Is compounded semaglutide or tirzepatide still legal?

The short answer

Compounding is still legal, but the rules for semaglutide and tirzepatide tightened once the national shortages ended. Since then, pharmacies generally cannot make routine copies of the FDA-approved drugs just because a lower-priced version is in demand. Narrow exceptions remain, and FDA has stepped up enforcement against mass-marketed compounded GLP-1s through 2025 and 2026.

Keep one fact in mind throughout: compounded drugs are not FDA-approved. FDA does not verify their safety, effectiveness or quality before they are sold, and they are not the same as generic drugs.

Key dates

During a shortage, federal law gives compounders more room to make versions of a drug. When FDA declared each shortage over, it allowed a short grace period before enforcing the normal limits. All dates below come from FDA's compounding policy page.

The court rulings came from lawsuits an outsourcing-facility trade group filed against both decisions. A federal district court denied the group's requests for preliminary injunctions, and FDA then confirmed the 503A grace periods had ended.

503A pharmacies vs 503B outsourcing facilities

Federal law has two compounding pathways, and different rules apply to each, as FDA explains.

What "essentially a copy" and a documented difference mean

For 503A pharmacies, the drug must be compounded for an individual patient based on a prescription, and the law bars compounding "essentially copies" of a commercially available drug regularly or in inordinate amounts. In an April 1, 2026 reminder, FDA said it generally treats a compounded drug as a copy when it has the same active ingredient in the same, similar or easily substitutable strength, and can be used by the same route, such as injection.

The exception is when a prescriber determines and documents that the compounded drug has a change that makes a significant difference for an identified individual patient. Calling a product "personalized" in marketing is not the same thing as that documented, patient-specific determination.

FDA gave an example: semaglutide mixed with vitamin B12 can still count as a copy if both amounts are within 10% of the strengths of the commercially available products. FDA also said it does not currently intend to act against a compounder that fills four or fewer prescriptions of such a copy in a calendar month.

For 503B outsourcing facilities, compounding from bulk ingredients is generally allowed only if the ingredient is on FDA's "503B bulks list" or the drug is on FDA's shortage list. As of FDA's April 2026 update, tirzepatide and semaglutide were on neither.

On April 30, 2026, FDA proposed formally excluding semaglutide, tirzepatide and liraglutide from that list, finding no clinical need. FDA extended the comment period to July 30, 2026 and said the comments will inform its final decision.

FDA enforcement in 2025 and 2026

• September 5, 2025: FDA created a "green list" import alert (66-80) for GLP-1 active ingredients. Ingredients from facilities that are not on the list are subject to detention at the border.
• September 2025: FDA began a crackdown on misleading direct-to-consumer drug advertising, including warning letters to telehealth firms that fall.
• February 6, 2026: FDA announced its intent to restrict GLP-1 ingredients meant for non-approved compounded drugs that are being mass-marketed, naming Hims & Hers and other compounding pharmacies. It said marketing cannot claim compounded products are generics, are the same as FDA-approved drugs, use the same active ingredient, or are clinically proven. It warned that violations could lead to seizure and injunction.
• March 3, 2026: FDA issued 30 warning letters to telehealth companies. The main problems were claims implying sameness with approved drugs, and branding that hid who actually compounded the product.
• April 30, 2026: FDA proposed the 503B bulks list exclusion described above.

FDA also says retatrutide and cagrilintide cannot be used in compounding under federal law. It knows of no lawful basis for compounding with semaglutide salt forms, such as semaglutide sodium or semaglutide acetate.

As of May 31, 2026, FDA had received 990 adverse event reports for compounded semaglutide and more than 730 for compounded tirzepatide. It notes that these are likely underreported.

What to watch for if you use a compounded GLP-1

The status described here is as of September 2026. FDA's consumer guidance lists warning signs, including a seller that:

• claims its compounded product is the same as an FDA-approved drug
• offers prices that seem too good to be true
• does not require a screening and a prescription from a licensed doctor
• has no licensed doctor available to answer questions after you receive the medicine
• ships medicine that looks different from before, or arrives in damaged packaging or without instructions
• has spelling errors on the label, or names a pharmacy you suspect is fraudulent

FDA also warns against:

• products labeled "for research purposes" or "not for human consumption"
• any injectable GLP-1 that arrives warm or without enough refrigeration

FDA's view is that compounded drugs should be used only when a patient's needs cannot be met by an FDA-approved drug. If you have questions about a compounded product you already have, ask your prescriber or the pharmacy that made it. You can check a pharmacy's license with the steps in how to check a compounding pharmacy's license.