The Compounding Wind-Down: Every Deadline, in Order

From shortage declaration to the proposed bulks-list removal. A dated reference for how the legal basis for mass GLP-1 compounding was assembled and then dismantled.

The compounded GLP-1 market did not appear because of a loophole. It appeared because federal law contains a deliberate provision allowing compounders to fill supply gaps during shortages, and a genuine shortage occurred. Understanding the wind-down requires holding that in view: the legal basis was real, and it expired.

1. 2022Semaglutide and tirzepatide enter shortage. Shortage-list status makes compounding of these drugs lawful under the Federal Food, Drug, and Cosmetic Act.
2. 2022–2024Compounded GLP-1s scale rapidly, generally priced in the range of roughly $150 to $300 per month against branded pricing above $1,000.
3. Late 2024FDA declares the tirzepatide shortage resolved, removing the shortage basis for compounding it.
4. February 18, 2025Deadline for 503A pharmacies to wind down mass tirzepatide compounding.
5. March 19, 2025Deadline for 503B outsourcing facilities to wind down mass tirzepatide compounding.
6. April 2025Eli Lilly sues compounders Strive Pharmacy and Empower; four telehealth companies are sued weeks later.
7. September 16, 2025FDA issues more than 55 warning letters to online sellers of compounded GLP-1s, citing misleading direct-to-consumer advertising.
8. Fall 2025IQVIA reports more than 80% of compounded semaglutide and tirzepatide prescriptions contain supplemental ingredients such as B vitamins or levocarnitine.
9. December 2025FDA approves oral semaglutide — the Wegovy pill.
10. January 2026Novo Nordisk launches the oral semaglutide tablet.
11. January 14, 2026Strive Compounding Pharmacy files an antitrust suit against Eli Lilly and Novo Nordisk in the Western District of Texas.
12. January 16, 2026FDA issues a warning letter to 503A pharmacy Boothwyn Pharmacy citing insanitary conditions and strength, quality, or purity noncompliance. Published February 10, 2026.
13. February 2026FDA issues roughly 30 warning letters to telehealth companies over claims implying FDA approval or evaluation. Novo Nordisk sues Hims & Hers for patent infringement.
14. March 2026Hims & Hers announces it will offer Novo Nordisk semaglutide injections and pills. An analysis identifies a tirzepatide-B12 adduct in mass-compounded tirzepatide formulated with B12.
15. April 1, 2026FDA approves Foundayo (orforglipron), the first GLP-1 pill without food or water timing restrictions.
16. April 2026Ro strikes a deal with Eli Lilly to prescribe Foundayo. A federal judge dismisses part of Lilly's suit against Empower; other claims proceed.
17. April 30, 2026FDA proposes removing semaglutide, tirzepatide, and liraglutide from the 503B Bulks List, finding no remaining clinical need.
18. May 31, 2026FDA adverse event totals stand at 990 reports for compounded semaglutide and more than 730 for compounded tirzepatide.
19. July 1, 2026Medicare Part D access to Foundayo opens at $50 per month for eligible patients.
20. August 6, 2026Judge Micaela Alvarez dismisses the Strive antitrust suit against Lilly and Novo Nordisk.

What survives

Not everything is being closed. Patient-specific compounding under section 503A, where a prescriber documents that an individual patient cannot use the approved product for a specific clinical reason, rests on separate statutory footing and is not eliminated by the proposed rule. Legitimate examples include a documented allergy to an inactive ingredient in the approved product, or a documented need for a dosage form that is not commercially available.

What has ended is the mass-market form: large-volume production of copies or near-copies for a general population on cost and convenience grounds.

Using this timeline

The dates matter because arguments in this space are routinely made with stale premises. A provider still citing shortage status is working from a 2024 fact pattern. An advocate arguing that no approved oral option exists is working from a 2025 one. The record above is the current state, and it will need updating again — this file is maintained.