Compounded semaglutide & tirzepatide in 2026: what clinics can order

Updated September 2026. Dates and statuses checked against FDA and court records as of September 23, 2026.

Short answer: Compounded semaglutide in 2026 is a much narrower option than it was during the shortages. FDA declared the tirzepatide and semaglutide injection shortages resolved (tirzepatide in October and December 2024, semaglutide in February 2025), its compounding wind-downs ended in 2025, and on August 27, 2026 the Fifth Circuit upheld FDA. What clinics can still order: FDA-approved products, and 503A compounded drugs for individual patients when the prescriber documents a significant clinical difference from the approved drug. Outsourcing facilities can't compound these molecules from bulk, and FDA has proposed making that exclusion formal.

Compounded semaglutide in 2026: what clinics can still order

GLP-1 compounding after the shortage: the timeline

While a drug is on FDA's shortage list, compounders may make copies of it. When FDA marks the shortage resolved, that permission ends. FDA's GLP-1 compounding page (content current as of April 1, 2026) sets out the dates:

Is compounded tirzepatide legal? The Fifth Circuit's August 27, 2026 ruling

The Outsourcing Facilities Association and a compounding pharmacy challenged FDA's tirzepatide decision under the Administrative Procedure Act. They argued FDA should have used notice-and-comment rulemaking and that its shortage finding was arbitrary. The district court in Texas ruled for FDA, and in No. 25-10600 a Fifth Circuit panel affirmed:

• Procedure. The court assumed, without deciding, that FDA erred by skipping notice and comment, and held that the compounders showed no prejudice. It noted that FDA posted public updates and took submissions for almost 60 days before its December 19, 2024 decision.
• Substance. The court held that FDA's conclusion that Eli Lilly's supply would meet or exceed demand was not arbitrary or capricious.
• Exclusivity. The opinion notes that Mounjaro and Zepbound are the only FDA-approved tirzepatide products and that Lilly's exclusive right to make tirzepatide products extends to 2027.

The same panel affirmed in the companion semaglutide case, No. 25-10758 (opinion revised September 1, 2026). Both opinions are unpublished. The practical effect is that the shortage-era permission is gone. The ordinary rules for patient-specific compounding, below, are unchanged.

503B semaglutide: FDA's 2026 proposal on the bulks list

A 503B outsourcing facility is the federal route for non-patient-specific office stock, but it may compound from a bulk ingredient only if the substance is on the 503B bulks list or the drug is in shortage. FDA says tirzepatide and semaglutide are on neither list.

On April 30, 2026, FDA proposed not to include semaglutide, tirzepatide or liraglutide on the 503B bulks list, finding no clinical need for outsourcing facilities to compound them from bulk. The proposal was published in the Federal Register on May 1, 2026 (91 FR 23431). FDA Commissioner Marty Makary said that when approved drugs are available, outsourcing facilities "cannot lawfully compound using bulk drug substances unless there is a clear clinical need." The comment period has closed. As of September 23, 2026, FDA had not published a final decision.

If a supplier offers 503B semaglutide or tirzepatide as office stock, it is reasonable to ask what legal basis it relies on and to keep the answer on file.

"Essentially a copy" and the clinical-difference documentation

Outside a shortage, both compounding lanes restrict copies of approved drugs, and both put a documentation step on the prescriber.

503A: patient-specific prescriptions

• What counts as a copy. Under FDA's 503A copies guidance, a compounded drug is generally a copy if it has the same active ingredient, in the same, similar or an easily substitutable strength, by a route the approved product can be used by.
• The documentation. The prescription must name the change and the significant difference it makes for that patient. A patient name plus a formulation is not enough, and a lower price is not a clinical difference.
• Additives. FDA has said it may treat a semaglutide and vitamin B12 product as a copy when the amounts are within 10% of the strengths of the commercially available products.
• Volume. FDA doesn't intend to act against a 503A compounder that fills four or fewer copy prescriptions in a calendar month.

503B: outsourcing facilities

FDA's 503B copies guidance says outsourcing facilities may not compound drugs that are identical or nearly identical to an approved drug unless it is in shortage. Otherwise, the prescriber's clinical-difference determination must be noted on the prescription or order.

Where the API comes from: Import Alert 66-80

FDA's Import Alert 66-80 lets it detain GLP-1 bulk drug substances, including semaglutide, tirzepatide and liraglutide, unless the manufacturer is on FDA's "Green List." FDA says 21% of the 48 GLP-1 API sites it evaluated were noncompliant, and describes sites that register, refuse records requests and then deregister. A 503A pharmacy can tell you whether its API maker is on the Green List.

FDA-approved GLP-1 options clinics can order

Sources: Drugs@FDA records for semaglutide and orforglipron, and the Fifth Circuit tirzepatide opinion. Indications differ by product, so check each label.

State rules still apply

Federal status is only half the check. MedGrid's state research found that all 50 states and DC require an out-of-state pharmacy to hold a license or registration before shipping prescriptions in (see the nonresident pharmacy map), and most states also license out-of-state 503B facilities (see the outsourcing facility map). The GLP-1 regulations page combines the federal rules with your state's. On MedGrid, the pharmacy directory shows where each compounding pharmacy and outsourcing facility is licensed, and 503A prescriptions route to a pharmacy licensed for the patient's state.

What to watch next

• FDA's final action on excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list.
• Final approval and launch timing for generic semaglutide.
• Changes to the Import Alert 66-80 Green List.

Sources

• FDA, FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize (2026-04-01)
• U.S. Court of Appeals for the Fifth Circuit, Outsourcing Facilities Ass'n v. FDA, No. 25-10600 (5th Cir. Aug. 27, 2026) (tirzepatide) (2026-08-27)
• U.S. Court of Appeals for the Fifth Circuit, Outsourcing Facilities Ass'n v. FDA, No. 25-10758 (5th Cir. Aug. 27, 2026, revised Sept. 1, 2026) (semaglutide) (2026-09-01)
• FDA, FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List (2026-04-30)
• FDA, Federal Register, List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B (proposal not to include semaglutide, tirzepatide, liraglutide), 91 FR 23431 (2026-05-01)
• FDA/CDER, Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A, Guidance for Industry (2018-01-01)
• FDA/CDER, Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B, Guidance for Industry (2018-01-01)
• FDA, Import Alert 66-80: Detention Without Physical Examination of GLP-1 Receptor Agonist Bulk Drug Substances (Green List) (2026-09-21)
• FDA (openFDA), Drugs@FDA records for semaglutide (Wegovy tablets NDA 218316; semaglutide ANDA 220314) (2026-09-22)
• FDA (openFDA), Drugs@FDA record for orforglipron (Foundayo, NDA 220934) (2026-09-22)

Frequently asked questions

Is compounded semaglutide still legal in 2026?

Only in a narrow form. The semaglutide shortage ended February 21, 2025 and FDA's wind-down periods ended in April and May 2025. A 503A pharmacy may still compound for an individual patient if the drug isn't essentially a copy of an approved product, which in practice means the prescriber documents a significant, patient-specific clinical difference.

Is compounded tirzepatide legal after the Fifth Circuit ruling?

The Fifth Circuit's August 27, 2026 decision upheld FDA's finding that the tirzepatide shortage is over, so shortage-based compounding is not coming back through that case. The ordinary 503A rules still apply: patient-specific prescriptions, and no essential copies of Mounjaro or Zepbound.

Can a 503B outsourcing facility supply compounded semaglutide for office use?

Not from bulk ingredient under current FDA policy. FDA says semaglutide and tirzepatide are on neither the 503B bulks list nor the drug shortage list, and in April 2026 it proposed to formally exclude them, along with liraglutide, from the 503B bulks list. As of September 23, 2026, the final decision had not been published.

What does 'essentially a copy' mean for GLP-1 prescriptions?

Under FDA's 503A guidance, a compounded drug is generally a copy if it has the same active ingredient, a similar or easily substitutable strength, and a route the approved product can be used by. FDA has said a semaglutide and vitamin B12 product within 10% of the approved strengths may be considered a copy. A lower price is not a clinical difference.

Is there a generic semaglutide?

Not on the market as of September 2026. Drugs@FDA shows a semaglutide injection application from Apotex (ANDA 220314) with tentative approval dated April 7, 2026. Tentative approval does not allow the product to be sold yet.

This article is general information, not legal advice. GLP-1 compounding rules are still moving; confirm current FDA status and your state's rules with your counsel and boards before ordering or prescribing.

Check the rules, then see what verified vendors list. Review GLP-1 rules for your state in the MedGrid regulations tool, and verify your NPI to see approved products and compounding options from diligence-cleared vendors. Sign-up is free.