Compounded GLP-1s after the shortage: where things stand in 2026

The FDA declared the semaglutide and tirzepatide shortages over in 2025. Here is what that changed for compounded versions, what the FDA is policing now, and why 'research' vials are another matter.

For about two years, many Americans got semaglutide or tirzepatide from compounding pharmacies instead of buying Ozempic, Wegovy, Mounjaro or Zepbound. That was legal mainly because the branded drugs were officially in shortage. The shortages are now over, and the rules have changed. Here is where things stand in the autumn of 2026.

Why compounding was allowed in the first place

US law lets pharmacies compound a drug that is "essentially a copy" of an approved product only in limited cases. One of those cases is when the approved drug is on the FDA's shortage list. During the 2022–2024 shortages, compounders and telehealth companies used that exception to sell large volumes of cheaper semaglutide and tirzepatide.

When the shortages ended

Tirzepatide: the FDA first took it off the shortage list in October 2024, then confirmed that decision in an order on December 19, 2024. It gave state-licensed pharmacies (503A) until February 18, 2025 to stop, and larger outsourcing facilities (503B) until March 19, 2025.
Semaglutide: the FDA declared the shortage resolved on February 21, 2025. It gave 503A pharmacies until April 22, 2025 and 503B facilities until May 22, 2025.

Once those grace periods ended, pharmacies could no longer make routine copies of these drugs. A pharmacy can still compound a version for a single patient if a prescriber decides that a real clinical difference is needed, such as a dose that isn't sold or an allergy to an ingredient. It cannot be a copy made just because it's cheaper.

What the FDA is policing in 2026

Compounded GLP-1s did not disappear. Many telehealth companies kept selling them, often with an extra ingredient added or a custom dose offered. In 2026, the FDA has targeted the gaps in that approach.

Marketing claims. In March 2026, the FDA announced about 30 warning letters to telehealth companies over their claims about compounded GLP-1s. Its main concerns were ads suggesting the products were the same as the approved brands, and branding that hid who actually made the drug. Another wave of letters followed in June.

"Add-an-ingredient" products. In a warning letter dated September 18, 2026, the FDA told Empower Pharmacy, a large Texas compounder, that tirzepatide mixed with niacinamide and semaglutide mixed with vitamin B12 were still "essentially copies" of the approved drugs. The letter said the volume of products being made "suggests that differences between products you are compounding and the FDA-approved products are pretextual." The same letter also cited sterile-manufacturing problems.

Ingredient forms. The FDA has warned against semaglutide sodium and semaglutide acetate. These are salt forms that differ from the approved drug, and the agency says it knows of no lawful basis for compounding with them.

Safety reports. As of May 31, 2026, the FDA had received 990 reports of adverse events linked to compounded semaglutide and more than 730 linked to compounded tirzepatide. Reports like these don't prove the drug caused the problem. Even so, the FDA has highlighted dosing errors in particular. Some patients drew up the wrong amount from multi-dose vials and ended up in hospital, and some prescribers worked out doses wrongly.

What changed for patients

Routine compounded copies are no longer a legal option, which leaves patients with fewer low-cost choices from pharmacies. At the same time, the drugmakers now sell lower-priced cash options directly. Lilly sells Zepbound in vials, and Novo Nordisk launched a Wegovy pill after FDA approval in December 2025. Prices and programs change often, so check current terms with the maker or your pharmacy.

If you are on a compounded product, ask who actually compounds it, whether it is a 503A pharmacy or a 503B facility, and what its label says. The FDA has stressed that compounded drugs are not FDA-approved and do not go through FDA review for safety, effectiveness or quality before they are sold.

Why "research" GLP-1s are a different thing

Compounded semaglutide comes from a licensed pharmacy, on a prescription, under state and federal pharmacy rules. A vial labeled "research use only" or "not for human consumption" has none of that. No one checks its identity, strength or sterility, and no pharmacist reviews the prescription.

This matters most for retatrutide, which isn't approved anywhere. It can't legally be compounded, so any retatrutide sold to the public is a gray-market product. The consumer group Public Citizen reported in June 2026 that the FDA had sent 14 warning letters to retatrutide sellers since late 2024. It found that most of those sellers continued to market unapproved peptides afterwards. The FDA's own guidance says it has acted against products "falsely labeled 'for research purposes'" that were really being sold to consumers with dosing instructions.

A "research" label doesn't make a product safer or legal for personal use. It mainly means nobody is responsible for what is in the vial.

To see how the approved drugs compare, read our semaglutide and tirzepatide pages.

This is educational information, not medical advice.