Are Compounded Semaglutide and Tirzepatide Still Legal in 2026

Compounded semaglutide and tirzepatide are not banned in 2026. The shortage exception that allowed mass-market compounding ended, tirzepatide in December 2024 and semaglutide in February 2025. What bars routine copies today is the separate essentially-a-copy prohibition. A narrow patient-specific pathway survives at 503A pharmacies, and a pending FDA proposal would close the 503B bulk route while supply stays normal.

This explainer tracks the dated federal record behind that shift. Every date below is traceable to an FDA page, a declaratory order, or a Federal Register notice. Warning letters record FDA allegations and not court findings.

What is compounded semaglutide?

A compounded drug is mixed or altered by a pharmacy to make something an approved product does not provide. Two different regimes govern who may do that. Under 503A, a pharmacy compounds for an identified patient on a valid prescription. A 503B outsourcing facility may compound bulk stock without individual prescriptions, provided the bulks-list or shortage-list conditions are met.

Neither route produces an FDA-approved drug. The agency does not review compounded preparations for safety, effectiveness, or quality before they reach the market.

Semaglutide is the active ingredient in Ozempic, Wegovy, and Rybelsus, which are Novo Nordisk trademarks. Tirzepatide is the active ingredient in Mounjaro and Zepbound, both Eli Lilly trademarks. Liraglutide appears in Victoza and Saxenda, also Novo Nordisk. Those brands went through the full approval process, and a compounded version carrying the same active ingredient did not.

Why was compounding allowed during the shortage?

Federal law keeps a safety valve open for shortages. The FDA maintains a public list of drugs whose demand exceeds supply. While a drug sits on that list, the agency does not treat it as commercially available, and the usual restriction on copying it falls away.

Demand for GLP-1 drugs outran supply quickly. Semaglutide injection products joined the shortage list in 2022, and tirzepatide injection products were added on December 15, 2022. For roughly two years, compounders could lawfully produce copies of both.

The regulatory timeline

Which rule made compounded copies unlawful?

One phrase carries most of the legal weight here. The Federal Food, Drug, and Cosmetic Act sets the limit. A compounding pharmacy may not compound drug products that are essentially copies of a commercially available drug, regularly or in inordinate amounts. That restriction sits in section 503A, and section 503B carries a parallel one for outsourcing facilities.

Here is the mechanism in plain terms. A drug on the shortage list is not treated as commercially available, so the copy restriction does not bite. Remove the drug from that list and it becomes commercially available again, which switches the restriction back on.

Two conditions generally make a compounded product essentially a copy. It carries the same active ingredient at the same, similar, or easily substitutable strength. The approved product can also be given by the same route. One documented exception survives, and a later section covers it.

How do 503A and 503B pharmacies differ?

What would the FDA proposal change for 503B?

On April 30, 2026, the FDA announced a proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulks List. The Federal Register notice published on May 1, 2026 under docket FDA-2018-N-3240.

Clinical need is the governing test. To earn a place on the list, a substance must show the FDA that outsourcing facilities have a clinical reason to compound it from bulk. The agency reviewed the nominations for all three GLP-1 substances and found no such reason. Convenience of a ready-to-use form does not count toward clinical need, and neither does cost compared with an approved product.

This is a proposed determination, not a final rule. The comment period opened on May 1, 2026 and ran 60 days. A 30-day extension published June 26 pushed the close to July 30, 2026. No final determination has been announced.

What the proposal would and would not do

Two qualifications keep this in proportion. A bulks-list exclusion is not a ban on compounding, and it closes only one route. The prohibition that actually ended routine copying in 2025 is the separate essentially-a-copy restriction, and this proposal does not touch it.

Section 503B also keeps a second door open. A facility may compound from a bulk substance while the finished drug appears on the FDA shortage list. That must hold at the time of compounding, distribution, and dispensing, and the condition is independent of the bulks list. So a future shortage listing could reopen the 503B route even if the exclusion is finalized.

Liraglutide shows how that works in practice. The injection remained on the shortage list in the weeks after the proposal. That left it available for 503B bulk compounding, despite being named in the same notice.

What compounding is still legal in 2026?

Under 503A, a pharmacy may still compound semaglutide or tirzepatide for an identified individual patient. The prescriber must determine and document that the compounded product contains a change producing a significant difference for that specific patient. Without that documented determination, the product falls back inside the copy restriction.

Cost alone does not qualify, and neither does convenience or a preference for a particular vial format. The difference has to be clinical and it has to belong to one identified person.

Volume tells its own story here. The FDA does not intend to act on essentially-copy compounding when a compounder fills four or fewer prescriptions of that product in a calendar month. Read that figure against a subscription business and the gap becomes obvious.

Do B12 blends and salt forms change the legal status?

Vitamin B12 combinations. The FDA addressed this directly on April 1, 2026. Semaglutide combined with another active ingredient such as cyanocobalamin may still count as essentially a copy. Two conditions trigger that reading, and both must hold. The route of administration matches, and both amounts fall within 10 percent of the respective commercially available strengths.

The September 2026 warning letter to Empower Pharmacy, a licensed 503A pharmacy, tested that position. The FDA named semaglutide with cyanocobalamin and tirzepatide with niacinamide, and said the production volumes suggested the differences were pretextual. The agency also questioned prescriber determinations that were missing from some orders and repeated word for word across others.

Salt forms. Some products sold as semaglutide are salt forms, including semaglutide sodium and semaglutide acetate. The FDA states these are different active ingredients from the one used in the approved drugs. The agency says it lacks information on whether they share the same chemical and pharmacologic properties. It adds that it is not aware of any lawful basis for using them in compounding.

Post-deadline rebranding. Language like personalized dosing or custom titration describes a marketing posture, not a legal category. The test remains exactly the same one.

What has the FDA reported about safety?

As of May 31, 2026, the FDA reported 990 adverse event reports associated with compounded semaglutide and more than 730 associated with compounded tirzepatide. State-licensed pharmacies that are not outsourcing facilities need not submit adverse event reports. The agency says the real figures are likely higher, and it notes that many reported events resemble those seen with the approved versions.

An adverse event report records a suspected association, and it does not establish that the drug caused the event.

What the evidence does not show

Several things remain open, and saying so is part of reporting this accurately. The 503B proposal has no final determination, so it changes nothing on its own yet. Clinical significance has no bright-line test in the agency's published guidance.

Warning letters remain allegations from start to finish. No company named through 2026 has been found liable by a court on the basis of those letters. Salt-form behavior is unstudied and not disproven, because the FDA says it lacks information. Adverse event totals are floors and not measurements, since reporting is voluntary for most 503A pharmacies.

Are research-grade GLP-1 peptides legal?

A separate market runs alongside the compounding one. Vendors sell GLP-1 active ingredients and peptides described as research grade. The FDA has warned companies that illegally sold unapproved drugs under research-purposes labeling. Those drugs contained semaglutide, tirzepatide, retatrutide, survodutide, or mazdutide, and the agency found they reached consumers for human use with dosing instructions.

That last detail is the hinge. The agency judges a product by its intended use, and it reads intended use from everything a seller says and does. A disclaimer is one input among many, and the rest of a website can outweigh it. Our September 2026 enforcement explainer covers how that standard reached five named vendors.

Upstream action has followed the letters. In September 2025 the FDA established a green list import alert, numbered 66-80, to stop GLP-1 active ingredients with potential quality concerns at the border.

What does a certificate of analysis actually prove?

A certificate of analysis is a lab report for one batch. Several specific things appear on a genuine third-party certificate. The document identifies the batch or lot, so it can be matched against the vial in hand. Identity comes next, usually by mass spectrometry. Purity follows, usually by high-performance liquid chromatography, expressed as a percentage of the chromatogram area.

The limits matter just as much. A certificate cannot confirm sterility unless sterility testing was performed and reported. It cannot confirm the contents of a different lot, since each batch needs its own report. Salt form and mass basis are absent unless the certificate states them. Counterion mass changes how much active material a stated milligram figure represents.

Read the lot number before anything else. If it does not match the vial, the rest of the document is describing something else.

Where does that leave compounded GLP-1s?

Compounded semaglutide and tirzepatide remain legal in one narrow form, which is 503A compounding for an identified patient with a documented clinical reason. Wider routine copying closed in spring 2025 under the essentially-a-copy prohibition. A pending proposal would shut the 503B bulks-list route while supply stays normal.

For the compounding-access side, see the July 2026 PCAC peptide vote. State-level action is tracked in our peptide laws by state tracker.