News explainer · FDA · GLP-1 access · Sources checked October 29, 2026

Published April 22, 2026 · Updated October 30, 2026

Is the semaglutide shortage over? What FDA and the courts have said

Yes. FDA determined on February 21, 2025 that the shortage of semaglutide injection products (the drug in Ozempic and Wegovy) was resolved.[1] On August 27, 2026, the U.S. Court of Appeals for the Fifth Circuit affirmed a lower-court judgment that upheld that decision, in a case brought by a compounders’ trade group and a compounding pharmacy.[2] As of October 29, 2026, FDA’s shortage data list no semaglutide injection or tirzepatide product in shortage.[3][5]

Disclaimer: This page is for informational purposes only and is not medical or legal advice. It does not recommend any medication, pharmacy or compounded product. If you think you’re having an emergency, call your local emergency number.

Correction (October 29, 2026): The first version of this page (April 22, 2026) said FDA ended the semaglutide shortage listing in April 2026. That was wrong. FDA’s decision is dated February 21, 2025; FDA’s April 1, 2026 entry on the same page is a reminder to compounders about the rules, not a new shortage decision.[1] We rewrote the page and added the court rulings and current shortage data.

Timeline, from FDA’s own updates and the court record

What FDA’s shortage data show now (October 29, 2026)

• Semaglutide: the only records are three Rybelsus tablet strengths (3, 7 and 14 mg), marked “To Be Discontinued” and first posted June 4, 2026. The record says: “These products will be replaced by Ozempic (semaglutide) tablets.” That is a discontinuation notice, not a shortage of Ozempic or Wegovy injections.[3]
• Tirzepatide and dulaglutide: no records in the same data.[3]
• Liraglutide (Victoza, Saxenda and generics): 9 of 11 records still carry the status “Current,” and 2 are marked “To Be Discontinued.”[4]

These counts come from openFDA, which says its results are unvalidated; FDA’s Drug Shortages Database is the official list and can change any day.[5]

What “shortage over” means for compounded semaglutide

The shortage list matters because of two compounding rules FDA restated on April 1, 2026:[1]

• Outsourcing facilities (503B) may compound from bulk ingredient only if the ingredient is on FDA’s 503B bulks list or the drug is on the shortage list at the time. FDA says semaglutide and tirzepatide are on neither.[1]
• State-licensed pharmacies and physicians (503A) may not compound “essentially a copy” of a commercially available drug “regularly or in inordinate amounts,” unless a prescriber documents a change that makes a significant difference for an identified patient. FDA’s example: semaglutide plus vitamin B12 in an injection can still count as a copy when the strengths are within 10% of the approved products. FDA says it does not intend to take action against a compounder that fills four or fewer prescriptions of such a product in a calendar month.[1]

FDA also states that compounded drugs are not FDA approved and do not go through its premarket review for safety, effectiveness and quality.[1] For FDA’s 2026 actions on how compounded GLP-1s are marketed, see our explainers on FDA’s February and March 2026 statements, the 30 telehealth warning letters and the compounded “Wegovy pill”. For where bulk semaglutide powder comes from, see our check of FDA’s own registration files.

Not the same as the peptide policy: HHS’s draft enforcement-discretion policy filed October 28, 2026 names six peptides (BPC-157, epitalon, KPV, MOTS-c, semax and TB-500). Semaglutide and tirzepatide are not among them.[6] Details: our policy explainer.

Our reading: for most people the court cases change little day to day. The shortage has been over since February 2025 and both courts have now sided with FDA. FDA itself said local pharmacies may still see short gaps, so a shortage listing doesn’t tell you whether your pharmacy has your dose this week. Ask your pharmacist and prescriber about that, and don’t switch products based on a web page.

The practical checklist: what to track when access changes

Think of this like a small “refill incident report.” You’re not trying to build a case or prove anything, you’re trying to reduce confusion and speed up the next step.

1) Your medication timeline (keep it boring and factual)

• Medication name and form: injection, tablets (if applicable), etc.
• Current dose and dosing day: plus the date you last took it (or last had it available).
• Start date / stop date: if anything changed recently, record the exact date.
• Lot/packaging details (optional): photos of label/box if you already have them.

2) Pharmacy attempt log (this is the big one)

• Date/time of each attempt or call
• Pharmacy name + location (or mail order name)
• Outcome: filled, partial fill, backorder, “can order”, “cannot order”, transfer required
• What they said they need: new Rx, diagnosis code, prior auth, insurance info, stock check date
• Next action + who owns it: you, prescriber, pharmacy, insurer

3) Paperwork folder (save once, reuse repeatedly)

• Prescription details: Rx date, prescriber name, pharmacy it was sent to, refills remaining
• Insurance artifacts: prior authorization letters, denial reasons, appeal submissions (if any)
• Receipts and out-of-pocket quotes: screenshots are fine, just include date/time
• Portal messages: screenshots/PDFs of instructions from the care team

4) “What changed” summary (two sentences)

Write a tiny summary you can paste into a portal message:

• Before: “I was filling X at Y pharmacy without issues through DATE.”
• After: “On DATE, they said Z, and I was told I need A/B (or that they can’t fill).”

This page summarizes regulatory documents, court records and FDA data. It is not medical or legal advice and does not recommend starting, stopping, switching or sourcing any medication.