug caused the event. What FDA describes most specifically is dosing: reports, some requiring hospitalization, that may be related to patients measuring and self-administering incorrect doses — and prescriptions that went beyond the approved label in the size of a dose, how often it was taken, or how fast it was increased. The approved dosage chart is the reference for that, even for a vial that has no label of its own.

Before buying, the checks that matter are the pharmacy’s name and license, the concentration and active ingredient on the label, and any FDA warning letter — four checks, ten minutes, and every letter this index has matched is on the trust page. What FDA has seen go wrong is gathered on is compounded semaglutide safe?

Questions

What is compounded semaglutide?
Semaglutide prepared by a pharmacy rather than sold as an approved product such as Wegovy or Ozempic. It is not FDA-approved, has no label of its own and is not a generic, and FDA has warned that some compounded semaglutide may be a salt form, a different active ingredient from the approved products'.
Is compounded semaglutide FDA-approved?
No. FDA states that compounded drugs are not FDA-approved, which means it does not verify their safety, effectiveness or quality before they are marketed.
What is compounded semaglutide made of?
Semaglutide, or possibly a salt form such as semaglutide sodium or acetate, in a solution whose concentration the pharmacy sets, sometimes with an add-in such as B12. Wegovy, by contrast, contains semaglutide with a short list of inactive ingredients and nothing added.
Can pharmacies still make compounded semaglutide?
Only under narrower conditions than before. FDA declared the shortage resolved on 21 February 2025; the 503A off-ramp closed on 22 April 2025 and the 503B off-ramp on 22 May 2025. A 503A pharmacy may still compound for a named patient, but not essentially a copy of the approved drug unless a prescriber documents a significant difference for that patient.
Is compounded semaglutide a generic Ozempic?
No. There is no generic semaglutide. A generic is approved by FDA as a match for the brand; a compounded preparation is not approved at all.

Sources

  1. FDA, Human Drug Compounding, content current as of 06/15/2026 FDA
  2. FDA, Compounding and the FDA: Questions and Answers, content current as of 09/16/2025 FDA
  3. FDA, 'FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss', content current as of 09/01/2026 FDA
  4. This site's legal-status page, which links the FDA orders, Federal Register entries and court dockets behind each date Read it
  5. FDA prescribing information for WEGOVY (semaglutide) injection and tablets, revision 6/2026 DailyMed