Why did compounded copies of Ozempic appear, and what did the FDA do?

Compounded copies appeared because of a shortage and a legal rule. In the United States, compounding pharmacies may prepare versions of a drug on the FDA's drug shortages list if conditions in federal law are met. The FDA declared a shortage for Ozempic and Wegovy starting in August 2022, and for tirzepatide in December 2022. Demand was high enough that semaglutide shortages were worldwide in 2023, and new UK prescriptions were not issued during the shortage. With the branded drugs scarce and expensive, compounded versions spread: as of January 2026, Novo's CEO said there were up to 1.5 million US users of compounded GLP-1 drugs.

Compounding itself is old and ordinary: it means preparing custom medications to fit unique prescriptions that mass-produced formulations cannot meet. Neither of the two main legal types is permitted for a drug deemed essentially a copy of a mass-produced drug, which is where the arguments about these products begin. Drugs from compounding pharmacies can be cheaper or alleviate shortages, but can pose a greater risk of contamination, partly because of lack of oversight.

What has the FDA said? It says compounded drugs are not FDA approved, so it does not review them for safety, effectiveness or quality before they are marketed. It declared the tirzepatide shortage over in October 2024, though enforcement was first delayed to the end of 2024 after compounding pharmacies sued, and on 21 February 2025 it declared the semaglutide shortage resolved. The grace periods then ran out in steps: for semaglutide, 22 April 2025 for state-licensed pharmacies and 22 May 2025 for larger outsourcing facilities. On a page last updated in April 2026, the FDA said neither drug was on its shortage list. As of May 31, 2026, it had received 990 adverse-event reports about compounded semaglutide and more than 730 about compounded tirzepatide, while noting that causation is not always clear.

Novo's CEO called some of these products unsafe knock-offs, while conceding that compounders capture price-sensitive consumers that his company's more expensive branded drugs do not. Positions in this dispute are the companies', the compounders' and the regulator's, and each is described here as theirs.