Compounded GLP-1s in 2026: what's left after the shortage ended

Quick answer

Mass-market compounding of semaglutide and tirzepatide for US patients effectively ended in 2025. Tirzepatide came off shortage in December 2024; semaglutide on February 21 2025. 503A pharmacies hit hard cut-offs in March and April 2025. 503B outsourcing facilities followed in March (tirzepatide) and May 2025 (semaglutide). On April 30 2026 the FDA proposed to permanently exclude semaglutide, tirzepatide and liraglutide from the 503B Bulks List, with a comment window that closes June 29 2026. Retatrutide is a separate case — FDA has explicitly stated it cannot be compounded at all.

The drug shortage that started the compounding boom

Between 2022 and 2024, demand for branded semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound) outran manufacturing. FDA's shortage listing gave compounding pharmacies a legal window: under section 503A, state-licensed pharmacies could compound copies of a drug on the shortage list for a patient with a prescription, and under section 503B, outsourcing facilities could compound in bulk. Telehealth platforms wired this window into a mass-market business — subscription GLP-1 access at prices well below the branded list.

How the shortage ended (Oct 2024 / Dec 2024 / Feb 2025)

FDA removed tirzepatide from its shortage list in December 2024 and declared the semaglutide injection shortage resolved on February 21 2025. Once a drug is off the shortage list, the section 503A justification for compounding a copy collapses unless the pharmacy can document a clinical need difference from the approved product (for example, a documented allergy to an inactive ingredient). FDA published explicit wind-down deadlines.

503A vs 503B compounding pharmacies, in plain language

A 503A pharmacy is a state-licensed retail pharmacy that compounds one prescription at a time for an individual named patient. It is not FDA-pre-approved, does not run to cGMP standards, and is inspected under FDA's insanitary-conditions guidance. A 503B facility is registered with FDA as an outsourcing facility, runs to current Good Manufacturing Practice, and can compound in bulk without patient-specific prescriptions — but only when the substance is either on the FDA shortage list or on the 503B Bulks List. The bulks-list distinction is why the April 2026 FDA proposal matters: if semaglutide, tirzepatide and liraglutide are excluded from the bulks list, the only remaining route for 503B is the shortage list, and they are no longer on it.

The April 2026 FDA proposal that closes the door

On April 30 2026 FDA published a proposed rule to exclude semaglutide, tirzepatide and liraglutide from the 503B Bulks List. The proposal cites a lack of clinical need justifying bulk compounding of these substances when the FDA-approved products are available. The public comment period closes June 29 2026. A final rule would permanently bar 503B outsourcing facilities from compounding any of the three from bulk API, even if a future shortage briefly recurred. 503A patient-specific prescription compounding remains possible in narrow circumstances under existing FDA guidance on "essentially a copy" (no more than four prescriptions per month per pharmacy from a single prescriber, with a documented clinical difference).

FDA enforcement actions, 2025–2026

FDA scaled enforcement in parallel with the shortage wind-down. In September 2025 the agency issued more than 50 Warning Letters to compounders and online marketers selling semaglutide, tirzepatide, retatrutide, BPC-157 and SARMs. In the same month FDA established Import Alert 66-80 (the "Green List") to block suspect foreign GLP-1 active pharmaceutical ingredients at the border and increased foreign API inspections. On February 6 2026 FDA announced it intended to take action against non-FDA-approved GLP-1 drugs, naming Hims & Hers; HHS subsequently referred Hims to the Department of Justice.

Documented adverse events from compounded GLP-1s

FDA's postmarket safety page on unapproved GLP-1 drugs reports 605 adverse-event reports for compounded semaglutide and 545 for compounded tirzepatide as of July 31 2025. The agency has separately warned about non-pharmaceutical-grade semaglutide salt forms (semaglutide sodium, semaglutide acetate) being marketed as if they were equivalent to the FDA-approved API, and has documented dosing-error hospitalizations where patients drew 5× to 20× the intended dose because compounded vial concentrations and patient syringes did not match. A 2025 pharmacovigilance paper in Expert Opinion on Drug Safety reported higher rates of certain adverse-event clusters with compounded versus branded supply.

Why telehealth platforms pivoted to branded supply

Once the wind-down deadlines hit and Eli Lilly cut Zepbound vial cash pricing to $299–$449 per month in December 2025 (down from $349–$499 earlier, against a roughly $1,086 list), the unit economics that supported compounded subscriptions collapsed. The starkest single illustration came on February 5 2026 when Hims & Hers launched a $49-per-month compounded oral semaglutide pill and withdrew it on February 7 2026 after FDA action and the DOJ referral — two days from launch to retreat. Major telehealth platforms broadly shifted toward branded Wegovy and Zepbound supply through 2025, though individual platform SKU mixes continue to change.

Active litigation: Strive v. Lilly+Novo, Lilly v. Strive

The compounding wind-down is being contested in court. In January 2026, Strive Specialties filed an antitrust suit in the Western District of Texas (Strive Specialties v. Eli Lilly and Novo Nordisk, 5:26-cv-00155) alleging that exclusive supply arrangements between the manufacturers and telehealth platforms blocked compounded GLP-1 access. Separately, Eli Lilly had previously sued Strive in the District of Arizona (October 2025) over "personalized" and "clinically proven" marketing claims attached to mass-compounded copies. The Outsourcing Facilities Association lost preliminary injunctions in OFA v. FDA in March and April 2025 (cases 4:24-cv-00953 and 4:25-cv-00174, Northern District of Texas).

Where retatrutide sits in this landscape

Retatrutide is a separate question from semaglutide and tirzepatide. FDA has explicitly stated that retatrutide cannot legally be compounded: it is an investigational drug, has not been approved by FDA, and is not on the shortage list or the 503B Bulks List. The Warning Letters in late 2025 specifically targeted online sellers of compounded retatrutide, and the agency made clear that "research use only" labeling on a product accompanied by human-dosing instructions is treated as an unlawful workaround rather than a safe harbor. Retatrutide remains in Phase 3 development (see the retatrutide approval status page for current trial readouts).

Research-use boundaries

This page documents the regulatory and enforcement landscape for compounded GLP-1 drugs in the United States. Remy Research does not frame this article as medical advice, as a recommendation to source compounded drugs from any pharmacy, or as a comparison of compounded products against research peptides. Research peptides and compounded pharmaceutical-grade drugs occupy distinct regulatory categories and are not interchangeable.

Sources

• FDA — Policies for Compounders as National GLP-1 Supply Stabilizes
• FDA — Proposes to Exclude Semaglutide, Tirzepatide and Liraglutide from 503B Bulks List (Apr 30 2026)
• FDA — Intends to Take Action Against Non-FDA-Approved GLP-1 Drugs (Feb 6 2026)
• FDA — Concerns with Unapproved GLP-1 Drugs Used for Weight Loss
• Reuters — Hims & Hers stops offering compounded semaglutide pill (Feb 7 2026)
• Reuters — Lilly and Novo sued by compounding pharmacy (Jan 15 2026)
• CNBC — Eli Lilly cuts Zepbound vials to $299–$449 (Dec 1 2025)
• Health Law Alliance — FDA targets GLP-1 and peptide compounding (Sept 2025)