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Retrospective · 2022-2026

The GLP-1 shortage, resolved — a retrospective of the 2022-2026 cycle

For roughly two years the FDA drug-shortage listing did more to shape the US GLP-1 market than any manufacturer or regulator decision. It legalized 503A compounded semaglutide at $99-249/mo, seeded a multi-billion-dollar cash-pay telehealth segment, and triggered multi-district litigation. Here is what happened, in order, with primary sources.

Timeline of every material event

  1. 2022-08FDA action

    FDA adds semaglutide to drug shortage database

    Semaglutide (Ozempic, Wegovy) shortage first listed on the FDA drug-shortage database. Novo Nordisk cites unprecedented demand tied to the obesity-treatment indication.

    FDA Drug Shortage database
  2. 2022-12FDA action

    FDA adds tirzepatide to drug shortage database

    Tirzepatide (Mounjaro) shortage listed. Zepbound (obesity indication) approval follows in November 2023 while tirzepatide is still on shortage.

    FDA Drug Shortage database
  3. 2023-05Compounding

    503A compounding of semaglutide expands rapidly

    The FDA drug-shortage listing legally allowed 503A pharmacies to compound semaglutide as long as the shortage persisted. Telehealth cash-pay providers (Hims, Ro, Henry, Mochi) launch or expand GLP-1 offerings at $99-$249/mo — an order of magnitude cheaper than brand cash prices.

    FDA compounding-in-shortage guidance
  4. 2023-11FDA action

    FDA warns about compounded GLP-1 impurities and dosing errors

    FDA issues an alert flagging cases of dosing errors and unapproved salt-form semaglutide (semaglutide sodium) at some compounding facilities. Enforcement action follows against several 503B outsourcing facilities.

    FDA compounded semaglutide alert
  5. 2024-10FDA action

    FDA declares tirzepatide shortage resolved

    FDA moves tirzepatide from "currently in shortage" to "resolved" — starting the 60-day 503B outsourcing-facility wind-down clock and prompting immediate legal action from compounding pharmacies challenging the decision.

    FDA tirzepatide status
  6. 2024-10Litigation

    OFA sues FDA over tirzepatide de-listing

    Outsourcing Facilities Association files suit in the Northern District of Texas challenging the FDA determination that tirzepatide is no longer in shortage. Federal court declines to grant an injunction; enforcement discretion for 503B facilities expires December 2024.

    OFA v. FDA complaint (N.D. Tex.)
  7. 2025-02FDA action

    FDA declares semaglutide shortage resolved

    FDA removes semaglutide from the drug-shortage database, triggering a similar 60-day 503B wind-down. 503A patient-specific compounding under state pharmacy-board authority continues but requires individualized medical necessity per patient.

    FDA semaglutide status
  8. 2025-04Compounding

    503B outsourcing enforcement transition ends

    FDA-designated enforcement-discretion window for 503B facilities compounding semaglutide expires. Some outsourcing facilities exit the GLP-1 market; others pivot to 503A-only patient-specific compounding.

    FDA 503B enforcement guidance
  9. 2025-06Litigation

    MDL-3094 consolidated in Eastern District of Pennsylvania

    JPML consolidates weight-loss injectable products-liability cases (semaglutide + tirzepatide) into MDL-3094 in the Eastern District of Pennsylvania, Judge Marston presiding. Focus is on gastroparesis, NAION, and suicidal-ideation allegations.

    JPML MDL-3094 order
  10. 2025-08Compounding

    Compounded semaglutide reader access remains, price stabilizes at $99-249/mo

    Legitimate 503A telehealth providers continue prescribing patient-specific compounded semaglutide + tirzepatide under state pharmacy board authority. Cash-pay pricing stabilizes at $99-249/mo range — well below brand-name cash prices but higher than the $69/mo lows of the peak shortage window.

    US Pharmacist (503A compounding coverage)
  11. 2026-03FDA action

    FDA re-confirms tirzepatide off shortage list — 6th consecutive month

    FDA confirms tirzepatide has been off the drug-shortage database for 6 consecutive months, closing the door on further 503B enforcement-discretion appeals.

    FDA Drug Shortages page

Three lessons from the cycle

  1. FDA shortage-list arbitrage is real. The gap between the FDA declaring a shortage and manufacturer capacity catching up created a two-year window where compounded semaglutide was legal, cheap, and accessible via cash-pay telehealth. That window is closed for tirzepatide (Oct 2024) and semaglutide (Feb 2025). Any future GLP-1 shortage (retatrutide, orforglipron) will reopen a similar window, but each is a discrete event, not a permanent state.
  2. Post-shortage 503A compounding continues — but individualized. A 503A pharmacy can still fill a patient-specific compounded semaglutide script if the prescriber documents medical necessity for a non-commercial formulation. This is the legal spine of the current cash-pay compounded telehealth market. It is narrower than the shortage-era mass compounding, but not gone.
  3. MDL-3094 is the case to watch. The consolidated products-liability litigation in E.D. Pa. is where gastroparesis, NAION, and suicidal-ideation allegations will be adjudicated. No trial verdict as of mid-2026, but discovery outputs (particularly manufacturer safety-signal internal documents) may shape 2027-2028 label changes and prescribing patterns.

Frequently asked

What did the GLP-1 shortage actually mean for patients?

At peak (2023-2024), patients trying to fill Wegovy or Zepbound at a retail pharmacy often waited 4-12 weeks, and pharmacies rationed dose strengths — the 0.5 mg and 1.0 mg Wegovy pens were the most available; 2.4 mg was scarce. The shortage is also what legalized cash-pay compounded semaglutide at $99-249/mo, which grew into a multi-billion-dollar market segment.

Is compounded semaglutide still legal after the shortage ended?

503A patient-specific compounding remains legal under state pharmacy board authority when a licensed prescriber determines the patient needs a formulation not commercially available (e.g., different concentration, sublingual, absence of an excipient). 503B bulk outsourcing-facility compounding of semaglutide is generally prohibited now that the FDA shortage listing has ended. In practice: reader access to compounded semaglutide from a legitimate 503A pharmacy continues, but the compound must be individualized per patient — not a generic mass-manufactured product.

What is MDL-3094?

MDL-3094 is a multi-district products-liability litigation consolidated in the Eastern District of Pennsylvania (Judge Marston presiding) covering weight-loss injectable products — primarily semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound). The consolidated allegations focus on gastroparesis, NAION (non-arteritic anterior ischemic optic neuropathy), and suicidal-ideation risks. No trial verdict has issued as of mid-2026; discovery is ongoing.

Are shortages likely to return?

Manufacturer capacity has grown substantially — Eli Lilly and Novo Nordisk both invested $5B+ in US injectable capacity across 2023-2025. Repeat shortages of Ozempic/Wegovy or Mounjaro/Zepbound at the peak-2024 scale are unlikely absent an unexpected demand shock. New molecules (Foundayo / orforglipron oral once-daily, retatrutide triple-agonist) could see initial-launch supply constraints but are separate SKUs.

How can I check current shortage status?

FDA maintains the authoritative drug-shortage database at accessdata.fda.gov/scripts/drugshortages. For our live tracker of semaglutide + tirzepatide status by dose, see /shortage-tracker — refreshed weekly against the FDA source.

Sources

Editorial notes

  • Freshness: reviewed July 17, 2026. Refresh triggered by any new FDA shortage listing/de-listing, MDL-3094 milestone, or material 503A/503B enforcement action.
  • Legal disclaimer: nothing here is legal advice. If you are contemplating joining MDL-3094 as a plaintiff, consult a plaintiffs'-side products-liability attorney; this page is a factual retrospective, not litigation counsel.
  • Citation: journalists and researchers are welcome to cite this retrospective — attribution to Glpverdict is the only requirement.
GLP-1 shortage retrospective 2024-2026 — timeline, compounding wind-down, MDL