Is compounded semaglutide still legal in 2026? Semaglutide and tirzepatide after the shortage

Quick answer

Is compounded semaglutide still legal? Only in narrow cases. Mass-market compounding of semaglutide and tirzepatide for US patients effectively ended in 2025 after FDA declared the shortages of both glucagon-like peptide-1 (GLP-1) medications resolved. Tirzepatide came off shortage in December 2024 and semaglutide on February 21 2025. 503A pharmacies hit hard cut-offs in March 2025 (tirzepatide) and April 2025 (semaglutide: FDA set April 22 2025 or the court ruling, whichever came later, and the court ruled on April 24 2025). 503B outsourcing facilities followed in March (tirzepatide) and May 2025 (semaglutide).

A narrow 503A route remains. A state-licensed pharmacy may compound for an individual patient based on receipt of a prescription. FDA does not intend to act when it fills four or fewer prescriptions of an essential copy in a calendar month, and a prescriber-documented significant difference for an identified patient takes a product outside the essential-copy test.

No final rule bans either drug. On April 30 2026 the FDA proposed to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list. FDA later extended the public comment window to July 30 2026, and it has since closed. As of October 22 2026 no final notice had been published (Federal Register docket FDA-2018-N-3240). 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 says these products had been in shortage since 2022 due to increased demand. FDA’s shortage listing gave compounding pharmacies a legal window. Under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), state-licensed pharmacies could compound copies of a drug on the shortage list for a patient with a prescription. Under section 503B, outsourcing facilities could compound in bulk. Telehealth platforms wired this window into a mass-market business — subscription GLP-1 access for weight loss at prices well below the branded list.

FDA’s drug shortage list: how the shortage ended (Oct 2024 / Dec 2024 / Feb 2025)

FDA first determined that the tirzepatide shortage was resolved on October 2 2024. During litigation that decision went back to the agency for re-evaluation, and FDA confirmed it on December 19 2024. The semaglutide shortage was declared resolved on February 21 2025. Once a drug is off FDA’s drug shortage list, the section 503A justification for compounding a copy collapses. Only the narrow limits described in the next section remain.

To avoid disrupting patient treatment, FDA gave compounders wind-down periods of enforcement discretion. For semaglutide, FDA’s March 10 2025 update said the period for a state-licensed pharmacy or physician compounding under section 503A would run until April 22 2025 or until the date of the district court’s decision on the preliminary injunction motion in OFA v. FDA (4:25-cv-00174), whichever was later. The court denied that motion on April 24 2025, and on April 28 2025 FDA confirmed that the 503A period had ended. Throughout the wind-down the agency said it could still act on other violations, such as findings that a product may be of substandard quality or otherwise unsafe. FDA published explicit wind-down deadlines.

Is compounded semaglutide still legal? What the 503A route still allows

A compounded drug must meet the conditions of section 503A or section 503B of the FD&C Act to qualify for the exemptions those sections provide. Compounded drugs do not have FDA approval, and they do not undergo FDA premarket review for safety, effectiveness or quality. FDA’s position is that compounded medications should be used only when a patient’s medical needs cannot be met by FDA-approved medications.

FDA’s April 1 2026 update (“FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize”) restates the 503A conditions. The drug product must be compounded for an individual patient based on receipt of a prescription. The compounder may not compound, regularly or in inordinate amounts, drug products that are essentially copies of a commercially available drug product. The agency treats a compounded drug product as essentially a copy when it has the same active pharmaceutical ingredient as the commercially available drug product in the same, similar or an easily substitutable strength, and the commercial product can be used by the same route.

Two limits keep a narrow route open. FDA has said it does not intend to take action against a 503A compounder that fills four or fewer prescriptions of an essentially-copied product in a calendar month. Separately, a compounded product is not an essential copy if the prescriber determines and documents a change that produces a significant difference for an identified patient (FDA, April 1 2026). A documented allergy to an inactive ingredient is one example. The enforcement discretion for state-licensed pharmacy or physician compounding of semaglutide has ended, so these two limits are what remain for 503A pharmacy compounding.

Adding vitamin B12 does not by itself change the answer. FDA’s example in the same update is a compounded drug product that combines semaglutide with vitamin B12 (cyanocobalamin). The agency may consider it essentially a copy of commercially available drug products when it is given by the same route and the amounts of semaglutide and vitamin B12 are within 10% of the strengths of the respective commercial products. In its alert on compounded semaglutide, FDA noted that some compounders add vitamin B12, vitamin B6, L-carnitine or NAD to their semaglutide products. It said the safety and effectiveness of combining semaglutide with other ingredients has not been established.

Is compounded tirzepatide still legal?

Compounded tirzepatide follows the same rules on an earlier timeline. FDA confirmed the tirzepatide shortage resolved on December 19 2024. For a state-licensed pharmacy or physician compounding under section 503A, the wind-down ended when the district court denied the preliminary injunction in OFA v. FDA (4:24-cv-00953) on March 5 2025. For 503B outsourcing facilities it ended on March 19 2025. FDA’s April 1 2026 update says tirzepatide and semaglutide do not currently appear on the 503B bulks list or on FDA’s drug shortage list. Outsourcing facilities therefore cannot compound tirzepatide from bulk drug substances (API), which leaves the narrow 503A route described above as the main remaining path. If FDA publishes a final notice on its April 2026 proposal, tirzepatide will also stay off the 503B bulks list.

503A vs 503B compounding pharmacies: patient-specific vs bulk compounding

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. It may use bulk drug substances (API) only when the substance appears on the 503B bulks list or the compounded drug is on FDA’s drug shortage list at the time of compounding, distribution and dispensing. The bulks-list distinction is why the April 2026 FDA proposal matters: if semaglutide, tirzepatide and liraglutide are excluded from the bulks list, 503B facilities could compound them only while they are on the FDA shortage list, and semaglutide and tirzepatide are no longer on it.

FDA proposes to drop semaglutide, tirzepatide and liraglutide from the 503B bulks list

In a Federal Register notice published May 1 2026 (2026-08552), announced on April 30, FDA proposed not to include semaglutide, tirzepatide and liraglutide on the 503B bulks list. After evaluating the nominations, the agency did not identify a clinical need for outsourcing facilities to compound the three GLP-1s from bulk drug substances. The proposal cites a lack of clinical need justifying bulk compounding of these substances when the FDA-approved products are available. “When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need,” said then-FDA Commissioner Marty Makary (FDA, April 30 2026). He said the action reflects FDA’s responsibility “to protect patients and preserve the integrity of the drug approval process.” The agency says a determination of clinical need is based on patient safety and medical necessity under the law.

The May 1 notice first asked for comments by June 30 2026. A Federal Register notice published June 26 2026 (2026-12937) extended the period to July 30 2026, and it has closed. The agency will consider submitted comments before making a final determination. As of October 22 2026 no final notice had been published (Federal Register docket FDA-2018-N-3240), so the exclusion remains a proposal. A final notice would mean 503B outsourcing facilities could compound any of the three from bulk drug substances only while the drug is on FDA’s drug shortage list. 503A patient-specific compounding stays possible within the narrow limits described above.

How FDA is enforcing the end of mass compounding

FDA scaled enforcement in parallel with the shortage wind-down. In September 2025 the agency 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. FDA says the alert does not stop legal imports of GLP-1 APIs from compliant manufacturers and does not create new limits on lawful compounding.

On February 6 2026 FDA said it intends to restrict GLP-1 active pharmaceutical ingredients meant for non-FDA-approved compounded drugs that are mass-marketed as similar alternatives to FDA-approved drugs. The same statement set limits on marketing. Companies may not claim that compounded products are generic versions of FDA-approved drugs or the same as them. They also may not say that compounded drugs use the same active ingredient as the approved drugs or that they are clinically proven to produce results.

Pricing moved too. 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. Major telehealth platforms broadly shifted toward supply of the branded weight loss drugs Wegovy (Novo Nordisk) and Zepbound (Eli Lilly) through 2025, though individual platform SKU mixes continue to change. FDA’s consumer page on unapproved GLP-1 drugs lists telehealth red flags. They include a claim that a compounded drug is the same as an FDA-approved drug, prices that seem too good to be true, and medicine supplied without a screening and prescription by a licensed doctor.

Documented adverse events and quality problems with compounded GLP-1s

FDA’s page on unapproved GLP-1 drugs used for weight loss (content current as of October 1 2026) reports 990 adverse-event reports for compounded semaglutide and more than 730 for compounded tirzepatide as of May 31 2026, and notes that adverse events from compounded products are likely underreported. Federal law does not require state-licensed pharmacies that are not outsourcing facilities to report adverse events to FDA. The agency says many of the events reported for compounded versions of these drugs appear consistent with those seen with the FDA-approved versions. 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.

FDA has also listed quality and safety concerns. Product concentrations may vary between compounders, and a single compounder may offer several concentrations of compounded semaglutide. The agency is aware of fraudulent compounded semaglutide and tirzepatide with false information on the label, including labels that name pharmacies that did not make the product. FDA has also received complaints that some compounded GLP-1 medications arrived warm or with inadequate ice packs. FDA says inadequate refrigeration can affect the drug’s quality.

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 states that retatrutide and cagrilintide cannot be used in compounding under federal law and are not components of FDA-approved drugs; retatrutide is an investigational drug and is not on the shortage list or the 503B bulks list. Retatrutide remains in Phase 3 development (see the retatrutide Phase 3 evidence tracker for current clinical trial readouts).

For the adjacent evidence boundaries, see the Remy Research guides to grey-market peptide supply, the 2026 obesity-drug approval tracker, and the FDA peptide reclassification outlook.

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)
• Federal Register — 503B Bulks List Notice, Extension of Comment Period (2026-12937, Jun 26 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
• FDA — Alert on Compounded Semaglutide Products (Jul 26 2024)
• FDA — 503B Bulk Drug Substances List
• Reuters — Lilly and Novo sued by compounding pharmacy (Jan 15 2026)
• CNBC — Eli Lilly cuts Zepbound vials to $299–$449 (Dec 1 2025)