Compounded GLP-1s After the Shortage: What the FDA Says

TL;DR: Compounded drugs are not FDA approved. The FDA declared the shortages of the two approved GLP-1 injections that compounders had been copying resolved, on December 19, 2024 and February 21, 2025, and the grace periods it gave compounders after those dates have ended. A state-licensed pharmacy can still compound a GLP-1 for an individual patient on a prescription, but it may not regularly make what the FDA calls “essentially a copy” of an approved product, unless the prescriber determines and documents a change that makes a significant difference for that patient. Separately, in April 2026 the FDA proposed keeping these GLP-1s off the list that would let large outsourcing facilities compound them from bulk ingredients. As of November 11, 2026, no final decision had been published.

Why compounding grew, and what changed

When a drug is on the FDA's drug shortage list, compounders have more room to make versions of it. The FDA says the approved tirzepatide and semaglutide injection products were both in shortage from 2022 because of demand. It then determined that the first shortage was resolved on December 19, 2024, and the second on February 21, 2025.

To avoid disrupting patients' treatment, the FDA gave compounders time to wind down work that depended on the shortage. Those periods have ended. For state-licensed pharmacies (503A), the FDA said these periods ended after court decisions on March 5, 2025 (the December 2024 shortage) and April 24, 2025 (the February 2025 shortage). For outsourcing facilities (503B), the periods ran until March 19, 2025 and May 22, 2025.

Two kinds of compounder

• 503A: state-licensed pharmacies. They compound a drug for an individual patient based on a prescription.
• 503B: outsourcing facilities. They can make larger batches, but in most cases they cannot compound from bulk drug substances unless the substance is on the FDA's 503B bulks list or the drug is on the drug shortage list. The FDA says neither of these GLP-1s is currently on either list.

The “essentially a copy” rule for pharmacies

A 503A pharmacy may not compound, regularly or in inordinate amounts, drugs that are essentially copies of a commercially available drug product. In its April 1, 2026 update, the FDA said it intends to treat a compounded drug as essentially a copy when it has the same active ingredient as the commercially available product in the same, similar or easily substitutable strength, and the commercially available product can be used by the same route, such as an injection.

The exception matters: a compounded drug is not treated as essentially a copy if a prescriber determines and documents that it contains a change that produces a significant difference from the commercially available product for an identified individual patient. The FDA also said it may treat a compounded GLP-1 that adds another ingredient, such as vitamin B12, as essentially a copy when it is given the same way as the approved products and each strength is within 10% of theirs.

The 2026 proposal on outsourcing facilities

On April 30, 2026, the FDA proposed to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list, saying it found no clinical need for outsourcing facilities to compound them from bulk drug substances. It said it would consider public comments before making a final determination. The comment period was later extended to July 30, 2026. As of November 11, 2026, no final notice had been published in the Federal Register.

The proposal concerns the 503B bulks list for outsourcing facilities. It is not a change to the 503A rules above.

What the FDA warns patients about

The FDA's page on unapproved GLP-1 drugs reports dosing errors with compounded products, some leading to hospitalization. It also warns that salt forms, such as semaglutide sodium and semaglutide acetate, have no lawful basis for compounding, and it has received adverse event reports for compounded semaglutide and compounded tirzepatide. Our guide to vetting a compounded GLP-1 provider turns these warnings into questions you can ask.

What this means for you

• Ask which pharmacy makes your medication, and whether it is a state-licensed pharmacy.
• Ask whether the product is made for you on a prescription.
• Ask why a compounded product is being prescribed for you rather than an FDA-approved one.
• Ask which form of the drug it is. The FDA says salt forms have no lawful basis for compounding.

At Innovare Tx

The compounded tirzepatide and compounded semaglutide we use are prepared by a state-licensed 503A compounding pharmacy and are NOT FDA approved. Compounded medications are prescribed when a patient has a clinical need that a commercially available product does not meet, a determination Charles Ortega, PA-C makes based on your individual health profile. You can ask him about it at your consultation. See weight management for how the program works.

Is compounded semaglutide still legal?

A state-licensed pharmacy may still compound for an individual patient on a prescription, within the limits of section 503A. It may not regularly make essentially copies of an approved product, unless the prescriber determines and documents a significant difference for that patient. Compounded drugs are not FDA approved.

Is compounded tirzepatide FDA approved?

No. Compounded drugs, including compounded tirzepatide, are not approved by the FDA.

Did the FDA ban compounded GLP-1s?

No final ban has been published. The FDA's April 2026 proposal concerns outsourcing facilities compounding from bulk ingredients, and as of November 11, 2026 no final decision had been published.

Sources

• FDA: FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize (content current as of April 1, 2026)
• FDA news release, April 30, 2026: FDA proposes to exclude semaglutide, tirzepatide and liraglutide on 503B bulks list
• Federal Register, June 26, 2026 (91 FR 38719): extension of comment period to July 30, 2026
• FDA: FDA's concerns with unapproved GLP-1 drugs used for weight loss